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This study is designed to evaluate the efficacy and to explore the best individualized stimulus paradigm of transcranial Electrical Stimulation for insomnia patients.
Full description
Twelve insomnia patients in Shanghai Mental Health Center who met the inclusion criteria will be recruited for transcranial electrical stimulation intervention. According to the patients' magnetic resonance structure and high density eeg parameters, personalized modeling was carried out to determine the specific stimulus parameter scheme.The stimulation will be performed for 2 weeks, once a night on weekdays, 10 times in total, and each stimulation will last for 20 minutes. Sleep rhythms will be recorded using a wearable device. Symptom assessment, magnetic resonance and high-density eeg data will be taken after the stimulation, and again 1 week after the stimulation.If the treatment is effective or clinical remission is achieved, the next cycle of stimulation will not be performed; If the treatment does not work, the patients choose to end the study or conduct modeling again to adjust the parameters and continue the next cycle of stimulation according to their wishes. For patients who choose to continue stimulation, the stimulation time of each cycle is still 2 weeks, once every night on weekdays, 10 times in total for each cycle, lasting 20 minutes each time. Each patient received up to four cycles of stimulation.
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Inclusion criteria
Between 18 and 50 years old;
The patients were diagnosed as insomnia according to the diagnostic and Statistical Manual of Mental Disorders (DSM-5) and Mini-International Neuropsychiatric Interview (M.I.N.I.) .
Exclusion criteria
Past or current DSM-5 diagnoses other than insomnia, anxiety disorder and depressive disorder
Severe anxiety or depression (HAMD-17 > 23 points or HAMA > 30 points)
Patients with obstructive sleep apnea syndrome;
Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.
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12 participants in 1 patient group
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Central trial contact
Zhen Wang; Zhen Wang
Data sourced from clinicaltrials.gov
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