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

Part of paid clinical trials in Bloomington, Indiana.

Sponsor
Indiana University
Study ID
NCT07594795
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 - 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.

Study Details

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
May 30, 2026
Status verified
May 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

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

Arms

  • Active Comparator: dACC 20Hz Active then Sham; Comparison frequency Active then Sham
    Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using two pairs of carbon fiber electrodes in the following order: 20 Hz TI Active, 20 Hz TI Sham, selected comparison frequency TI Active, then selected comparison frequency TI Sham. The comparison frequency will be within the 1-100 Hz range.
  • Active Comparator: dACC 20Hz Sham then Active; Comparison Frequency Sham then Active
    Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: 20 Hz TI Sham, 20 Hz TI Active, selected comparison frequency TI Sham, then selected comparison frequency TI Active. The comparison frequency will be in the 1-100 Hz range.
  • Active Comparator: dACC Comparison Frequency Sham then Active; 20Hz Sham then Active
    Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: selected comparison frequency TI Sham, selected comparison frequency TI Active, 20 Hz TI Sham, then 20 Hz TI Active. The comparison frequency will be in the 1-100 Hz range.
  • Active Comparator: dACC Comparison Frequency Active then Sham; 20Hz Active then Sham
    Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: selected comparison frequency TI Active, selected comparison frequency TI Sham, 20 Hz TI Active, then 20 Hz TI Sham. The comparison frequency will be in the 1-100 Hz range.

Primary Outcome Measure

Change in brain activity in the dorsal anterior cingulate cortex during 20 Hz versus selected comparison frequency 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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