Temporal Interference for Healthy Subjects
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 to better understand how deep brain structures affect thinking and behavior. The goal is to determine if TI can safely and precisely stimulate specific brain parts without affecting surrounding areas. This research could eventually aid in developing treatments for conditions like addiction, OCD, and Parkinson's. Suitable candidates for this trial are healthy individuals aged 18-50 who are not on certain medications and have no history of neurological or cognitive issues. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could lead to innovative treatments for challenging neurological conditions.
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 neurostimulation is safe for healthy subjects?
In a previous study, researchers found that temporal interference (TI) electrical neurostimulation is likely well-tolerated by participants. Most people using TI have not experienced serious side effects. The technology targets deep brain areas without affecting the outer parts. Although this method is newer, studies so far have not shown major safety concerns. However, since the current trial tests the procedure in healthy people, the treatment is still under careful safety evaluation in humans.12345
Why are researchers excited about this trial?
Researchers are excited about temporal interference (TI) electrical stimulation because it offers a non-invasive way to target specific brain regions like the dorsal anterior cingulate cortex without the need for surgery or implanted devices. Unlike traditional brain stimulation treatments that often require direct electrode placement on the brain surface, TI uses scalp electrodes and sophisticated interference patterns to focus the stimulation deeper into the brain. This novel approach could potentially offer more precise and flexible treatment options for neurological conditions by altering brain activity with minimal discomfort and side effects. The ability to adjust the frequency within a wide range (1-100 Hz) adds another layer of customization, potentially enhancing its effectiveness for various needs.
What evidence suggests that temporal interference electrical stimulation is effective for understanding deep brain function?
This trial will explore the effects of temporal interference (TI) electrical stimulation on the dorsal anterior cingulate cortex (dACC) in healthy subjects. Research has shown that TI can target deep brain areas like the dACC without affecting the brain's outer layers. Studies using functional MRI (fMRI) have found that TI can boost activity in specific brain regions. This might help researchers learn more about how these deep brain areas influence thoughts and behavior. Previous research also suggests that TI could treat conditions like addiction, OCD, and Parkinson's disease by focusing on the involved brain areas. Although researchers are still exploring this technology, its ability to reach deep brain regions offers exciting possibilities for future treatments. Participants in this trial will receive TI stimulation in various sequences of active and sham conditions to assess its effects.14678
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 adults who do not have any neurological or psychiatric conditions. Participants should not have metal implants, pacemakers, or other medical devices that could be affected by electrical stimulation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a single study visit with fMRI scanning while receiving active and sham TI stimulation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Temporal Interference (TI) Electrical Stimulation
Trial Overview
Researchers are testing a new non-invasive brain stimulation method called temporal interference (TI) to see how it affects deep brain activity. Different frequencies and sham (placebo) stimulations will be compared in a controlled study.
How Is the Trial Designed?
4
Treatment groups
Active Control
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
Citations
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 ...
Theta-Band Temporal Interference Stimulation of the ...
To our knowledge, the present study provides the first evidence that theta-band tTIS targeting the dorsal anterior cingulate cortex (dACC) ...
Target engagement of the subgenual anterior cingulate cortex ...
Target engagement of the subgenual anterior cingulate cortex with transcranial temporal interference stimulation in major depressive disorder
4.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT07339072/temporal-interference-methods-for-non-invasive-deep-brain-stimulation-study-12Temporal 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 ...
The Distinct Roles of the Dorsolateral Prefrontal Cortex and ...
Our study provides functional evidence for the distinct roles of brain regions centered on the dorsolateral prefrontal cortex (dlPFC) and ...
The Distinct Roles of the Dorsolateral Prefrontal Cortex and ...
Distinct effects of dlPFC and dACC stimulation on cognitive control in varying WMC levels support the hypothesis that they play differing roles. TI stimulation ...
Theta-Band Temporal Interference Stimulation of the ...
Transcranial temporal interference stimulation (tTIS) offers a non-invasive approach to modulate deep cortical regions including the dACC.
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 ...
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