Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous SystemNCT07029386
Effects of Transcranial Electrical Stimulation on Cognitive Impairment in CNS Inflammatory Demyelinating Diseases
A study testing tES in people with Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Background: Central nervous system inflammatory demyelinating diseases often lead to significant cognitive impairment, presenting a critical challenge in patient management. Objective: To evaluate the effectiveness of individualized transcranial electrical stimulation (tES) in improving cognitive function among… 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?
- tES
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 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 with Neuromyelitis Optica Spectrum Disorders (NMOSD), Multiple Sclerosis (MS), and other Central Nervous System Inflammatory Demyelinating Diseases that meet diagnostic criteria;
- Patients with SDMT scores <55 or subjective cognitive decline;
- Age between 18 and 65 years, gender unrestricted;
- Hamilton Anxiety and Depression Scale scores <7 points for both scales;
- No relapse or medication changes in the past month;
- EDSS (Expanded Disability Status Scale) score ≤6;
- Right-handed, native Chinese speakers with sufficient educational background to understand the test instructions;
- Willing to participate and have signed informed consent.-
Who cannot join
- Relapse record within the past month;
- Medication adjustment within the past month or having undergone modified electroconvulsive therapy, transcranial magnetic stimulation, or other neuromodulation techniques;
- Participating in any other clinical research within 1 month prior to enrollment or currently;
- Presence of cochlear hearing aids, cardiac pacemakers, or implanted brain stimulation devices;
- Skin integrity damage at electrode placement sites, or allergy to electrode gel or adhesives;
- History of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections;
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- Pregnant or lactating women, or those planning pregnancy in the near future;
- Scoring ≥3 on item 3 (suicide item) of the HDRS-17 or concurrent severe mental illness;
- Concurrent severe or unstable organic diseases;
- Unable to cooperate with treatment, follow-up, or clinical, EEG, and imaging data collection due to poor patient compliance;
- Other situations deemed inappropriate for study participation by the researchers.
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: The Effectiveness of Individualized Transcranial Electrical Stimulation in Improving Cognitive Impairment in Patients With Central Nervous System Inflammatory Demyelinating Diseases
Background: Central nervous system inflammatory demyelinating diseases often lead to significant cognitive impairment, presenting a critical challenge in patient management.
Objective: To evaluate the effectiveness of individualized transcranial electrical stimulation (tES) in improving cognitive function among patients with inflammatory demyelinating disorders.
Read more
Methods: This study will assess cognitive performance through standardized neuropsychological assessments before and after individualized tES intervention, measuring changes in cognitive domains including memory, attention, executive function, and processing speed.
Anticipated Results: the investigators hypothesize that personalized transcranial electrical stimulation will demonstrate significant improvements in cognitive performance, potentially offering a non-invasive therapeutic approach for managing cognitive decline in central nervous system inflammatory demyelinating diseases.
Significance: This research may provide novel insights into neuromodulation strategies for cognitive rehabilitation in patients with complex neurological conditions.
- Being tested
- tES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tESDevice
his study employs a randomized controlled trial (RCT) design, randomly dividing eligible participants into a neuromodulation group and a sham neuromodulation group.
Neuromodulation Group:
Receive individualized transcranial electrical stimulation (tES) treatment Combined with cognitive training
Stimulation parameters:
Total current: approximately 2mA Duration: 21 minutes Electroencephalogram (EEG) and multimodal MRI monitoring before and after electrical stimulation
tESDevice
Use the same device and procedure as the neuromodulation group Stimulation device automatically turns off after 30 seconds Maintain device connection Design creates similar initial sensations to actual stimulation Maintains the double-blind nature of the study
| Study group | Role | What they receive |
|---|---|---|
| Neuromodulation Group | Active comparator | Not described Receives: Device: tES |
| sham Neuromodulation Group | Sham comparator | Not described Receives: Device: tES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Auditory Verbal Learning Test (AVLT) Score
The Auditory Verbal Learning Test (AVLT) evaluates verbal learning and memory performance. The AVLT consists of multiple components, including immediate recall, delayed recall, and recognition memory. The immediate recall score is obtained from three consecutive learning trials and ranges from 0 to 36. The 5-minute delayed recall score ranges from 0 to 12, and the 20-minute delayed recall score ranges from 0 to 12. The recognition score ranges from 0 to 24 after interference trials. Higher scores indicate better cognitive performance.
Measured: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).
Secondary outcomes (8)
Change in Symbol Digit Modalities Test (SDMT) Score
The Symbol Digit Modalities Test (SDMT) assesses information processing speed. The SDMT score ranges from 0 to 110, with higher scores indicating better cognitive performance.
Measured: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).
Change in EEG Power Spectral Density
Changes in EEG power spectral density (PSD) will be assessed across delta, theta, alpha, beta, and gamma frequency bands. PSD values will be calculated using spectral analysis and expressed in decibels (dB) after logarithmic transformation. Higher or lower PSD values indicate changes in oscillatory brain activity, and the direction of change will be evaluated statistically.
Measured: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).
Change in Resting-State Functional MRI Network Connectivity
Changes in resting-state functional connectivity between the dorsolateral prefrontal cortex (DLPFC) and other brain regions will be evaluated using resting-state functional MRI to characterize changes in functional interactions associated with the stimulation target.
Measured: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).
