The Effects of Transcranial Current Stimulation on Insomnia

NCT07340268 | Recruiting

• 1 other identifier: TCS-V01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Effect of transcranial current stimulation on insomnia disorder

Conditions

Insomnia, Psychophysiological

Outcome Measures

Primary Outcomes (6)

• Change in global blood-oxygen-level-dependent (gBOLD) signal amplitude

  The amplitude of the global blood-oxygen-level-dependent (gBOLD) signal was derived from resting-state functional MRI and reflects the overall magnitude of spontaneous brain activity. Unit of Measure: Z-score

  2 weeks and 3 months

• Change in resting-state functional connectivity strength

  Resting-state functional connectivity strength was calculated as the correlation coefficient between predefined brain regions based on functional magnetic resonance imaging data.

  2 weeks and 3 months

• Change in amplitude of low-frequency fluctuations

  Amplitude of low-frequency fluctuations was calculated from resting-state fMRI to quantify spontaneous neural activity.

  2 weeks and 3 months

• Change in regional homogeneity

  Regional homogeneity was used to assess the synchronization of local spontaneous brain activity

  2 weeks and 3 months

• Change in phase difference of dynamic cerebral autoregulation

  Dynamic cerebral autoregulation was assessed using the phase difference between cerebral blood flow velocity and arterial blood pressure fluctuations. Larger phase differences indicate better autoregulatory function.

  2 weeks and 3 months

• Change in gain of dynamic cerebral autoregulation

  Gain represents the magnitude of cerebral blood flow velocity changes in response to blood pressure fluctuations, with lower gain values indicating more effective autoregulation.

  2 weeks and 3 months

Secondary Outcomes (10)

• the score of Insomnia Severity Index scale

  2 weeks and 3 months

• the score of 14-item Hamilton anxiety rating scale

  2 weeks and 3 months

• the score of 17-item Hamilton depression rating scale

  2 weeks and 3 months

• Change in plasma corticotropin-releasing factor (CRF) level

  2 weeks and 3 months

• Change in plasma cortisol level

  2 weeks and 3 months

Study Arms (2)

active transcranial current stimulation

ACTIVE COMPARATOR

14 daily 20-min, 1.1-mA sessions of active or sham transcranial current stimulation, at the beginning and end of treatment, there is a 30 second period of current fading in and out

Device: transcranial current stimulation

sham transcranial current stimulation

SHAM COMPARATOR

only wore the device and had no stimulation

Device: Sham stimulation

Interventions

Sham stimulation DEVICE

only wore the device and had no stimulation

sham transcranial current stimulation

transcranial current stimulation DEVICE

consecutive daily 20-min, 1.1-mA sessions

active transcranial current stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of insomnia disorder
• Cooperate to complete the questionnaire surveys

You may not qualify if:

• Presence of mental disorders
• Current use of central nervous system stimulants
• Use of analgesics,sedatives or hypnotic medications, theophylline preparations, steroid medications
• Alcohol abuse or regular alcohol consumption
• Diagnosis of other sleep disorders, including obstructive sleep apnea, rapid eye movement sleep behavior disorder, or restless legs syndrome
• Sleep disorders secondary to organic diseases, such as epilepsy, diabetes, or renal failure
• Shift work or irregular work schedules that disrupt normal circadian rhythms
• Use of medications affecting central nervous system function within the past one month
• Recent sleep-related confounding behaviors within the past two weeks, including staying up late, alcohol consumption, or smoking
• Presence of organic brain lesions on head MRI and contraindications to MRI examination

Sponsors & Collaborators

• Zan Wang: lead

Study Sites (2)

the First Hospital of Jilin University

Ch’ang-ch’un, Jilin, 130021, China

COMPLETED

the First Hospital of Jilin University

Ch’ang-ch’un, Jilin, 130021, China

RECRUITING

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

Central Study Contacts

Zan Wang, MD, PhD

CONTACT

+86 88782678; wangzan@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sleep Center Director

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 14, 2026
• Study Start: January 18, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

CN (2)