Effectiveness of Personalized Alternating Current Stimulation for Treating Emotional Disorders in CNS Demyelination Patients
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
Xuanwu Hospital, Beijing
65 participants
Dec 29, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria11
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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 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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06933537