Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System
Conditions
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 . 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.
Interventions
DEVICEtranscranial electrical stimulation treatment.
Stimulation targeting the primary motor cortex, current intensity is 1-2mA, duration is 30 minutes, once daily for 5 consecutive days
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | From enrollment to the end of treatment at 1 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MMSE (Mini-Mental State Examination) Score | From enrollment to the end of treatment at 1 month | 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. |
| Epworth Sleepiness Scale scores | From enrollment to the end of treatment at 1 month | 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. |
| Short Form Health Survey-36 Score | From enrollment to the end of treatment at 1 month | 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. |
| NRS scores | From enrollment to the end of treatment at 1 month | 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. |
| SF-MPQ scores | From enrollment to the end of treatment at 1 month | 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. |
| Modified Ashworth scale | From enrollment to the end of treatment at 1 month | 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. |
| The HAMD (Hamilton Depression Rating Scale) scores | From enrollment to the end of treatment at 1 month | 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. |
| The HAMD (Hamilton Anxiety Rating Scale) scores | From enrollment to the end of treatment at 1 month | 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. |
| Fatigue Severity Scale | From enrollment to the end of treatment at 1 month | 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. |
| Functional Connectivity of EEG data | From enrollment to the end of treatment at 1 month | the statistical dependencies between spatially separated brain regions, reflecting how different parts of the brain communicate during rest. |
| Microstate Analysis of EEG data | From enrollment to the end of treatment at 1 month | 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. |
| Nonlinear Dynamics of EEG data | From enrollment to the end of treatment at 1 month | 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. |
| Graph theory metrics of EEG data | From enrollment to the end of treatment at 1 month | 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). |
| Structural measures from T1-weighted MRI | From enrollment to the end of treatment at 1 month | Structural measures from T1-weighted MRI assess the brain's anatomical properties |
| Functional measures of resting-state fMRI | From enrollment to the end of treatment at 1 month | Functional measures of resting-state fMRI capture spontaneous brain activity and inter-regional communication by analyzing low-frequency BOLD signal fluctuations. |
| The Pittsburgh Sleep Quality Index (PSQI) | From enrollment to the end of treatment at 1 month | 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. |
| EEG features of Absolute Power | From enrollment to the end of treatment at 1 month | 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. |
Countries
China
Contacts
Primary ContactJunwei Hao, MD
Outcome results
None listed