Transcranial Electrical Stimulation for Treating Chronic Pain in Inflammatory Demyelinating Diseases

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

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.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System
• Intervention / Treatment: Device: transcranial electrical stimulation treatment.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junwei Hao, MD; Phone Number: 01083198277; Email: haojunwei@vip.163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Xuanwu Hospital, Capital Medical University
    • Contact: Junwei Hao, MD; Phone Number: 01083198277; Email: haojunwei@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Sham neurostimulation group
Experimental: Neurostimulation group	Device: transcranial electrical stimulation treatment.; Stimulation targeting the primary motor cortex, current intensity is 1-2mA, duration is 30 minutes, once daily for 5 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS scores	The NRS (Numerical Rating Scale) is a self-reported tool that measures pain intensity on a scale from 0, indicating no pain, to 10, representing the worst possible pain.	From enrollment to the end of treatment at 1 month
SF-MPQ scores	The SF-MPQ (Short-Form McGill Pain Questionnaire) measures pain quality and intensity using a set of descriptive words rated on an intensity scale; higher scores indicate greater pain severity.	From enrollment to the end of treatment at 1 month
Modified Ashworth scale	The Modified Ashworth Scale (MAS) is used to assess muscle spasticity by measuring resistance during passive soft-tissue stretching, with scores ranging from 0 (no increase in muscle tone) to 4 (rigid in flexion or extension), where higher scores indicate greater spasticity.	From enrollment to the end of treatment at 1 month
The HAMD (Hamilton Depression Rating Scale) scores	The HAMD (Hamilton Depression Rating Scale) is a clinician-administered questionnaire used to assess the severity of depression, with scores typically ranging from 0 to 52; higher scores indicate more severe depressive symptoms.	From enrollment to the end of treatment at 1 month
The HAMD (Hamilton Anxiety Rating Scale) scores	The HAMD Anxiety Subscale refers to the anxiety-related items within the Hamilton Depression Rating Scale, which are used to assess both psychological and somatic symptoms of anxiety, such as tension, worry, restlessness, fear, and somatic complaints. Higher scores indicate more severe anxiety symptoms. This subscale is clinician-rated and commonly used to evaluate anxiety levels in patients with depression.	From enrollment to the end of treatment at 1 month
Fatigue Severity Scale	The FSS (Fatigue Severity Scale) is a self-reported questionnaire used to assess the impact of fatigue on a person's daily functioning, consisting of 9 items rated on a scale from 1 (strongly disagree) to 7 (strongly agree); higher scores indicate more severe fatigue.	From enrollment to the end of treatment at 1 month
MMSE (Mini-Mental State Examination) Score	The MMSE (Mini-Mental State Examination) is a widely used clinician-administered tool for screening cognitive function, with scores ranging from 0 to 30; higher scores indicate better cognitive performance, while lower scores suggest cognitive impairment.	From enrollment to the end of treatment at 1 month
Epworth Sleepiness Scale scores	The ESS (Epworth Sleepiness Scale) is a self-reported questionnaire used to assess daytime sleepiness by asking individuals to rate their likelihood of dozing off in various daily situations; scores range from 0 to 24, with higher scores indicating greater daytime sleepiness.	From enrollment to the end of treatment at 1 month
Short Form Health Survey-36 Score	The SF-36 (Short Form Health Survey-36) is a self-reported questionnaire that measures overall health-related quality of life across eight domains, including physical functioning, bodily pain, general health, and mental health. Scores for each domain range from 0 to 100, with higher scores indicating better health status and quality of life.	From enrollment to the end of treatment at 1 month
EEG features of Absolute Power	Reflects the raw amplitude strength within a specific frequency band (e.g., delta, theta, alpha, beta, gamma), calculated by integrating the power spectral density (PSD) over that band.	From enrollment to the end of treatment at 1 month
EEG features of Absolute Power	Power spectral analysis of EEG data quantifies the distribution of signal power across different frequency bands(e.g., delta, theta, alpha, beta, gamma), providing insights into the brain's oscillatory activity. It is typically performed using Fourier or wavelet transforms to compute.	From enrollment to the end of treatment at 1 month
Functional Connectivity of EEG data	the statistical dependencies between spatially separated brain regions, reflecting how different parts of the brain communicate during rest.	From enrollment to the end of treatment at 1 month
Microstate Analysis of EEG data	EEG microstate analysis involves segmenting the continuous EEG signal into short periods of quasi-stable topographic maps, each representing a distinct brain functional state. These microstates are identified using clustering algorithms (e.g., k-means) on scalp voltage maps derived from the EEG's global field power peaks.	From enrollment to the end of treatment at 1 month
Nonlinear Dynamics of EEG data	Nonlinear dynamics of EEG data provide a general measure of the brain's complexity and the unpredictable nature of neural activity. These analyses help reveal hidden patterns and dynamic properties that are not captured by traditional linear methods.	From enrollment to the end of treatment at 1 month
Graph theory metrics of EEG data	Graph theory metrics of EEG data characterize the brain's functional network organization by modeling connectivity patterns as a graph of nodes (electrodes or regions) and edges (functional connections).	From enrollment to the end of treatment at 1 month
Structural measures from T1-weighted MRI	Structural measures from T1-weighted MRI assess the brain's anatomical properties	From enrollment to the end of treatment at 1 month
Functional measures of resting-state fMRI	Functional measures of resting-state fMRI capture spontaneous brain activity and inter-regional communication by analyzing low-frequency BOLD signal fluctuations.	From enrollment to the end of treatment at 1 month
The Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is a self-administered questionnaire that assesses subjective sleep quality and disturbances over a one-month period. It generates seven component scores (including sleep latency, duration, efficiency and disturbances) which are summed into a global score (0-21), with higher scores indicating poorer sleep quality.	From enrollment to the end of treatment at 1 month

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: January 19, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 26, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Chronic Pain; Central Nervous System Diseases; Demyelinating Diseases
• Other Study ID Numbers: xw-tES-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No