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Neurology International
Volume 17
Issue 1
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Neurol. Int., Volume 17, Issue 1 (January 2025) – 14 articles

Cover Story (view full-size image): Neuroinflammation has been implicated in nearly every major central nervous system disease, ranging from Alzheimer’s disease to brain cancer.  Understanding and modeling neuroinflammation is critical for the identification of novel therapeutic targets in the treatment of these diseases. Unfortunately, the translation of findings from non-human models has left many questions unanswered. This review systematically discusses the role of human pluripotent stem cell (hPSC)-derived glia and the supporting cells within the CNS, including astrocytes, microglia, oligodendrocyte precursor cells (OPCs), pericytes, and endothelial cells, to describe the present state of the field and foster hope for future discoveries. There is much left to explore in the application of these hPSC-derived models of neuroinflammation as they become further integrated into bench-to-bedside practice.  View this paper
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8 pages, 1907 KiB  
Case Report
Electroencephalographic and Epilepsy Findings in ZNF711 Variants: A Case Series of Two Siblings
by Michele Minerva, Lorenzo Perilli, Samanta Carbone, Margherita Maria Rossi, Federica Lotti, Luisa Lonoce, Maria Rosaria Curcio and Salvatore Grosso
Neurol. Int. 2025, 17(1), 14; https://doi.org/10.3390/neurolint17010014 - 20 Jan 2025
Viewed by 392
Abstract
Background/Objectives: ZNF711(Zinc finger protein 711) encodes a zinc finger protein of currently undefined function, located on the X chromosome. Current knowledge includes a limited number of case reports where this gene has been exclusively associated with X-linked intellectual disability (XLID). As far as [...] Read more.
Background/Objectives: ZNF711(Zinc finger protein 711) encodes a zinc finger protein of currently undefined function, located on the X chromosome. Current knowledge includes a limited number of case reports where this gene has been exclusively associated with X-linked intellectual disability (XLID). As far as we are aware, we report the first cases of epilepsy associated with this particular variant. Our aim is to further delineate the phenotypic spectrum of ZNF711 gene pathogenic variants, adding clinical features to this rare condition, following a genotype-first approach. Case presentation: We describe the familiar case of two male siblings presenting with moderate intellectual disability (ID), language delay, and motor stereotypies. Additionally, they experienced generalized tonic–clonic seizures (GTCSs) and myoclonic seizures with interictal electroencephalographic abnormalities. Both children underwent various genetic testing and counselling, including an extended next-generation sequencing (NGS) panel, revealing a hemizygous c.657C > G pathogenic variant in the ZNF711 gene from maternal inheritance. Conclusions: This case expands the clinical range of ZNF711 variants by highlighting epilepsy as a potential comorbidity and suggesting other possible causal candidates for generalized epilepsy. Moreover, it emphasizes the need for further research into the phenotypic spectrum associated with this variant. Full article
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13 pages, 674 KiB  
Review
Optical Coherence Tomography in Huntington's Disease—A Potential Future Biomarker for Neurodegeneration?
by Clancy Cerejo, Nicolas De Cleene, Elias Mandler, Katarina Schwarzová, Samuel Labrecque, Philipp Mahlknecht, Florian Krismer, Atbin Djamshidian, Klaus Seppi and Beatrice Heim
Neurol. Int. 2025, 17(1), 13; https://doi.org/10.3390/neurolint17010013 - 20 Jan 2025
Viewed by 455
Abstract
Huntington's disease (HD) is a progressive neurodegenerative disorder for which, until now, only symptomatic treatment has been available. Lately, there have been multiple ongoing clinical trials targeting therapeutic agents for preventing disease onset or slowing disease progression in HD. These studies are in [...] Read more.
Huntington's disease (HD) is a progressive neurodegenerative disorder for which, until now, only symptomatic treatment has been available. Lately, there have been multiple ongoing clinical trials targeting therapeutic agents for preventing disease onset or slowing disease progression in HD. These studies are in constant need of reliable biomarkers for neurodegeneration in HD. In recent years, retinal biomarkers have attracted significant attention in neurodegenerative disorders. Likewise, optical coherence tomography (OCT) is being evaluated as a potential biomarker in HD. In this article, we review the existing literature on OCT as a biomarker for neurodegeneration in HD. Full article
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14 pages, 2570 KiB  
Article
Analysis of Upper Facial Weakness in Central Facial Palsy Following Acute Ischemic Stroke
by Monton Wongwandee and Kantham Hongdusit
Neurol. Int. 2025, 17(1), 12; https://doi.org/10.3390/neurolint17010012 - 19 Jan 2025
Viewed by 451
Abstract
Background: Central facial palsy (CFP), resulting from upper motor neuron lesions in the corticofacial pathway, is traditionally characterized by the sparing of the upper facial muscles. However, reports of upper facial weakness in CFP due to acute ischemic stroke have challenged this long-held [...] Read more.
