Clinical trial NCT06933537: Effectiveness of Personalized Alternating Current Stimulation for Treating Emotional Disorders in CNS Demyelination Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: HAMA (Hamilton Anxiety Rating Scale)
timeFrame: From enrollment to the end of treatment at 1month
measure: HADS (Hospital Anxiety and Depression Scale)
timeFrame: From enrollment to the end of treatment at 1month
measure: SPS (Social Phobia Scale)
timeFrame: From enrollment to the end of treatment at 1month
measure: PSWQ (Penn State Worry Questionnaire)
timeFrame: From enrollment to the end of treatment at 1month
Secondary outcomes:
measure: EDSS (Expanded Disability Status Scale)
timeFrame: From enrollment to 1 month later
measure: FSS (Fatigue Severity Scale)
timeFrame: From enrollment to 1 month later
measure: HAMD (Hamilton Depression Rating Scale)
timeFrame: From enrollment to 1 month later
measure: MMSE (Mini-Mental State Examination)
timeFrame: From enrollment to 1 month later
measure: MoCA (Montreal Cognitive Assessment)
timeFrame: From enrollment to 1 month later
measure: SDMT (Symbol Digit Modalities Test)
timeFrame: From enrollment to 1 month later
measure: DST (DigiScan Test)
timeFrame: From enrollment to 1 month later
measure: BVMT (Brief Visuospatial Memory Test)
timeFrame: From enrollment to 1 month later
measure: NRS (Numerical Rating Scale)
timeFrame: From enrollment to 1 month later
measure: SF-MPQ (Short-Form McGill Pain Questionnaire)
timeFrame: From enrollment to 1 month later
measure: ESS (Epworth Sleepiness Scale)
timeFrame: From enrollment to 1 month later
measure: Ashworth Scale
timeFrame: From enrollment to 1 month later
measure: SF-36 (Short Form 36 Health Survey)
timeFrame: From enrollment to 1 month later
measure: CGI-I (Clinical Global Impression - Improvement)
timeFrame: From enrollment to 1 month later
measure: EGI Recording EEG Data and MRI Data
timeFrame: From enrollment to 1 month later
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
References: