Assessment of Transcranial Alternating Current Stimulation's Clinical Efficacy in Treating Cognitive Impairment of Idiopathic Inflammatory Demyelinating Diseases

NCT ID: NCT07087873

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-30

Study Completion Date

2027-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System MS (Multiple Sclerosis) NMOSD Acute Disseminated Encephalomyelitis Transcranial Alternating Current Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Neuromodulation group

Group Type ACTIVE_COMPARATOR

Neuroelectrical modulation group

Intervention Type DEVICE

Participants received transcranial electrical stimulation using the Spanish Neuroelectrics StarStim 32 device.

Pseudoneuromodulation group

Group Type PLACEBO_COMPARATOR

Pseudo-neuromodulation group

Intervention Type DEVICE

Pseudo-stimulation is performed using the same equipment and procedures as in the neuromodulation group.

Interventions

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Neuroelectrical modulation group

Participants received transcranial electrical stimulation using the Spanish Neuroelectrics StarStim 32 device.

Intervention Type DEVICE

Pseudo-neuromodulation group

Pseudo-stimulation is performed using the same equipment and procedures as in the neuromodulation group.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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huang huijin, Ph.D.

Role: CONTACT

+8618510510804

Facility Contacts

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Huijin Huang, Ph.D.

Role: primary

18510510804

Other Identifiers

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[2025]086-002

Identifier Type: -

Identifier Source: org_study_id

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