Using electrical stimulation to relieve chronic pain in patients with inflammatory demyelinating diseases

A Study on the Therapeutic Effects of Transcranial Electrical Stimulation Combined on Chronic Pain in Central Nervous System Inflammatory Demyelinating Diseases

This study is testing whether a type of electrical stimulation can help relieve chronic pain in people with inflammatory demyelinating diseases.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06942611 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of transcranial electrical stimulation combined with a visual placebo on alleviating symptoms such as painful spasms in patients with idiopathic inflammatory demyelinating disorders of the central nervous system. It aims to assess the therapeutic efficacy of this non-invasive neurostimulation approach while considering individual differences in neural responsiveness. The study will also explore the relationship between imaging characteristics, electrophysiological features, and clinical manifestations of the disease. By analyzing these factors, the research seeks to identify key determinants of treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18 to 65 diagnosed with neuromyelitis optica spectrum disorder, multiple sclerosis, or other related conditions, who have a pain score of 4 or higher.

Not a fit: Patients with recent relapses, significant medication adjustments, or those with implanted devices like pacemakers may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve pain management for patients suffering from chronic pain associated with inflammatory demyelinating diseases.

How similar studies have performed: While non-invasive neurostimulation has shown promise in similar contexts, this specific combination of techniques is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

Patients diagnosed with neuromyelitis optica spectrum disorder, multiple sclerosis, or other central nervous system inflammatory demyelinating diseases that meet the diagnostic criteria;

Numeric Rating Scale (NRS) pain score ≥4;

Age between 18 and 65 years, regardless of gender;

Stable dose of immunosuppressive therapy for at least one month;

EDSS score ≤6;

Right-handed;

Agree to participate and sign the informed consent form.

Exclusion Criteria:

A history of relapse within the past month;

Recent medication adjustments or treatment with modified electroconvulsive therapy, transcranial magnetic stimulation, or other neurostimulation techniques within the past month;

Participation in any other clinical trial within the past month or currently participating in another clinical trial;

Presence of cochlear implants, pacemakers, or implanted stimulators in the brain;

Skin integrity at the electrode placement site is compromised, or allergy to electrode gel or adhesive;

A history of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections;

Pregnant or breastfeeding women, or those planning to become pregnant in the near future;

A score of ≥3 on item 3 (suicide item) of the HDRS-17, or a history of severe psychiatric disorders;

Presence of severe or unstable organic diseases;

Poor patient compliance preventing cooperation with treatment, follow-up, or clinical, EEG, and imaging data collection;

Any other situation deemed unsuitable for participation in the study by the investigator.

Where this trial is running

Beijing

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

Study contacts

• Study coordinator: Junwei Hao, MD

Conditions Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System