Healthy VolunteersNCT07215299
Temporal Interference Methods for Non-invasive Deep Brain Stimulation, Study 1.1
A study testing Temporal Interference (TI) Electrical Stimulation - NAcc TI Active and Temporal Interference (TI) Electrical Stimulation - NAcc No-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 TI Active and Temporal Interference (TI) Electrical Stimulation - NAcc No-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
- 12 Nov 2025to 2 Feb 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 1.1 (Aim 1, Study 1) 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 two 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. The first block will apply active TI stimulation with 2000Hz in one channel and 2020Hz in the other channel. The second block will be a sham TI stimulation, identical to the first block but with the "on" condition immediately ramping down as soon as it reaches 2mA after ramp up. The third and fourth blocks will be identical to the first and second blocks, except that both electrode pairs will stimulate at 2000Hz, resulting in a "NO-TI active" and "NO-TI sham" conditions. The order of blocks, and whether the "on" or "off" condition occurs first within a block, will be counterbalanced across subjects.
- Conditions
- Healthy Volunteers
- Being tested
- Temporal Interference (TI) Electrical Stimulation - NAcc TI Active, Temporal Interference (TI) Electrical Stimulation - NAcc TI Sham, Temporal Interference (TI) Electrical Stimulation - NAcc No-TI Active, Temporal Interference (TI) Electrical Stimulation - NAcc No-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 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 (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.
Temporal Interference (TI) Electrical Stimulation - NAcc TI ShamDevice
Also called TI Electrical Neurostimulation, TI Neurostimulation
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.
Temporal Interference (TI) Electrical Stimulation - NAcc No-TI ActiveDevice
Also called TI Electrical Neurostimulation, TI Neurostimulation
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.
Temporal Interference (TI) Electrical Stimulation - NAcc No-TI ShamDevice
Also called TI Electrical Neurostimulation, TI Neurostimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| NAcc TI Active, then NAcc TI Sham, then NAcc No-TI Active, then NAcc No-TI Sham | Active comparator | Participants 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. Receives: Device: Temporal Interference (TI) Electrical Stimulation - NAcc TI Active; Device: Temporal Interference (TI) Electrical Stimulation - NAcc TI Sham; Device: Temporal Interference (TI) Electrical Stimulation - NAcc No-TI Active; Device: Temporal Interference (TI) Electrical Stimulation - NAcc No-TI Sham |
| NAcc No-TI Active, then NAcc No-TI Sham, then NAcc TI Active, then NAcc TI Sham | Active comparator | Participants 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. Receives: Device: Temporal Interference (TI) Electrical Stimulation - NAcc TI Active; Device: Temporal Interference (TI) Electrical Stimulation - NAcc TI Sham; Device: Temporal Interference (TI) Electrical Stimulation - NAcc No-TI Active; Device: Temporal Interference (TI) Electrical Stimulation - NAcc No-TI Sham |
| NAcc TI Sham, then NAcc TI Active, then NAcc No-TI Sham, then NAcc No-TI Active | Active comparator | Participants 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. Receives: Device: Temporal Interference (TI) Electrical Stimulation - NAcc TI Active; Device: Temporal Interference (TI) Electrical Stimulation - NAcc TI Sham; Device: Temporal Interference (TI) Electrical Stimulation - NAcc No-TI Active; Device: Temporal Interference (TI) Electrical Stimulation - NAcc No-TI Sham |
| NAcc No-TI Sham, then NAcc No-TI Active, then NAcc TI Sham, then NAcc TI Active | Active comparator | Participants 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. Receives: Device: Temporal Interference (TI) Electrical Stimulation - NAcc TI Active; Device: Temporal Interference (TI) Electrical Stimulation - NAcc TI Sham; Device: Temporal Interference (TI) Electrical Stimulation - NAcc No-TI Active; Device: Temporal Interference (TI) Electrical Stimulation - NAcc No-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 Active Versus Sham Stimulation
Brain activity in the nucleus accumbens was measured using functional magnetic resonance imaging (fMRI) during active temporal interference (TI) brain stimulation compared to sham stimulation. Activity change from baseline (no stimulation) was quantified using region-of-interest (ROI) beta estimates extracted from the nucleus accumbens. 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 clusters after correction for multiple comparisons; therefore, descriptive ROI-level beta estimates are reported.
