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 range18 Years – 65 Years
SexALL
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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;
✓. Willing to participate and have signed informed consent.-
Exclusion criteria
✕. Relapse record within the past month;
✕
What they're measuring
1
Cognitive Assessments
Timeframe: Before treatment, on the last 1 day of treatment, and one month after treatment.
. 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;