Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous SystemNCT06933537
Effectiveness of Personalized Alternating Current Stimulation for Treating Emotional Disorders in CNS Demyelination Patients
A study testing Neuroelectrics StarStim 32 in people with Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This study is designed to evaluate the efficacy of personalized alternating current stimulation in the treatment of emotional disorders in patients with inflammatory demyelination of the central nervous system. 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?
- Neuroelectrics StarStim 32
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2024to 1 Oct 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 inflammatory demyelinating diseases of the central nervous system, such as neuromyelitis optica spectrum disorders (NMOSD) and multiple sclerosis (MS)
- Hamilton Anxiety Scale (HAM-A) score > 14
- Aged between 18 and 65 years, with no gender restrictions
- Receiving stable doses of immunosuppressive therapy for at least one month
- Expanded Disability Status Scale (EDSS) score ≤ 6
- Right-handed
- Willing to participate and sign informed consent
Who cannot join
- Recorded relapse within the past month
- Recent medication adjustments or treatments involving modified electroconvulsive therapy, transcranial magnetic stimulation, or other neuromodulation techniques within the past month
- Participation in any other clinical study within the past month or currently
- Presence of cochlear implants, cardiac pacemakers, or implanted stimulators in the brain
- Impaired skin integrity at the electrode placement site or allergies to electrode gel or adhesives
- 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 conceive in the near future
- Hamilton Depression Scale suicide item score ≥ 3 or comorbid severe mental disorders
- Presence of severe or unstable organic diseases
- Poor compliance preventing cooperation with treatment, follow-up, or clinical, EEG, and imaging data collection
- Any condition deemed unsuitable for study participation 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, Beijing Municipality, 100000
zhao, 010
About this study
Official title: This Study is Designed to Evaluate the Efficacy of Personalized Alternating Current Stimulation in the Treatment of Emotional Disorders in Patients With Inflammatory Demyelination of the Central Nervous System
This study is designed to evaluate the efficacy of personalized alternating current stimulation in the treatment of emotional disorders in patients with inflammatory demyelination of the central nervous system.
- Being tested
- Neuroelectrics StarStim 32
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroelectrics StarStim 32Device
Using the advanced Neuroelectrics StarStim 32 device from Spain, individualized imaging modeling systems are employed to precisely target the frontal cortex. Personalized EEG-guided electrical stimulation protocols are selected. The stimulation parameters are as follows: a current intensity of 2 mA, a duration of 21 minutes per session, once daily for five consecutive days, with EEG monitoring conducted before and after electrical stimulation.
Neuroelectrics StarStim 32Device
Sham stimulation is performed using the same device and procedures as the neuromodulation group. The stimulator automatically shuts off after 30 seconds, while maintaining the device's connection. This design creates an initial sensation similar to actual stimulation while preserving the double-blind nature of the study.
| Study group | Role | What they receive |
|---|---|---|
| Neuromodulation Group | Active comparator | Not described Receives: Device: Neuroelectrics StarStim 32 |
| Sham-Neuromodulation Group | Sham comparator | Not described Receives: Device: Neuroelectrics StarStim 32 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAMA (Hamilton Anxiety Rating Scale)
A clinician-administered scale used to assess the severity of a patient's anxiety based on a series of symptoms.
Range: 0-56
Higher Scores: Indicate more severe anxiety.
Purpose: Used to evaluate the severity of anxiety symptoms in patients, primarily in clinical and research settings.
Measured: From enrollment to the end of treatment at 1month
HADS (Hospital Anxiety and Depression Scale)
Description:
A self-report scale used to identify the levels of anxiety and depression in patients, particularly in a hospital setting. It consists of 14 items, split into two subscales: one for anxiety and one for depression.
Range: 0-42 (for each subscale)
Higher Scores: Indicate higher levels of anxiety or depression.
Purpose: Used for screening and evaluating the severity of anxiety and depression in patients, especially those with physical illnesses.
Measured: From enrollment to the end of treatment at 1month
SPS (Social Phobia Scale)
A self-report scale used to measure the severity of social anxiety or social phobia.
Range: 0-120
Higher Scores: Indicate greater severity of social anxiety.
Purpose: Used to assess the intensity of social anxiety and its impact on the individual's daily life.
