Temporal Interference Methods for Non-invasive Deep Brain Stimulation, Study 1.3
2 other identifiers
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy-volunteers
Started May 2026
Shorter than P25 for not_applicable healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2026
CompletedFirst Posted
Study publicly available on registry
May 19, 2026
CompletedStudy Start
First participant enrolled
May 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
Study Completion
Last participant's last visit for all outcomes
July 31, 2026
May 19, 2026
May 1, 2026
2 months
May 11, 2026
May 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in brain activity in the dorsal anterior cingulate cortex during 20 Hz versus selected comparison frequency temporal interference stimulation
Brain activity in the dorsal anterior cingulate cortex will be measured using functional magnetic resonance imaging (fMRI) during temporal interference (TI) stimulation at 20 Hz compared to a selected comparison beat frequency. The comparison frequency will be in the 1-100 Hz range. Activity will be reported as the percent change in blood-oxygen-level-dependent (BOLD) signal, which reflects changes in neural activity. Higher BOLD values indicate stronger brain activation.
During fMRI scan on study day (approximately 60 minutes)
Secondary Outcomes (3)
Change in brain activity in the dorsal anterior cingulate cortex during active versus sham stimulation at 20 Hz
During fMRI scan on study day (approximately 60 minutes)
Change in brain activity in the dorsal anterior cingulate cortex during active versus sham stimulation at the selected comparison frequency
During fMRI scan on study day (approximately 60 minutes)
Change in brain connectivity between the dorsal anterior cingulate cortex and other brain regions during temporal interference stimulation
During fMRI scan on study day (approximately 60 minutes)
Study Arms (4)
dACC 20Hz Active then Sham; Comparison frequency Active then Sham
ACTIVE COMPARATORParticipants 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.
dACC 20Hz Sham then Active; Comparison Frequency Sham then Active
ACTIVE COMPARATORParticipants 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.
dACC Comparison Frequency Sham then Active; 20Hz Sham then Active
ACTIVE COMPARATORParticipants 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.
dACC Comparison Frequency Active then Sham; 20Hz Active then Sham
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
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.
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
You may qualify if:
- Between the ages of 18 and 50
- Must have at least a 6th grade education
- Ability to speak and read English for all phases
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Indiana University Bloomington, Imaging Research Facility
Bloomington, Indiana, 47408, United States
Related Publications (3)
Violante IR, Alania K, Cassara AM, Neufeld E, Acerbo E, Carron R, Williamson A, Kurtin DL, Rhodes E, Hampshire A, Kuster N, Boyden ES, Pascual-Leone A, Grossman N. Non-invasive temporal interference electrical stimulation of the human hippocampus. Nat Neurosci. 2023 Nov;26(11):1994-2004. doi: 10.1038/s41593-023-01456-8. Epub 2023 Oct 19.
PMID: 37857775BACKGROUNDModak P, Fine J, Colon B, Need E, Cheng H, Hulvershorn L, Finn P, Brown JW. Temporal interference electrical neurostimulation at 20 Hz beat frequency leads to increased fMRI BOLD activation in orbitofrontal cortex in humans. Brain Stimul. 2024 Jul-Aug;17(4):867-875. doi: 10.1016/j.brs.2024.07.014. Epub 2024 Jul 24.
PMID: 39059712BACKGROUNDGrossman N, Bono D, Dedic N, Kodandaramaiah SB, Rudenko A, Suk HJ, Cassara AM, Neufeld E, Kuster N, Tsai LH, Pascual-Leone A, Boyden ES. Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields. Cell. 2017 Jun 1;169(6):1029-1041.e16. doi: 10.1016/j.cell.2017.05.024.
PMID: 28575667BACKGROUND
Related Links
- Lab website for study. The Cognitive Control Lab aims to understand the neural mechanisms of goal-directed behavior, using a combination of fMRI, computational neural modeling, and neurostimulation methods in healthy and clinical human populations.
- Project details for the NIMH-funded study on temporal interference stimulation, including abstract, funding, and key personnel.
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua W Brown, PhD
Indiana University, Bloomington
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pyschological and Brain Science
Study Record Dates
First Submitted
May 11, 2026
First Posted
May 19, 2026
Study Start (Estimated)
May 30, 2026
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
May 19, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share