Background: Central facial palsy (CFP), resulting from upper motor neuron lesions in the corticofacial pathway, is traditionally characterized by the sparing of the upper facial muscles. However, reports of upper facial weakness in CFP due to acute ischemic stroke have challenged this long-held assumption. This study aimed to determine the prevalence of upper facial weakness in CFP and identify its associated clinical factors. Methods: In this cross-sectional study, we evaluated consecutive patients with acute ischemic stroke admitted to a university hospital in Thailand from January 2022 to June 2023. Full-face video recordings were analyzed using the Sunnybrook Facial Grading System. Upper facial weakness was defined as asymmetry in at least one upper facial expression. Multivariable logistic regression was performed to identify factors associated with upper facial weakness. Results: Of 108 patients with acute ischemic stroke, 92 had CFP, and among these, 70 (76%) demonstrated upper facial weakness. Tight eye closure (force and wrinkle formation, both 42%) was the most sensitive indicator for detecting upper facial weakness. Greater stroke severity, as reflected by higher NIHSS scores (adjusted odds ratio [aOR], 1.42; 95% CI 1.07–1.88) and the presence of lower facial weakness (aOR, 6.56; 95% CI 1.85–23.29) were significantly associated with upper facial involvement. Although upper facial weakness was generally milder than lower facial weakness, its severity correlated with increasing lower facial asymmetry during movement. Conclusions: Contrary to traditional teaching, upper facial weakness is common in CFP due to acute ischemic stroke. The severity of stroke and the presence of lower facial weakness are key predictors of upper facial involvement. These findings underscore the need for clinicians to reconsider the diagnostic paradigm, recognizing that upper facial weakness can occur in CFP. Enhanced awareness may improve diagnostic accuracy, inform treatment decisions, and ultimately lead to better patient outcomes. Full article
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11 pages, 670 KiB  
Review
Early Polytherapy for Probably Benzodiazepine Refractory Naïve Status Epilepticus (Stage 1 Plus)
by Giuseppe Magro
Neurol. Int. 2025, 17(1), 11; https://doi.org/10.3390/neurolint17010011 - 19 Jan 2025
Viewed by 541
Abstract
Stage 1 Plus is defined here as a naïve, previously untreated, status epilepticus (SE) that is probably refractory to Benzodiazepines (BDZ). These cases include not only prolonged SE as previously proposed by the author (SE lasting > 10 min) but also other cases [...] Read more.
Stage 1 Plus is defined here as a naïve, previously untreated, status epilepticus (SE) that is probably refractory to Benzodiazepines (BDZ). These cases include not only prolonged SE as previously proposed by the author (SE lasting > 10 min) but also other cases notoriously associated with BDZ refractoriness such as the absence of prominent motor phenomena and acute etiology (especially primary central nervous system etiology). Interestingly, the absence of prominent motor phenomena as is the case of non convulsive SE might implicitly fall in the category of prolonged SE due to the delay in recognition and treatment. Future studies should help identify other factors associated with BDZ refractoriness, therefore widening the definition of Stage 1 Plus. The appropriate timing for defining prolonged SE may also differ depending on different etiology. Consequently, in future tailored models of SE, the definition of prolonged SE could be enhanced by defining it for a longer duration than Tx, a time point that changes based on different etiologies (x), Tx being much shorter than 10 min in acute etiologies. These cases of naïve probably BDZ refractory SE (Stage 1 Plus) might require a different approach: combined polytherapy from the start. The objective of this review is to provide pathophysiological and pre-clinical evidence, mostly from animal studies, for the different approach of combined polytherapy from the start for those cases of SE falling in the definition of Stage 1 Plus. Full article
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10 pages, 272 KiB  
Article
Initial Contact with Forefoot or Rearfoot in Spastic Patients After Stroke—Three-Dimensional Gait Analysis
by Inês Mendes-Andrade, Miguel Reis e Silva and Jorge Jacinto
Neurol. Int. 2025, 17(1), 10; https://doi.org/10.3390/neurolint17010010 - 18 Jan 2025
Viewed by 356
Abstract
Background/Objectives: Post-stroke hemiparetic gait often presents with asymmetric patterns to compensate for stability deficits. This study examines gait differences in chronic stroke patients with spastic hemiparesis based on initial foot contact type—forefoot versus rearfoot. Methods: Thirty-four independently walking spastic hemiparetic patients were retrospectively [...] Read more.
