Clinical trial NCT06942611: Transcranial Electrical Stimulation With Visual Comfort for Treating Chronic Pain in Inflammatory Demyelinating Diseases
Official title: A Study on the Therapeutic Effects of Transcranial Electrical Stimulation Combined With Visual Contextual Comfort on Chronic Pain in Central Nervous System Inflammatory Demyelinating Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[20\]. 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.


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.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: From enrollment to the end of treatment at 1 month
Secondary outcomes:
measure: NRS scores
timeFrame: From enrollment to the end of treatment at 1 month
measure: SF-MPQ scores
timeFrame: From enrollment to the end of treatment at 1 month
measure: Modified Ashworth scale
timeFrame: From enrollment to the end of treatment at 1 month
measure: The HAMD (Hamilton Depression Rating Scale) scores
timeFrame: From enrollment to the end of treatment at 1 month
measure: The HAMD (Hamilton Anxiety Rating Scale) scores
timeFrame: From enrollment to the end of treatment at 1 month
measure: Fatigue Severity Scale
timeFrame: From enrollment to the end of treatment at 1 month
measure: MMSE (Mini-Mental State Examination) Score
timeFrame: From enrollment to the end of treatment at 1 month
measure: Epworth Sleepiness Scale scores
timeFrame: From enrollment to the end of treatment at 1 month
measure: Short Form Health Survey-36 Score
timeFrame: From enrollment to the end of treatment at 1 month
measure: EEG features of Absolute Power
timeFrame: From enrollment to the end of treatment at 1 month
measure: EEG features of Absolute Power
timeFrame: From enrollment to the end of treatment at 1 month
measure: Functional Connectivity of EEG data
timeFrame: From enrollment to the end of treatment at 1 month
measure: Microstate Analysis of EEG data
timeFrame: From enrollment to the end of treatment at 1 month
measure: Nonlinear Dynamics of EEG data
timeFrame: From enrollment to the end of treatment at 1 month
measure: Graph theory metrics of EEG data
timeFrame: From enrollment to the end of treatment at 1 month
measure: Structural measures from T1-weighted MRI
timeFrame: From enrollment to the end of treatment at 1 month
measure: Functional measures of resting-state fMRI
timeFrame: From enrollment to the end of treatment at 1 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
References: