Clinical Efficacy and Mechanism of High Definition tDCS Based on dmPFC in the Intervention of Chronic Insomnia

Last updated: March 4, 2025
Sponsor: WANG KAI
Overall Status: Completed

Phase

N/A

Condition

Insomnia

Restless Leg Syndrome

Treatment

transcranial direct current stimulation

sham transcranial direct current stimulation

Clinical Study ID

NCT06290492
AHMU-tDCS-insomnia
  • Ages 15-65
  • All Genders

Study Summary

To investigate the intervention effect of transcranial direct current stimulation (tDCS) on subjective and objective insomnia symptoms and daytime function of chronic insomnia patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. age between 15 and 65 years,

  2. diagnosed with chronic insomnia based on the Diagnostic Criteria and TreatmentGuidelines for Adult Insomnia (2017),

  3. no previous application of any insomnia pharmacological therapy for at least oneweek before baseline visit.

Exclusion

Exclusion Criteria:

  1. diagnosis of other sleep disorders, such as sleep apnoea-hypopnoea syndrome, REMbehaviour disorder, and restless legs syndrome,

  2. history of head trauma or presence of serious organic diseases,

  3. presence of comorbid anxiety or depression, as assessed by a Hamilton Anxiety Scale [HAMA] score of 17 or Hamilton Depression Scale [HAMD] score of 14.

Study Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: transcranial direct current stimulation
Phase:
Study Start date:
May 01, 2023
Estimated Completion Date:
November 01, 2024

Study Description

Fifty patients with chronic insomnia disorder diagnosed by the Diagnostic Criteria and Treatment Guidelines for Adult Insomnia (2017) were recruited from the first affiliated Hospital of Anhui Medical University. After meeting the inclusion criteria and obtaining informed consent, each participant will complete the subjective measures consisting of sleep questionnaires, polysomnography (PSG) and tDCS treatment conducted by trained researchers at the Neurology Department of Anhui Medical University. All the participants were randomized (1:1) to receive "active" or "sham" treatment protocol. The anode electrode was placed on the DMPFC (Fz) surrounded by four cathodes with a 1cm diameter (FPz, F3, Cz, and F4). Each participant received 30 min of tDCS stimulation once daily for 10 consecutive days. The stimulation direct current magnitude was set at 2 mA in the active group. In the sham intervention phase, the sensation was simulated by applying a 30s rising current until 2 mA was reached, with a 30s immediate decline at the beginning and end of each phase.

At the beginning and after a 10-day intervention, subjective measures consisting of sleep questionnaires, including the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI), were assessed. The Flinders Fatigue Scale (FFS) and the Epworth Sleepiness Scale (ESS) were used to assess daytime sleepiness. Additionally, the HAMA and HAMD were used synchronously for emotional assessment. Afterwards, they were unblinded by the study coordinator.

Connect with a study center

  • Anhui Medical University

    Hefei, Anhui
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.