Background/Objectives: Post-stroke hemiparetic gait often presents with asymmetric patterns to compensate for stability deficits. This study examines gait differences in chronic stroke patients with spastic hemiparesis based on initial foot contact type—forefoot versus rearfoot. Methods: Thirty-four independently walking spastic hemiparetic patients were retrospectively analyzed. Using 3D gait analysis, patients were categorized by initial contact type. Spatiotemporal descriptors, joint kinematics, kinetics, and EMG patterns were compared across groups. Results: Patients with rearfoot initial contact (G1) showed higher cadence, longer single-limb support time and shorter stride times than those with forefoot contact (G0). G1 patients also demonstrated greater knee flexion during stance, enhancing stability. Additionally, G1 patients with abnormal lateral gastrocnemius activation in the swing phase showed increased ankle power at the end of the stance phase. Conclusions: In post-stroke spastic hemiparetic patients, the type of initial foot contact—forefoot or rearfoot—appears to influence gait characteristics, with rearfoot contact associated with a trend toward improved gait parameters, such as increased cadence and longer single-limb support. Full article
30 pages, 6503 KiB  
Review
Non-Thrombotic Filling Defects in Cerebral Veins and Sinuses: When Normal Structures Mimic a Disease
by Marialuisa Zedde and Rosario Pascarella
Neurol. Int. 2025, 17(1), 9; https://doi.org/10.3390/neurolint17010009 - 17 Jan 2025
Viewed by 327
Abstract
Cerebral venous thrombosis (CVT) is a rare and potentially critical cerebrovascular disease involving intracranial dural sinuses and veins. The diagnosis is a stepwise pathway starting from clinical suspicion and employing several neuroradiological techniques, mainly Computed Tomography (CT)-based and Magnetic Resonance Imaging (MRI)-based modalities. [...] Read more.
Cerebral venous thrombosis (CVT) is a rare and potentially critical cerebrovascular disease involving intracranial dural sinuses and veins. The diagnosis is a stepwise pathway starting from clinical suspicion and employing several neuroradiological techniques, mainly Computed Tomography (CT)-based and Magnetic Resonance Imaging (MRI)-based modalities. The neuroradiological findings, both in the diagnostic phase and in the follow-up phase, may provide some results at risk for misdiagnosis. Non-thrombotic filling defects of intracranial dural sinuses are among them, and the potential sources are artefactual and or anatomical (venous septa and arachnoid granulations). The misdiagnosis of these findings as CVT is potentially linked to dangerous consequences. A potential strategy to avoid this is to increase the knowledge about technical and anatomical reasons for non-thrombotic filling defects of intracranial dural sinuses and their imaging features. The main aim of this review is to address these issues, including the variability of the intracranial venous pathways, providing the solutions for overcoming the above-cited potential misdiagnosis of non-thrombotic filling defects as CVT. Full article
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10 pages, 426 KiB  
Perspective
An “Engram-Centric” Approach to Transient Global Amnesia (TGA) and Other Acute-Onset Amnesias
by Andrew J. Larner
Neurol. Int. 2025, 17(1), 8; https://doi.org/10.3390/neurolint17010008 - 15 Jan 2025
Viewed by 404
Abstract
The differential diagnosis of acute-onset amnesia includes transient global amnesia (TGA), transient epileptic amnesia (TEA), and functional (or psychogenic) amnesia. The most common of these, TGA, is a rare but well-described condition characterised by a self-limited episode of dense anterograde amnesia with variable [...] Read more.
