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A Preliminary Study of Model-driven Individualized Transcranial Electrical Stimulation for Insomnia

S

Shanghai Mental Health Center

Status

Enrolling

Conditions

Insomnia

Treatments

Device: High-Definition transcranial electrical stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05445999
SMHC-ISM-001

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.) .

      • No psychiatric drugs were taken within 8 weeks before enrollment; ④ Junior high school education or above.

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.

          • Previous history of neurological diseases (such as epilepsy, cerebrovascular accidents, etc.) or brain trauma, brain surgery; ⑥Have received ECT, rTMS, tES, or cognitive behavioral therapy for insomnia; ⑦Any current significant medical condition. ⑧Women who are pregnant or planning to become pregnant recently

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

tES treatment
Experimental group
Description:
The stimulation type is cathode direct current stimulation and alternating current stimulation. The maximum stimulation current of a single channel is not more than 3mA. The frequency of electrical stimulation was 0-10Hz; DLPFC was preferentially selected for electrical stimulation, and other candidate brain regions were: orbitofrontal cortex premotor cortex, motor cortex, sensorimotor cortex, auditory cortex, posterior parietal cortex, and cerebellar cortex. The brain state changes caused by each stimulus parameter combination were compared with sleep state to determine the optimal stimulus parameters. Each cycle of stimulation was 2 weeks, once a night on weekdays, a total of 10 times
Treatment:
Device: High-Definition transcranial electrical stimulation

Trial contacts and locations

1

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Central trial contact

Zhen Wang; Zhen Wang

Data sourced from clinicaltrials.gov

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