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

NCT06290492 | Completed

• 1 other identifier: AHMU-tDCS-insomnia
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Insomnia; Transcranial Direct Current Stimulation

Keywords

Chronic Insomnia; HD-tDCS

Outcome Measures

Primary Outcomes (5)

• subjective sleep quality assessed by the PSQI

  The Pittsburgh Sleep Quality Index (PSQI) consist of 18 items divided into 7 dimensions, such as sleep duration, sleep efficiency, sleep disorders and daytime dysfunction. The PSQI total score ranges from 0 to 21, the higher the score indicates the more worse sleep quality.

  before and after 10-day intervention

• subjective sleep quality assessed by the ISI

  The Insomnia Severity Index (ISI) is a 7-item scale to measure insomnia symptoms, where each item is rated on a scale from 0 to 4. The ISI total score ranges from 0 to 28, The higher the score indicates the more worse sleep quality.

  before and after 10-day intervention

• daytime sleepiness assessed by the FFS

  the Fatigue Severity Scale (FFS) is a 7-item scale to measure daytime sleepiness, where each item is rated on a scale from 0 to 3. The FFS total score ranges from 0 to 31, the higher the score indicates the more serious daytime sleepiness.

  before and after 10-day intervention

• daytime sleepiness assessed by the ESS

  The Epworth Sleepiness Scale (ESS) is a 8-item scale to measure daytime sleepiness, where each item is rated on a scale from 0 to 3. The ESS total score ranges from 0 to 23, the higher the score indicates the more serious daytime sleepiness.

  before and after 10-day intervention

• objective sleep quality assessed by the PSG

  the change of objective sleep quality assessed by polysomnography(PSG) will constitute the major research outcome measure, to assess response to tDCS. Recorded details included data on SOL(sleep onset latency), TST(total sleep time), WASO(wake after sleep onset), EF(sleep Efficiency), and percentages of slow-wave sleep, stage 2 sleep, stage 1 sleep, and REM sleep.

  before and after 10-day intervention

Secondary Outcomes (2)

• emotional symptoms assessed by the HAMA

  before and after 10-day intervention

• emotional symptoms assessed by the HAMD

  before and after 10-day intervention

Study Arms (2)

real stimulation

ACTIVE COMPARATOR

Participants will receive active HD-tDCS daily for 10 consecutive days. The anode electrode was placed on the DMPFC (Fz) surrounded by four cathodes with a 1cm diameter (FPz, F3, Cz, and F4). The stimulation direct current magnitude was set at 2 mA with a 30-s immediate decline at the beginning and end of each phase.

Device: transcranial direct current stimulation

sham stimulation

SHAM COMPARATOR

In the sham intervention phase, the sensation was simulated by applying a 30-s rising current until 2 mA was reached, with a 30-s immediate decline at the beginning and end of each phase.

Device: sham transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

tDCS is described as a non-invasive form of brain stimulation that uses a low-intensity, direct current applied directly to the head through scalp electrodes

real stimulation

sham transcranial direct current stimulation DEVICE

Sham tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.

sham stimulation

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 15 and 65 years,
• diagnosed with chronic insomnia based on the Diagnostic Criteria and Treatment Guidelines for Adult Insomnia (2017),
• no previous application of any insomnia pharmacological therapy for at least one week before baseline visit.

You may not qualify if:

• diagnosis of other sleep disorders, such as sleep apnoea-hypopnoea syndrome, REM behaviour disorder, and restless legs syndrome,
• history of head trauma or presence of serious organic diseases,
• 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.

Sponsors & Collaborators

• WANG KAI: lead

Study Sites (1)

Anhui Medical University

Hefei, Anhui, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of medical psychological department

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: March 4, 2024
• Study Start: May 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: November 1, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

CN (1)