Healthy VolunteersNCT07594795
Temporal Interference Methods for Non-invasive Deep Brain Stimulation, Study 1.3
A study testing Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Active and Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Active in people with Healthy Volunteers, run by Indiana University at 1 site in United States.
Trial 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. 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 - dACC 20 Hz TI Active and Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency 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
- 16 Jul 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University Bloomington, Imaging Research Facility
Bloomington, Indiana, 47408
Josh W Brown, PhD, 812-856-1846, cclab@iu.edu
Irene Jang, BS, (812) 856-1846, cclabmgr@iu.edu
About this study
Official title: Temporal Interference Methods for Non-invasive Deep Brain Stimulation
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 1.3 (Aim 1, Study 1.3) will test whether TI can focally modulate activity in the dorsal anterior cingulate cortex, around MNI coordinates 0, 30, 30, as measured by fMRI BOLD signal. Healthy subjects (n=30) will complete a single study visit during which they will undergo fMRI while receiving TI stimulation through carbon fiber electrodes attached to the scalp with conductive gel. Electrode placement may vary by participant to optimize dACC targeting using individualized finite element modeling.
Participants will receive active and sham TI stimulation at a selected beat frequency potentially including 5 Hz, 30 Hz, 40 Hz, or another frequency in the 1-100 Hz range. Stimulation will follow an on/off sequence of 2 minutes on, 2 minutes off, 2 minutes on, and 2 minutes off, with 30-second ramp up and ramp down periods beginning at the start of each 2-minute stimulation period. Study 1.3 will also examine whether increased stimulation intensity improves modulation of BOLD activity in the dACC. Stimulation may be delivered up to ±5 mA per channel, corresponding to 10 mA peak-to-peak, with the second stimulation channel linearly scaled based on individualized modeling to maintain optimal targeting. Active and sham stimulation blocks will be counterbalanced across subjects.
- Conditions
- Healthy Volunteers
- Being tested
- Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Active, Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Sham, Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Active, Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency 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 - dACC 20 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 ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC 20 Hz TI Active condition, one channel will deliver 2000 Hz and the other 2020 Hz, producing a 20 Hz beat frequency targeting the dorsal anterior cingulate cortex. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.
Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI ShamDevice
Also called TI Electrical Neurostimulation, TI Neurostimulation
Same setup as the dACC 20 Hz TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.
Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI 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 ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC comparison frequency TI Active condition, stimulation will be delivered using a selected beat frequency in the 1-100 Hz range. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.
Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI ShamDevice
Also called TI Electrical Neurostimulation, TI Neurostimulation
Same setup as the dACC comparison frequency TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.
| Study group | Role | What they receive |
|---|---|---|
| dACC 20Hz Active then Sham; Comparison frequency Active then Sham | Active comparator | Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using two pairs of carbon fiber electrodes in the following order: 20 Hz TI Active, 20 Hz TI Sham, selected comparison frequency TI Active, then selected comparison frequency TI Sham. The comparison frequency will be within the 1-100 Hz range. Receives: Device: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Active; Device: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Sham; Device: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Active; Device: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Sham |
| dACC 20Hz Sham then Active; Comparison Frequency Sham then Active | Active comparator | Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: 20 Hz TI Sham, 20 Hz TI Active, selected comparison frequency TI Sham, then selected comparison frequency TI Active. The comparison frequency will be in the 1-100 Hz range. Receives: Device: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Active; Device: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Sham; Device: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Active; Device: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Sham |
| dACC Comparison Frequency Sham then Active; 20Hz Sham then Active | Active comparator | Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: selected comparison frequency TI Sham, selected comparison frequency TI Active, 20 Hz TI Sham, then 20 Hz TI Active. The comparison frequency will be in the 1-100 Hz range. Receives: Device: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Active; Device: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Sham; Device: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Active; Device: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Sham |
| dACC Comparison Frequency Active then Sham; 20Hz Active then Sham | Active comparator | Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: selected comparison frequency TI Active, selected comparison frequency TI Sham, 20 Hz TI Active, then 20 Hz TI Sham. The comparison frequency will be in the 1-100 Hz range. Receives: Device: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Active; Device: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Sham; Device: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Active; Device: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Brain activity in the dorsal anterior cingulate cortex will be measured using fMRI during active versus sham temporal interference stimulation at a 20 Hz beat frequency. Activity will be reported as the percent change in blood-oxygen-level-dependent (BOLD) signal.
Measured: 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
Brain activity in the dorsal anterior cingulate cortex will be measured using fMRI during active versus sham temporal interference stimulation at the selected comparison beat frequency. The comparison frequency will be within the 1-100 Hz range. Activity will be reported as the percent change in blood-oxygen-level-dependent (BOLD) signal.
Measured: 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
Functional connectivity between the dorsal anterior cingulate cortex and other brain regions will be measured using fMRI-based analyses during active versus sham temporal interference stimulation. Higher correlation values indicate stronger communication between brain regions. The primary test statistic will be the whole-brain psychophysiological interaction (PPI) between dorsal anterior cingulate cortex BOLD activity and stimulation condition.
