Effectiveness of Personalized Alternating Current Stimulation for Treating Cognitive Impairment in CNS Demyelination Patients
Recruiting · NCT06968039 · Interventional (participants receive a specific treatment) · Lead sponsor: Xuanwu Hospital, Beijing
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 a one-time tES intervention, measuring changes in cognitive domains including working memory, attention, executive function, and processing speed. Anticipated Results: We 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 take part
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;
- 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;
- 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;
- Concurrent severe or unstable organic diseases;
- Unable to cooperate with treatment, follow-up, or clinical, EEG, and imaging data collection due to poor patient compliance;
- Other situations deemed inappropriate for study participation by the researchers.
Where it is running
1 location listed.
- Xuanwu Hospital, Capital Medical University - Beijing, Beijing Municipality, China