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

Shanghai Mental Health Center20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Insomnia

Interventions

High-Definition transcranial electrical stimulationDEVICE

The first and final sessions will include clinical assessments and acquisition of MRI and EEG data. To minimize variability, each patient will undergo tDCS at a consistent time in the afternoon or evening and will remain lying in bed with eyes closed throughout stimulation. Stimulation will be delivered using the GTEN 200 system (Magstim EGI, Oregon, USA), which also enables simultaneous EEG recording. The stimulation current will be limited to 1.5 mA, with a maximum of 0.15 mA per electrode (up to 20 electrodes). Electrode placement and current intensity will be individualized to achieve the targeted electric field strength (0.1 or 0.2 V/m at SMHC;). Each session will include 5 min of resting-state EEG immediately before and after stimulation to assess tDCS-induced changes in brain dynamics. Current onset and offset will be gradual, with 2-s ramp-up and ramp-down periods.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Insomnia Severity Index

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).

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)

Secondary Outcomes

Pittsburgh Sleep Quality Index (PSQI)

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)

Change in Beck Depression Inventory, BDI

It consists of 21 items and uses a 0 to 3 severity scale. Total scores range from 0 to 63, with higher scores indicating more severe depression symptoms.

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)

Change in Beck Anxiety Inventory, BAI

It is an inventory of anxiety symptoms with 18 items that are rated on a 5-point Likert scale(0 to 4). Total scores range from 0 to 72, with higher scores indicating more severe anxiety symptoms.

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)

Change in Side-effect questionnaire

It consists of 10-item and uses 0 to 3 severity scale to rate the intensity of side effects. Total scores range from 0 to 30, with higher scores indicating more severe side-effect. It also assesses the relation between side-effect and the effects of tDCS using 0 to 4 scale. Total scores range from 0 to 40, with higher score indicating the greater relation.

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).

Data from ClinicalTrials.gov

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