The Effects of Transcranial Current Stimulation on Insomnia

Effect of transcranial current stimulation on insomnia disorder

Study Overview

• Status: Recruiting
• Conditions: Insomnia, Psychophysiological
• Intervention / Treatment: Device: transcranial current stimulation; Device: Sham stimulation

Detailed Description

Insomnia disorder represents a prevalent clinical challenge, transcranial current stimulation has emerged as a promising noninvasive therapeutic approach; however, its specific effects on neurophysiological mechanisms underlying sleep-related brain structure and functional change, and neurobiological change remain unclear.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zan Wang, MD, PhD; Phone Number: +86 88782678; Email: wangzan@jlu.edu.cn

Study Locations

• China
  • Jilin
    • Ch’ang-ch’un, Jilin, China, 130021
      • Completed
      • The First Hospital of Jilin University
    • Ch’ang-ch’un, Jilin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Zan Wang Prof, PhD; Phone Number: +86-13843025938; Email: wnagzan@jlu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: active transcranial current stimulation; 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; consecutive daily 20-min, 1.1-mA sessions
Sham Comparator: sham transcranial current stimulation; only wore the device and had no stimulation	Device: Sham stimulation; only wore the device and had no stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the score of Insomnia Severity Index scale	The total score ranges from 0 to 28, and a higher score indicates higher levels of insomnia severity. A score of 8 or greater is the cut point for clinically possible insomnia	2 weeks and 3 months
the score of 14-item Hamilton anxiety rating scale	The total score ranges from 0 to 56, and a higher score indicates higher levels of anxiety symptoms. A score of 7 or greater is the cut point for clinically possible anxiety	2 weeks and 3 months
the score of 17-item Hamilton depression rating scale	tThe total score ranges from 0 to 52, and a higher score indicates higher levels of depression symptoms. A score of 7 or greater is the cut point for clinically possible depression symptom	2 weeks and 3 months
Change in plasma corticotropin-releasing factor (CRF) level	Plasma corticotropin-releasing factor (CRF) concentration was measured as a biomarker of hypothalamic-pituitary-adrenal (HPA) axis activity. Higher levels indicate increased neuroendocrine stress response. Unit of Measure: pg/mL	2 weeks and 3 months
Change in plasma cortisol level	Plasma cortisol concentration was assessed as an indicator of hypothalamic-pituitary-adrenal (HPA) axis function. Higher levels reflect increased physiological stress response. Unit of Measure: μg/dL	2 weeks and 3 months
Change in serum interleukin-6 level	Serum interleukin-6 concentration was measured as a marker of systemic inflammation. Higher levels indicate greater inflammatory activity. Unit of Measure: pg/mL	2 weeks and 3 months
Change in serum brain-derived neurotrophic factor level	Serum brain-derived neurotrophic factor concentration was measured as a biomarker associated with neuroplasticity and neuronal function. Higher levels indicate enhanced neurotrophic activity. Unit of Measure: pg/mL	2 weeks and 3 months
Change in total sleep time (TST) measured by polysomnography		2 weeks and 3 months
Change in sleep onset latency (SOL) measured by polysomnography		2 weeks and 3 months
Change in wake after sleep onset (WASO) measured by polysomnography		2 weeks and 3 months

Collaborators and Investigators

• Sponsor: Zan Wang

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 4, 2026
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Therapeutics; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; Transcranial Direct Current Stimulation
• Other Study ID Numbers: TCS-V01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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