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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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;
Show all 11Show fewer
  • 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.

Junwei Hao, MD contact

01083198277

haojunwei@vip.163.com

China1 site, 1 recruiting
  • Xuanwu Hospital, Capital Medical University

    Beijing

    Junwei Hao, MD, 01083198277, haojunwei@vip.163.com

    Recruiting

Other trials in China

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 groups in NCT06942611
Study groupRoleWhat they receive
Neurostimulation groupExperimentalNot described
Receives: Device: transcranial electrical stimulation treatment.
Sham neurostimulation groupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to the end of treatment at 1 month

Secondary outcomes (18)
  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.

    Measured: From enrollment to the end of treatment at 1 month

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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.

  1. First posted24 Apr 2025
  2. Study start3 May 2025
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

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)
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

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.

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