Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous SystemTACS-CI-IIDDsNCT07087873
Assessment of Transcranial Alternating Current Stimulation's Clinical Efficacy in Treating Cognitive Impairment of Idiopathic Inflammatory Demyelinating Diseases
A study testing Neuroelectrical modulation group and Pseudo-neuromodulation group in people with Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System and MS (Multiple Sclerosis), run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This study aims to explore the imaging and electrophysiological characteristics of idiopathic inflammatory demyelinating diseases (IIDDs), and their correlation with clinical manifestations. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System, MS (Multiple Sclerosis), NMOSD
- What is being tested?
- Neuroelectrical modulation group and Pseudo-neuromodulation group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2025to 31 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-60 years old.
- Diagnosis: Patients with neuromyelitis optica spectrum disease, multiple sclerosis and other inflammatory demyelinating diseases of the central nervous system that meet the diagnostic criteria.
- Medications have been stable for at least three months.
Who cannot join
- Recurrence has been recorded in the past 3 months.
- Have a pacemaker or other metal implant in the body.
- Impaired skin integrity at the site of electrode placement.
- Previous organic brain disease such as epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infection.
- Combined with severe or unstable organic diseases, such as heart, liver and kidney and other organ dysfunction.
- Pregnant or lactating women, those who are planning to become pregnant in the near future.
- Patient compliance is poor.
- In the opinion of the investigator, there is a situation that is not suitable to participate in this study.
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, 100053
Huijin Huang, Ph.D., 18510510804, huanghuijinmail@sina.com
About this study
This study aims to explore the imaging and electrophysiological characteristics of idiopathic inflammatory demyelinating diseases (IIDDs), and their correlation with clinical manifestations. It also evaluates the effectiveness of transcranial electrical stimulation in alleviating clinical symptoms of IIDDs patients, and analyzes the key factors affecting the treatment efficacy. By uncovering the overall and individual characteristics of IIDDs, this study seeks to enhance therapeutic outcomes through personalized neuromodulation programs. The findings will provide a basis for applying non-invasive brain stimulation (NIBS) in IIDDs treatment and offer new ideas for future personalized medicine approaches.
- Conditions
- Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System, MS (Multiple Sclerosis), NMOSD, Acute Disseminated Encephalomyelitis, Transcranial Alternating Current Stimulation
- Being tested
- Neuroelectrical modulation group, Pseudo-neuromodulation group
- Medical subject headings
- Multiple Sclerosis, Encephalomyelitis, Acute Disseminated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroelectrical modulation groupDevice
Participants received transcranial electrical stimulation using the Spanish Neuroelectrics StarStim 32 device.
Pseudo-neuromodulation groupDevice
Pseudo-stimulation is performed using the same equipment and procedures as in the neuromodulation group.
| Study group | Role | What they receive |
|---|---|---|
| Neuromodulation group | Active comparator | Not described Receives: Device: Neuroelectrical modulation group |
| Pseudoneuromodulation group | Placebo comparator | Not described Receives: Device: Pseudo-neuromodulation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expanded Disability Status Scale, EDSS score
0-10 points, the higher the score, the more serious
Measured: At the 5-day point of treatment and 1 month following the end of treatment
Symbol Digit Modalities Test (SDMT) scale
0-110 points, the higher the score, the better the cognitive function
Measured: At the 5-day point of treatment and 1 month following the end of treatment
Scoring results for tasks 1 and 7 in the Alzheimer disease assessment scale-cog(ADAS-cog)
the higher the score, the better the cognitive function
Measured: At the 5-day point of treatment and 1 month following the end of treatment
Secondary outcomes (6)
Mini-mental State Examination（MMSE）
0-30，the higher the score, the better the cognitive function
Measured: At the 5-day point of treatment and 1 month following the end of treatment
Montreal-Cognitive Assessment（MoCA）
0-30，the higher the score, the better the cognitive function
Measured: At the 5-day point of treatment and 1 month following the end of treatment
Stroop Color-Word Test score
the higher the score, the better the cognitive function
Measured: At the 5-day point of treatment and 1 month following the end of treatment
Hamilton Depression Scale，HAMD
The higher the score, the worse the depression.
Measured: At the 5-day point of treatment and 1 month following the end of treatment
Hamilton Anxiety Scale，HAMA
The higher the score, the worse the anxiety.
