Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous SystemNCT06942611
Transcranial Electrical Stimulation for Treating Chronic Pain in Inflammatory Demyelinating Diseases
A study testing transcranial electrical stimulation treatment. in people with Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System
- What is being tested?
- transcranial electrical stimulation treatment.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 3 May 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing
Junwei Hao, MD, 01083198277, haojunwei@vip.163.com
About this study
Official title: 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.
- Being tested
- transcranial electrical stimulation treatment.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial electrical stimulation treatment.Device
Stimulation targeting the primary motor cortex, current intensity is 1-2mA, duration is 30 minutes, once daily for 5 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Neurostimulation group | Experimental | Not described Receives: Device: transcranial electrical stimulation treatment. |
| Sham neurostimulation group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 1 month
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start3 May 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous SystemStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942611
- Sponsor's protocol ID
- xw-tES-03
- Status last verified
- May 2025
- First submitted
- 19 Jan 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Therapeutic Effects of Transcranial Electrical Stimulation Combined on Chronic Pain in Central Nervous System Inflammatory Demyelinating Diseases
- ClinicalTrials.gov ID
- NCT06942611
- Acronym / sponsor ID
- xw-tES-03
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 3 May 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurostimulation group | Experimental | Device: transcranial electrical stimulation treatment. |
| Sham neurostimulation group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Neurostimulation group |
Primary outcome
Visual Analog Scale
Time frame: 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.
18 secondary outcomes
NRS scores
Time frame: From enrollment to the end of treatment at 1 month
SF-MPQ scores
Time frame: From enrollment to the end of treatment at 1 month
Modified Ashworth scale
Time frame: From enrollment to the end of treatment at 1 month
The HAMD (Hamilton Depression Rating Scale) scores
Time frame: From enrollment to the end of treatment at 1 month
The HAMD (Hamilton Anxiety Rating Scale) scores
Time frame: From enrollment to the end of treatment at 1 month
Fatigue Severity Scale
Time frame: From enrollment to the end of treatment at 1 month
MMSE (Mini-Mental State Examination) Score
Time frame: From enrollment to the end of treatment at 1 month
Epworth Sleepiness Scale scores
Time frame: From enrollment to the end of treatment at 1 month
Short Form Health Survey-36 Score
Time frame: From enrollment to the end of treatment at 1 month
EEG features of Absolute Power
Time frame: From enrollment to the end of treatment at 1 month
EEG features of Absolute Power
Time frame: From enrollment to the end of treatment at 1 month
Functional Connectivity of EEG data
Time frame: From enrollment to the end of treatment at 1 month
Microstate Analysis of EEG data
Time frame: From enrollment to the end of treatment at 1 month
Nonlinear Dynamics of EEG data
Time frame: From enrollment to the end of treatment at 1 month
Graph theory metrics of EEG data
Time frame: From enrollment to the end of treatment at 1 month
Structural measures from T1-weighted MRI
Time frame: From enrollment to the end of treatment at 1 month
Functional measures of resting-state fMRI
Time frame: From enrollment to the end of treatment at 1 month
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: From enrollment to the end of treatment at 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial electrical stimulation treatment. in people with Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junwei Hao, MD (01083198277, haojunwei@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: From enrollment to the end of treatment at 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.