Depression - Major Depressive DisorderNCT07282678
Closed-Loop Transcranial Alternating Current 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 investigate a closed-loop transcranial alternating current stimulation (tACS) device to evaluate its ability to reduce symptoms of major depressive disorder Read more about this study
- Who is it for?
- Ages 22 years and older
- 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
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Mar 2029
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 22 years of age;
- with at least moderate symptom severity (HAM-D17 ≥ 17);
- who are currently in a depressive episode;
- who have used at least 1 antidepressant in the current or previous episode, but have not found adequate symptom relief or who were not able to tolerate medication side effects;
- who, for 6 weeks prior to enrollment, are either;
- not taking antidepressant medication, or:
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- are taking a stable psychiatric medication regimen with one or more stable antidepressant medication dose(s) and agree to continue the same regimen throughout study participation
- if currently engaged in depression-focused psychotherapy, have maintained stable frequency of therapy for at least 8 weeks prior to enrollment and agree to continue the same regimen throughout study participation;
- are able and willing to comply with the protocol and follow up schedule and protocol, in the opinion of the investigator;
- who understand English and are able to provide written informed consent;
- who are currently under the care of a psychiatric clinician or a primary care physician for major depressive disorder, and who agree to promptly inform the study staff of any change of psychiatric or mental health providers during study participation;
- who agree to allow any and all forms of communication between the investigators/study staff and their current or past (within 2 years) healthcare providers;
- who agree to provide the names and verifiable contact information (email and mailing addresses, mobile and/or land-line phone numbers, as applicable) for at least two persons (≥ age 18) who reside within a 60-minute drive of their residence and whom the research staff are at liberty to contact, as they deem necessary, to ensure participant safety for the duration of study participation;
Who cannot join
- Subjects with current / past six months use of an external stimulation device for MDD, including electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), or other brain or cranial nerve stimulation;
- Subjects with (lifetime) history of failure to response to an adequate trial of ECT, TMS, or implanted vagus nerve stimulation;
- Subjects who currently receive esketamine, ketamine, or psilocybin treatment
- Subjects who are pregnant or of childbearing potential and not using adequate contraception, as determined by the investigator;
- Subjects who are breastfeeding.
- Subjects whose current depressive episode had onset within 6 months post-partum;
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- Presence of active skin disorder on the forehead that could be exacerbated by stimulation electrodes in the opinion of the investigator.
- Subjects with clinical or historical features which, in the opinion of the investigator, make them an inappropriate candidate for participation in this trial;
- Subjects whose current depressive episode has not responded to 3 or more adequate trials of FDA approved antidepressant medications;
- Subjects with current suicidal ideation with plan or intent, or suicidal behavior or preparation in the past 3 months, as determined by CSSRS assessment or by the Investigator;
- Subjects with a diagnosis of epilepsy or unexplained seizures;
- Subjects with a diagnosis or clinical history suggestive of bipolar disorder, hypomania, mania, or psychosis, as determined by the Investigator and/or by the DIAMOND assessment.
- Subjects currently participating, or intending to participate (during the next 3 months) in another study involving an investigational drug or device treatment that, in the opinion of the investigator, could impact symptoms of MDD or use of the investigational device;
- Subjects with a history of intracranial surgery;
- Subjects with implanted neurostimulators, nonremovable or implanted electrical devices or intracranial metal objects, with the exception of dental metal;
- Subjects with cognitive impairment or memory disorders, which, in the opinion of the investigator, could impact their ability to comply with study requirements;
- Subjects currently meeting diagnostic criteria for obsessive compulsive disorder determined by the Investigator and/or by the DIAMOND assessment;
- Subjects who meet DSM-V criteria for moderate/severe alcohol use disorder or other substance use disorders (except tobacco/nicotine) within the past 6 months as confirmed by the DIAMOND interview;
- Subjects who meet DSM-V criteria for moderate/severe cannabis use disorder (CUD) within the past 6 months as confirmed by the DIAMOND interview. Subjects with recreational or prescription use (including medical marijuana cards) not considered moderate to severe CUD will be included.
- Subjects with a current neurological condition or disease which, in the opinion of the investigator, is likely to manifest a depressive syndrome or symptoms that would substantially confound the diagnosis or serial assessment of major depressive disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Qortical Clinical Partners
Durham, North Carolina, 27707
Genesis Garcia, 910-477-4947, genesis@qortical.com
David Rubinow, MD
About this study
Official title: Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder: Double-Blind, Controlled Randomized Multicenter Clinical Trial
The purpose of this research study is to investigate a closed-loop transcranial alternating current stimulation (tACS) device to evaluate its ability to reduce symptoms of major depressive disorder
Read the detailed description
This study examines the efficacy of closed-loop transcranial alternating current stimulation (CL-tACS) for the treatment of major depressive disorder (MDD) in a double-blind, controlled parallel group multi-site clinical trial. 214 participants will be randomized into receiving 5 consecutive days of active or control CL-tACS (1:1 allocation) to achieve approximately 192 participants completing the primary endpoint at week 3, assuming a 10% lost to follow-up rate. Clinical assessments of depression and anxiety symptoms are performed at Screening, Baseline, Day 5, Follow-Up 1 (week 3), and Follow-Up 2 (week 5). Additional assessments of quality of life are included.
