24 Participants NeededMy employer runs this trial

Temporal Interference Stimulation for Healthy Adults

(CAP-TI Trial)

SP
Overseen BySean Prahl
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 aims to explore whether a type of non-invasive brain stimulation, known as temporal interference stimulation, can affect brain activity during sleep. Researchers focus on sleep spindles, specific brain rhythms that occur during sleep. The study involves up to 24 healthy participants attending three overnight sessions. Individuals who are healthy, reside in Dane County, Wisconsin, and have no history of neurological disorders or sleep issues might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on sleep and brain activity.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications that can affect seizure thresholds, such as ADHD stimulants, some antidepressants, antipsychotics, bronchodilators, certain antibiotics, antivirals, and some over-the-counter antihistamines.

What prior data suggests that temporal interference stimulation is safe for healthy adults?

Research has shown that temporal interference stimulation (TI-TES) is generally safe and well-tolerated. Studies identified mild sensations, such as tingling or itching on the skin, as the most common side effects. Many participants reported these sensations, but they were not serious. Other research found no significant problems with brain or mental functions due to TI-TES. Most participants found the treatment comfortable and did not experience major issues. Overall, TI-TES appears to be a safe option for those considering participation in a clinical trial.12345

Why are researchers excited about this trial?

Researchers are excited about Temporal Interference Stimulation because it offers a novel way to target specific areas of the brain non-invasively. Unlike traditional brain stimulation techniques that directly activate neurons, this method uses intersecting electrical fields to focus the stimulation deep within the brain, potentially reaching regions like the thalamus without affecting the surrounding tissues. This fine-tuned targeting could enhance our understanding of brain functions and lead to more effective treatments for neurological conditions in the future.

What evidence suggests that temporal interference stimulation is effective for altering brain activity during sleep?

Research has shown that temporal interference stimulation (TI-TES) can meaningfully change brain activity. One study found that TI-TES improved working memory by boosting activity in specific brain areas. Other research indicated that TI-TES could increase activity in deeper brain regions, suggesting potential benefits for various brain functions. Some studies have also demonstrated short-term benefits for conditions like Parkinson's and epilepsy, though more evidence is needed. Overall, TI-TES appears promising for temporarily altering brain activity and enhancing certain cognitive functions.56789

Who Is on the Research Team?

LA

Larissa Albantakis, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for healthy adults in Dane County, Wisconsin who are U.S. citizens or permanent residents and can speak English. Participants must be medically healthy based on self-report and a review by the study team.

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Baseline Assessment

Participants complete a structural MRI for personalized montage optimization

1 week
1 visit (in-person)

Treatment

Participants undergo three overnight hdEEG and PSG sleep sessions with TI-TES delivered during NREM sleep

3 weeks
3 visits (overnight, in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Temporal Interference Stimulation

Trial Overview

Researchers are testing different ways of using non-invasive electrical brain stimulation (TI-TES) during sleep to see how it affects brain activity patterns. Some participants will get real stimulation at various thalamic locations; others will receive sham (placebo) stimulation. MRI scans may also be used.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: All ParticipantsExperimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Citations

Temporal Interference Stimulation Boosts Working Memory ...

Our finding showed that frontoparietal TI stimulation enhanced working memory performance. Compared to sham stimulation, TI stimulation reduced the parietal ...

Non-invasive temporal interference electrical stimulation of ...

The effects of transcranial alternating current stimulation on memory performance in healthy adults: a systematic review. Cortex 147, 112 ...

The safety and efficacy of applying a high-current temporal ...

This study aimed to introduce a high-current TI electrical stimulation protocol to enhance its intensity and evaluate its safety and efficacy

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 accumbens (NAcc) and ...

Human applications of transcranial temporal interference ...

20 studies show tTIS is safe and well-tolerated in healthy and clinical cohorts. •. One tTIS session improves bradykinesia and tremor in Parkinsonism within 1 h ...

Principles of Electrical Neuromodulation and Adverse Effects

it was found that the most common AE during stimulation was skin irritation, specifically tingling sensations, reported by 76.9% of subjects ...

Safety Recommendations for Temporal Interference ...

While TIS holds promise for a variety of clinical and non-clinical applications, little data is yet available regarding its effects in humans.

Safety Evaluation of Employing Temporal Interference ... - PMC

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

Safety, tolerability and blinding efficiency of non-invasive ...

tTIS-evoked sensations were generally rated as 'mild', were equivalent in active and placebo tTIS conditions and did not enable participants to ...