24 Participants NeededMy employer runs this trial

TES-TI for Brain Stimulation

(MINT Trial)

MS
Overseen ByMINT Study Team
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 how a non-invasive brain stimulation technique, transcranial electrical stimulation with temporal interference (TES-TI), affects brain activity in healthy adults. Participants will undergo three sessions where an EEG will record their brain activity during customized electrical stimulation. Researchers are testing different settings to observe changes in brain responses. This study suits healthy individuals without a history of neurological disorders or significant head injuries. Participants must be comfortable lying still with their eyes closed during the sessions. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research in brain stimulation techniques.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications that are known to lower the seizure threshold, like chlorpromazine or clozapine. The trial protocol does not specify other medications, so it's best to discuss your current medications with the study team.

What prior data suggests that TES-TI is safe for brain stimulation?

Research has shown that transcranial electrical stimulation with temporal interference (TES-TI) is generally safe. Studies have found that TES-TI can be used safely at various settings. Most participants experience only mild and temporary side effects, such as tingling or slight discomfort at the electrode sites. These studies have reported no serious problems directly caused by TES-TI.

As a non-invasive brain stimulation method, TES-TI does not involve surgery or breaking the skin, making it less risky than more invasive procedures. Overall, evidence suggests that TES-TI is a safe option for those considering participation in trials using this treatment.

Why are researchers excited about this trial?

Researchers are excited about the TES-TI brain stimulation technique because it offers a novel approach to non-invasively modulating brain activity using transcranial electrical stimulation with temporal interference. Unlike standard treatments like medications or traditional brain stimulation methods, TES-TI targets specific brain regions more precisely by delivering electrical currents at varying frequencies, potentially reducing unwanted side effects. This method could improve our understanding of brain function and lead to more personalized and effective interventions for neurological conditions. By comparing different stimulation patterns and frequencies, this trial aims to uncover optimal settings for therapeutic brain stimulation.

What evidence suggests that TES-TI is effective for changing brain activity in healthy adults?

Research has shown that transcranial electrical stimulation with temporal interference (TES-TI) can target and activate specific deep brain areas, such as the hippocampus. This method precisely alters brain activity without surgery. Studies have found TES-TI to be safe and well-tolerated, with no major short-term side effects. It has also improved deep sleep, which is crucial for feeling rested. In this trial, participants will experience different TES-TI conditions across various sessions to assess its effects. Although more research is needed on long-term safety, current evidence suggests that TES-TI can safely and effectively adjust brain activity.12345

Who Is on the Research Team?

LA

Larissa Albantakis, PhD

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

This trial is for healthy adults who do not have any major medical or psychiatric conditions. Participants should be able to undergo MRI scans and attend three afternoon sessions over several weeks.

Inclusion Criteria

Medically healthy based on self-report and study team review
U.S. citizen or holding permanent resident status
English-speaking and able to provide consent and complete questionnaires

Exclusion Criteria

I am currently taking medications that can increase my risk of seizures.
Possible pregnancy or plan to become pregnant in the next 6 months (self-reported)
Any metal in the head
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRI and Montage Optimization

Participants undergo a structural MRI scan to support individualized electric-field modeling and personalized montage optimization for thalamic targeting.

1 week
1 visit (in-person)

Stimulation Sessions

Participants undergo three afternoon stimulation sessions with simultaneous high-density EEG during eyes-closed wakefulness. Each session includes four stimulation conditions administered in randomized/counterbalanced order.

3 sessions over 3-12 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after stimulation sessions.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Transcranial Electrical Stimulation with Temporal Interference (TES-TI)

Trial Overview

The study tests a non-invasive brain stimulation method called TES-TI, which uses electrical currents applied through the scalp while recording brain activity with high-density EEG. Each participant's electrode placement is customized using an MRI scan.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Session C: Frequency DependenceExperimental Treatment1 Intervention
Group II: Session B: BenchmarkingExperimental Treatment1 Intervention
Group III: Session A: Amplitude Modulation SpecificityExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Citations

a review of transcranial temporal interference stimulation for ...

While existing studies have reported no significant short-term adverse effects, the long-term safety of TI stimulation remains largely ...

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, ...

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, ...

Advances in the application of temporal interference ...

This study provides compelling evidence that TIS can effectively activate neurons in the hippocampal region, allowing for more precise modulation of deep brain ...

Temporal Interference - Brainbox Neuro

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