Transcranial Electrical Stimulation With Visual Comfort for Treating Chronic Pain in Inflammatory Demyelinating Diseases

Capital Medical University

Status: Enrolling

Conditions: Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System

Treatments: Device: transcranial electrical stimulation treatment.; Behavioral: scenario-based placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06942611

xw-tES-03

Details and patient eligibility

About

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 [20]. Therefore, this study aims to assess the therapeutic effect of transcranial electrical stimulation combined with visual placebo 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 4 patient groups, including a placebo group

Neurostimulation combined with scenario-based placebo group

Experimental group

Treatment:

Behavioral: scenario-based placebo

Device: transcranial electrical stimulation treatment.

Neurostimulation combined with non-scenario placebo group

Placebo Comparator group

Treatment:

Device: transcranial electrical stimulation treatment.

Sham neurostimulation combined with scenario-based placebo group

Sham Comparator group

Treatment:

Behavioral: scenario-based placebo

Sham neurostimulation group

No Intervention group