Measured: During fMRI scanning for each study session (active and sham stimulation), approximately 60 minutes
Secondary outcomes (3)
Change From Baseline (no Stimulation) in Brain Activity in the Nucleus Accumbens During No-TI Active Versus No-TI Sham High-frequency Stimulation
Brain activity in the nucleus accumbens was measured using functional magnetic resonance imaging (fMRI) during no-temporal interference (no-TI) control stimulation, in which both electrode pairs delivered the same frequency. Change in activity from baseline (no stimulation) was quantified using region-of-interest (ROI) beta estimates extracted from the nucleus accumbens during NO-TI active versus NO-TI sham high-frequency stimulation to determine whether high-frequency stimulation alone altered brain activity. 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 no-TI stimulation conditions), approximately 60 minutes
Change From Baseline (no Stimulation) in Brain Activity in the Nucleus Accumbens During Active TI Stimulation Versus Active No-TI Stimulation
Brain activity in the nucleus accumbens was compared between active temporal interference (TI) stimulation and active high-frequency no-temporal interference (no-TI) stimulation using functional magnetic resonance imaging (fMRI). Change in activity from baseline (no stimulation) was quantified using region-of-interest (ROI) beta estimates extracted from the nucleus accumbens to determine whether TI stimulation produced greater task-related activation than high-frequency stimulation alone. 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 TI and active no-TI stimulation conditions), approximately 60 minutes
Change in Brain Connectivity Between the Nucleus Accumbens and Other Brain Regions During Stimulation
Functional connectivity between the nucleus accumbens and other brain regions was planned to be evaluated using fMRI-based psycho-physiological interaction (PPI) analyses during active versus sham temporal interference (TI) stimulation. 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 (active vs. sham TI). 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 (active and 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 posted10 Oct 2025
- Study start12 Nov 2025
- Primary completion2 Feb 2026
- Study completion2 Feb 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 1.1, a 20Hz beat frequency will be evaluated for its effect 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
- NCT07215299
- Sponsor's protocol ID
- 26941, Study 1.1
- Other IDs
- 1R21MH140210-01
- Status last verified
- Jun 2026
- First submitted
- 29 Sep 2025
- Last updated
- 3 Aug 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 3 Aug 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
- NCT07215299
- Acronym / sponsor ID
- 26941, Study 1.1
- 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
- 12 Nov 2025 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 10 Oct 2025 (actual)
- Results
- Posted 3 Aug 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 1.1 (Aim 1, Study 1) 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 two 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. The first block will apply active TI stimulation with 2000Hz in one channel and 2020Hz in the other channel. The second block will be a sham TI stimulation, identical to the first block but with the "on" condition immediately ramping down as soon as it reaches 2mA after ramp up. The third and fourth blocks will be identical to the first and second blocks, except that both electrode pairs will stimulate at 2000Hz, resulting in a "NO-TI active" and "NO-TI sham" conditions. The order of blocks, and whether the "on" or "off" condition occurs first within a block, 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 1.1, a 20Hz beat frequency will be evaluated for its effect on the nucleus accumbens.
