Actively Recruiting
Efficacy of Personalized Alternating Current Stimulation for Emotional Disorders in Patients With Inflammatory Demyelination of the Central Nervous System
Led by Xuanwu Hospital, Beijing · Updated on 2025-04-18
65
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of personalized alternating current stimulation for treating emotional disorders in patients with inflammatory demyelination of the central nervous system, such as neuromyelitis optica spectrum disorders and multiple sclerosis. This study aims to understand if this targeted electrical stimulation can improve symptoms related to anxiety, depression, and social phobia in these patients. The trial is sponsored by Xuanwu Hospital, Beijing, and includes adults aged 18 to 65 years. The study compares two groups: one receiving active neuromodulation using the Neuroelectrics StarStim 32 device and another receiving sham stimulation that mimics the sensation but without ongoing current. Personalized EEG-guided stimulation targets the frontal cortex with a current intensity of 2 mA for 21 minutes daily over five consecutive days. EEG monitoring is conducted before and after each stimulation session to ensure accuracy and safety. Participants will be involved in assessments from enrollment through one month after treatment. Researchers will measure anxiety, depression, social phobia, fatigue, cognitive function, disability status, pain, sleepiness, and overall health using various scales and tests including HAMA, HADS, SPS, PSWQ, and EEG and MRI data. Safety and treatment adherence are monitored, and participants will be followed closely to gather clinical and imaging data during the study period.
CONDITIONS
Brief Title
Effectiveness of Personalized Alternating Current Stimulation for Treating Emotional Disorders in CNS Demyelination Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with inflammatory demyelinating diseases of the central nervous system, such as neuromyelitis optica spectrum disorders and multiple sclerosis
- Hamilton Anxiety Scale (HAM-A) score greater than 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 or less
- Right-handed
- Willing to participate and sign informed consent
You will not qualify if you...
- 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 higher 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 consecutive days
Participants receive personalized alternating current stimulation using the Neuroelectrics StarStim 32 device targeting the frontal cortex with EEG-guided protocols.
5 daily visits (in-person)
Duration - Up to 1 month after treatment
Participants are monitored for treatment effects and safety after stimulation ends.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
J
junwei Hao, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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