Transcranial alternating current stimulation for cognitive problems in inflammatory demyelinating CNS disorders
Assessment of Transcranial Alternating Current Stimulation's Clinical Efficacy in Treating Cognitive Impairment of Idiopathic Inflammatory Demyelinating Diseases
NA · Xuanwu Hospital, Beijing · NCT07087873
This trial will try transcranial alternating current stimulation to see if it improves thinking and memory in adults with multiple sclerosis and related inflammatory demyelinating central nervous system disorders.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing (other) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07087873 on ClinicalTrials.gov |
What this trial studies
The study will enroll adults with idiopathic inflammatory demyelinating disorders and perform baseline imaging and electrophysiological testing to characterize disease-related brain changes. Participants will be assigned to active neuroelectrical modulation or a pseudo-neuromodulation (sham) group and receive repeated noninvasive stimulation sessions. Clinical cognitive outcomes will be measured alongside imaging and electrophysiology to identify factors linked to response. The goal is to define overall and individual response patterns to enable more personalized neuromodulation programs.
Who should consider this trial
Good fit: Adults 18–60 with diagnosed MS, NMOSD, ADEM, or other idiopathic inflammatory demyelinating CNS disorders who have been on stable medications for at least three months and have had no relapse in the past three months.
Not a fit: Patients with recent relapse, implanted pacemakers or metal devices, active skin problems at electrode sites, prior structural brain disease (e.g., epilepsy, tumors), severe unstable organ dysfunction, or who are pregnant or breastfeeding are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, this approach could reduce cognitive problems and support personalized noninvasive brain stimulation treatments for people with demyelinating CNS disorders.
How similar studies have performed: Prior small trials of noninvasive electrical brain stimulation (including tDCS/tACS) in MS and related disorders have shown mixed but sometimes promising effects on cognition, so the approach is partially tested but not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 18-60 years old. * Diagnosis: Patients with neuromyelitis optica spectrum disease, multiple sclerosis and other inflammatory demyelinating diseases of the central nervous system that meet the diagnostic criteria. * Medications have been stable for at least three months. Exclusion Criteria: * Recurrence has been recorded in the past 3 months. * Have a pacemaker or other metal implant in the body. * Impaired skin integrity at the site of electrode placement. * Previous organic brain disease such as epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infection. * Combined with severe or unstable organic diseases, such as heart, liver and kidney and other organ dysfunction. * Pregnant or lactating women, those who are planning to become pregnant in the near future. * Patient compliance is poor. * In the opinion of the investigator, there is a situation that is not suitable to participate in this study.
Where this trial is running
Beijing, Beijing Municipality
- Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Study coordinator: huang huijin, Ph.D.
- Email: huanghuijinmail@sina.com
- Phone: +8618510510804
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System, MS, NMOSD, Acute Disseminated Encephalomyelitis, Transcranial Alternating Current Stimulation