Clinical trial NCT05445999: A Preliminary Study of Model-driven Individualized Transcranial Electrical Stimulation for Insomnia
Official title: A Preliminary Study of Model-driven Individualized Transcranial Electrical Stimulation for Insomnia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: Transcranial electrical stimulation
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the efficacy and to explore the best individualized stimulus paradigm of transcranial Electrical Stimulation for insomnia patients.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in sleep latency
timeFrame: Up to 3 months
measure: Change in sleep time
timeFrame: Up to 3 months
measure: Change in sleep efficiency
timeFrame: Up to 3 months
measure: Change in Pittsburgh Sleep Quality Index(PSQI)
timeFrame: Up to 3 months
Secondary outcomes:
measure: Change in Insomnia Severity Index，ISI
timeFrame: Up to 3 months
measure: Change in Epworth Sleepiness Scale, ESS
timeFrame: Up to 3 months
measure: Change in Ford Insomnia Response to Stress Test, FIRST
timeFrame: Up to 3 months
measure: Change in Beck Depression Inventory, BDI
timeFrame: Up to 3 months
measure: Change in Beck Anxiety Inventory, BAI
timeFrame: Up to 3 months
measure: Change in Side-effect questionnaire
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Zhen Wang, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References: