Clinical trial NCT06671457: Model-Driven Individualized Transcranial Direct Current Stimulation for the Treatment of Insomnia Disorders
Official title: Model-Driven Individualized Transcranial Direct Current Stimulation for the Treatment of Insomnia Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: insomnia
transcranial direct current stimulation
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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: This study employs a randomized double-blind placebo-controlled design, with blinding applied to both the assessors and patients, while the therapists remain unblinded. A total of 40 patients with insomnia disorders meeting the inclusion criteria were recruited from the Shanghai Mental Health Center and randomly assigned to either the tDCS active stimulation group or the tDCS sham stimulation group, with 20 patients in each group. All patients underwent clinical assessments, magnetic resonance imaging (MRI) scans, and high-density electroencephalogram (EEG) parameter collections at baseline. Based on the MRI structural images and high-density EEG parameters, individualized modeling was conducted to determine specific stimulation parameter schemes (stimulation sites, stimulation intensity, and electrode placement methods). Detailed modeling methods and selection of stimulation parameters can be found in the intervention methods section. Stimulation was carried out for a total of 2 weeks, with one session per day on weekdays, totaling 10 sessions, each lasting thirty minutes.

Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 65 years;
2. Meets the diagnostic criteria for insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
3. Has not taken psychiatric medications in the 8 weeks prior to enrollment or has been on stable psychiatric medication for 8 weeks (excluding benzodiazepines);
4. Insomnia severity as indicated by an ISI score \> 10;
5. Minimum education level of junior high school or above.

Exclusion Criteria:

1. Past or current diagnosis of disorders other than insomnia disorder, anxiety disorder, or depressive disorder according to DSM-5;
2. Currently using benzodiazepines as sleep aids;
3. Moderate to severe anxiety or depression (HAMD-17 score \> 16 or HAMA score \> 24);
4. Patients with obstructive sleep apnea syndrome;
5. Previous treatment with ECT, rTMS, tES, or cognitive behavioral therapy for insomnia disorder;
6. Severe physical illnesses or any condition that may induce seizures or intracranial hypertension, including cardiovascular or respiratory diseases;
7. History of neurological disorders (e.g., epilepsy, cerebrovascular accidents) or history of brain injury or brain surgery;
8. Presence of implantable medical devices such as intracranial stents, cardiac pacemakers, coronary stents, or cochlear implants;
9. Severe negative thoughts or high suicide risk;
10. Pregnant or planning to conceive in the near future.

Primary outcomes:
measure: Insomnia Severity Index change
timeFrame: The study endpoint is set at 2 weeks after the end of treatment
Secondary outcomes:
measure: Insomnia Severity Index score change
timeFrame: after tDCS intervention and 4 weeks post-intervention
measure: response/remission rate
timeFrame: After tDCS intervention, 2 weeks post-intervention, and 4 weeks post-intervention
measure: Sleep onset latency, sleep efficiency, and nighttime sleep duration (as defined by the sleep diary).
timeFrame: After tDCS intervention and 2 weeks post-tDCS intervention
measure: Hamilton Depression Rating Scale-17 change
timeFrame: After tDCS intervention, 2 weeks post-tDCS intervention, and 4 weeks post-intervention
measure: Hamilton Anxiety Rating Scale Change
timeFrame: After tDCS intervention, 2 weeks post-tDCS intervention, and 4 weeks post-intervention
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: