Personalized electrical stimulation for emotional disorders in patients with CNS demyelination
This Study is Designed to Evaluate the Efficacy of Personalized Alternating Current Stimulation in the Treatment of Emotional Disorders in Patients With Inflammatory Demyelination of the Central Nervous System
This study is testing if a new type of electrical stimulation can help people with multiple sclerosis and similar conditions feel less anxious.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06933537 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of personalized alternating current stimulation in treating emotional disorders among patients diagnosed with inflammatory demyelinating diseases of the central nervous system, such as multiple sclerosis and neuromyelitis optica spectrum disorders. Participants will receive treatment using the Neuroelectrics StarStim 32 device while being monitored for changes in their emotional health. The study aims to determine if this innovative approach can alleviate anxiety symptoms in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with inflammatory demyelinating diseases and a Hamilton Anxiety Scale score greater than 14.
Not a fit: Patients who have experienced a relapse in the past month or have undergone recent neuromodulation treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve emotional well-being and quality of life for patients suffering from emotional disorders related to CNS demyelination.
How similar studies have performed: While the approach of using personalized electrical stimulation is innovative, similar studies in neuromodulation for emotional disorders have shown promising results, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with inflammatory demyelinating diseases of the central nervous system, such as neuromyelitis optica spectrum disorders (NMOSD) and multiple sclerosis (MS) * Hamilton Anxiety Scale (HAM-A) score \> 14 * Aged between 18 and 65 years, with no gender restrictions * Receiving stable doses of immunosuppressive therapy for at least one month * Expanded Disability Status Scale (EDSS) score ≤ 6 * Right-handed * Willing to participate and sign informed consent Exclusion Criteria: * Recorded relapse within the past month * Recent medication adjustments or treatments involving modified electroconvulsive therapy, transcranial magnetic stimulation, or other neuromodulation techniques within the past month * Participation in any other clinical study within the past month or currently * Presence of cochlear implants, cardiac pacemakers, or implanted stimulators in the brain * Impaired skin integrity at the electrode placement site or allergies to electrode gel or adhesives * History of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections * Pregnant or breastfeeding women, or those planning to conceive in the near future * Hamilton Depression Scale suicide item score ≥ 3 or comorbid severe mental disorders * Presence of severe or unstable organic diseases * Poor compliance preventing cooperation with treatment, follow-up, or clinical, EEG, and imaging data collection * Any condition deemed unsuitable for study participation by the investigator
Where this trial is running
Beijing, Beijing Municipality
- Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: junwei Hao, MD
- Email: haojunwei@vip.163.com
- Phone: 01083198277
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.