Transcranial Electrical Stimulation for Treating Chronic Pain in Inflammatory Demyelinating Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXuanwu Hospital, Beijing
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
transcranial electrical stimulation treatment.
DeviceStimulation targeting the primary motor cortex, current intensity is 1-2mA, duration is 30 minutes, once daily for 5 consecutive days
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Neurostimulation groupExperimental treatment 1 intervention
Group B: Sham neurostimulation groupNo intervention 0 interventions
Trial outcomes
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.
Time frame
From enrollment to the end of treatment at 1 monthSecondary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 1 month2
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.
Time frame
From enrollment to the end of treatment at 1 month3
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.
Time frame
From enrollment to the end of treatment at 1 month4
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.
Time frame
From enrollment to the end of treatment at 1 monthSponsors and contacts
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Source ClinicalTrials.gov