Temporal Interference Methods for Non-invasive Deep Brain Stimulation, Study 1.1
2 other identifiers
interventional
30
1 country
1
Brief 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.
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 Nov 2025
Typical duration 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
September 29, 2025
CompletedFirst Posted
Study publicly available on registry
October 10, 2025
CompletedStudy Start
First participant enrolled
November 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 2, 2027
February 10, 2026
February 1, 2026
1.2 years
September 29, 2025
February 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in brain activity in the nucleus accumbens during active versus sham stimulation
Brain activity in the nucleus accumbens will be measured using functional magnetic resonance imaging (fMRI) during active temporal interference (TI) brain stimulation compared to sham (placebo) stimulation. Activity will be reported as the percent change in blood-oxygen-level-dependent (BOLD) signal, which reflects changes in brain 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 nucleus accumbens during no-TI active versus no-TI sham high-frequency stimulation
During fMRI scan on study day (approximately 60 minutes)
Change in brain activity in the nucleus accumbens during active TI stimulation versus active no-TI stimulation
During fMRI scan on study day (approximately 60 minutes)
Change in brain connectivity between the nucleus accumbens and other brain regions during stimulation
During fMRI scan on study day (approximately 60 minutes)
Study Arms (4)
NAcc TI Active, then NAcc TI Sham, then NAcc No-TI Active, then NAcc No-TI Sham
ACTIVE COMPARATORParticipants in this Arm receive temporal interference (TI) electrical stimulation with two pairs of carbon fiber electrodes in this order: NAcc TI Active, then NAcc TI Sham, then NAcc No-TI Active, then NAcc No-TI Sham.
NAcc No-TI Active, then NAcc No-TI Sham, then NAcc TI Active, then NAcc TI Sham
ACTIVE COMPARATORParticipants in this Arm receive temporal interference (TI) electrical stimulation with two pairs of carbon fiber electrodes in this order: NAcc No-TI Active, then NAcc No-TI Sham, then NAcc TI Active, then NAcc TI Sham.
NAcc TI Sham, then NAcc TI Active, then NAcc No-TI Sham, then NAcc No-TI Active
ACTIVE COMPARATORParticipants in this Arm receive temporal interference (TI) electrical stimulation with two pairs of carbon fiber electrodes in this order: NAcc TI Sham, then NAcc TI Active, then NAcc No-TI Sham, then NAcc No-TI Active.
NAcc No-TI Sham, then NAcc No-TI Active, then NAcc TI Sham, then NAcc TI Active
ACTIVE COMPARATORParticipants in this Arm receive temporal interference (TI) electrical stimulation with two pairs of carbon fiber electrodes in this order: NAcc No-TI Sham, then NAcc No-TI Active, then NAcc TI Sham, then NAcc TI Active.
Interventions
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies (e.g., 2000 Hz and 2020 Hz) at up to 2 mA per electrode. This stimulation creates a beat frequency interference pattern (e.g., 20 Hz) that focally stimulates deep brain regions without activating overlying cortex. For the NAcc TI Active condition, 2000Hz will be administered in one channel and 2020Hz in the other. These frequencies will be administered in 2 minutes on/2 minutes off cycles with a 30 second ramp up and ramp down beginning at the start of each 2 minute period.
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies (e.g., 2000 Hz and 2020 Hz) at up to 2 mA per electrode. This stimulation creates a beat frequency interference pattern (e.g., 20 Hz) that focally stimulates deep brain regions without activating overlying cortex. For the NAcc TI Sham condition, 2000Hz will be administered in one channel and 2020Hz in the other. These frequencies will be administered in 2 minutes on/2 minutes off cycles, however, instead of the 30 second ramp up and ramp down at the beginning of each 2 minute period (as seen in the Active TI condition), the stimulation in the NAcc TI Sham condition will immediately ramp down as soon as it reaches 2mA after ramp up.
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using the same current frequencies at up to 2 mA per electrode. For the NAcc No-TI Active condition, 2000Hz will be administered in both channels. These frequencies will be administered in 2 minutes on/2 minutes off cycles with a 30 second ramp up and ramp down beginning at the start of each 2 minute period.
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using the same current frequencies at up to 2 mA per electrode. For the NAcc No-TI Sham condition, 2000Hz will be administered in both channels. These frequencies will be administered in 2 minutes on/2 minutes off cycles, however, instead of the 30 second ramp up and ramp down at the beginning of each 2 minute period (as seen in the NAcc No-TI Active condition), the stimulation in the NAcc No-TI Sham condition will immediately ramp down as soon as it reaches 2mA after ramp up.
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
September 29, 2025
First Posted
October 10, 2025
Study Start
November 12, 2025
Primary Completion (Estimated)
February 2, 2027
Study Completion (Estimated)
February 2, 2027
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share