Healthy VolunteersNCT07339072
Temporal Interference Methods for Non-invasive Deep Brain Stimulation, Study 1.2
A study testing Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Active and Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI Active in people with Healthy Volunteers, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Active and Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI Active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2026to 13 Mar 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18 and 50
- Must have at least a 6th grade education
- Ability to speak and read English for all phases
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Bloomington, Imaging Research Facility
Bloomington, Indiana, 47408
About this study
Official title: Temporal Interference Methods for Non-invasive Deep Brain Stimulation
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.
Read the detailed description
Through the grant's duration, the investigators hypothesize that temporal interference (TI) electrical neurostimulation will be well tolerated and effective at focally manipulating deep brain activity as measured by functional MRI (fMRI) BOLD signals. The investigators will investigate whether TI stimulation can increase BOLD activity in targeted deep brain regions including the nucleus accumbens (NAcc) and dorsal anterior cingulate cortex (dACC), and whether this stimulation can influence cognitive functions controlled by these regions. TI works by applying alternating currents of slightly different frequencies through multiple electrode pairs, creating an interference pattern that can stimulate deep brain regions without significantly affecting superficial cortical areas. This method is similar to traditional transcranial direct current stimulation (tDCS), however TI can stimulate deeper brain structures that tDCS cannot reach effectively. The study is broken up into two main aims with multiple sub-studies. In Aim 1, the investigators will characterize the effects of TI on fMRI BOLD signals, test different beat frequencies, and compare TI effects in the nucleus accumbens versus dorsal anterior cingulate cortex. In Aim 2, the investigators will apply TI to the dorsal anterior cingulate cortex to test causal theories about its role in cognitive control, conflict monitoring, risk avoidance, and foraging behavior using established cognitive tasks while subjects undergo fMRI scanning.
Study 1.2 (Aim 1, Study 12) will test the ability to focally activate the nucleus accumbens without activating the overlying cortex, and also its effects on functional connectivity. Healthy subjects (n=30) will present for a single study visit during which they will be placed in the fMRI scanner and administered a temporal interference protocol. Specifically, subjects will have four pairs of carbon fiber electrodes attached to the scalp with conductive gel. They will receive one 8-minute block of stimulation at 2mA per electrode pair. The stimulation sequence will be 2 minutes on, 2 minutes off, 2 minutes on, and 2 minutes off with 30 second ramp up and ramp down beginning at the start of each 2-minute period. For Study 1.2, two TI beat frequencies will be evaluated: 5 Hz (produced by channels at 2000 Hz and 2005 Hz) and 10 Hz (produced by channels at 2000 Hz and 2010 Hz). Each beat frequency will have an Active block (30-second ramp to 2 mA, 2 min on / 2 min off cycles) and a matching Sham block where the stimulation immediately ramps down as soon as it reaches 2 mA after ramp up. The order of blocks and whether the "on" or "off" condition occurs first will be counterbalanced across subjects.