The differential diagnosis of acute-onset amnesia includes transient global amnesia (TGA), transient epileptic amnesia (TEA), and functional (or psychogenic) amnesia. The most common of these, TGA, is a rare but well-described condition characterised by a self-limited episode of dense anterograde amnesia with variable retrograde amnesia. Although the clinical phenomenology of TGA is well described, its pathogenesis is not currently understood, thus preventing the development of evidence-based therapeutic recommendations. Here, TGA, TEA, and functional amnesia are considered in light of the historical engram conception of memory, now informed by recent experimental research, as disturbances in distributed ensembles of engram neurones active during memory formation and recall. This analysis affords therapeutic implications for these conditions, should interventions to reactivate latent or silent engrams become available. Full article
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8 pages, 441 KiB  
Article
Clinical Outcome After Surgical Treatment of Traumatic Peroneal Nerve Injury: An Analysis of Risk Factors After Different Surgical Approaches
by Daniel N. Werkmann, Ute M. Bäzner, Martin Petkov, Lena Minzenmay, Gregor Durner, Gregor Antoniadis, Christian R. Wirtz, Maria T. Pedro, Andreas Knoll and Andrej Pala
Neurol. Int. 2025, 17(1), 7; https://doi.org/10.3390/neurolint17010007 - 13 Jan 2025
Viewed by 584
Abstract
Background: This study aims to analyze potential risk factors that may influence the clinical outcomes following surgical treatment of traumatic peroneal nerve lesions. Methods: We conducted a retrospective analysis of patients with traumatic peroneal nerve injuries treated with decompression, split repair, or nerve [...] Read more.
Background: This study aims to analyze potential risk factors that may influence the clinical outcomes following surgical treatment of traumatic peroneal nerve lesions. Methods: We conducted a retrospective analysis of patients with traumatic peroneal nerve injuries treated with decompression, split repair, or nerve grafting between 2010 and 2020. Motor function and potential risk factors were evaluated. Results: Out of 93 patients, 42 (45%) underwent decompression, 15 (16%) received split repair, and 36 (39%) required autologous nerve grafting. Up to one year after surgery, weakness of the anterior tibial muscle improved from a median of M0 to M3. After one year following nerve decompression, functional recovery was observed in 28 (65%) cases, in 9 (21%) cases after split repair, and in 7 (16%) cases following autologous nerve grafting. A defect greater than 8 cm was associated with significantly poorer improvement of extensor hallucis longus (p = 0.037, HR 0.109). We found no significant associations between age, diabetes mellitus, arterial hypertension, obesity, and postoperative outcomes. Conclusions: According to the present data, a significant number of patients achieved functional improvement following surgical treatment, indicating that this procedure should be considered an important treatment option in selected cases. Full article
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25 pages, 717 KiB  
Review
The Rise of Pluripotent Stem Cell-Derived Glia Models of Neuroinflammation
by Srishti Kala, Andrew G. Strutz and Moriah E. Katt
Neurol. Int. 2025, 17(1), 6; https://doi.org/10.3390/neurolint17010006 - 13 Jan 2025
Viewed by 550
Abstract
Neuroinflammation is a blanket term that describes the body’s complex inflammatory response in the central nervous system (CNS). It encompasses a phenotype shift to a proinflammatory state, the release of cytokines, the recruitment of peripheral immune cells, and a wide variety of other [...] Read more.
Neuroinflammation is a blanket term that describes the body’s complex inflammatory response in the central nervous system (CNS). It encompasses a phenotype shift to a proinflammatory state, the release of cytokines, the recruitment of peripheral immune cells, and a wide variety of other processes. Neuroinflammation has been implicated in nearly every major CNS disease ranging from Alzheimer’s disease to brain cancer. Understanding and modeling neuroinflammation is critical for the identification of novel therapeutic targets in the treatment of CNS diseases. Unfortunately, the translation of findings from non-human models has left much to be desired. This review systematically discusses the role of human pluripotent stem cell (hPSC)-derived glia and supporting cells within the CNS, including astrocytes, microglia, oligodendrocyte precursor cells, pericytes, and endothelial cells, to describe the state of the field and hope for future discoveries. hPSC-derived cells offer an expanded potential to study the pathobiology of neuroinflammation and immunomodulatory cascades that impact disease progression. While much progress has been made in the development of models, there is much left to explore in the application of these models to understand the complex inflammatory response in the CNS. Full article
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12 pages, 1566 KiB  
Article
Endocrine Outcome and Quality of Life After Transsphenoidal Resection of Pituitary Adenoma—A Prospective Randomized Single-Blinded Study Comparing Endoscopic Versus Microscopic Resection
by Andrej Pala, Nadja Grübel, Benjamin Mayer, Ralf Becker, Fabian Sommer, Bernd Schmitz, Gwendolin Etzrodt-Walter, Christian Rainer Wirtz and Michal Hlavac
Neurol. Int. 2025, 17(1), 5; https://doi.org/10.3390/neurolint17010005 - 10 Jan 2025
Viewed by 347
Abstract
Background: Endoscopic pituitary surgery might yield better endocrine outcomes compared to microscopic resection. We conducted a prospective, randomized, single-blinded study to compare the endocrine outcome and quality of life (QoL) of patients with newly diagnosed pituitary adenoma who underwent either endoscopic or microscopic [...] Read more.
