Depression - Major Depressive DisorderCL-tACS RCTNCT06874374
Individualized Non-invasive Brain Stimulation for the Treatment of Major Depressive Disorder
A study testing Closed-loop tACS in people with Depression - Major Depressive Disorder and Transcranial Alternating Current Stimulation, run by Pulvinar Neuro, LLC at 1 site in United States.
Trial summary
The purpose of this research study is to study a closed-loop transcranial alternating current stimulation (tACS) device to evaluate feasibility of the product in a clinical trial and collect preliminary data on potential effects on symptoms of depression in people with major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression - Major Depressive Disorder, Transcranial Alternating Current Stimulation
- What is being tested?
- Closed-loop tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2025to 22 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any gender, aged 18 - 70
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- DSM-5 diagnosis of unipolar, non-psychotic MDD as evidenced by the DIAMOND
- HDRS-17 score ≥14
- Low suicide risk (defined for this study as no active suicidal ideation in the past month and no suicide attempts, preparatory actions, or significant non-suicidal self-harm in the previous 2 years). Risk will be assessed utilizing the C-SSRS screen and triage version with further exploration of positive responses.
- Capacity to understand all relevant risks and potential benefits of the study (informed consent)
- For people of childbearing potential: use of highly effective contraception as determined by the Investigator for at least 1 month prior to screening and agreement to use such a method during study participation
Who cannot join
- DSM-5 diagnosis of severe alcohol use disorder (AUD) within the last 12 months, as evidenced by the DIAMOND
- DSM-5 diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months, as evidenced by the DIAMOND
- Lifetime history of bipolar disorder, as evidenced by DIAMOND
- Schizophrenia spectrum and other psychotic disorders, as evidenced by DIAMOND
- History of autism spectrum disorder
- Initiated any new psychotropic medication in the 6 weeks prior to screening or had a dose change in the preceding 6 weeks
Show all 17Show fewer
- Initiated a new course of psychotherapy in the 6 weeks preceding screening
- Received any neurostimulation treatment in the 6 weeks preceding screening
- History of seizures (excluding febrile seizures in childhood or Electroconvulsive Therapy (ECT) induced seizures)
- Neurological disorders that would increase risk of participation or present a significant confounder in the opinion of the investigator (for example, dementia, history of stroke, Parkinson's disease, multiple sclerosis, history of traumatic brain injury with prolonged loss of consciousness, ruptured cerebral aneurysm, previous CNS radiation)
- Previously failed to respond to ECT or transcranial magnetic stimulation (TMS)
- Prior brain surgery and/or brain implants
- Implanted medical device that uses electricity
- Current pregnancy or lactation
- Currently enrolled in another clinical trial for depression
- For the optional MRI session only: Contraindication to MRI according to MRI Screening Form
- Unstable medical disorder or anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study, in the opinion of the Investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolina Center for Neurostimulation
Chapel Hill, North Carolina, 27516
About this study
Official title: Closed-Loop Transcranial Alternating Current Stimulation (CL-tACS) for the Treatment of Major Depressive Disorder: Double-Blind, Sham-Controlled Randomized Pilot Study
The purpose of this research study is to study a closed-loop transcranial alternating current stimulation (tACS) device to evaluate feasibility of the product in a clinical trial and collect preliminary data on potential effects on symptoms of depression in people with major depressive disorder.
Read the detailed description
The purpose of this study is to investigate device feasibility and performance of the XCSITE 100 Pro V2 device and assess preliminary efficacy of closed-loop transcranial alternating current stimulation (CL-tACS) for reducing symptoms of major depressive disorder (MDD) in a double-blind, sham-controlled, parallel group, single-site clinical trial. A total of 40 participants will be randomized to receive active or sham CL-tACS via carbon-silicone electrodes for up to 40 minutes over 5 consecutive days. Device feasibility and performance data will be collected from every stimulation session. Clinical assessments of depression and related symptoms will be performed at Baseline (Day 1), End Of Treatment (EOT; Day 5), and Follow-Up (FUP, 2-weeks post-treatment, Day 19). High-density electroencephalography (HD-EEG) will be performed at Baseline, EOT and FUP. An optional MRI will be performed up to 30 days before, or on Baseline, to provide anatomical data for EEG brain connectivity analysis.