- Conditions
- Healthy Volunteers
- Being tested
- Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Active, Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Sham, Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI Active, Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI Sham
- Keywords
- Temporal Interference, fMRI, BOLD Signal, Cognitive Control, Dorsal Anterior Cingulate Cortex, Non-invasive deep brain stimulation, Neurostimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI ActiveDevice
Also called TI Electrical Neurostimulation, TI Neurostimulation
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 ShamDevice
Also called TI Electrical Neurostimulation, TI Neurostimulation
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 ActiveDevice
Also called TI Electrical Neurostimulation, TI Neurostimulation
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 ShamDevice
Also called TI Electrical Neurostimulation, TI Neurostimulation
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 group | Role | What they receive |
|---|---|---|
| NAcc 5 Hz TI Active, then NAcc 5 Hz TI Sham, then NAcc 10 Hz TI Active, then NAcc 10 Hz TI Sham | Active comparator | 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. Receives: Device: Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Active; Device: Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Sham; Device: Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI Active; Device: Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI Sham |
| NAcc 5 Hz TI Sham, then NAcc 5 Hz TI Active, then NAcc 10 Hz TI Sham, then NAcc 10 Hz TI Active | Active comparator | 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. Receives: Device: Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Active; Device: Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Sham; Device: Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI Active; Device: Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI Sham |
| NAcc 10 Hz TI Sham, then NAcc 10 Hz TI Active, then NAcc 5 Hz TI Sham, then NAcc 5 Hz TI Active | Active comparator | 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. Receives: Device: Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Active; Device: Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Sham; Device: Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI Active; Device: Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI Sham |
| NAcc 10 Hz TI Active, then NAcc 10 Hz TI Sham, then NAcc 5 Hz TI Active, then NAcc 5 Hz TI Sham | Active comparator | 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. Receives: Device: Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Active; Device: Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Sham; Device: Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI Active; Device: Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline (no Stimulation) in Brain Activity in the Nucleus Accumbens During 5 Hz Versus 10 Hz Temporal Interference Stimulation
Brain activity in the nucleus accumbens was measured using functional magnetic resonance imaging (fMRI) during temporal interference (TI) stimulation at 5 Hz compared with 10 Hz. Change in activity from baseline (no stimulation) was quantified using region-of-interest (ROI) beta estimates extracted from the nucleus accumbens to evaluate differences in task-related activation between stimulation frequencies. The beta estimates were derived from blood-oxygen-level-dependent (BOLD) signal changes measured during fMRI and reflect the magnitude of task-related neural activation within the ROI. Higher beta values indicate greater task-related activation. Whole-brain voxelwise analyses did not identify statistically significant activation differences after correction for multiple comparisons; therefore, descriptive ROI-level beta estimates are reported.
Measured: During fMRI scanning for each study session (5 Hz and 10 Hz stimulation conditions), approximately 60 minutes
Secondary outcomes (3)
Change From Baseline (no Stimulation) in Brain Activity in the Nucleus Accumbens During Active Versus Sham Stimulation at 5 Hz
Brain activity in the nucleus accumbens was measured using functional magnetic resonance imaging (fMRI) during 5 Hz temporal interference (TI) stimulation. Change in activity from baseline (no stimulation) was quantified using region-of-interest (ROI) beta estimates extracted from the nucleus accumbens during active versus sham 5 Hz stimulation to determine whether active 5 Hz stimulation altered brain activity relative to sham stimulation. The beta estimates were derived from blood-oxygen-level-dependent (BOLD) signal changes measured during fMRI and reflect the magnitude of task-related neural activation within the ROI. Higher beta values indicate greater task-related activation. Whole-brain voxelwise analyses did not identify statistically significant activation differences after correction for multiple comparisons; therefore, descriptive ROI-level beta estimates are reported
Measured: During fMRI scanning for each study session (active and sham 5 Hz stimulation conditions), approximately 60 minutes
Change From Baseline (no Stimulation) in Brain Activity in the Nucleus Accumbens During Active Versus Sham Stimulation at 10 Hz
Brain activity in the nucleus accumbens was measured using functional magnetic resonance imaging (fMRI) during 10 Hz temporal interference (TI) stimulation. Change in activity from baseline (no stimulation) was quantified using region-of-interest (ROI) beta estimates extracted from the nucleus accumbens during active versus sham 10 Hz stimulation to determine whether active 10 Hz stimulation altered brain activity relative to sham stimulation. The beta estimates were derived from blood-oxygen-level-dependent (BOLD) signal changes measured during fMRI and reflect the magnitude of task-related neural activation within the ROI. Higher beta values indicate greater task-related activation. Whole-brain voxelwise analyses did not identify statistically significant activation differences after correction for multiple comparisons; therefore, descriptive ROI-level beta estimates are reported.
Measured: During fMRI scanning for each study session (active and sham 10 Hz stimulation conditions), approximately 60 minutes
Change in Brain Connectivity Between the Nucleus Accumbens and Other Brain Regions During Temporal Interference Stimulation
Functional connectivity between the nucleus accumbens and other brain regions was planned to be evaluated using fMRI-based psycho-physiological interaction (PPI) analyses across temporal interference (TI) stimulation conditions. Higher correlation values indicate stronger functional connectivity between brain regions. The primary test statistic was the whole-brain interaction term between seed-region BOLD activity and stimulation condition. This analysis was not performed because no statistically significant activation clusters were identified from which to define a seed region.
