Effectiveness of Personalized Alternating Current Stimulation for Trea
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
What it found
No result yet.
What was tested
Treatment tested
- Neuroelectrics StarStim 32
Placebo
- Neuroelectrics StarStim 32
What it measured
Main measures
HAMA (Hamilton Anxiety Rating Scale)
From enrollment to the end of treatment at 1month
Mood and sleepHADS (Hospital Anxiety and Depression Scale)
From enrollment to the end of treatment at 1month
Mood and sleepSPS (Social Phobia Scale)
From enrollment to the end of treatment at 1month
Mood and sleepPSWQ (Penn State Worry Questionnaire)
From enrollment to the end of treatment at 1month
Mood and sleep
Other measures (15)
EDSS (Expanded Disability Status Scale)
From enrollment to 1 month later
Disability progressionFSS (Fatigue Severity Scale)
From enrollment to 1 month later
FatigueHAMD (Hamilton Depression Rating Scale)
From enrollment to 1 month later
Mood and sleepMMSE (Mini-Mental State Examination)
From enrollment to 1 month later
Thinking and memoryMoCA (Montreal Cognitive Assessment)
From enrollment to 1 month later
Thinking and memorySDMT (Symbol Digit Modalities Test)
From enrollment to 1 month later
Thinking and memoryDST (DigiScan Test)
From enrollment to 1 month later
Thinking and memoryBVMT (Brief Visuospatial Memory Test)
From enrollment to 1 month later
Thinking and memoryNRS (Numerical Rating Scale)
From enrollment to 1 month later
PainSF-MPQ (Short-Form McGill Pain Questionnaire)
From enrollment to 1 month later
Pain
Who could take part
MS (type not specified) · 18 to 65
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
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History
Started
Dec 2024
Main results due
Jul 2027
Finished
Oct 2027