Measured: From enrollment to the end of treatment at 1month
PSWQ (Penn State Worry Questionnaire)
A self-report scale used to assess the frequency and intensity of a person's worry.
Range: 16-80
Higher Scores: Indicate more frequent and intense worry.
Purpose: Primarily used in research and clinical settings to evaluate generalized anxiety and worry tendencies.
Measured: From enrollment to the end of treatment at 1month
Secondary outcomes (15)
EDSS (Expanded Disability Status Scale)
A clinician-administered scale used to measure the severity of disability in patients with multiple sclerosis (MS). It assesses neurological impairment in eight functional systems.
Range: 0-10
Higher Scores: Indicate greater disability, with 0 representing normal neurological function and 10 representing death due to MS.
Purpose: Used to assess the degree of disability and monitor changes over time in MS patients.
Measured: From enrollment to 1 month later
FSS (Fatigue Severity Scale)
A self-report scale designed to assess the impact of fatigue on a patient's daily life. It evaluates the intensity of fatigue in relation to physical activities, work, and social life.
Range: 9-63
Higher Scores: Indicate more severe fatigue.
Purpose: Used primarily in multiple sclerosis and other neurological disorders to quantify fatigue severity.
Measured: From enrollment to 1 month later
HAMD (Hamilton Depression Rating Scale)
A clinician-administered scale used to assess the severity of depression in patients, based on mood, feelings of guilt, and somatic symptoms.
Range: 0-52
Higher Scores: Indicate more severe depression.
Purpose: Primarily used to assess depression severity in clinical settings and for treatment evaluation.
Measured: From enrollment to 1 month later
MMSE (Mini-Mental State Examination)
A brief 30-point test used to screen for cognitive impairment and assess the level of cognitive function in patients, focusing on orientation, memory, and attention.
Range: 0-30
Higher Scores: Indicate better cognitive function, with scores below 24 suggesting cognitive impairment.
Purpose: Used to assess cognitive function, often in patients with suspected dementia or other cognitive disorders.
Measured: From enrollment to 1 month later
MoCA (Montreal Cognitive Assessment)
A screening tool used to detect mild cognitive impairment. It evaluates multiple cognitive domains, including attention, memory, language, and executive function.
Range: 0-30
Higher Scores: Indicate better cognitive function, with a score below 26 typically suggesting cognitive impairment.
Purpose: Commonly used to assess cognitive function in patients with early dementia, stroke, or neurological disorders.
Measured: From enrollment to 1 month later
SDMT (Symbol Digit Modalities Test)
A neuropsychological test assessing processing speed, attention, and visual-motor coordination. It requires the patient to match symbols to digits based on a key.
Range: Varies based on time and performance (measured in seconds or correct responses).
Higher Scores: Indicate better processing speed and cognitive function.
Purpose: Used to assess cognitive performance and processing speed in clinical research and patient assessments.
Measured: From enrollment to 1 month later
DST (DigiScan Test)
A neuropsychological test used to evaluate attention and working memory by requiring patients to process and manipulate digital sequences.
Range: Dependent on the version of the test used (typically time-based or score-based).
Higher Scores: Indicate better cognitive performance, particularly in attention and working memory.
Purpose: Assesses cognitive function, often used in the evaluation of neurodegenerative diseases or brain injury.
Measured: From enrollment to 1 month later
BVMT (Brief Visuospatial Memory Test)
A test designed to measure visuospatial memory and learning ability, asking patients to remember and recall spatially presented objects.
Range: Varies depending on the test format (measured in correct responses or recall time).
Higher Scores: Indicate better visuospatial memory performance.
Purpose: Used to assess memory, particularly in the context of cognitive disorders like MS and Alzheimer's disease.
Measured: From enrollment to 1 month later
NRS (Numerical Rating Scale)
A self-reported scale that asks patients to rate the intensity of their pain on a scale from 0 to 10.
Range: 0-10
Higher Scores: Indicate more intense pain.
Purpose: Commonly used in clinical practice to measure pain intensity and assess treatment efficacy.
Measured: From enrollment to 1 month later
SF-MPQ (Short-Form McGill Pain Questionnaire)
A self-reported questionnaire used to assess the quality and intensity of pain, measuring sensory, affective, and evaluative dimensions of pain.