Measured: At the 5-day point of treatment and 1 month following the end of treatment
a subjective questionnaire，adverse effects
The intensity is scored from 0 to 4
Measured: Following the first day of treatment，Following the second day of treatment，Following the third day of treatment，Following the fourth day of treatment，Following the fifth day of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start30 May 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 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, Investigator
- Enrolment
- 128 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
- NCT07087873
- Sponsor's protocol ID
- [2025]086-002
- Acronym
- TACS-CI-IIDDs
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 28 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 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Transcranial Alternating Current Stimulation's Clinical Efficacy in Treating Cognitive Impairment of Idiopathic Inflammatory Demyelinating Diseases
- ClinicalTrials.gov ID
- NCT07087873
- Acronym / sponsor ID
- TACS-CI-IIDDs / [2025]086-002
- Conditions
- Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System, MS (Multiple Sclerosis), NMOSD, Acute Disseminated Encephalomyelitis, Transcranial Alternating Current Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 28 Jul 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 aims to explore the imaging and electrophysiological characteristics of idiopathic inflammatory demyelinating diseases (IIDDs), and their correlation with clinical manifestations. It also evaluates the effectiveness of transcranial electrical stimulation in alleviating clinical symptoms of IIDDs patients, and analyzes the key factors affecting the treatment efficacy. By uncovering the overall and individual characteristics of IIDDs, this study seeks to enhance therapeutic outcomes through personalized neuromodulation programs. The findings will provide a basis for applying non-invasive brain stimulation (NIBS) in IIDDs treatment and offer new ideas for future personalized medicine approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromodulation group | Active comparator | Device: Neuroelectrical modulation group |
| Pseudoneuromodulation group | Placebo comparator | Device: Pseudo-neuromodulation group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 18-60 years old.
- Diagnosis: Patients with neuromyelitis optica spectrum disease, multiple sclerosis and other inflammatory demyelinating diseases of the central nervous system that meet the diagnostic criteria.
- Medications have been stable for at least three months.
Key exclusion criteria (8 listed)
- Recurrence has been recorded in the past 3 months.
- Have a pacemaker or other metal implant in the body.
- Impaired skin integrity at the site of electrode placement.
- Previous organic brain disease such as epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infection.
- Combined with severe or unstable organic diseases, such as heart, liver and kidney and other organ dysfunction.
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 |
|---|---|---|
| Neuroelectrical modulation groupParticipants received transcranial electrical stimulation using the Spanish Neuroelectrics StarStim 32 device. | Device | Neuromodulation group |
| Pseudo-neuromodulation groupPseudo-stimulation is performed using the same equipment and procedures as in the neuromodulation group. | Device | Pseudoneuromodulation group |
Primary outcome
Expanded Disability Status Scale, EDSS score
Time frame: At the 5-day point of treatment and 1 month following the end of treatment
0-10 points, the higher the score, the more serious
Symbol Digit Modalities Test (SDMT) scale
Time frame: At the 5-day point of treatment and 1 month following the end of treatment
0-110 points, the higher the score, the better the cognitive function
Scoring results for tasks 1 and 7 in the Alzheimer disease assessment scale-cog(ADAS-cog)
Time frame: At the 5-day point of treatment and 1 month following the end of treatment
the higher the score, the better the cognitive function
6 secondary outcomes
Mini-mental State Examination（MMSE）
Time frame: At the 5-day point of treatment and 1 month following the end of treatment
Montreal-Cognitive Assessment（MoCA）
Time frame: At the 5-day point of treatment and 1 month following the end of treatment
Stroop Color-Word Test score
Time frame: At the 5-day point of treatment and 1 month following the end of treatment
Hamilton Depression Scale，HAMD
Time frame: At the 5-day point of treatment and 1 month following the end of treatment
Hamilton Anxiety Scale，HAMA
Time frame: At the 5-day point of treatment and 1 month following the end of treatment
a subjective questionnaire，adverse effects
Time frame: Following the first day of treatment，Following the second day of treatment，Following the third day of treatment，Following the fourth day of treatment，Following the fifth day of treatment
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 28 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 Neuroelectrical modulation group and Pseudo-neuromodulation group in people with Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System and MS (Multiple Sclerosis), 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 3 inclusion and 8 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 28 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. 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 huang huijin, Ph.D. (+8618510510804, huanghuijinmail@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expanded Disability Status Scale, EDSS score (time frame: At the 5-day point of treatment and 1 month following the end of treatment). The study lists 3 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 28 Jul 2025.