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Recruiting NCT06933537

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

No phase Interventional Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neuroelectrics StarStim 32, Neuroelectrics StarStim 32.
Who it may be relevant to
Registry conditions: Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Device 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.
  • 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.

Primary outcome measures

  • HAMA (Hamilton Anxiety Rating Scale) [Time frame: From enrollment to the end of treatment at 1month]
  • HADS (Hospital Anxiety and Depression Scale) [Time frame: From enrollment to the end of treatment at 1month]
  • SPS (Social Phobia Scale) [Time frame: From enrollment to the end of treatment at 1month]
  • PSWQ (Penn State Worry Questionnaire) [Time frame: From enrollment to the end of treatment at 1month]
Secondary outcome measures (12)
  • EDSS (Expanded Disability Status Scale) [Time frame: From enrollment to 1 month later]
  • FSS (Fatigue Severity Scale) [Time frame: From enrollment to 1 month later]
  • HAMD (Hamilton Depression Rating Scale) [Time frame: From enrollment to 1 month later]
  • MMSE (Mini-Mental State Examination) [Time frame: From enrollment to 1 month later]
  • MoCA (Montreal Cognitive Assessment) [Time frame: From enrollment to 1 month later]
  • SDMT (Symbol Digit Modalities Test) [Time frame: From enrollment to 1 month later]
  • DST (DigiScan Test) [Time frame: From enrollment to 1 month later]
  • BVMT (Brief Visuospatial Memory Test) [Time frame: From enrollment to 1 month later]
  • NRS (Numerical Rating Scale) [Time frame: From enrollment to 1 month later]
  • SF-MPQ (Short-Form McGill Pain Questionnaire) [Time frame: From enrollment to 1 month later]
  • ESS (Epworth Sleepiness Scale) [Time frame: From enrollment to 1 month later]
  • Ashworth Scale [Time frame: From enrollment to 1 month later]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Xuanwu Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT06933537 · xw-tES-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