InsomniaNCT06671457
Model-Driven Individualized Transcranial Direct Current Stimulation for the Treatment of Insomnia Disorders
A study testing Active transcranial direct current stimulation in people with Insomnia, run by Zhen Wang at 1 site in China.
Trial summary
This study is designed to evaluate the efficacy and to explore the best individualized stimulus paradigm of transcranial Electrical Stimulation for insomnia patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Active transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2024to 1 Apr 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years;
- Meets the diagnostic criteria for insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- Has not taken psychiatric medications in the 8 weeks prior to enrollment or has been on stable psychiatric medication for 8 weeks (excluding benzodiazepines);
- Insomnia severity as indicated by an ISI score > 10;
- Minimum education level of junior high school or above.
Who cannot join
- Past or current diagnosis of disorders other than insomnia disorder, anxiety disorder, or depressive disorder according to DSM-5;
- Currently using benzodiazepines as sleep aids;
- Moderate to severe anxiety or depression (HAMD-17 score > 16 or HAMA score > 24);
- Patients with obstructive sleep apnea syndrome;
- Previous treatment with ECT, rTMS, tES, or cognitive behavioral therapy for insomnia disorder;
- Severe physical illnesses or any condition that may induce seizures or intracranial hypertension, including cardiovascular or respiratory diseases;
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- History of neurological disorders (e.g., epilepsy, cerebrovascular accidents) or history of brain injury or brain surgery;
- Presence of implantable medical devices such as intracranial stents, cardiac pacemakers, coronary stents, or cochlear implants;
- Severe negative thoughts or high suicide risk;
- Pregnant or planning to conceive in the near future.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Zhen Wang, +86 64387250, wangzhen@smhc.org.cn
About this study
This study is designed to evaluate the efficacy and to explore the best individualized stimulus paradigm of transcranial Electrical Stimulation for insomnia patients.
Read the detailed description
This study employs a randomized double-blind placebo-controlled design, with blinding applied to both the assessors and patients, while the therapists remain unblinded. A total of 40 patients with insomnia disorders meeting the inclusion criteria were recruited from the Shanghai Mental Health Center and randomly assigned to either the tDCS active stimulation group or the tDCS sham stimulation group, with 20 patients in each group. All patients underwent clinical assessments, magnetic resonance imaging (MRI) scans, and high-density electroencephalogram (EEG) parameter collections at baseline. Based on the MRI structural images and high-density EEG parameters, individualized modeling was conducted to determine specific stimulation parameter schemes (stimulation sites, stimulation intensity, and electrode placement methods). Detailed modeling methods and selection of stimulation parameters can be found in the intervention methods section. Stimulation was carried out for a total of 2 weeks, with one session per day on weekdays, totaling 10 sessions, each lasting thirty minutes.
- Conditions
- Insomnia
- Being tested
- Active transcranial direct current stimulation, Sham transcranial direct current stimulation
- Keywords
- insomnia, transcranial direct current 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.
Active transcranial direct current stimulationDevice
The intervention uses transcranial direct current stimulation (tDCS). The targeted brain regions are identified by conducting simultaneous fMRI-EEG data collection and sleep staging, comparing fMRI data between wakefulness and sleep states. Brain regions that show differences are calculated as potential targets for electrical stimulation. If no differentiated regions are found in a participant, specific areas are chosen based on individualized modeling results from previous experiments, targeting areas such as the dorsolateral prefrontal cortex (DLPFC), orbitofrontal cortex (OPFC), medial prefrontal cortex (mPFC), and posterior cingulate cortex (PCC). Two regions are selected within each brain area for parameter scanning (with each stimulation lasting 10 seconds and EEG data recorded 10 seconds before and after stimulation).
