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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
Stimulation targeting the primary motor cortex, current intensity is 1-2mA, duration is 30 minutes, once daily for 5 consecutive days
Xuanwu Hospital, Capital Medical University
Beijing, China
RECRUITINGVisual 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 month
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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 1 month
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