Background: Endoscopic pituitary surgery might yield better endocrine outcomes compared to microscopic resection. We conducted a prospective, randomized, single-blinded study to compare the endocrine outcome and quality of life (QoL) of patients with newly diagnosed pituitary adenoma who underwent either endoscopic or microscopic transsphenoidal surgery (NCT03515603). Methods: Due to slow recruitment, this study had to be stopped prematurely. Out of 170 transsphenoidal pituitary surgeries performed during the study period, 36 patients were enrolled in this study. The primary endpoint was based on the development of a new hypopituitarism. Secondary endpoints included the extent of resection, complications, and QoL. Results: Endoscopic surgery was performed in 47.2% (n = 17). A new hypopituitarism was found in 8.3% (n = 3). All these cases underwent microscopic resection. Arginine vasopressin deficiency was found in 2.7% (n = 1) after microscopic resection. Gross total resection was achieved in 94.4% (n = 34). No surgical complications or new neurological deficits were observed. QoL improved significantly after the surgery, as measured by EQ-VAS (p = 0.003). According to EQ-5D3L, QoL improved or remained unchanged in almost all patients. No significant difference was found in QoL between the endoscopic and microscopic groups. Conclusion: The endoscopic technique appears to offer benefits in the treatment of pituitary adenomas, particularly in terms of achieving a favorable endocrine outcome. Full article
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1 pages, 166 KiB  
Correction
Correction: AlTawari et al. Nusinersen Treatment for Spinal Muscular Atrophy: Retrospective Multicenter Study of Pediatric and Adult Patients in Kuwait. Neurol. Int. 2024, 16, 631–642
by Asma AlTawari, Mohammad Zakaria, Walaa A. Kamel, Nayera Shaalan, Gamal Ahmed Ismail Elghazawi, Mohamed Esmat Anwar Ali, Dalia Salota, Amr Attia, Ehab Elsayed Ali Elanany, Osama Shalaby, Fatema Alqallaf, Vesna Mitic and Laila Bastaki
Neurol. Int. 2025, 17(1), 4; https://doi.org/10.3390/neurolint17010004 - 2 Jan 2025
Viewed by 305
Abstract
In the published publication [...] Full article
10 pages, 2672 KiB  
Case Report
Subsequent Acute Ischemic Stroke in a Patient with Monocular Vision Loss Associated with Isolated Internal Carotid Artery Occlusion: A Case Report
by Jessica Seetge, Balázs Cséke, Zsófia Nozomi Karádi, Eszter Szalai, Valéria Gaál and László Szapáry
Neurol. Int. 2025, 17(1), 3; https://doi.org/10.3390/neurolint17010003 - 26 Dec 2024
Viewed by 484
Abstract
Background/Objectives: Acute retinal ischemia, including central retinal artery occlusion (CRAO), is recognized as a stroke equivalent by the American Heart Association/American Stroke Association (AHA/ASA), necessitating immediate multidisciplinary evaluation and management. However, referral patterns among ophthalmologists remain inconsistent, and evidence-based therapeutic interventions to improve [...] Read more.
Background/Objectives: Acute retinal ischemia, including central retinal artery occlusion (CRAO), is recognized as a stroke equivalent by the American Heart Association/American Stroke Association (AHA/ASA), necessitating immediate multidisciplinary evaluation and management. However, referral patterns among ophthalmologists remain inconsistent, and evidence-based therapeutic interventions to improve visual outcomes are currently lacking. CRAO is associated with a significantly elevated risk of subsequent acute ischemic stroke (AIS), particularly within the first week following diagnosis, yet the role of intravenous thrombolysis (IVT) in this setting remains controversial. This case report presents a unique case of CRAO with concurrent internal carotid artery (ICA) occlusion, followed by an AIS affecting the middle cerebral artery (MCA). Case presentation: An 83-year-old woman presented with acute, painless monocular vision loss to the emergency department. IVT was administered within 4.5 h of admission for suspected CRAO associated with ICA occlusion (ICAO) identified on CT-angiography (CTA). One hour post-thrombolysis, CT-perfusion (CTP) confirmed MCA occlusion (MCAO), necessitating mechanical thrombectomy (MT). Successful recanalization was achieved without complications, and the patient demonstrated no functional impairments at discharge. Conclusions: This case underscores the importance of maintaining a vigilant approach to stroke management in CRAO patients. It highlights the diagnostic challenges encountered in clinical practice and advocates for further research into the role of IVT in CRAO cases with ICAO, emphasizing the need for consensus in treatment. Full article
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7 pages, 200 KiB  
Brief Report
Internal Tremor in Long COVID May Be a Symptom of Dysautonomia and Small Fiber Neuropathy
by Svetlana Blitshteyn, Ilene S. Ruhoy, Lauren R. Natbony and David S. Saperstein
Neurol. Int. 2025, 17(1), 2; https://doi.org/10.3390/neurolint17010002 - 25 Dec 2024
Viewed by 7204
Abstract
Background/Objectives: Internal tremor (IT) is often reported by patients with post-acute sequelae of SARS-CoV-2, also known as Long COVID, as a distressing and disabling symptom. Similarly, physicians are typically perplexed by the nature and etiology of IT and find it extremely challenging to [...] Read more.
