Insomnia, PsychophysiologicalNCT07340268
The Effects of Transcranial Current Stimulation on Insomnia
A study testing transcranial current stimulation in people with Insomnia, Psychophysiological, run by Zan Wang at 2 sites in China.
Trial summary
Effect of transcranial current stimulation on insomnia disorder Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Psychophysiological
- What is being tested?
- transcranial current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 18 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of insomnia disorder
- Cooperate to complete the questionnaire surveys
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 1 recruiting
- Completed
the First Hospital of Jilin University
Ch’ang-ch’un, Jilin, 130021
- Recruiting
the First Hospital of Jilin University
Ch’ang-ch’un, Jilin, 130021
Zan Wang Prof, PhD, +86-13843025938, wnagzan@jlu.edu.cn
About this study
Effect of transcranial current stimulation on insomnia disorder
Read the 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.
- Conditions
- Insomnia, Psychophysiological
- Being tested
- transcranial current stimulation, Sham stimulation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial current stimulationDevice
consecutive daily 20-min, 1.1-mA sessions
Sham stimulationDevice
only wore the device and had no stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: transcranial current stimulation |
| sham transcranial current stimulation | Sham comparator | only wore the device and had no stimulation Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 2 weeks and 3 months
Change in regional homogeneity
Regional homogeneity was used to assess the synchronization of local spontaneous brain activity
Measured: 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.
Measured: 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.
Measured: 2 weeks and 3 months
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 weeks and 3 months
Change in total sleep time (TST) measured by polysomnography
Measured: 2 weeks and 3 months
Change in sleep onset latency (SOL) measured by polysomnography
Measured: 2 weeks and 3 months
Change in wake after sleep onset (WASO) measured by polysomnography
Measured: 2 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start18 Jan 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insomnia, PsychophysiologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zan Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zan Wang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340268
- Sponsor's protocol ID
- TCS-V01
- Status last verified
- Feb 2026
- First submitted
- 4 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 42310658
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transcranial Current Stimulation on Insomnia
- ClinicalTrials.gov ID
- NCT07340268
- Acronym / sponsor ID
- TCS-V01
- Conditions
- Insomnia, Psychophysiological
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zan WangUniversity, hospital or other
- Study start
- 18 Jan 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active transcranial current stimulation | Active comparator | Device: transcranial current stimulation14 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 |
| sham transcranial current stimulation | Sham comparator | Device: Sham stimulationonly wore the device and had no stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of insomnia disorder
- Cooperate to complete the questionnaire surveys
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial current stimulationconsecutive daily 20-min, 1.1-mA sessions | Device | active transcranial current stimulation |
| Sham stimulationonly wore the device and had no stimulation | Device | sham transcranial current stimulation |
Primary outcome
Change in global blood-oxygen-level-dependent (gBOLD) signal amplitude
Time frame: 2 weeks and 3 months
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
Change in resting-state functional connectivity strength
Time frame: 2 weeks and 3 months
Resting-state functional connectivity strength was calculated as the correlation coefficient between predefined brain regions based on functional magnetic resonance imaging data.
Change in amplitude of low-frequency fluctuations
Time frame: 2 weeks and 3 months
Amplitude of low-frequency fluctuations was calculated from resting-state fMRI to quantify spontaneous neural activity.
Change in regional homogeneity
Time frame: 2 weeks and 3 months
Regional homogeneity was used to assess the synchronization of local spontaneous brain activity
Change in phase difference of dynamic cerebral autoregulation
Time frame: 2 weeks and 3 months
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.
Change in gain of dynamic cerebral autoregulation
Time frame: 2 weeks and 3 months
Gain represents the magnitude of cerebral blood flow velocity changes in response to blood pressure fluctuations, with lower gain values indicating more effective autoregulation.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Derived from this study: PubMed 42310658Zhang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial current stimulation in people with Insomnia, Psychophysiological, run by Zan Wang at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zan Wang, MD, PhD (+86 88782678, wangzan@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global blood-oxygen-level-dependent (gBOLD) signal amplitude (time frame: 2 weeks and 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07340268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.