Smart brain zapper aims to lift depression
NCT ID NCT06874374
First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times
Summary
This study tests a new device that uses mild electrical currents to stimulate the brain in people with major depression. The device adjusts the stimulation in real time based on brain activity. The goal is to see if the device works correctly and if it can help reduce depression symptoms. Forty adults will take part in this early-stage pilot study.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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40 people
The number who actually took part.
- Started
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Apr 2025
- Finished
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May 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Carolina Center for Neurostimulation
Chapel Hill, North Carolina, 27516, United States
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Other studies related to the condition(s) this trial covers.
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