In our prior studies, we observed a decrease in EEG microstate complexity during sleep, with electrical stimulation influencing this complexity reduction to some
Sham transcranial direct current stimulationDevice
In the sham stimulation group, the placement of the tDCS electrodes is identical to that of the active stimulation group. After the stimulation begins, the current gradually increases over 15 seconds. However, upon reaching the therapeutic current level, it immediately begins to decrease, lowering to 0 mA within 15 seconds and remaining at 0 mA throughout the rest of the session. During the last 15 seconds of the stimulation, there is another gradual decrease in current to 0 mA. This approach creates a similar subjective sensation to the real stimulation, making it difficult for participants to discern which type of electrical stimulation they are receiving.
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Experimental | To optimize stimulation parameters, electromagnetic modeling and parameter space scanning of the participant's brain are conducted. The specific method includes performing MRI scans before stimulation. MRI structural data is then used to create individualized models of the participant's brain and simulate the electromagnetic fields within biological tissues. High-density EEG is collected during the participant's sleep state, using a 256-channel stimulation-recording device (MagStim EGI, GTEN 200) to record EEG changes induced by stimulation across multiple brain regions. The type of electrical stimulation is cathodal direct current stimulation, targeting brain regions with an intensity equivalent to the traditional 2mA single-channel current, with each electrode not exceeding 200μA. Target brain regions for stimulation include the dorsolateral prefrontal cortex (DLPFC), orbitofrontal cortex (OPFC), medial prefrontal cortex (mPFC), and posterior cingulate cortex (PCC). Changes in brain Receives: Device: Active transcranial direct current stimulation |
| Sham Group | Sham comparator | In the sham stimulation group, the placement of the tDCS electrodes is identical to that of the active stimulation group. After the stimulation begins, the current gradually increases over 15 seconds. However, upon reaching the therapeutic current level, it immediately begins to decrease, lowering to 0 mA within 15 seconds and remaining at 0 mA throughout the rest of the session. During the last 15 seconds of the stimulation, there is another gradual decrease in current to 0 mA. This approach creates a similar subjective sensation to the real stimulation, making it difficult for participants to discern which type of electrical stimulation they are receiving. Receives: Device: Sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index change
The change of the Insomnia Severity Index (ISI) score.The scale consists of 7 items, scored on a 5-point Likert scale ranging from 0 to 4 for each item, with a total score ranging from 0 to 28. Higher scores indicate more severe insomnia.
Measured: The study endpoint is set at 2 weeks after the end of treatment
Secondary outcomes (5)
Insomnia Severity Index score change
the change in the Insomnia Severity Index (ISI) score after tDCS intervention and 4 weeks post-intervention.
Measured: after tDCS intervention and 4 weeks post-intervention
response/remission rate
Treatment effectiveness is defined as a reduction of more than 7 points in the Insomnia Severity Index (ISI) score post-treatment. Clinical remission is defined as a total ISI score of less than 8 points.
Measured: After tDCS intervention, 2 weeks post-intervention, and 4 weeks post-intervention
Sleep onset latency, sleep efficiency, and nighttime sleep duration (as defined by the sleep diary).
Changes in sleep onset latency, sleep efficiency, and nighttime sleep duration after tDCS intervention and 2 weeks post-tDCS intervention.
Measured: After tDCS intervention and 2 weeks post-tDCS intervention
Hamilton Depression Rating Scale-17 change
Hamilton Depression Rating Scale 17 score change after tDCS intervention, 2 weeks post-tDCS intervention, and 4 weeks post-intervention. For the HDRS17 , a score of 0-7 is generally accepted to be within the normal Hamilton Depression Rating Scale (HDRS) range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial. Higher scores indicate more severe depression.
