A Preliminary Study of Model-driven Individualized Transcranial Electrical Stimulation for Insomnia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Insomnia Severity Index
Study Overview
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 is an open-label clinical trial. A total of 40 patients with insomnia who meet the inclusion and exclusion of criteria will be recruited from the SMHC (20) and be assigned to receive individualized tDCS treatment. Patients will undergo ten days of daily individualized tDCS treatment for 20 min (sessions 2-11, SMHC) over a two-week period, which session 7 of patients for re-screening of tDCS target. In addition, normal control subjects and insomnia patients meeting eligibility criteria will be recruited from SMHC to identify biomarkers of wakefulness and sleep through simultaneous fMRI-EEG and high-density EEG recordings. These participants will not receive tDCS and will serve as controls for comparison with the treatment group.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants will be recruited from the Shanghai Mental Health Center (SMHC) in Shanghai. Eligible insomnia participants were adults (18-50 years at SMHC) and diagnosed with insomnia disorder according to DSM-5 criteria by neurologists or psychiatrists using the procedure of Mini-International Neuropsychiatric Interview. Inclusion criteria were: (1) ≥ 9 years of education, (2) medication-free or had received stable medication for at least 2 months before entering the study and continued the same medication throughout the study.
Exclusion Criteria
- •included: (1) serious medical, neurological, or psychiatric disorders other than anxiety or mild-to-moderate depression secondary to insomnia, (2) obstructive sleep apnea syndrome, (3) pregnancy or recent preparation for pregnancy, (4) previous treatments with ECT, rTMS, tES, and CBT-I.
Arms & Interventions
tES treatment
Patients will receive ten sessions of daily individualized tDCS over a two-week period, delivered for 20 min at SMHC (sessions 2-11).
Intervention: High-Definition transcranial electrical stimulation (Device)
Outcomes
Primary Outcomes
Insomnia Severity Index
Time Frame: At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6, SMHC)
The primary outcome is measured as the Insomnia Severity Index (ISI) at baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6, SMHC).
Secondary Outcomes
- Change in Side-effect questionnaire(At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6).)
- Pittsburgh Sleep Quality Index (PSQI)(At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6))
- Change in Beck Depression Inventory, BDI(At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6))
- Change in Beck Anxiety Inventory, BAI(At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6))
- sleep Diary(At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3))
- Remission Rate(week 2, weeks 3 and week 6)
Investigators
Zhen Wang
vice-president
Shanghai Mental Health Center