Status:
RECRUITING
Individualized Non-invasive Brain Stimulation for the Treatment of Major Depressive Disorder
Lead Sponsor:
Pulvinar Neuro, LLC
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
University of North Carolina, Chapel Hill
Conditions:
Depression - Major Depressive Disorder
Transcranial Alternating Current Stimulation
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 prelimina...
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 stimulati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06874374
Start Date
April 11 2025
End Date
February 28 2026
Last Update
April 16 2025
Active Locations (1)
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1
Carolina Center for Neurostimulation
Chapel Hill, North Carolina, United States, 27516