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Recruiting NCT07340268

The Effects of Transcranial Current Stimulation on Insomnia

No phase Interventional Insomnia, Psychophysiological

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transcranial current stimulation, Sham stimulation.
Who it may be relevant to
Registry conditions: Insomnia, Psychophysiological. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

Effect of transcranial current stimulation on insomnia disorder

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.

Interventions

  • Device transcranial current stimulation
    consecutive daily 20-min, 1.1-mA sessions
  • Device Sham stimulation
    only wore the device and had no stimulation

Primary outcome measures

  • Change in global blood-oxygen-level-dependent (gBOLD) signal amplitude [Time frame: 2 weeks and 3 months]
  • Change in resting-state functional connectivity strength [Time frame: 2 weeks and 3 months]
  • Change in amplitude of low-frequency fluctuations [Time frame: 2 weeks and 3 months]
  • Change in regional homogeneity [Time frame: 2 weeks and 3 months]
  • Change in phase difference of dynamic cerebral autoregulation [Time frame: 2 weeks and 3 months]
  • Change in gain of dynamic cerebral autoregulation [Time frame: 2 weeks and 3 months]
Secondary outcome measures (10)
  • the score of Insomnia Severity Index scale [Time frame: 2 weeks and 3 months]
  • the score of 14-item Hamilton anxiety rating scale [Time frame: 2 weeks and 3 months]
  • the score of 17-item Hamilton depression rating scale [Time frame: 2 weeks and 3 months]
  • Change in plasma corticotropin-releasing factor (CRF) level [Time frame: 2 weeks and 3 months]
  • Change in plasma cortisol level [Time frame: 2 weeks and 3 months]
  • Change in serum interleukin-6 level [Time frame: 2 weeks and 3 months]
  • Change in serum brain-derived neurotrophic factor level [Time frame: 2 weeks and 3 months]
  • Change in total sleep time (TST) measured by polysomnography [Time frame: 2 weeks and 3 months]
  • Change in sleep onset latency (SOL) measured by polysomnography [Time frame: 2 weeks and 3 months]
  • Change in wake after sleep onset (WASO) measured by polysomnography [Time frame: 2 weeks and 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • the First Hospital of Jilin University — Ch’ang-ch’un
  • the First Hospital of Jilin University — Ch’ang-ch’un

Publications

  • Zhang Y, Sun Q, Zhang X, Li W, Wang Y, Cai L, Wang Z. Transcranial direct current stimulation improves reduced global BOLD-CSF coupling in patients with insomnia disorder and comorbid anxiety: a resting-state functional MRI study. BMC Psychiatry. 2026 Jun 17. doi: 10.1186/s12888-026-08304-6. Online ahead of print. PMID 42310658

Identifiers

NCT: NCT07340268 · TCS-V01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