For subjects who are not considered responders at the Week 3 primary endpoint, there will be a phase 2 retreatment with active CL-tACS which will mirror the same 5-day protocol. Patients in this arm will complete additional data collection at Phase 2 baseline, Phase 2 Day 5, Phase 2 Follow-up 1 (phase 2 week 3), and phase 2 follow-up 2 (phase 2 week 5).
- 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
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 |
| Open Label, Active Closed-loop tACS Retreatment | Experimental | An open label, second dose of Closed-loop individual alpha tACS daily for five consecutive days. Assignment to this arm occurs after participation in the closed label active or sham arms. Receives: Device: Closed-loop tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rates (at least 50% reduction in Hamilton Depression Rating Scale (HDRS) score) at Week 3 Phase 1 Evaluation
Response rates (at least 50% reduction in HDRS-D17 score) (0-52 score range, higher score is worse) in Active vs. Control groups.
Measured: Timeframe: Baseline to Week 3
Secondary outcomes (12)
Change in mean Hamilton Depression Rating Scale (HDRS) Score
Change in mean HDRS-17 Score (0-52 score range, higher score is worse) in Active vs Control groups.
Measured: Timeframe: Baseline to Week 3
The State-Trait Anxiety Inventory (STAI) Score
Change in self-reported anxiety symptoms STAI Trait (score range is 20-80, higher is worse) in Active vs Control groups
Measured: Timeframe: Baseline to week 3, Phase 1
Hamilton Depression Rating Scale (HDRS) Remission Rate
Remission rates (HDRS-17 score ≤ 7) (0-52 score range, higher score is worse) in Active vs Control groups.
Measured: Timeframe: Baseline to Week 3, Phase 1
Difference in change in Hamilton Depression Rating Scale (HDRS) in Active vs control groups between patients with MDD and GAD and patients with MDD and not GAD
Difference in the change in mean HDRS-17 Score (0-52 score range, higher score is worse) in Active vs Control groups between MDD patients with and without a comorbid GAD diagnosis.
Measured: Timeframe: Baseline to Week 3
Hamilton Depression Rating Scale (HDRS) Remission Rate at Day 5
Remission rates (HDRS-17 score ≤ 7) (0-52 score range, higher score is worse) in Active vs Control groups.
Measured: Timeframe: Baseline to Day 5
Response rates (at least 50% reduction in Hamilton Depression Rating Scale (HDRS) score) at Day 5
Responder rates (at least 50% reduction in HDRS-17 score) (0-52 score range, higher score is worse) in Active vs Control groups.
Measured: Timeframe: Baseline to Day 5
Change in Hamilton Depression Rating Scale (HDRS) Score at Day 5
Change in HDRS-17 Score (0-52 score range, higher score is worse) in Active vs Control groups.
Measured: Timeframe: Baseline to Day 5
Difference in change in Hamilton Depression Rating Scale (HDRS) in Active vs control groups between patients with MDD and GAD and patients with MDD and not GAD at Day 5
Difference in the change in mean HDRS-17 Score (0-52 score range, higher score is worse) in Active vs Control groups between MDD patients with and without a comorbid GAD diagnosis.
Measured: Timeframe: Baseline to Day 5
Remission rates (Hamilton Depression Rating Scale (HDRS) score ≤ 7) at Week 5
Remission rates (HDRS-17 score ≤ 7) (0-52 score range, higher score is worse) in Active vs Control groups.
Measured: Timeframe: Baseline to Week 5
Response rates (at least 50% reduction in Hamilton Depression Rating Scale (HDRS) score) at Week 5
Responder rates (at least 50% reduction in HDRS-17 score) (0-52 score range, higher score is worse) in Active vs Control groups.
Measured: [Timeframe: Baseline to Week 5].
Change in Hamilton Depression Rating Scale (HDRS) score at Week 5
Change in HDRS-17 (0-52 score range, higher score is worse) in Active vs Control groups.
Measured: Timeframe: Baseline to Week 5
Difference in change in Hamilton Depression Rating Scale (HDRS) in Active vs control groups between patients with MDD and GAD and patients with MDD and not GAD at Week 5
Difference in the change in mean HDRS-17 Score (0-52 score range, higher score is worse) in Active vs Control groups between MDD patients with and without a comorbid GAD diagnosis.
