Effectiveness of Personalized Alternating Current Stimulation for Treating Emotional Disorders in CNS Demyelination Patients

Capital Medical University

Status: Enrolling

Conditions: Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System

Treatments: Device: Neuroelectrics StarStim 32

Study type: Interventional

Funder types: Other

Identifiers

NCT06933537

xw-tES-02

Details and patient eligibility

About

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.

Enrollment: 65 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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65 participants in 2 patient groups

Neuromodulation Group

Active Comparator group

Treatment:

Device: Neuroelectrics StarStim 32

Device: Neuroelectrics StarStim 32

Sham-Neuromodulation Group

Sham Comparator group

Treatment:

Device: Neuroelectrics StarStim 32

Device: Neuroelectrics StarStim 32