Background/Objectives: Internal tremor (IT) is often reported by patients with post-acute sequelae of SARS-CoV-2, also known as Long COVID, as a distressing and disabling symptom. Similarly, physicians are typically perplexed by the nature and etiology of IT and find it extremely challenging to manage. Methods: We describe a patient with Long COVID who experienced IT as part of post-COVID postural orthostatic tachycardia syndrome (POTS) and small fiber neuropathy (SFN) and review the limited literature available on this topic. Results: Our patient’s IT improved significantly after intravenous saline infusions, but there was no effect on IT with oral hydration, increased oral sodium chloride intake, neuropathic pain medications, muscle relaxants, or medications used for the treatment of POTS. Conclusions: Based on this case, our clinical experience, and the limited literature available to date, we believe IT is a manifestation of POTS and SFN, which may be driven by hypovolemia, cerebral hypoperfusion, sympathetic overactivity, neuropathic pain, and mast cell hyperactivation. Subjective description, objective findings, and diagnostic and therapeutic considerations in patients with IT and Long COVID are discussed. Full article
(This article belongs to the Special Issue COVID-19, Neuroinflammation and Therapeutics, 2nd Edition)
11 pages, 952 KiB  
Article
Leaflet: Operative Steps for Interventional Studies in Neuroscience
by Maria Meringolo, Sergio Delle Monache, Giuseppina Martella and Antonella Peppe
Neurol. Int. 2025, 17(1), 1; https://doi.org/10.3390/neurolint17010001 - 24 Dec 2024
Viewed by 389
Abstract
Background/Objectives: Drug development involves multiple stages, spanning from initial discovery to clinical trials. This intricate process entails understanding disease mechanisms, identifying potential drug targets, and evaluating the efficacy and safety of candidate drugs. Clinical trials are designed to assess the effects of drugs [...] Read more.
Background/Objectives: Drug development involves multiple stages, spanning from initial discovery to clinical trials. This intricate process entails understanding disease mechanisms, identifying potential drug targets, and evaluating the efficacy and safety of candidate drugs. Clinical trials are designed to assess the effects of drugs on humans, focusing on determining safety profiles, appropriate modes of administration, and comparative efficacy against placebos. Notably, neuroscience drug development encounters distinct challenges, including the complex nature of diseases, limitations imposed by the blood–brain barrier, the absence of reliable predictive preclinical models, and regulatory hurdles. Ethical and safety considerations are pivotal due to the potential cognitive and motor effects of CNS-active drugs. Methods: Our manuscript outlines the procedures for CNS clinical trials and highlights the key elements of study design, methodological considerations, and ethical frameworks. To achieve our objectives, we considered the official websites of regulatory authorities, the EQUATOR network, and recent publications in the field. The paper includes key elements such as criteria for subject selection, methods of evaluation, variable analysis, and statistical methodology approaches. Results: We want to furnish a concise and comprehensive guide tailored to individuals new to CNS clinical trials, providing foundational elements necessary for the design and execution of such trials. The manuscript seeks to outline sources of relevant materials and elucidate adaptability, particularly in instances where sponsors may be absent. Conclusions: By meeting the needs of less-experienced researchers or those with limited resources, the intention is to facilitate an understanding of the intricate nature of the process and offer guidance on appropriately navigating its complexities. It is essential to note that this manuscript does not aim to be exhaustive but endeavors to serve as a structured checklist. Through its approach, the manuscript aspires to offer guidance and support to individuals navigating the challenges inherent in this intricate domain. Full article
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