Personalized brain stimulation for thinking problems in inflammatory demyelinating disorders

The Effectiveness of Individualized Transcranial Electrical Stimulation in Improving Cognitive Impairment in Patients With Central Nervous System Inflammatory Demyelinating Diseases

This project will test whether personalized transcranial electrical stimulation can improve thinking and memory in adults with inflammatory demyelinating diseases such as MS and NMOSD.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 85 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07029386 on ClinicalTrials.gov

What this trial studies

Central nervous system inflammatory demyelinating diseases often cause measurable declines in memory, attention, processing speed, and executive function. This interventional protocol delivers individualized transcranial electrical stimulation (tES) tailored to each participant and measures cognitive performance before and after the intervention. Standardized neuropsychological tests including SDMT and domain-specific assessments will be used to quantify changes in memory, attention, executive function, and processing speed. Participants must be stable, right-handed native Chinese speakers and will attend in-person sessions at the enrolling hospital.

Who should consider this trial

Good fit: Adults 18–65 with MS, NMOSD, or related inflammatory demyelinating CNS disorders who have cognitive complaints or SDMT scores below 55, are right-handed native Chinese speakers, have EDSS ≤6, stable medications, and low anxiety/depression scores.

Not a fit: Patients with a relapse or medication changes within the past month, recent or prior neuromodulation therapies, significant mood symptoms, non–right-handedness, or who cannot attend in-person visits are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, personalized tES could offer a noninvasive way to improve memory, attention, and processing speed for patients with inflammatory demyelinating CNS disorders.

How similar studies have performed: Small pilot studies of tES in neurological conditions have shown mixed but sometimes promising cognitive effects, so the approach is preliminary but not entirely untested.

Eligibility criteria

Inclusion Criteria:、

1. Patients with Neuromyelitis Optica Spectrum Disorders (NMOSD), Multiple Sclerosis (MS), and other Central Nervous System Inflammatory Demyelinating Diseases that meet diagnostic criteria;
2. Patients with SDMT scores \<55 or subjective cognitive decline;
3. Age between 18 and 65 years, gender unrestricted;
4. Hamilton Anxiety and Depression Scale scores \<7 points for both scales;
5. No relapse or medication changes in the past month;
6. EDSS (Expanded Disability Status Scale) score ≤6;
7. Right-handed, native Chinese speakers with sufficient educational background to understand the test instructions;
8. Willing to participate and have signed informed consent.-

Exclusion Criteria:

1. Relapse record within the past month;
2. Medication adjustment within the past month or having undergone modified electroconvulsive therapy, transcranial magnetic stimulation, or other neuromodulation techniques;
3. Participating in any other clinical research within 1 month prior to enrollment or currently;
4. Presence of cochlear hearing aids, cardiac pacemakers, or implanted brain stimulation devices;
5. Skin integrity damage at electrode placement sites, or allergy to electrode gel or adhesives;
6. History of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections;
7. Pregnant or lactating women, or those planning pregnancy in the near future;
8. Scoring ≥3 on item 3 (suicide item) of the HDRS-17 or concurrent severe mental illness;
9. Concurrent severe or unstable organic diseases;
10. Unable to cooperate with treatment, follow-up, or clinical, EEG, and imaging data collection due to poor patient compliance;
11. Other situations deemed inappropriate for study participation by the researchers.

Where this trial is running

Beijing

• Xuanwu Hospital, Capital Medical University — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Jun wei Hao,MD

Conditions Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System