Effects of Transcranial Electrical Stimulation on Cognitive Impairment in CNS Inflammatory Demyel… (NCT07029386) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Transcranial Electrical Stimulation on Cognitive Impairment in CNS Inflammatory Demyelinating Diseases
China85 participantsStarted 2024-12-15
Plain-language summary
Background: Central nervous system inflammatory demyelinating diseases often lead to significant cognitive impairment, presenting a critical challenge in patient management.
Objective: To evaluate the effectiveness of individualized transcranial electrical stimulation (tES) in improving cognitive function among patients with inflammatory demyelinating disorders.
Methods: This study will assess cognitive performance through standardized neuropsychological assessments before and after individualized tES intervention, measuring changes in cognitive domains including memory, attention, executive function, and processing speed.
Anticipated Results: the investigators hypothesize that personalized transcranial electrical stimulation will demonstrate significant improvements in cognitive performance, potentially offering a non-invasive therapeutic approach for managing cognitive decline in central nervous system inflammatory demyelinating diseases.
Significance: This research may provide novel insights into neuromodulation strategies for cognitive rehabilitation in patients with complex neurological conditions.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with Neuromyelitis Optica Spectrum Disorders (NMOSD), Multiple Sclerosis (MS), and other Central Nervous System Inflammatory Demyelinating Diseases that meet diagnostic criteria;
. Patients with SDMT scores \<55 or subjective cognitive decline;
. Age between 18 and 65 years, gender unrestricted;
. Hamilton Anxiety and Depression Scale scores \<7 points for both scales;
. No relapse or medication changes in the past month;
. EDSS (Expanded Disability Status Scale) score ≤6;
. Right-handed, native Chinese speakers with sufficient educational background to understand the test instructions;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cognitive Assessments
Timeframe: Before treatment, on the last 1 day of treatment, and one month after treatment.
. Willing to participate and have signed informed consent.-
Exclusion criteria
. Relapse record within the past month;
. Medication adjustment within the past month or having undergone modified electroconvulsive therapy, transcranial magnetic stimulation, or other neuromodulation techniques;
. Participating in any other clinical research within 1 month prior to enrollment or currently;
. Presence of cochlear hearing aids, cardiac pacemakers, or implanted brain stimulation devices;
. Skin integrity damage at electrode placement sites, or allergy to electrode gel or adhesives;
. History of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections;
. Pregnant or lactating women, or those planning pregnancy in the near future;
. Scoring ≥3 on item 3 (suicide item) of the HDRS-17 or concurrent severe mental illness;