| Arm | Type | Receives |
|---|---|---|
| NAcc TI Active, then NAcc TI Sham, then NAcc No-TI Active, then NAcc No-TI Sham | Active comparator | Device: Temporal Interference (TI) Electrical Stimulation - NAcc TI Active, Device: Temporal Interference (TI) Electrical Stimulation - NAcc TI Sham, Device: Temporal Interference (TI) Electrical Stimulation - NAcc No-TI Active, Device: Temporal Interference (TI) Electrical Stimulation - NAcc No-TI ShamParticipants 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 comparator | Device: Temporal Interference (TI) Electrical Stimulation - NAcc TI Active, Device: Temporal Interference (TI) Electrical Stimulation - NAcc TI Sham, Device: Temporal Interference (TI) Electrical Stimulation - NAcc No-TI Active, Device: Temporal Interference (TI) Electrical Stimulation - NAcc No-TI ShamParticipants 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 comparator | Device: Temporal Interference (TI) Electrical Stimulation - NAcc TI Active, Device: Temporal Interference (TI) Electrical Stimulation - NAcc TI Sham, Device: Temporal Interference (TI) Electrical Stimulation - NAcc No-TI Active, Device: Temporal Interference (TI) Electrical Stimulation - NAcc No-TI ShamParticipants 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 comparator | Device: Temporal Interference (TI) Electrical Stimulation - NAcc TI Active, Device: Temporal Interference (TI) Electrical Stimulation - NAcc TI Sham, Device: Temporal Interference (TI) Electrical Stimulation - NAcc No-TI Active, Device: Temporal Interference (TI) Electrical Stimulation - NAcc No-TI ShamParticipants 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. |
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 TI ActiveAlso: TI Electrical Neurostimulation, TI NeurostimulationNon-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. | Device | NAcc No-TI Active, then NAcc No-TI Sham, then NAcc TI Active, then NAcc TI Sham, NAcc No-TI Sham, then NAcc No-TI Active, then NAcc TI Sham, then NAcc TI Active, NAcc TI Active, then NAcc TI Sham, then NAcc No-TI Active, then NAcc No-TI Sham, NAcc TI Sham, then NAcc TI Active, then NAcc No-TI Sham, then NAcc No-TI Active |
| Temporal Interference (TI) Electrical Stimulation - NAcc TI ShamAlso: TI Electrical Neurostimulation, TI NeurostimulationNon-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. | Device | NAcc No-TI Active, then NAcc No-TI Sham, then NAcc TI Active, then NAcc TI Sham, NAcc No-TI Sham, then NAcc No-TI Active, then NAcc TI Sham, then NAcc TI Active, NAcc TI Active, then NAcc TI Sham, then NAcc No-TI Active, then NAcc No-TI Sham, NAcc TI Sham, then NAcc TI Active, then NAcc No-TI Sham, then NAcc No-TI Active |
| Temporal Interference (TI) Electrical Stimulation - NAcc No-TI ActiveAlso: TI Electrical Neurostimulation, TI NeurostimulationNon-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. | Device | NAcc No-TI Active, then NAcc No-TI Sham, then NAcc TI Active, then NAcc TI Sham, NAcc No-TI Sham, then NAcc No-TI Active, then NAcc TI Sham, then NAcc TI Active, NAcc TI Active, then NAcc TI Sham, then NAcc No-TI Active, then NAcc No-TI Sham, NAcc TI Sham, then NAcc TI Active, then NAcc No-TI Sham, then NAcc No-TI Active |
| Temporal Interference (TI) Electrical Stimulation - NAcc No-TI ShamAlso: TI Electrical Neurostimulation, TI NeurostimulationNon-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. | Device | NAcc No-TI Active, then NAcc No-TI Sham, then NAcc TI Active, then NAcc TI Sham, NAcc No-TI Sham, then NAcc No-TI Active, then NAcc TI Sham, then NAcc TI Active, NAcc TI Active, then NAcc TI Sham, then NAcc No-TI Active, then NAcc No-TI Sham, NAcc TI Sham, then NAcc TI Active, then NAcc No-TI Sham, then NAcc No-TI Active |
Primary outcome
Change From Baseline (no Stimulation) in Brain Activity in the Nucleus Accumbens During Active Versus Sham Stimulation
Time frame: During fMRI scanning for each study session (active and sham stimulation), approximately 60 minutes
Brain activity in the nucleus accumbens was measured using functional magnetic resonance imaging (fMRI) during active temporal interference (TI) brain stimulation compared to sham stimulation. Activity change from baseline (no stimulation) was quantified using region-of-interest (ROI) beta estimates extracted from the nucleus accumbens. 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 clusters 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 No-TI Active Versus No-TI Sham High-frequency Stimulation
Time frame: During fMRI scanning for each study session (active and sham no-TI stimulation conditions), approximately 60 minutes
Change From Baseline (no Stimulation) in Brain Activity in the Nucleus Accumbens During Active TI Stimulation Versus Active No-TI Stimulation
Time frame: During fMRI scanning for each study session (active TI and active no-TI stimulation conditions), approximately 60 minutes
Change in Brain Connectivity Between the Nucleus Accumbens and Other Brain Regions During Stimulation
Time frame: During fMRI scanning for each study session (active and 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 3 Aug 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 TI Active and Temporal Interference (TI) Electrical Stimulation - NAcc No-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 3 Aug 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 3 Aug 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 Active Versus Sham Stimulation (time frame: During fMRI scanning for each study session (active and sham stimulation), 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 NCT07215299, 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 3 Aug 2026.