Measured: During fMRI scanning for each study session (5 Hz active, 5 Hz sham, 10 Hz active, and 10 Hz sham stimulation conditions), approximately 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start4 Feb 2026
- Primary completion13 Mar 2026
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study uses a within-subject crossover design. Participants receive both active temporal interference (TI) stimulation and sham stimulation, in both "on" and "off" conditions during fMRI scanning. The order of active vs. sham stimulation and the order of on vs off conditions is counterbalanced across participants. Beat frequency, electrode placement, and behavioral paradigm vary by sub-study (e.g., reward-related tasks targeting the nucleus accumbens, cognitive control and decision-making tasks targeting the dorsal anterior cingulate cortex). For Study 1.2, two temporal interference beat frequencies (5 Hz and 10 Hz) will be evaluated for their effects on the nucleus accumbens.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Joshua Brown, PHD, Indiana University
- Investigators
- Joshua W Brown, PhD, Principal investigator, Indiana University, Bloomington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339072
- Sponsor's protocol ID
- 26941, Study 1.2
- Other IDs
- 1R21MH140210-01
- Status last verified
- Aug 2026
- First submitted
- 12 Jan 2026
- Last updated
- 15 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37857775Modak 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.
PubMed 39059712Grossman 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.
PubMed 28575667
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Interference Methods for Non-invasive Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT07339072
- Acronym / sponsor ID
- 26941, Study 1.2
- Conditions
- Healthy Volunteers
- Keywords
- Temporal Interference, fMRI, BOLD Signal, Cognitive Control, Dorsal Anterior Cingulate Cortex, Non-invasive deep brain stimulation, Neurostimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 13 Mar 2026 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 14 Jan 2026 (actual)
- Results
- Posted 15 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Through the grant's duration, the investigators hypothesize that temporal interference (TI) electrical neurostimulation will be well tolerated and effective at focally manipulating deep brain activity as measured by functional MRI (fMRI) BOLD signals. The investigators will investigate whether TI stimulation can increase BOLD activity in targeted deep brain regions including the nucleus accumbens (NAcc) and dorsal anterior cingulate cortex (dACC), and whether this stimulation can influence cognitive functions controlled by these regions. TI works by applying alternating currents of slightly different frequencies through multiple electrode pairs, creating an interference pattern that can stimulate deep brain regions without significantly affecting superficial cortical areas. This method is similar to traditional transcranial direct current stimulation (tDCS), however TI can stimulate deeper brain structures that tDCS cannot reach effectively. The study is broken up into two main aims with multiple sub-studies. In Aim 1, the investigators will characterize the effects of TI on fMRI BOLD signals, test different beat frequencies, and compare TI effects in the nucleus accumbens versus dorsal anterior cingulate cortex. In Aim 2, the investigators will apply TI to the dorsal anterior cingulate cortex to test causal theories about its role in cognitive control, conflict monitoring, risk avoidance, and foraging behavior using established cognitive tasks while subjects undergo fMRI scanning.
