Actively Recruiting
Transcranial Electrical Stimulation for Chronic Pain in Central Nervous System Inflammatory Demyelinating Diseases A Study on Therapeutic Effects and Symptom Improvement
Led by Xuanwu Hospital, Beijing · Updated on 2025-07-01
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of transcranial electrical stimulation on chronic pain symptoms in patients with idiopathic inflammatory demyelinating disorders (IIDDs) of the central nervous system, such as neuromyelitis optica spectrum disorder and multiple sclerosis. This study aims to understand how this non-invasive neurostimulation may improve symptoms like painful spasms, considering individual differences in neural responsiveness and exploring imaging and electrophysiological features related to clinical symptoms. The study involves a randomized, triple-blind design comparing two groups: one receiving actual transcranial electrical stimulation targeting the primary motor cortex, and the other receiving sham stimulation with no intervention. The stimulation is applied once daily for 30 minutes over 5 consecutive days at a current intensity of 1 to 2 mA. This approach will allow researchers to assess the treatment's effects on patients with stable immunosuppressive therapy and specific symptom severity. Participants will be involved in assessments from enrollment through one month after treatment, including pain scales such as the Visual Analog Scale and Numeric Rating Scale, mental health evaluations, fatigue and sleep quality questionnaires, cognitive tests, and advanced EEG and MRI imaging analyses. Researchers will monitor changes in these measures to evaluate treatment impact and safety, with follow-up lasting one month post-treatment to collect clinical, electrophysiological, and imaging data.
CONDITIONS
Brief Title
Transcranial Electrical Stimulation for Treating Chronic Pain in Inflammatory Demyelinating Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with neuromyelitis optica spectrum disorder, multiple sclerosis, or other central nervous system inflammatory demyelinating diseases meeting diagnostic criteria
- Numeric Rating Scale (NRS) pain score of 4 or higher
- Age between 18 and 65 years, any gender
- Stable dose of immunosuppressive therapy for at least one month
- EDSS score of 6 or less
- Right-handed
- Agree to participate and sign informed consent form
You will not qualify if you...
- History of relapse within the past month
- Recent medication changes or treatments like electroconvulsive therapy, transcranial magnetic stimulation, or neurostimulation within the past month
- Participation in another clinical trial within the past month or currently
- Presence of cochlear implants, pacemakers, or brain stimulators
- Skin problems or allergy at electrode placement sites
- History of epilepsy, hydrocephalus, CNS tumors, brain injury, or intracranial infections
- Pregnant, breastfeeding, or planning pregnancy soon
- High suicide risk or severe psychiatric disorders
- Severe or unstable organic diseases
- Poor compliance preventing cooperation with treatment or data collection
- Any other condition deemed unsuitable 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 days
Participants receive transcranial electrical stimulation targeting the primary motor cortex once daily for 5 consecutive days.
5 daily visits (in-person)
Duration - Up to 1 month after treatment
Participants are monitored for symptom improvement and therapeutic effects after treatment ends.
Approximately 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital, Capital Medical University
Beijing, China
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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