Temporal Interference Methods for Non-invasive Deep Brain Stimulation, Study 1.2

Part of paid clinical trials in Bloomington, Indiana.

Sponsor
Indiana University
Study ID
NCT07339072
Status
Recruiting
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Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Active — DEVICE
    Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to 2 mA per electrode. For the NAcc 5 Hz TI Active condition, one channel will deliver 2000 Hz and the other 2005 Hz, producing a 5 Hz beat frequency that focally stimulates deep brain regions without activating overlying 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 - NAcc 5 Hz TI Sham — DEVICE
    Same setup as the 5 Hz TI Active condition, except that the stimulation immediately ramps down as soon as it reaches 2 mA after ramp up, producing a sham condition.
  • Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI Active — DEVICE
    Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to 2 mA per electrode. For the NAcc 10 Hz TI Active condition, one channel will deliver 2000 Hz and the other 2010 Hz, producing a 10 Hz beat frequency that focally stimulates deep brain regions without activating overlying 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 - NAcc 10 Hz TI Sham — DEVICE
    Same setup as the 10 Hz TI Active condition, except that the stimulation immediately ramps down as soon as it reaches 2 mA after ramp up, producing a sham condition.

Study Details

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.

Key Dates

Start date
Feb 3, 2026
Status verified
Feb 2026
Primary completion
Apr 1, 2027
Completion
Apr 8, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: NAcc 5 Hz TI Active, then NAcc 5 Hz TI Sham, then NAcc 10 Hz TI Active, then NAcc 10 Hz TI Sham
    Participants in this arm receive temporal interference (TI) electrical stimulation targeting the nucleus accumbens using two pairs of carbon fiber electrodes in the following order: 5 Hz TI Active, 5 Hz TI Sham, 10 Hz TI Active, then 10 Hz TI Sham.
  • Active Comparator: NAcc 5 Hz TI Sham, then NAcc 5 Hz TI Active, then NAcc 10 Hz TI Sham, then NAcc 10 Hz TI Active
    Participants in this arm receive temporal interference (TI) electrical stimulation targeting the nucleus accumbens using two pairs of carbon fiber electrodes in the following order: 5 Hz TI Sham, 5 Hz TI Active, 10 Hz TI Sham, then 10 Hz TI Active.
  • Active Comparator: NAcc 10 Hz TI Sham, then NAcc 10 Hz TI Active, then NAcc 5 Hz TI Sham, then NAcc 5 Hz TI Active
    Participants in this arm receive temporal interference (TI) electrical stimulation targeting the nucleus accumbens using two pairs of carbon fiber electrodes in the following order: 10 Hz TI Sham, 10 Hz TI Active, 5 Hz TI Sham, then 5 Hz TI Active.
  • Active Comparator: NAcc 10 Hz TI Active, then NAcc 10 Hz TI Sham, then NAcc 5 Hz TI Active, then NAcc 5 Hz TI Sham
    Participants in this arm receive temporal interference (TI) electrical stimulation targeting the nucleus accumbens using two pairs of carbon fiber electrodes in the following order: 10 Hz TI Active, 10 Hz TI Sham, 5 Hz TI Active, then 5 Hz TI Sham.

Primary Outcome Measure

Change in brain activity in the nucleus accumbens during 5 Hz versus 10 Hz temporal interference stimulation [ Time Frame: During fMRI scan on study day (approximately 60 minutes) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University Bloomington, Imaging Research FacilityBloomingtonIndiana47408
Josh W Brown, PhD
[email protected]
812-856-1846
Kendall E Moore, BS
[email protected]
(812) 856-1846

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Indiana University Bloomington, Imaging Research Facility· Bloomington, IN

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