- Being tested
- Closed-loop tACS, Sham Comparator
- Keywords
- tACS, Depression, Major Depressive Disorder, Transcranial Alternating Current Stimulation
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop tACSDevice
Also called CL-tACS
Individual alpha tACS
Sham ComparatorDevice
Sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active Closed-loop tACS | Experimental | Closed-loop individual alpha tACS daily for five consecutive days. Receives: Device: Closed-loop tACS |
| Sham Closed-loop tACS | Sham comparator | Sham closed-loop individual alpha tACS daily for five consecutive days. Receives: Device: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct Assignment by Device of Study Arm
Successful assignment by device software to correct study arm for each participant for each session, Day 1 (D1) through Day 5 (D5). Measured as percentage of successful assignments compared to intended programming.
Measured: 5 days
Accuracy of Device Study Arm Parameters by Device
Verification of correct study arm parameters applied by device for each participant for each session, Day 1 (D1) through Day 5 (D5).
Measured: 5 days
Accuracy of Stimulation Initiation Based on EEG by Device
Verification of correct stimulation initiation decisions for each evaluated EEG window by device for each participant for each session, Day 1 (D1) through Day 5 (D5).
Measured: 5 days
Accuracy of Device Logs Uploaded to Cloud by Device
Verification of equivalence between logs stored on local device and corresponding logs uploaded to cloud for each participant for each session, Day 1 (D1) through Day 5 (D5).
Measured: 5 days
Secondary outcomes (2)
HDRS-17 Change
Change in HDRS-17 from two week follow-up (FUP) to D1 between Experimental and Sham Comparator study arms; minimum value is 0, maximum value is 52. Higher scores indicate worse outcome.
Measured: 21 Days
Change in Alpha Oscillation Power
Change in EEG alpha oscillation power between D1 and D5 between Experimental and Sham Comparator study arms.
Measured: 5 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start11 Apr 2025
- Primary completion22 May 2026
- Study completion22 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depression - Major Depressive DisorderStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulvinar Neuro, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Rubinow, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874374
- Sponsor's protocol ID
- 24-2166
- Other IDs
- R44MH119872
- Acronym
- CL-tACS RCT
- Status last verified
- May 2026
- First submitted
- 28 Jan 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Schwippel T, Pupillo F, Feldman Z, Walker C, Townsend L, Rubinow D, Frohlich F. Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder: An Open-Label Pilot Study. Am J Psychiatry. 2024 Sep 1;181(9):842-845. doi: 10.1176/appi.ajp.20230838. Epub 2024 Aug 7. No abstract available.
PubMed 39108159Alexander ML, Alagapan S, Lugo CE, Mellin JM, Lustenberger C, Rubinow DR, Frohlich F. Double-blind, randomized pilot clinical trial targeting alpha oscillations with transcranial alternating current stimulation (tACS) for the treatment of major depressive disorder (MDD). Transl Psychiatry. 2019 Mar 5;9(1):106. doi: 10.1038/s41398-019-0439-0.
PubMed 30837453
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-Loop Transcranial Alternating Current Stimulation (CL-tACS) for the Treatment of Major Depressive Disorder: Double-Blind, Sham-Controlled Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT06874374
- Acronym / sponsor ID
- CL-tACS RCT / 24-2166
- Keywords
- tACS, Depression, Major Depressive Disorder, Transcranial Alternating Current Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pulvinar Neuro, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), University of North Carolina, Chapel Hill
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 13 Mar 2025 (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.
The purpose of this research study is to study a closed-loop transcranial alternating current stimulation (tACS) device to evaluate feasibility of the product in a clinical trial and collect preliminary data on potential effects on symptoms of depression in people with major depressive disorder.
