Personalized electrical stimulation for cognitive impairment in demyelination patients

This Study is Designed to Evaluate the Efficacy of Personalized Alternating Current Stimulation in the Treatment of Working Memory in Patients With Inflammatory Demyelination of the Central Nervous System

This study is testing if personalized electrical stimulation can help improve thinking skills in people with conditions like Multiple Sclerosis and Neuromyelitis Optica.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 85 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06968039 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of individualized transcranial electrical stimulation (tES) in improving cognitive function in patients with inflammatory demyelinating disorders such as Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders. Participants will undergo a one-time tES intervention, with cognitive performance assessed through standardized neuropsychological tests before and after the treatment. The study aims to measure improvements in cognitive domains including working memory, attention, executive function, and processing speed. The hypothesis is that personalized tES will lead to significant cognitive enhancements, providing a non-invasive therapeutic option for cognitive decline in these patients.

Who should consider this trial

Good fit: Ideal candidates include patients aged 18 to 65 with diagnosed Multiple Sclerosis or similar conditions, experiencing cognitive decline.

Not a fit: Patients who have had a relapse or medication changes in the past month, or those with certain medical devices, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could offer a new non-invasive treatment option to improve cognitive function in patients with demyelinating diseases.

How similar studies have performed: While there is ongoing research in neuromodulation techniques, the specific application of personalized tES for cognitive impairment in this patient population is relatively novel.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Study coordinator: Jun wei Hao, MD

Conditions: Multiple Sclerosis, Electric Stimulation