Transcranial Electrical Stimulation for Treating Chronic Pain in Inflammatory Demyelinating Diseases

NCT06942611 | Recruiting

• 1 other identifier: xw-tES-03
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Non-invasive neurostimulation can effectively improve patients' symptoms and has shown good therapeutic efficacy in alleviating the symptoms of IIDDs (Inflammatory Immune-mediated Demyelinating Diseases). However, some patients have not achieved the desired results, which may be due to individual differences in neural responsiveness . Therefore, this study aims to assess the therapeutic effect of transcranial electrical stimulation on improving symptoms such as painful spasm in IIDDs patients, by considering both the overall characteristics of IIDDs disease symptoms and individual differences in patients. The study will explore the imaging characteristics, electrophysiological features of the disease symptoms, and their relationship with clinical manifestations, while analyzing the key factors that influence treatment efficacy.

Conditions

Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  VAS Score (Visual Analog Scale) is a commonly used tool to assess pain intensity. It usually consists of a line marked with "no pain" (0 points) and "worst possible pain" (such as 0-100 points). The patient marks their level of pain on the line to provide a score. The advantage of the VAS is its simplicity, clarity, and ease of use for patients.

  From enrollment to the end of treatment at 1 month

Secondary Outcomes (18)

• NRS scores

  From enrollment to the end of treatment at 1 month

• SF-MPQ scores

  From enrollment to the end of treatment at 1 month

• Modified Ashworth scale

  From enrollment to the end of treatment at 1 month

• The HAMD (Hamilton Depression Rating Scale) scores

  From enrollment to the end of treatment at 1 month

• The HAMD (Hamilton Anxiety Rating Scale) scores

  From enrollment to the end of treatment at 1 month

Study Arms (2)

Neurostimulation group

EXPERIMENTAL

Device: transcranial electrical stimulation treatment.

Sham neurostimulation group

NO INTERVENTION

Interventions

transcranial electrical stimulation treatment. DEVICE

Stimulation targeting the primary motor cortex, current intensity is 1-2mA, duration is 30 minutes, once daily for 5 consecutive days

Neurostimulation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

RECRUITING

Central Study Contacts

Junwei Hao, MD

CONTACT

01083198277; haojunwei@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: April 24, 2025
• Study Start: May 3, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)