Range: 0-78 (higher scores indicate greater pain severity)
Higher Scores: Indicate greater pain intensity and distress.
Purpose: Often used to assess pain in clinical and research settings, providing both quantitative and qualitative measures of pain.
Measured: From enrollment to 1 month later
ESS (Epworth Sleepiness Scale)
A self-report questionnaire used to assess daytime sleepiness and the likelihood of falling asleep in various situations.
Range: 0-24
Higher Scores: Indicate higher levels of daytime sleepiness.
Purpose: Used to assess sleepiness, often in the context of sleep disorders like sleep apnea or narcolepsy.
Measured: From enrollment to 1 month later
Ashworth Scale
A clinician-administered scale used to measure muscle spasticity. It evaluates the resistance of a muscle to passive movement in response to varying speeds.
Range: 0-4
Higher Scores: Indicate greater spasticity, with 0 being no spasticity and 4 being severe spasticity.
Purpose: Commonly used in neurological conditions such as cerebral palsy, multiple sclerosis, and stroke.
Measured: From enrollment to 1 month later
SF-36 (Short Form 36 Health Survey)
A self-reported health survey designed to measure quality of life, including physical, emotional, and social well-being. It consists of 36 questions grouped into eight domains.
Range: 0-100 for each domain (higher scores indicate better health status).
Higher Scores: Indicate better health and quality of life.
Purpose: Used widely to assess general health status, particularly in chronic illness and clinical trials.
Measured: From enrollment to 1 month later
CGI-I (Clinical Global Impression - Improvement)
A clinician-administered scale that evaluates the overall improvement of a patient's condition since the initiation of treatment.
Range: 1-7
Higher Scores: Indicate less improvement, with a score of 1 indicating "very much improved" and 7 indicating "very much worse."
Purpose: Used to assess treatment effectiveness in clinical trials and practice, particularly in psychiatric and neurological conditions.
Measured: From enrollment to 1 month later
EGI Recording EEG Data and MRI Data
EEG (Electroencephalography): A technique used to measure electrical activity in the brain. It records brain waves and can help identify abnormalities related to seizures, sleep disorders, or other neurological conditions.
MRI (Magnetic Resonance Imaging): A non-invasive imaging technique that uses magnetic fields and radio waves to create detailed images of organs and tissues. It is commonly used to assess brain structure, identify lesions, and detect abnormalities.
Purpose: Both EEG and MRI are used to monitor and assess brain activity and structure in patients, providing valuable insights into neurological conditions and helping in diagnosis and treatment planning.
Measured: From enrollment to 1 month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start29 Dec 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Oct 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
- 65 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
- NCT06933537
- Sponsor's protocol ID
- xw-tES-02
- Status last verified
- Apr 2025
- First submitted
- 19 Jan 2025
- Last updated
- 18 Apr 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 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This Study is Designed to Evaluate the Efficacy of Personalized Alternating Current Stimulation in the Treatment of Emotional Disorders in Patients With Inflammatory Demyelination of the Central Nervous System
- ClinicalTrials.gov ID
- NCT06933537
- Acronym / sponsor ID
- xw-tES-02
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 29 Dec 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 18 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.
This study is designed to evaluate the efficacy of personalized alternating current stimulation in the treatment of emotional disorders in patients with inflammatory demyelination of the central nervous system.