Detailed description
The purpose of this study is to investigate device feasibility and performance of the XCSITE 100 Pro V2 device and assess preliminary efficacy of closed-loop transcranial alternating current stimulation (CL-tACS) for reducing symptoms of major depressive disorder (MDD) in a double-blind, sham-controlled, parallel group, single-site clinical trial. A total of 40 participants will be randomized to receive active or sham CL-tACS via carbon-silicone electrodes for up to 40 minutes over 5 consecutive days. Device feasibility and performance data will be collected from every stimulation session. Clinical assessments of depression and related symptoms will be performed at Baseline (Day 1), End Of Treatment (EOT; Day 5), and Follow-Up (FUP, 2-weeks post-treatment, Day 19). High-density electroencephalography (HD-EEG) will be performed at Baseline, EOT and FUP. An optional MRI will be performed up to 30 days before, or on Baseline, to provide anatomical data for EEG brain connectivity analysis.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Closed-loop tACS | Experimental | Device: Closed-loop tACSClosed-loop individual alpha tACS daily for five consecutive days. |
| Sham Closed-loop tACS | Sham comparator | Device: Sham ComparatorSham closed-loop individual alpha tACS daily for five consecutive days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Any gender, aged 18 - 70
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- DSM-5 diagnosis of unipolar, non-psychotic MDD as evidenced by the DIAMOND
- HDRS-17 score ≥14
Key exclusion criteria (17 listed)
- DSM-5 diagnosis of severe alcohol use disorder (AUD) within the last 12 months, as evidenced by the DIAMOND
- DSM-5 diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months, as evidenced by the DIAMOND
- Lifetime history of bipolar disorder, as evidenced by DIAMOND
- Schizophrenia spectrum and other psychotic disorders, as evidenced by DIAMOND
- History of autism spectrum 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 |
|---|---|---|
| Closed-loop tACSAlso: CL-tACSIndividual alpha tACS | Device | Active Closed-loop tACS |
| Sham ComparatorSham stimulation | Device | Sham Closed-loop tACS |
Primary outcome
Correct Assignment by Device of Study Arm
Time frame: 5 days
Successful assignment by device software to correct study arm for each participant for each session, Day 1 (D1) through Day 5 (D5). Measured as percentage of successful assignments compared to intended programming.
Accuracy of Device Study Arm Parameters by Device
Time frame: 5 days
Verification of correct study arm parameters applied by device for each participant for each session, Day 1 (D1) through Day 5 (D5).
Accuracy of Stimulation Initiation Based on EEG by Device
Time frame: 5 days
Verification of correct stimulation initiation decisions for each evaluated EEG window by device for each participant for each session, Day 1 (D1) through Day 5 (D5).
Accuracy of Device Logs Uploaded to Cloud by Device
Time frame: 5 days
Verification of equivalence between logs stored on local device and corresponding logs uploaded to cloud for each participant for each session, Day 1 (D1) through Day 5 (D5).
2 secondary outcomes
HDRS-17 Change
Time frame: 21 Days
Change in Alpha Oscillation Power
Time frame: 5 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 39108159Schwippel T, Pupillo F, Feldman Z, Walker C, Townsend L, Rubinow D, Frohlich F. Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder: An Open-Label Pilot Study. Am J Psychiatry. 2024 Sep 1;181(9):842-845. doi: 10.1176/appi.ajp.20230838. Epub 2024 Aug 7. No abstract available.
- Background: PubMed 30837453Alexander ML, Alagapan S, Lugo CE, Mellin JM, Lustenberger C, Rubinow DR, Frohlich F. Double-blind, randomized pilot clinical trial targeting alpha oscillations with transcranial alternating current stimulation (tACS) for the treatment of major depressive disorder (MDD). Transl Psychiatry. 2019 Mar 5;9(1):106. doi: 10.1038/s41398-019-0439-0.
- 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. This study is not recruiting at the moment.
David Rubinow, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed-loop tACS in people with Depression - Major Depressive Disorder and Transcranial Alternating Current Stimulation, run by Pulvinar Neuro, LLC at 1 site in United States.
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 8 inclusion and 17 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: finished, as of the sponsor's last update on 18 Aug 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct Assignment by Device of Study Arm (time frame: 5 days). The study lists 4 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 NCT06874374, which also lists 2 linked publications.
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 18 Aug 2026.