Temporal Interference Methods for Non-invasive Deep Brain Stimulation, Study 1.1 (NCT07215299) | Clinical Trial Compass
CompletedNot Applicable
Temporal Interference Methods for Non-invasive Deep Brain Stimulation, Study 1.1
United States30 participantsStarted 2025-11-12
Plain-language summary
In its totality, this grant aims to develop a line of research using temporal interference (TI) electrical neurostimulation technology to understand the causal role of deep brain structures in cognition. In the short term, the investigators aim to validate and characterize the effects of TI on brain activity as measured by fMRI and demonstrate its ability to focally stimulate deep brain regions without affecting overlying cortex. In the longer term, investigators aim to use these data to resolve longstanding debates about the function of deeper brain regions and lay the foundation for future clinical applications of TI for treating addiction, Obsessive-Compulsive Disorder (OCD), Parkinson's disease, and other disorders involving deep brain dysfunction. The grant supports 2 distinct aims, each of which will be evaluated through a series of independent studies.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Between the ages of 18 and 50
* Must have at least a 6th grade education
* Ability to speak and read English for all phases
Exclusion Criteria:
* Currently taking psychotropic medications for ADHD, other mental illness, or medications for cancer
* History of epilepsy or seizure disorders
* History of migraines or other neurological syndromes
* History of AIDS (due to potential cognitive deficits)
* History of head trauma or cognitive impairments
* Personal experiences consistent with symptoms of psychosis (e.g., hallucinations, delusions of control or special powers)
* History of skull defects (e.g., holes bored into the skull or known cranial fissures)
* Metal implants in the head or under the scalp
* Does not meet fMRI safety screening criteria (e.g., metal implants in the body, permanent jewelry, tattoos on the head or neck)
* Uses an intrauterine device (IUD) for birth control and cannot provide documentation to verify MRI safety
* Pregnancy (self-reported; no pregnancy test administered)
* Weight over 440 lbs (scanner weight limit)
* Presence of pacemakers
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline (no Stimulation) in Brain Activity in the Nucleus Accumbens During Active Versus Sham Stimulation
Timeframe: During fMRI scanning for each study session (active and sham stimulation), approximately 60 minutes