Measured: After tDCS intervention, 2 weeks post-tDCS intervention, and 4 weeks post-intervention
Hamilton Anxiety Rating Scale Change
Hamilton Anxiety Rating Scale score change after tDCS intervention, 2 weeks post-tDCS intervention, and 4 weeks post-intervention.Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Measured: After tDCS intervention, 2 weeks post-tDCS intervention, and 4 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start10 Nov 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 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 InsomniaStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhen Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhen Wang, Shanghai Mental Health Center
- Investigators
- Zhen Wang, PhD,MD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671457
- Sponsor's protocol ID
- SMHC-ISM-002
- Status last verified
- Aug 2025
- First submitted
- 31 Oct 2024
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang Y, Jia W, Zhang Z, Bai T, Xu Q, Jiang J, Wang Z. Model-driven individualized transcranial direct current stimulation for the treatment of insomnia disorder: protocol for a randomized, sham-controlled, double-blind study. BMC Psychiatry. 2025 Sep 26;25(1):869. doi: 10.1186/s12888-025-07347-5.
PubMed 41013363
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model-Driven Individualized Transcranial Direct Current Stimulation for the Treatment of Insomnia Disorders
- ClinicalTrials.gov ID
- NCT06671457
- Acronym / sponsor ID
- SMHC-ISM-002
- Conditions
- Insomnia
- Keywords
- insomnia, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhen WangUniversity, hospital or other
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 4 Nov 2024 (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.
This study is designed to evaluate the efficacy and to explore the best individualized stimulus paradigm of transcranial Electrical Stimulation for insomnia patients.
Detailed description
This study employs a randomized double-blind placebo-controlled design, with blinding applied to both the assessors and patients, while the therapists remain unblinded. A total of 40 patients with insomnia disorders meeting the inclusion criteria were recruited from the Shanghai Mental Health Center and randomly assigned to either the tDCS active stimulation group or the tDCS sham stimulation group, with 20 patients in each group. All patients underwent clinical assessments, magnetic resonance imaging (MRI) scans, and high-density electroencephalogram (EEG) parameter collections at baseline. Based on the MRI structural images and high-density EEG parameters, individualized modeling was conducted to determine specific stimulation parameter schemes (stimulation sites, stimulation intensity, and electrode placement methods). Detailed modeling methods and selection of stimulation parameters can be found in the intervention methods section. Stimulation was carried out for a total of 2 weeks, with one session per day on weekdays, totaling 10 sessions, each lasting thirty minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Group | Experimental | Device: Active transcranial direct current stimulationTo optimize stimulation parameters, electromagnetic modeling and parameter space scanning of the participant's brain are conducted. The specific method includes performing MRI scans before stimulation. MRI structural data is then used to create individualized models of the participant's brain and simulate the electromagnetic fields within biological tissues. High-density EEG is collected during the participant's sleep state, using a 256-channel stimulation-recording device (MagStim EGI, GTEN 200) to record EEG changes induced by stimulation across multiple brain regions. The type of electrical stimulation is cathodal direct current stimulation, targeting brain regions with an intensity equivalent to the traditional 2mA single-channel current, with each electrode not exceeding 200μA. Target brain regions for stimulation include the dorsolateral prefrontal cortex (DLPFC), orbitofrontal cortex (OPFC), medial prefrontal cortex (mPFC), and posterior cingulate cortex (PCC). Changes in brain |
| Sham Group | Sham comparator | Device: Sham transcranial direct current stimulationIn the sham stimulation group, the placement of the tDCS electrodes is identical to that of the active stimulation group. After the stimulation begins, the current gradually increases over 15 seconds. However, upon reaching the therapeutic current level, it immediately begins to decrease, lowering to 0 mA within 15 seconds and remaining at 0 mA throughout the rest of the session. During the last 15 seconds of the stimulation, there is another gradual decrease in current to 0 mA. This approach creates a similar subjective sensation to the real stimulation, making it difficult for participants to discern which type of electrical stimulation they are receiving. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years;
- Meets the diagnostic criteria for insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- Has not taken psychiatric medications in the 8 weeks prior to enrollment or has been on stable psychiatric medication for 8 weeks (excluding benzodiazepines);
- Insomnia severity as indicated by an ISI score > 10;
- Minimum education level of junior high school or above.