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 |
|---|---|---|
| Neuromodulation Group | Active comparator | Device: Neuroelectrics StarStim 32 |
| Sham-Neuromodulation Group | Sham comparator | Device: Neuroelectrics StarStim 32 |
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 inflammatory demyelinating diseases of the central nervous system, such as neuromyelitis optica spectrum disorders (NMOSD) and multiple sclerosis (MS)
- Hamilton Anxiety Scale (HAM-A) score > 14
- Aged between 18 and 65 years, with no gender restrictions
- Receiving stable doses of immunosuppressive therapy for at least one month
- Expanded Disability Status Scale (EDSS) score ≤ 6
Key exclusion criteria (11 listed)
- Recorded relapse within the past month
- Recent medication adjustments or treatments involving modified electroconvulsive therapy, transcranial magnetic stimulation, or other neuromodulation techniques within the past month
- Participation in any other clinical study within the past month or currently
- Presence of cochlear implants, cardiac pacemakers, or implanted stimulators in the brain
- Impaired skin integrity at the electrode placement site or allergies to electrode gel or adhesives
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 |
|---|---|---|
| Neuroelectrics StarStim 32Using the advanced Neuroelectrics StarStim 32 device from Spain, individualized imaging modeling systems are employed to precisely target the frontal cortex. Personalized EEG-guided electrical stimulation protocols are selected. The stimulation parameters are as follows: a current intensity of 2 mA, a duration of 21 minutes per session, once daily for five consecutive days, with EEG monitoring conducted before and after electrical stimulation. | Device | Neuromodulation Group |
| Neuroelectrics StarStim 32Sham stimulation is performed using the same device and procedures as the neuromodulation group. The stimulator automatically shuts off after 30 seconds, while maintaining the device's connection. This design creates an initial sensation similar to actual stimulation while preserving the double-blind nature of the study. | Device | Sham-Neuromodulation Group |
Primary outcome
HAMA (Hamilton Anxiety Rating Scale)
Time frame: From enrollment to the end of treatment at 1month
A clinician-administered scale used to assess the severity of a patient's anxiety based on a series of symptoms. Range: 0-56 Higher Scores: Indicate more severe anxiety. Purpose: Used to evaluate the severity of anxiety symptoms in patients, primarily in clinical and research settings.
HADS (Hospital Anxiety and Depression Scale)
Time frame: From enrollment to the end of treatment at 1month
Description: A self-report scale used to identify the levels of anxiety and depression in patients, particularly in a hospital setting. It consists of 14 items, split into two subscales: one for anxiety and one for depression. Range: 0-42 (for each subscale) Higher Scores: Indicate higher levels of anxiety or depression. Purpose: Used for screening and evaluating the severity of anxiety and depression in patients, especially those with physical illnesses.
SPS (Social Phobia Scale)
Time frame: From enrollment to the end of treatment at 1month
A self-report scale used to measure the severity of social anxiety or social phobia. Range: 0-120 Higher Scores: Indicate greater severity of social anxiety. Purpose: Used to assess the intensity of social anxiety and its impact on the individual's daily life.
PSWQ (Penn State Worry Questionnaire)
Time frame: From enrollment to the end of treatment at 1month
A self-report scale used to assess the frequency and intensity of a person's worry. Range: 16-80 Higher Scores: Indicate more frequent and intense worry. Purpose: Primarily used in research and clinical settings to evaluate generalized anxiety and worry tendencies.
15 secondary outcomes
EDSS (Expanded Disability Status Scale)
Time frame: From enrollment to 1 month later
FSS (Fatigue Severity Scale)
Time frame: From enrollment to 1 month later
HAMD (Hamilton Depression Rating Scale)
Time frame: From enrollment to 1 month later
MMSE (Mini-Mental State Examination)
Time frame: From enrollment to 1 month later
MoCA (Montreal Cognitive Assessment)
Time frame: From enrollment to 1 month later
SDMT (Symbol Digit Modalities Test)
Time frame: From enrollment to 1 month later
DST (DigiScan Test)
Time frame: From enrollment to 1 month later
BVMT (Brief Visuospatial Memory Test)
Time frame: From enrollment to 1 month later
NRS (Numerical Rating Scale)
Time frame: From enrollment to 1 month later
SF-MPQ (Short-Form McGill Pain Questionnaire)
Time frame: From enrollment to 1 month later
ESS (Epworth Sleepiness Scale)
Time frame: From enrollment to 1 month later
Ashworth Scale
Time frame: From enrollment to 1 month later
SF-36 (Short Form 36 Health Survey)
Time frame: From enrollment to 1 month later
CGI-I (Clinical Global Impression - Improvement)
Time frame: From enrollment to 1 month later
EGI Recording EEG Data and MRI Data
Time frame: From enrollment to 1 month later
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 18 Apr 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 Neuroelectrics StarStim 32 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 18 Apr 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. Some participants in this study may receive a placebo. 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?
HAMA (Hamilton Anxiety Rating Scale) (time frame: From enrollment to the end of treatment at 1month). The study lists 4 primary outcomes in all. 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 18 Apr 2025.