Change in Fractional Anisotropy (FA)
Changes in fractional anisotropy (FA), a diffusion tensor imaging metric reflecting white matter microstructural integrity, will be assessed before and after treatment.
Measured: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).
Change in EEG Functional Connectivity
Changes in EEG functional connectivity between the dorsolateral prefrontal cortex (DLPFC) and other brain regions will be evaluated across different frequency bands, including delta, theta, alpha, beta, and gamma bands.
Measured: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).
Change in Mean Diffusivity (MD)
Changes in mean diffusivity (MD), a diffusion tensor imaging metric reflecting overall water diffusion within white matter tissue, will be assessed before and after treatment.
Measured: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).
Change in Axial Diffusivity (AD)
Changes in axial diffusivity (AD), a diffusion tensor imaging metric reflecting diffusion along the principal fiber direction, will be assessed before and after treatment.
Measured: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).
Change in Radial Diffusivity (RD)
Changes in radial diffusivity (RD), a diffusion tensor imaging metric reflecting diffusion perpendicular to the principal fiber direction, will be assessed before and after treatment.
Measured: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start15 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
- 40 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
- NCT07029386
- Sponsor's protocol ID
- xw-tES-01
- Status last verified
- Jun 2026
- First submitted
- 19 Jan 2025
- Last updated
- 19 Aug 2026
- 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Individualized Transcranial Electrical Stimulation in Improving Cognitive Impairment in Patients With Central Nervous System Inflammatory Demyelinating Diseases
- ClinicalTrials.gov ID
- NCT07029386
- Acronym / sponsor ID
- xw-tES-01
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 19 Jun 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.
Background: Central nervous system inflammatory demyelinating diseases often lead to significant cognitive impairment, presenting a critical challenge in patient management.
Objective: To evaluate the effectiveness of individualized transcranial electrical stimulation (tES) in improving cognitive function among patients with inflammatory demyelinating disorders.
Methods: This study will assess cognitive performance through standardized neuropsychological assessments before and after individualized tES intervention, measuring changes in cognitive domains including memory, attention, executive function, and processing speed.
Anticipated Results: the investigators hypothesize that personalized transcranial electrical stimulation will demonstrate significant improvements in cognitive performance, potentially offering a non-invasive therapeutic approach for managing cognitive decline in central nervous system inflammatory demyelinating diseases.
Significance: This research may provide novel insights into neuromodulation strategies for cognitive rehabilitation in patients with complex neurological conditions.
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: tES |
| sham Neuromodulation Group | Sham comparator | Device: tES |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with Neuromyelitis Optica Spectrum Disorders (NMOSD), Multiple Sclerosis (MS), and other Central Nervous System Inflammatory Demyelinating Diseases that meet diagnostic criteria;
- Patients with SDMT scores <55 or subjective cognitive decline;
- Age between 18 and 65 years, gender unrestricted;
- Hamilton Anxiety and Depression Scale scores <7 points for both scales;
- No relapse or medication changes in the past month;
Key exclusion criteria (11 listed)
- Relapse record within the past month;
- Medication adjustment within the past month or having undergone modified electroconvulsive therapy, transcranial magnetic stimulation, or other neuromodulation techniques;
- Participating in any other clinical research within 1 month prior to enrollment or currently;
- Presence of cochlear hearing aids, cardiac pacemakers, or implanted brain stimulation devices;
- Skin integrity damage at electrode placement sites, or allergy 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 |
|---|---|---|
| tEShis study employs a randomized controlled trial (RCT) design, randomly dividing eligible participants into a neuromodulation group and a sham neuromodulation group. Neuromodulation Group: Receive individualized transcranial electrical stimulation (tES) treatment Combined with cognitive training Stimulation parameters: Total current: approximately 2mA Duration: 21 minutes Electroencephalogram (EEG) and multimodal MRI monitoring before and after electrical stimulation | Device | Neuromodulation Group |
| tESUse the same device and procedure as the neuromodulation group Stimulation device automatically turns off after 30 seconds Maintain device connection Design creates similar initial sensations to actual stimulation Maintains the double-blind nature of the study | Device | sham Neuromodulation Group |
Primary outcome
Change in Auditory Verbal Learning Test (AVLT) Score
Time frame: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).
The Auditory Verbal Learning Test (AVLT) evaluates verbal learning and memory performance. The AVLT consists of multiple components, including immediate recall, delayed recall, and recognition memory. The immediate recall score is obtained from three consecutive learning trials and ranges from 0 to 36. The 5-minute delayed recall score ranges from 0 to 12, and the 20-minute delayed recall score ranges from 0 to 12. The recognition score ranges from 0 to 24 after interference trials. Higher scores indicate better cognitive performance.
8 secondary outcomes
Change in Symbol Digit Modalities Test (SDMT) Score
Time frame: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).
Change in EEG Power Spectral Density
Time frame: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).
Change in Resting-State Functional MRI Network Connectivity
Time frame: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).
Change in Fractional Anisotropy (FA)
Time frame: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).
Change in EEG Functional Connectivity
Time frame: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).
Change in Mean Diffusivity (MD)
Time frame: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).
Change in Axial Diffusivity (AD)
Time frame: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).
Change in Radial Diffusivity (RD)
Time frame: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).
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 19 Aug 2026.
- 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 tES 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 8 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 19 Aug 2026. 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 Jun wei 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?
Change in Auditory Verbal Learning Test (AVLT) Score (time frame: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).). 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 19 Aug 2026.