Key exclusion criteria (10 listed)
- Past or current diagnosis of disorders other than insomnia disorder, anxiety disorder, or depressive disorder according to DSM-5;
- Currently using benzodiazepines as sleep aids;
- Moderate to severe anxiety or depression (HAMD-17 score > 16 or HAMA score > 24);
- Patients with obstructive sleep apnea syndrome;
- Previous treatment with ECT, rTMS, tES, or cognitive behavioral therapy for insomnia disorder;
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 |
|---|---|---|
| Active transcranial direct current stimulationThe intervention uses transcranial direct current stimulation (tDCS). The targeted brain regions are identified by conducting simultaneous fMRI-EEG data collection and sleep staging, comparing fMRI data between wakefulness and sleep states. Brain regions that show differences are calculated as potential targets for electrical stimulation. If no differentiated regions are found in a participant, specific areas are chosen based on individualized modeling results from previous experiments, targeting areas such as the dorsolateral prefrontal cortex (DLPFC), orbitofrontal cortex (OPFC), medial prefrontal cortex (mPFC), and posterior cingulate cortex (PCC). Two regions are selected within each brain area for parameter scanning (with each stimulation lasting 10 seconds and EEG data recorded 10 seconds before and after stimulation). In our prior studies, we observed a decrease in EEG microstate complexity during sleep, with electrical stimulation influencing this complexity reduction to some | Device | Active Group |
| Sham transcranial direct current stimulationIn the sham stimulation group, the placement of the tDCS electrodes is identical to that of the active stimulation group. After the stimulation begins, the current gradually increases over 15 seconds. However, upon reaching the therapeutic current level, it immediately begins to decrease, lowering to 0 mA within 15 seconds and remaining at 0 mA throughout the rest of the session. During the last 15 seconds of the stimulation, there is another gradual decrease in current to 0 mA. This approach creates a similar subjective sensation to the real stimulation, making it difficult for participants to discern which type of electrical stimulation they are receiving. | Device | Sham Group |
Primary outcome
Insomnia Severity Index change
Time frame: The study endpoint is set at 2 weeks after the end of treatment
The change of the Insomnia Severity Index (ISI) score.The scale consists of 7 items, scored on a 5-point Likert scale ranging from 0 to 4 for each item, with a total score ranging from 0 to 28. Higher scores indicate more severe insomnia.
5 secondary outcomes
Insomnia Severity Index score change
Time frame: after tDCS intervention and 4 weeks post-intervention
response/remission rate
Time frame: After tDCS intervention, 2 weeks post-intervention, and 4 weeks post-intervention
Sleep onset latency, sleep efficiency, and nighttime sleep duration (as defined by the sleep diary).
Time frame: After tDCS intervention and 2 weeks post-tDCS intervention
Hamilton Depression Rating Scale-17 change
Time frame: After tDCS intervention, 2 weeks post-tDCS intervention, and 4 weeks post-intervention
Hamilton Anxiety Rating Scale Change
Time frame: After tDCS intervention, 2 weeks post-tDCS intervention, and 4 weeks post-intervention
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 21 Aug 2025.
- Derived from this study: PubMed 41013363Wang Y, Jia W, Zhang Z, Bai T, Xu Q, Jiang J, Wang Z. Model-driven individualized transcranial direct current stimulation for the treatment of insomnia disorder: protocol for a randomized, sham-controlled, double-blind study. BMC Psychiatry. 2025 Sep 26;25(1):869. doi: 10.1186/s12888-025-07347-5.
- 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.
Zhen Wang, PhD,MD principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active transcranial direct current stimulation in people with Insomnia, run by Zhen Wang at 1 site 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 5 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 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Zhen Wang, PhD,MD (+86 34773516, wangzhen@smhc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index change (time frame: The study endpoint is set at 2 weeks after the end of treatment). 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 NCT06671457, 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 21 Aug 2025.