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

NCT06933537 | Recruiting

• 1 other identifier: xw-tES-02
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• HAMA (Hamilton Anxiety Rating Scale)

  A clinician-administered scale used to assess the severity of a patient's anxiety based on a series of symptoms. Range: 0-56 Higher Scores: Indicate more severe anxiety. Purpose: Used to evaluate the severity of anxiety symptoms in patients, primarily in clinical and research settings.

  From enrollment to the end of treatment at 1month

• HADS (Hospital Anxiety and Depression Scale)

  Description: A self-report scale used to identify the levels of anxiety and depression in patients, particularly in a hospital setting. It consists of 14 items, split into two subscales: one for anxiety and one for depression. Range: 0-42 (for each subscale) Higher Scores: Indicate higher levels of anxiety or depression. Purpose: Used for screening and evaluating the severity of anxiety and depression in patients, especially those with physical illnesses.

  From enrollment to the end of treatment at 1month

• SPS (Social Phobia Scale)

  A self-report scale used to measure the severity of social anxiety or social phobia. Range: 0-120 Higher Scores: Indicate greater severity of social anxiety. Purpose: Used to assess the intensity of social anxiety and its impact on the individual's daily life.

  From enrollment to the end of treatment at 1month

• PSWQ (Penn State Worry Questionnaire)

  A self-report scale used to assess the frequency and intensity of a person's worry. Range: 16-80 Higher Scores: Indicate more frequent and intense worry. Purpose: Primarily used in research and clinical settings to evaluate generalized anxiety and worry tendencies.

  From enrollment to the end of treatment at 1month

Secondary Outcomes (15)

• EDSS (Expanded Disability Status Scale)

  From enrollment to 1 month later

• FSS (Fatigue Severity Scale)

  From enrollment to 1 month later

• HAMD (Hamilton Depression Rating Scale)

  From enrollment to 1 month later

• MMSE (Mini-Mental State Examination)

  From enrollment to 1 month later

• MoCA (Montreal Cognitive Assessment)

  From enrollment to 1 month later

Study Arms (2)

Neuromodulation Group

ACTIVE COMPARATOR

Device: Neuroelectrics StarStim 32

Sham-Neuromodulation Group

SHAM COMPARATOR

Device: Neuroelectrics StarStim 32

Interventions

Neuroelectrics StarStim 32 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.

Neuromodulation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

RECRUITING

Central Study Contacts

junwei Hao, MD

CONTACT

01083198277; haojunwei@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: April 18, 2025
• Study Start: December 29, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)