Individualized Non-invasive Brain Stimulation for the Treatment of Major Depressive Disorder (CL-tACS RCT)

August 17, 2026 updated by: Pulvinar Neuro, LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • Carolina Center for Neurostimulation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active Closed-loop tACS
Closed-loop individual alpha tACS daily for five consecutive days.
Device: Closed-loop tACS
Individual alpha tACS
Other Names:
  • CL-tACS
Sham Comparator: Sham Closed-loop tACS
Sham closed-loop individual alpha tACS daily for five consecutive days.
Device: Sham Comparator
Sham stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
5 days
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).
5 days
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).
5 days
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).
5 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HDRS-17 Change
Time Frame: 21 Days
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.
21 Days
Change in Alpha Oscillation Power
Time Frame: 5 Days
Change in EEG alpha oscillation power between D1 and D5 between Experimental and Sham Comparator study arms.
5 Days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Alpha Oscillation Power and Connectivity
Time Frame: 21 Days
Change in HD-EEG alpha oscillation power and connectivity at D1, D5, and FUP between Experimental and Sham Comparator study arms.
21 Days
Remission Rate
Time Frame: 21 Days
Difference in remission rates between Experimental and Sham Comparator study arms at FUP. Remission defined as HDRS-17 score of less than or equal to 7.
21 Days
Response Rate
Time Frame: 21 Days
Difference in response rates between Experimental and Sham Comparator study arms at FUP. Response defined as greater than or equal to 50% reduction in HDRS-17 score from D1 to FUP.
21 Days
SSRI Effect on HDRS-17 Change
Time Frame: 21 Days
Change in HDRS-17 for Experimental study arm from two week follow-up (FUP) to D1 between patients on SSRI medication and patients not on SSRI medication; minimum value is 0, maximum value is 52. Higher scores indicate worse outcome.
21 Days
Change in Quick Inventory of Depressive Symptomatology (QIDS)
Time Frame: 21 Days
Change in QIDS from D1 to FUP between Experimental and Sham Comparator study arms; minimum value is 0, maximum value is 27. Higher scores indicate worse outcome.
21 Days
Change in Snaith-Hamilton Pleasure Scale (SHAPS)
Time Frame: 21 Days
Change in SHAPS from D1 to FUP between Experimental and Sham Comparator study arms; minimum value is 0, maximum value is 14. Higher scores indicate worse outcome.
21 Days
Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF)
Time Frame: 21 Days
Change in Q-LES-Q-SF from D1 to FUP between Experimental and Sham Comparator study arms; minimum value is 0, maximum value is 14. Higher scores indicate worse outcome.
21 Days
Change in Clinical Global Impression Scale (CGI)
Time Frame: 21 Days
Change in CGI from D1 to FUP between Experimental and Sham Comparator study arms; CGI scale contains two scoring components, 1) Severity of Illness (0-7) and 2) Global Improvement (0-7). Higher scores in component 1 indicate worse symptoms while higher numbers in component 2 indicate worse clinical outcomes.
21 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pulvinar Neuro, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
University of North Carolina, Chapel Hill

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Rubinow, MD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 22, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 22, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-2166
  • R44MH119872 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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