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

NCT ID: NCT06933537

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-29
• Study Completion Date: 2027-10-01

Brief Summary

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.

Conditions

Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Neuromodulation Group

Group Type: ACTIVE_COMPARATOR

Neuroelectrics StarStim 32

Intervention Type: DEVICE

Using the advanced Neuroelectrics StarStim 32 device from Spain, individualized imaging modeling systems are employed to precisely target the frontal cortex. Personalized EEG-guided electrical stimulation protocols are selected. The stimulation parameters are as follows: a current intensity of 2 mA, a duration of 21 minutes per session, once daily for five consecutive days, with EEG monitoring conducted before and after electrical stimulation.

Sham-Neuromodulation Group

Group Type: SHAM_COMPARATOR

Neuroelectrics StarStim 32

Intervention Type: DEVICE

Sham stimulation is performed using the same device and procedures as the neuromodulation group. The stimulator automatically shuts off after 30 seconds, while maintaining the device's connection. This design creates an initial sensation similar to actual stimulation while preserving the double-blind nature of the study.

Interventions

Neuroelectrics StarStim 32

Using the advanced Neuroelectrics StarStim 32 device from Spain, individualized imaging modeling systems are employed to precisely target the frontal cortex. Personalized EEG-guided electrical stimulation protocols are selected. The stimulation parameters are as follows: a current intensity of 2 mA, a duration of 21 minutes per session, once daily for five consecutive days, with EEG monitoring conducted before and after electrical stimulation.

Intervention Type: DEVICE

Neuroelectrics StarStim 32

Sham stimulation is performed using the same device and procedures as the neuromodulation group. The stimulator automatically shuts off after 30 seconds, while maintaining the device's connection. This design creates an initial sensation similar to actual stimulation while preserving the double-blind nature of the study.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

junwei Hao, MD

Role: CONTACT

haojunwei@vip.163.com

01083198277

Facility Contacts

zhao

Role: primary

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Other Identifiers

xw-tES-02

Identifier Type: -

Identifier Source: org_study_id