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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Insomnia; Transcranial Direct Current Stimulation
• Intervention / Treatment: Device: transcranial direct current stimulation; Device: sham transcranial direct current stimulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kai Wang, PhD; Phone Number: +86-0551-62923704; Email: baiyunong1990@163.com
• Study Contact Backup: Name: Chengjuan Xie; Phone Number: +8615656989777; Email: xie_chengjuan@126.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • Anhui Medical University
      • Contact: Kai Wang, PhD; Phone Number: +86-0551-62923704; Email: wangkai1964@126.com
      • Contact: Chengjuan Xie; Phone Number: +8615656989777; Email: xie_chengjuan@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. diagnosis of other sleep disorders, such as sleep apnoea-hypopnoea syndrome, REM behaviour 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: real stimulation; 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; 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
Sham Comparator: sham stimulation; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
emotional symptoms assessed by the HAMA	The HAMA is a 14-item scale to measure the severity of anxiety symptoms, where each item is rated on a scale from 0 to 4. The HAMA total score ranges from 0 to 56, with lower scores indicating less anxiety symptoms.	before and after 10-day intervention
emotional symptoms assessed by the HAMD	The HAMD is a clinic ian-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome.	before and after 10-day intervention

Collaborators and Investigators

• Sponsor: WANG KAI

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): December 30, 2023
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: December 28, 2023
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Estimated): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Insomnia; HD-tDCS
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: AHMU-tDCS-insomnia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No