30 Participants NeededMy employer runs this trial

Transcranial Temporal Interference Stimulation for Healthy Adults

JH
Overseen ByJoanne Hall, M.Sc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new brain stimulation method called Transcranial Temporal Interference Stimulation (TIS), which targets specific brain areas without surgery. Researchers aim to understand how this technology affects the brain's motor cortex, the area controlling movement. They will test different TIS frequencies to determine the most effective approach for future medical treatments. Participants must be right-handed adults without neurological or orthopedic conditions that could affect participation.

As an unphased trial, this study allows participants to contribute to groundbreaking research that could lead to innovative treatments for neurological conditions.

Will I have to stop taking my current medications?

Yes, you will need to stop taking most prescription and over-the-counter medications to participate in this trial, except for birth control and certain allergy medications.

What prior data suggests that transcranial temporal interference stimulation is safe for humans?

Earlier studies used a technique called transcranial temporal interference stimulation (TIS) on 820 people over several sessions. The findings show that TIS is generally safe and well-tolerated. Some participants experienced minor effects like changes in attention or mood, but serious side effects were rare. Researchers have ensured that the stimulation levels remain safe for humans. Although TIS is still under investigation, the results so far suggest it is a promising and safe option for brain stimulation.12345

Why are researchers excited about this trial?

Researchers are excited about Transcranial Temporal Interference Stimulation (TTIS) because it offers a novel way to modulate brain activity using non-invasive electrical stimulation. Unlike traditional treatments that might rely on medication or direct electrical stimulation at a single frequency, TTIS uses two high-frequency currents that intersect to create a low-frequency electrical field deep in the brain. This approach allows for targeted stimulation without needing surgical implants or surface electrodes, potentially offering a safer and more precise option for influencing brain function. By exploring different frequency combinations, researchers hope to better understand how specific brain regions can be selectively activated, which might open up new avenues for treating various neurological conditions.

What evidence suggests that transcranial temporal interference stimulation is effective for neuromodulation?

Studies have shown that transcranial temporal interference stimulation (TIS) can reach deep brain areas without surgery. Human trials found TIS safe and easy to tolerate. Some early research suggests it may help with short-term improvements in conditions like Parkinson's and epilepsy. Additionally, TIS has been linked to better memory and faster reaction times in healthy individuals. Although more research is needed, these findings highlight TIS's potential to effectively change brain activity. Participants in this trial will join different experimental arms testing various frequencies of TIS, or a sham comparator, to further explore its effects on brain activity.12367

Who Is on the Research Team?

MY

Mathew Yarossi, PhD

Principal Investigator

Northeastern University

Are You a Good Fit for This Trial?

This trial is for healthy adults. People with any neurological or psychiatric conditions, implanted medical devices, or other health issues that could interfere with brain stimulation are likely excluded.

Inclusion Criteria

I am between 18 and 65 years old.
I do not have nerve or bone problems that limit my participation.
I am right-handed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Application of transcranial temporal interference stimulation (TIS) to the motor cortex and assessment of corticospinal excitability using transcranial magnetic stimulation (TMS)

Periprocedural
Multiple sessions as per experimental protocol

Follow-up

Participants are monitored for neuroplastic effects and retention of neuromodulation post-stimulation

0, 15, and 30 minutes post-stimulation
3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Transcranial Temporal Interference Stimulation

Trial Overview

Researchers are testing a new non-invasive brain stimulation method called transcranial temporal interference stimulation (TIS) on the motor cortex to see how it affects brain activity and excitability in healthy people.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Placebo Group

Group I: 990-1010 Hz fbExperimental Treatment1 Intervention
Group II: 2000-2000 Hz fbExperimental Treatment1 Intervention
Group III: 20 HzExperimental Treatment1 Intervention
Group IV: 1990-2010 Hz fbExperimental Treatment1 Intervention
Group V: 1000-1000 Hz fbExperimental Treatment1 Intervention
Group VI: shamPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northeastern University

Lead Sponsor

Trials
103
Recruited
72,600+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Citations

Human Applications of Transcranial Temporal Interference ...

Phase 1 studies demonstrate that tTIS is safe, well-tolerated, and capable of engaging deep brain targets in humans. Well-controlled Phase 2 trials are needed ...

Overcoming the Barriers to Effective Transcranial Temporal ...

Transcranial temporal interference stimulation (TIS) is a non-invasive neuromodulation method with much more favorable focus in deep brain ...

Systematic review of experimental studies in humans on ...

Clinical evidence remains limited, with two Parkinson's pilots and one epilepsy study showing short-term benefits. Overall, tTIS shows potential ...

Human Applications of Transcranial Temporal Interference ...

Conclusions Phase 1 studies demonstrate that tTIS is safe, well-tolerated, and capable of engaging deep brain targets in humans. Well-controlled ...

Overcoming the Barriers to Effective Transcranial Temporal ...

Safety and tolerability of TIS has recently been demonstrated in humans with findings indicating that TIS poses no greater risk than other ...

Temporal Interference | Brainbox

Transcranial temporal interference stimulation (tTIS, TI) aims to non-invasively stimulate deep brain regions by manipulating certain electrical properties ...

Temporal Interference Methods for Non-invasive Deep ...

The investigators will investigate whether TI stimulation can increase BOLD activity in targeted deep brain regions including the nucleus ...