Measured: Timeframe: Baseline to Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study startSep 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulvinar Neuro, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark George, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282678
- Sponsor's protocol ID
- PN1000
- Status last verified
- Aug 2026
- First submitted
- 5 Dec 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder: Double-Blind, Controlled Randomized Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT07282678
- Acronym / sponsor ID
- PN1000
- Keywords
- tACS, Depression, Major Depressive Disorder, Transcranial Alternating Current Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Pulvinar Neuro, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 15 Dec 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 investigate a closed-loop transcranial alternating current stimulation (tACS) device to evaluate its ability to reduce symptoms of major depressive disorder
Detailed description
This study examines the efficacy of closed-loop transcranial alternating current stimulation (CL-tACS) for the treatment of major depressive disorder (MDD) in a double-blind, controlled parallel group multi-site clinical trial. 214 participants will be randomized into receiving 5 consecutive days of active or control CL-tACS (1:1 allocation) to achieve approximately 192 participants completing the primary endpoint at week 3, assuming a 10% lost to follow-up rate. Clinical assessments of depression and anxiety symptoms are performed at Screening, Baseline, Day 5, Follow-Up 1 (week 3), and Follow-Up 2 (week 5). Additional assessments of quality of life are included.
For subjects who are not considered responders at the Week 3 primary endpoint, there will be a phase 2 retreatment with active CL-tACS which will mirror the same 5-day protocol. Patients in this arm will complete additional data collection at Phase 2 baseline, Phase 2 Day 5, Phase 2 Follow-up 1 (phase 2 week 3), and phase 2 follow-up 2 (phase 2 week 5).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| 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. |
| Open Label, Active Closed-loop tACS Retreatment | Experimental | Device: Closed-loop tACSAn open label, second dose of Closed-loop individual alpha tACS daily for five consecutive days. Assignment to this arm occurs after participation in the closed label active or sham arms. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- ≥ 22 years of age;
- with at least moderate symptom severity (HAM-D17 ≥ 17);
- who are currently in a depressive episode;
- who have used at least 1 antidepressant in the current or previous episode, but have not found adequate symptom relief or who were not able to tolerate medication side effects;
- who, for 6 weeks prior to enrollment, are either;
Key exclusion criteria (20 listed)
- Subjects with current / past six months use of an external stimulation device for MDD, including electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), or other brain or cranial nerve stimulation;
- Subjects with (lifetime) history of failure to response to an adequate trial of ECT, TMS, or implanted vagus nerve stimulation;
- Subjects who currently receive esketamine, ketamine, or psilocybin treatment
- Subjects who are pregnant or of childbearing potential and not using adequate contraception, as determined by the investigator;
- Subjects who are breastfeeding.
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 tACSIndividual alpha tACS | Device | Active Closed-loop tACS, Open Label, Active Closed-loop tACS Retreatment |
| Sham ComparatorSham stimulation | Device | Sham Closed-loop tACS |
Primary outcome
Response rates (at least 50% reduction in Hamilton Depression Rating Scale (HDRS) score) at Week 3 Phase 1 Evaluation
Time frame: Timeframe: Baseline to Week 3
Response rates (at least 50% reduction in HDRS-D17 score) (0-52 score range, higher score is worse) in Active vs. Control groups.
12 secondary outcomes
Change in mean Hamilton Depression Rating Scale (HDRS) Score
Time frame: Timeframe: Baseline to Week 3
The State-Trait Anxiety Inventory (STAI) Score
Time frame: Timeframe: Baseline to week 3, Phase 1
Hamilton Depression Rating Scale (HDRS) Remission Rate
Time frame: Timeframe: Baseline to Week 3, Phase 1
Difference in change in Hamilton Depression Rating Scale (HDRS) in Active vs control groups between patients with MDD and GAD and patients with MDD and not GAD
Time frame: Timeframe: Baseline to Week 3
Hamilton Depression Rating Scale (HDRS) Remission Rate at Day 5
Time frame: Timeframe: Baseline to Day 5
Response rates (at least 50% reduction in Hamilton Depression Rating Scale (HDRS) score) at Day 5
Time frame: Timeframe: Baseline to Day 5
Change in Hamilton Depression Rating Scale (HDRS) Score at Day 5
Time frame: Timeframe: Baseline to Day 5
Difference in change in Hamilton Depression Rating Scale (HDRS) in Active vs control groups between patients with MDD and GAD and patients with MDD and not GAD at Day 5
Time frame: Timeframe: Baseline to Day 5
Remission rates (Hamilton Depression Rating Scale (HDRS) score ≤ 7) at Week 5
Time frame: Timeframe: Baseline to Week 5
Response rates (at least 50% reduction in Hamilton Depression Rating Scale (HDRS) score) at Week 5
Time frame: [Timeframe: Baseline to Week 5].
Change in Hamilton Depression Rating Scale (HDRS) score at Week 5
Time frame: Timeframe: Baseline to Week 5
Difference in change in Hamilton Depression Rating Scale (HDRS) in Active vs control groups between patients with MDD and GAD and patients with MDD and not GAD at Week 5
Time frame: Timeframe: Baseline to Week 5
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 8 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Mark George, MD principal investigator
Medical University of South Carolina
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 13 inclusion and 20 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 8 Oct 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?
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 Christopher Walker, PhD (910-447-6576, chris.walker@pulvinarneuro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rates (at least 50% reduction in Hamilton Depression Rating Scale (HDRS) score) at Week 3 Phase 1 Evaluation (time frame: Timeframe: Baseline to Week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.