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RECRUITING Not applicable ClinicalTrials.gov

Temporal Interference Methods for Non-invasive Deep Brain Stimulation, Study 1.3

Sponsor: Indiana University • ClinicalTrials.gov ID: NCT07594795

Registry updated: 2026-09-11
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Description

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.

Interventions

  • Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Active (Device)
    Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC 20 Hz TI Active condition, one channel will deliver 2000 Hz and the other 2020 Hz, producing a 20 Hz beat frequency targeting the dorsal anterior cingulate cortex. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.
  • Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Sham (Device)
    Same setup as the dACC 20 Hz TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.
  • Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Active (Device)
    Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC comparison frequency TI Active condition, stimulation will be delivered using a selected beat frequency in the 1-100 Hz range. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.
  • Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Sham (Device)
    Same setup as the dACC comparison frequency TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.

Eligibility criteria

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

Conditions

Healthy Volunteers

Locations

  • Indiana University Bloomington, Imaging Research Facility — Bloomington, Indiana, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record