Study 1.2 (Aim 1, Study 12) will test the ability to focally activate the nucleus accumbens without activating the overlying cortex, and also its effects on functional connectivity. Healthy subjects (n=30) will present for a single study visit during which they will be placed in the fMRI scanner and administered a temporal interference protocol. Specifically, subjects will have four pairs of carbon fiber electrodes attached to the scalp with conductive gel. They will receive one 8-minute block of stimulation at 2mA per electrode pair. The stimulation sequence will be 2 minutes on, 2 minutes off, 2 minutes on, and 2 minutes off with 30 second ramp up and ramp down beginning at the start of each 2-minute period. For Study 1.2, two TI beat frequencies will be evaluated: 5 Hz (produced by channels at 2000 Hz and 2005 Hz) and 10 Hz (produced by channels at 2000 Hz and 2010 Hz). Each beat frequency will have an Active block (30-second ramp to 2 mA, 2 min on / 2 min off cycles) and a matching Sham block where the stimulation immediately ramps down as soon as it reaches 2 mA after ramp up. The order of blocks and whether the "on" or "off" condition occurs first will be counterbalanced across subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- This study uses a within-subject crossover design. Participants receive both active temporal interference (TI) stimulation and sham stimulation, in both "on" and "off" conditions during fMRI scanning. The order of active vs. sham stimulation and the order of on vs off conditions is counterbalanced across participants. Beat frequency, electrode placement, and behavioral paradigm vary by sub-study (e.g., reward-related tasks targeting the nucleus accumbens, cognitive control and decision-making tasks targeting the dorsal anterior cingulate cortex). For Study 1.2, two temporal interference beat frequencies (5 Hz and 10 Hz) will be evaluated for their effects on the nucleus accumbens.
| Arm | Type | Receives |
|---|---|---|
| NAcc 5 Hz TI Active, then NAcc 5 Hz TI Sham, then NAcc 10 Hz TI Active, then NAcc 10 Hz TI Sham | Active comparator | Device: Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Active, Device: Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Sham, Device: Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI Active, Device: Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI ShamParticipants 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. |
| NAcc 5 Hz TI Sham, then NAcc 5 Hz TI Active, then NAcc 10 Hz TI Sham, then NAcc 10 Hz TI Active | Active comparator | Device: Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Active, Device: Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Sham, Device: Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI Active, Device: Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI ShamParticipants 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. |
| NAcc 10 Hz TI Sham, then NAcc 10 Hz TI Active, then NAcc 5 Hz TI Sham, then NAcc 5 Hz TI Active | Active comparator | Device: Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Active, Device: Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Sham, Device: Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI Active, Device: Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI ShamParticipants 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. |
| NAcc 10 Hz TI Active, then NAcc 10 Hz TI Sham, then NAcc 5 Hz TI Active, then NAcc 5 Hz TI Sham | Active comparator | Device: Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Active, Device: Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Sham, Device: Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI Active, Device: Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI ShamParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between the ages of 18 and 50
- Must have at least a 6th grade education
- Ability to speak and read English for all phases
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI ActiveAlso: TI Electrical Neurostimulation, TI NeurostimulationNon-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. | Device | NAcc 10 Hz TI Active, then NAcc 10 Hz TI Sham, then NAcc 5 Hz TI Active, then NAcc 5 Hz TI Sham, NAcc 10 Hz TI Sham, then NAcc 10 Hz TI Active, then NAcc 5 Hz TI Sham, then NAcc 5 Hz TI Active, NAcc 5 Hz TI Active, then NAcc 5 Hz TI Sham, then NAcc 10 Hz TI Active, then NAcc 10 Hz TI Sham, NAcc 5 Hz TI Sham, then NAcc 5 Hz TI Active, then NAcc 10 Hz TI Sham, then NAcc 10 Hz TI Active |
| Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI ShamAlso: TI Electrical Neurostimulation, TI NeurostimulationSame 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. | Device | NAcc 10 Hz TI Active, then NAcc 10 Hz TI Sham, then NAcc 5 Hz TI Active, then NAcc 5 Hz TI Sham, NAcc 10 Hz TI Sham, then NAcc 10 Hz TI Active, then NAcc 5 Hz TI Sham, then NAcc 5 Hz TI Active, NAcc 5 Hz TI Active, then NAcc 5 Hz TI Sham, then NAcc 10 Hz TI Active, then NAcc 10 Hz TI Sham, NAcc 5 Hz TI Sham, then NAcc 5 Hz TI Active, then NAcc 10 Hz TI Sham, then NAcc 10 Hz TI Active |
| Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI ActiveAlso: TI Electrical Neurostimulation, TI NeurostimulationNon-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. | Device | NAcc 10 Hz TI Active, then NAcc 10 Hz TI Sham, then NAcc 5 Hz TI Active, then NAcc 5 Hz TI Sham, NAcc 10 Hz TI Sham, then NAcc 10 Hz TI Active, then NAcc 5 Hz TI Sham, then NAcc 5 Hz TI Active, NAcc 5 Hz TI Active, then NAcc 5 Hz TI Sham, then NAcc 10 Hz TI Active, then NAcc 10 Hz TI Sham, NAcc 5 Hz TI Sham, then NAcc 5 Hz TI Active, then NAcc 10 Hz TI Sham, then NAcc 10 Hz TI Active |
| Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI ShamAlso: TI Electrical Neurostimulation, TI NeurostimulationSame 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. | Device | NAcc 10 Hz TI Active, then NAcc 10 Hz TI Sham, then NAcc 5 Hz TI Active, then NAcc 5 Hz TI Sham, NAcc 10 Hz TI Sham, then NAcc 10 Hz TI Active, then NAcc 5 Hz TI Sham, then NAcc 5 Hz TI Active, NAcc 5 Hz TI Active, then NAcc 5 Hz TI Sham, then NAcc 10 Hz TI Active, then NAcc 10 Hz TI Sham, NAcc 5 Hz TI Sham, then NAcc 5 Hz TI Active, then NAcc 10 Hz TI Sham, then NAcc 10 Hz TI Active |
Primary outcome
Change From Baseline (no Stimulation) in Brain Activity in the Nucleus Accumbens During 5 Hz Versus 10 Hz Temporal Interference Stimulation
Time frame: During fMRI scanning for each study session (5 Hz and 10 Hz stimulation conditions), approximately 60 minutes
Brain activity in the nucleus accumbens was measured using functional magnetic resonance imaging (fMRI) during temporal interference (TI) stimulation at 5 Hz compared with 10 Hz. Change in activity from baseline (no stimulation) was quantified using region-of-interest (ROI) beta estimates extracted from the nucleus accumbens to evaluate differences in task-related activation between stimulation frequencies. The beta estimates were derived from blood-oxygen-level-dependent (BOLD) signal changes measured during fMRI and reflect the magnitude of task-related neural activation within the ROI. Higher beta values indicate greater task-related activation. Whole-brain voxelwise analyses did not identify statistically significant activation differences after correction for multiple comparisons; therefore, descriptive ROI-level beta estimates are reported.
3 secondary outcomes
Change From Baseline (no Stimulation) in Brain Activity in the Nucleus Accumbens During Active Versus Sham Stimulation at 5 Hz
Time frame: During fMRI scanning for each study session (active and sham 5 Hz stimulation conditions), approximately 60 minutes
Change From Baseline (no Stimulation) in Brain Activity in the Nucleus Accumbens During Active Versus Sham Stimulation at 10 Hz
Time frame: During fMRI scanning for each study session (active and sham 10 Hz stimulation conditions), approximately 60 minutes
Change in Brain Connectivity Between the Nucleus Accumbens and Other Brain Regions During Temporal Interference Stimulation
Time frame: During fMRI scanning for each study session (5 Hz active, 5 Hz sham, 10 Hz active, and 10 Hz sham stimulation conditions), approximately 60 minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37857775Violante 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.
- Background: PubMed 39059712Modak 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.
- Background: PubMed 28575667Grossman 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.
- 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.Link provided by the sponsor.
- Project details for the NIMH-funded study on temporal interference stimulation, including abstract, funding, and key personnel.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua W Brown, PhD principal investigator
Indiana University, Bloomington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporal Interference (TI) Electrical Stimulation - NAcc 5 Hz TI Active and Temporal Interference (TI) Electrical Stimulation - NAcc 10 Hz TI Active in people with Healthy Volunteers, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline (no Stimulation) in Brain Activity in the Nucleus Accumbens During 5 Hz Versus 10 Hz Temporal Interference Stimulation (time frame: During fMRI scanning for each study session (5 Hz and 10 Hz stimulation conditions), approximately 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07339072, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.