Non-invasive brain stimulation for treating major depression
Closed-Loop Transcranial Alternating Current Stimulation (CL-tACS) for the Treatment of Major Depressive Disorder: Double-Blind, Sham-Controlled Randomized Pilot Study
This study is testing a new brain stimulation device to see if it can help people with major depression feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Pulvinar Neuro, LLC Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06874374 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and preliminary efficacy of a closed-loop transcranial alternating current stimulation (CL-tACS) device for reducing symptoms of major depressive disorder (MDD). A total of 40 participants will be randomly assigned to receive either active or sham stimulation over five consecutive days, with clinical assessments conducted at baseline, end of treatment, and follow-up. The study will also utilize high-density electroencephalography (HD-EEG) to analyze brain connectivity and may include optional MRI scans for anatomical data. The goal is to gather data on the device's performance and its potential impact on depression symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a diagnosis of unipolar, non-psychotic major depressive disorder and a minimum HDRS-17 score of 14.
Not a fit: Patients with severe alcohol use disorder or those with active suicidal ideation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel non-invasive treatment option for patients suffering from major depressive disorder.
How similar studies have performed: While the use of tACS for depression is an emerging field, similar studies have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chapel Hill, North Carolina
- Carolina Center for Neurostimulation — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: David Rubinow, MD — University of North Carolina, Chapel Hill
- Study coordinator: Athena Stein, PhD
- Email: astein1@email.unc.edu
- Phone: 919-966-9929
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.