Assessment of Transcranial Alternating Current Stimulation's Clinical Efficacy in Treating Cognitive Impairment of Idiopathic Inflammatory Demyelinating Diseases (TACS-CI-IIDDs)

Capital Medical University

Status: Enrolling

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

Treatments: Device: Pseudo-neuromodulation group; Device: Neuroelectrical modulation group

Study type: Interventional

Funder types: Other

Identifiers

NCT07087873

[2025]086-002

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 2 patient groups, including a placebo group

Neuromodulation group

Active Comparator group

Treatment:

Device: Neuroelectrical modulation group

Pseudoneuromodulation group

Placebo Comparator group

Treatment:

Device: Pseudo-neuromodulation group