Temporal Interference for Brain Stimulation in Healthy Subjects

Overseen By Kendall E Moore, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Psychotropics, Cancer medications

Disqualifiers: Epilepsy, Migraines, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new technology called temporal interference (TI) electrical stimulation, aiming to understand how deep brain regions affect thinking and behavior. The goal is to determine if TI can target these deep brain areas without affecting the brain's surface, potentially paving the way for future treatments for conditions like addiction and OCD. The trial involves different sequences of TI and sham (placebo) treatments to test its effects. Eligible participants should be between 18 and 50, have at least a 6th-grade education, and not have a history of seizures or current use of medications for mental health issues. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to innovative treatments.

Will I have to stop taking my current medications?

If you are currently taking psychotropic medications for ADHD, other mental illnesses, or medications for cancer, you will not be eligible to participate in this trial.

What prior data suggests that temporal interference electrical stimulation is safe for brain stimulation?

Research has shown that temporal interference (TI) electrical stimulation is generally safe and well-tolerated. In one study, participants did not experience any major problems with brain or mental functions, indicating that the treatment likely doesn't harm brain activity or mental health. Another study found that higher levels of TI stimulation are both safe and effective for brain stimulation. These findings support using TI as a non-invasive method to reach deep brain areas without damaging surrounding brain tissue. Overall, current evidence suggests that TI electrical stimulation is a safe option for those considering participation in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about temporal interference (TI) electrical stimulation because it offers a novel way to non-invasively target specific brain areas using electrical fields. Unlike traditional brain stimulation methods, which often require direct contact with the brain or are less precise, TI uses intersecting electrical fields to stimulate deep brain regions without affecting the surrounding tissue. This could lead to more precise and effective treatments with fewer side effects. Additionally, the versatility of TI in switching between active and sham modes could help refine our understanding of its effects, potentially opening doors to new therapeutic applications in neurological conditions.

What evidence suggests that temporal interference electrical stimulation is effective for brain stimulation?

Research has shown that temporal interference (TI) electrical stimulation effectively reaches deep parts of the brain. Studies have found that TI stimulation is safe for humans and generally causes only minor side effects. In animal studies, TI improved motor skills by helping the brain form new connections, a process known as neuroplasticity. This technology targets deep brain areas like the hippocampus without affecting the layers above. These encouraging results suggest that TI could help treat conditions like addiction and OCD, which involve problems in deep brain areas. Participants in this trial will experience different sequences of TI stimulation and sham treatments to further explore its effects. ^{5 6 7 8 9}

Who Is on the Research Team?

Joshua W Brown, PhD

Principal Investigator

Indiana University, Bloomington

Are You a Good Fit for This Trial?

This trial is for healthy individuals interested in participating in a study that explores how non-invasive brain stimulation affects cognition. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be screened for suitability.

Inclusion Criteria

Must have at least a 6th grade education

Ability to speak and read English for all phases

I am between 18 and 50 years old.

Exclusion Criteria

Pregnancy (self-reported; no pregnancy test administered)

Weight over 440 lbs (scanner weight limit)

Presence of pacemakers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive temporal interference (TI) electrical stimulation during a single study visit

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Temporal Interference (TI) Electrical Stimulation

Trial Overview The study tests Temporal Interference (TI) electrical stimulation's ability to target deep brain regions without affecting the cortex. It involves different TI setups: active NAcc TI, sham NAcc TI, active No-TI, and sham No-TI, with effects measured by fMRI.

How Is the Trial Designed?

Group I: NAcc TI Sham, then NAcc TI Active, then NAcc No-TI Sham, then NAcc No-TI Active Active Control 4 Interventions

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.

Group II: NAcc No-TI Sham, then NAcc No-TI Active, then NAcc TI Sham, then NAcc TI Active Active Control 4 Interventions

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.

Group III: NAcc TI Active, then NAcc TI Sham, then NAcc No-TI Active, then NAcc No-TI Sham Active Control 4 Interventions

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.

Group IV: NAcc No-TI Active, then NAcc No-TI Sham, then NAcc TI Active, then NAcc TI Sham Active Control 4 Interventions

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.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12162641/

Advances in the application of temporal interference stimulation Qi et al. (2024) demonstrated that TI electric field brain stimulation significantly enhances motor skills in mice by promoting neuroplasticity.

2. nature.com nature.com/articles/s41593-023-01456-8

Non-invasive temporal interference electrical stimulation of ... We demonstrate the safety and tolerability of TI stimulation in humans, the ability to focally target the stimulation locus to the hippocampus, ...

3. cell.com cell.com/the-innovation/fulltext/S2666-6758(25)00006-2

Temporal interference stimulation for human brain In summary, TI stimulation demonstrates good tolerance, with mild side effects and no significant adverse reactions, making it a promising non- ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X25003699

Human Applications of Transcranial Temporal Interference ... Of published studies, 16 single-session and 4 multi-session studies assessed safety, mechanistic outcomes, or therapeutic effects of tTIS in 820 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07215299

Temporal Interference Methods for Non-invasive Deep ... Through the grant's duration, the investigators hypothesize that temporal interference (TI) electrical neurostimulation will be well tolerated and effective at ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9496688/

Safety Evaluation of Employing Temporal Interference ... These results support that TI-tACS is safe and tolerable in terms of neurological and neuropsychological functions and adverse effects for use ...

7. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2024.1484593/full

The safety and efficacy of applying a high-current temporal ... Conclusion: The proposed high-current TI electrical stimulation is both safe and effective for stimulating the human brain. Moreover, the ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03747601

NCT03747601 | Temporal Interference Brain Stimulation The primary aim of this study is to translate temporal interference (TI) stimulation methodology into humans and examine its safety, feasibility, ...

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/bem.22542

Recommendations for the Safe Application of Temporal ... Temporal interference stimulation (TIS) is a new non-invasive brain stimulation method capable of targeting deep brain structures, unlike ...