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 technique called temporal interference (TI) electrical stimulation to understand how deep brain regions affect thinking and behavior. The researchers aim to see how TI can target these deep areas without affecting those above, using brain scans to measure changes. This research could aid in developing future treatments for conditions like addiction, OCD, and Parkinson's disease. The trial suits healthy individuals who speak English and are not taking certain medications or have a history of neurological issues like seizures or migraines. 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 need to stop taking them to participate in this trial.
What prior data suggests that temporal interference electrical stimulation is safe for healthy subjects?
Research has shown that temporal interference (TI) electrical stimulation is generally safe for people. One study found that high levels of TI stimulation are both safe and effective for the brain. Although specific data on TI is limited, it is expected to have side effects similar to other electrical brain treatments. Common effects reported in similar treatments include mild itching, tingling, and headaches. These effects also appeared during placebo treatments, suggesting they might not be directly caused by the actual treatment. Overall, TI is considered well-tolerated, making it a promising option for future clinical use.12345
Why are researchers excited about this trial?
Researchers are excited about temporal interference (TI) electrical stimulation because it offers a novel way to stimulate specific areas of the brain, like the nucleus accumbens, without invasive procedures. Unlike typical brain stimulation therapies that might require surgical implants or surface electrodes, TI uses pairs of carbon fiber electrodes to create overlapping electrical fields, allowing for deeper and more targeted stimulation. This innovative technique could potentially lead to more precise treatments with fewer side effects for conditions that affect brain function.
What evidence suggests that temporal interference electrical stimulation is effective for understanding deep brain structures?
Research has shown that Temporal Interference (TI) electrical stimulation can effectively reach deep brain areas, such as the nucleus accumbens, without affecting nearby brain regions. This trial will explore different sequences of TI stimulation, including both active and sham conditions at 5 Hz and 10 Hz frequencies. This technique might help with conditions such as OCD and Parkinson's. Studies have found that TI can boost activity in certain brain regions, often measured using fMRI, a type of brain scan. Additionally, early evidence suggests that the duration of TI stimulation can impact its effects. These findings indicate that TI could be a promising tool for treating disorders related to deep brain issues.678910
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 aged 18 to 50 who have completed at least a sixth-grade education and are proficient in English. Specific details on who cannot participate were not provided.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive temporal interference (TI) electrical stimulation targeting the nucleus accumbens during a single study visit
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
The study tests Temporal Interference (TI) electrical stimulation, aiming to stimulate deep brain regions without affecting the cortex. It involves comparing active TI at different frequencies (5 Hz and 10 Hz) with sham (placebo) treatments using fMRI measurements.
How Is the Trial Designed?
4
Treatment groups
Active Control
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the nucleus accumbens using two pairs of carbon fiber electrodes in the following order: 5 Hz TI Active, 5 Hz TI Sham, 10 Hz TI Active, then 10 Hz TI Sham.
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the nucleus accumbens using two pairs of carbon fiber electrodes in the following order: 5 Hz TI Sham, 5 Hz TI Active, 10 Hz TI Sham, then 10 Hz TI Active.
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the nucleus accumbens using two pairs of carbon fiber electrodes in the following order: 10 Hz TI Sham, 10 Hz TI Active, 5 Hz TI Sham, then 5 Hz TI Active.
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the nucleus accumbens using two pairs of carbon fiber electrodes in the following order: 10 Hz TI Active, 10 Hz TI Sham, 5 Hz TI Active, then 5 Hz TI Sham.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
Citations
The Efficacy of Temporal Interference Stimulation in the ...
This study aims to evaluate the efficacy of Temporal Interference (TI) stimulation in treating patients with obsessive-compulsive disorder (OCD) ...
Longer Temporal Interference Stimulation Induces ...
Our study provides the first neuroimaging evidence that stimulation duration is a key parameter influencing TI-induced neuromodulatory effects, ...
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 ...
Population-level insights into temporal interference for ...
This work aimed to investigate the effectiveness of targeting deep brain areas using TI in different populations.
Temporal interference electrical neurostimulation at 20 Hz ...
Results indicate that TI can induce increased BOLD activation in the region that receives the highest magnitude of TI amplitude modulation in humans.
Principles of Electrical Neuromodulation and Adverse Effects
The prevalence of AEs during the sham stimulation were: itching (32.9%), tingling (18.3%), headache (16.2%), general discomfort (13.4%) and ...
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frontiersin.org
frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2024.1484593/fullThe 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 ...
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.
Recommendations for the Safe Application of Temporal ...
A review of adverse effects and safety considerations from related neurostimulation techniques was conducted to inform TIS safety guidelines ...
NCT03747601 | Temporal Interference Brain Stimulation
It is hypothesized that TI will be well tolerated by human subjects and side effects will be consistent with other forms of transcranial electric current ...
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