RecruitingNot ApplicableNCT06874374

Individualized Non-invasive Brain Stimulation for the Treatment of Major Depressive Disorder

Closed-Loop Transcranial Alternating Current Stimulation (CL-tACS) for the Treatment of Major Depressive Disorder: Double-Blind, Sham-Controlled Randomized Pilot Study

Sponsor

Pulvinar Neuro, LLC

Enrollment

40 participants

Start Date

Apr 11, 2025

Study Type

INTERVENTIONAL

Conditions

Depression - Major Depressive Disorder Transcranial Alternating Current Stimulation

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria8

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 Criteria17

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

Interventions

DEVICEClosed-loop tACS

Individual alpha tACS

DEVICESham Comparator

Sham stimulation

Locations(1)

Carolina Center for Neurostimulation

Chapel Hill, North Carolina, United States

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NCT06874374

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