Measured: During fMRI scan on study day (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 posted19 May 2026
- Study start16 Jul 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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. For Study 1.3, TI stimulation will target the dorsal anterior cingulate cortex, and the beat frequency will be selected and adjusted within the 1-100 Hz range. Study 1.3 will also evaluate whether increased stimulation intensity, up to ±5 mA per channel, improves modulation of BOLD activity in the dorsal anterior cingulate cortex.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
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
- NCT07594795
- Sponsor's protocol ID
- 26941, Study 1.3
- Other IDs
- 1R21MH140210-01
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- 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 11 Sep 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
- NCT07594795
- Acronym / sponsor ID
- 26941, Study 1.3
- 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
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 1.3 (Aim 1, Study 1.3) will test whether TI can focally modulate activity in the dorsal anterior cingulate cortex, around MNI coordinates 0, 30, 30, as measured by fMRI BOLD signal. Healthy subjects (n=30) will complete a single study visit during which they will undergo fMRI while receiving TI stimulation through carbon fiber electrodes attached to the scalp with conductive gel. Electrode placement may vary by participant to optimize dACC targeting using individualized finite element modeling.
Participants will receive active and sham TI stimulation at a selected beat frequency potentially including 5 Hz, 30 Hz, 40 Hz, or another frequency in the 1-100 Hz range. Stimulation will follow an on/off sequence of 2 minutes on, 2 minutes off, 2 minutes on, and 2 minutes off, with 30-second ramp up and ramp down periods beginning at the start of each 2-minute stimulation period. Study 1.3 will also examine whether increased stimulation intensity improves modulation of BOLD activity in the dACC. Stimulation may be delivered up to ±5 mA per channel, corresponding to 10 mA peak-to-peak, with the second stimulation channel linearly scaled based on individualized modeling to maintain optimal targeting. Active and sham stimulation blocks 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. For Study 1.3, TI stimulation will target the dorsal anterior cingulate cortex, and the beat frequency will be selected and adjusted within the 1-100 Hz range. Study 1.3 will also evaluate whether increased stimulation intensity, up to ±5 mA per channel, improves modulation of BOLD activity in the dorsal anterior cingulate cortex.
| Arm | Type | Receives |
|---|---|---|
| dACC 20Hz Active then Sham; Comparison frequency Active then Sham | Active comparator | Device: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Active, Device: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Sham, Device: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Active, Device: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI ShamParticipants 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 comparator | Device: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Active, Device: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Sham, Device: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Active, Device: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI ShamParticipants 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 comparator | Device: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Active, Device: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Sham, Device: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Active, Device: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI ShamParticipants 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 comparator | Device: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Active, Device: Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Sham, Device: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Active, Device: Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI ShamParticipants 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. |
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 - dACC 20 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 ±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. | Device | dACC 20Hz Active then Sham; Comparison frequency Active then Sham, dACC 20Hz Sham then Active; Comparison Frequency Sham then Active, dACC Comparison Frequency Active then Sham; 20Hz Active then Sham, dACC Comparison Frequency Sham then Active; 20Hz Sham then Active |
| Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI ShamAlso: TI Electrical Neurostimulation, TI NeurostimulationSame 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. | Device | dACC 20Hz Active then Sham; Comparison frequency Active then Sham, dACC 20Hz Sham then Active; Comparison Frequency Sham then Active, dACC Comparison Frequency Active then Sham; 20Hz Active then Sham, dACC Comparison Frequency Sham then Active; 20Hz Sham then Active |
| Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency 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 ±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. | Device | dACC 20Hz Active then Sham; Comparison frequency Active then Sham, dACC 20Hz Sham then Active; Comparison Frequency Sham then Active, dACC Comparison Frequency Active then Sham; 20Hz Active then Sham, dACC Comparison Frequency Sham then Active; 20Hz Sham then Active |
| Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI ShamAlso: TI Electrical Neurostimulation, TI NeurostimulationSame 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. | Device | dACC 20Hz Active then Sham; Comparison frequency Active then Sham, dACC 20Hz Sham then Active; Comparison Frequency Sham then Active, dACC Comparison Frequency Active then Sham; 20Hz Active then Sham, dACC Comparison Frequency Sham then Active; 20Hz Sham then Active |
Primary outcome
Change in brain activity in the dorsal anterior cingulate cortex during 20 Hz versus selected comparison frequency temporal interference stimulation
Time frame: During fMRI scan on study day (approximately 60 minutes)
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.
3 secondary outcomes
Change in brain activity in the dorsal anterior cingulate cortex during active versus sham stimulation at 20 Hz
Time frame: 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
Time frame: 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
Time frame: During fMRI scan on study day (approximately 60 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- 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.
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 - dACC 20 Hz TI Active and Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency 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: looking for participants now, as of the sponsor's last update on 11 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua W Brown, PhD (812-855-9282, cclab@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brain activity in the dorsal anterior cingulate cortex during 20 Hz versus selected comparison frequency temporal interference stimulation (time frame: During fMRI scan on study day (approximately 60 minutes)). 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 NCT07594795, 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 11 Sep 2026.