60 Participants Needed

Transcranial Magnetic Stimulation for Healthy Subjects

JA
Overseen ByJohn A Westbrook, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Rutgers, The State University of New Jersey
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

If you are currently taking psychoactive medication, you cannot participate in this trial. The protocol does not specify about other medications, but it seems you should not be on any medications that could affect brain activity.

What data supports the effectiveness of the treatment Transcranial Magnetic Stimulation for healthy subjects?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can improve cognitive processing and motor performance in healthy subjects. Studies found that rTMS can decrease reaction times and enhance cognitive functions, indicating its potential effectiveness.12345

Is repetitive transcranial magnetic stimulation (rTMS) safe for healthy individuals?

Repetitive transcranial magnetic stimulation (rTMS) is generally considered safe, but it can cause seizures and other side effects like cognitive changes. Safety guidelines have been developed to minimize risks, and these guidelines have been updated over the years to ensure safe use.678910

How is transcranial magnetic stimulation different from other treatments?

Transcranial magnetic stimulation (TMS) is unique because it is a non-invasive and painless method that uses magnetic fields to stimulate specific areas of the brain. Unlike medications, TMS directly targets brain regions to modulate their activity, which can be beneficial for conditions like depression and cognitive processing without the systemic side effects of drugs.211121314

What is the purpose of this trial?

The project examines electroencephalography, MRI, and behavioral measures indexing flexibility (critical state dynamics) in the brain when healthy young adults do demanding cognitive tasks, and in response to transcranial magnetic stimulation.

Research Team

JA

John A Westbrook, PhD

Principal Investigator

Rutgers University

Eligibility Criteria

This trial is for healthy, neurologically normal adults aged 18-45 who speak English fluently and have at least a high school education. Participants must have normal vision or corrected-to-normal vision, be willing to follow the MRI and stimulation protocol, and commit to the study duration.

Inclusion Criteria

I am healthy with no diagnosed mental or physical illness.
I am willing to follow the MRI and stimulation protocol exactly.
I am fluent in English.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Theta-burst Stimulation

Participants receive either sham, continuous, or intermittent theta-burst stimulation to the right frontal eye field in a cross-over design

1 session per stimulation type
3 visits (in-person)

Cognitive Task Performance

Participants perform control-demanding cognitive tasks to assess the effects of stimulation on cognitive control and subjective effort

Immediately after each stimulation session

Follow-up

Participants are monitored for safety and effectiveness after stimulation

4 weeks

Treatment Details

Interventions

  • Transcranial Magnetic Stimulation
Trial Overview The study is testing how the brain's flexibility responds during challenging cognitive tasks by using transcranial magnetic stimulation (TMS), along with monitoring through electroencephalography (EEG) and MRI scans in healthy young adults.
Participant Groups
3Treatment groups
Active Control
Placebo Group
Group I: Intermittent theta burst stimulationActive Control1 Intervention
In a cross-over design, all participants will, in one session, receive intermittent theta burst stimulation, to the right frontal eye field. Session order will be counter-balanced across participants, and stimulation protocol will be blinded to participants and the Investigator until after data collection is complete.
Group II: Continuous theta burst stimulationActive Control1 Intervention
In a cross-over design, all participants will, in one session, receive continuous theta burst stimulation, to the right frontal eye field. Session order will be counter-balanced across participants, and stimulation protocol will be blinded to participants and the Investigator until after data collection is complete.
Group III: Sham theta burst stimulationPlacebo Group1 Intervention
In a cross-over design, all participants will, in one session, receive sham theta burst stimulation, to the right frontal eye field. Session order will be counter-balanced across participants, and stimulation protocol will be blinded to participants and the Investigator until after data collection is complete.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

Findings from Research

In a study involving 27 healthy right-handed subjects, ipsilateral repetitive transcranial magnetic stimulation (rTMS) before motor training negatively affected finger tracking performance, while contralateral rTMS showed no significant impact.
The results suggest that ipsilateral rTMS may disrupt motor performance temporarily, indicating potential differences in how rTMS could affect individuals with abnormal brain function, such as stroke patients, by possibly enhancing performance in their affected hand.
rTMS combined with motor learning training in healthy subjects.Carey, JR., Fregni, F., Pascual-Leone, A.[2007]
In a study involving 14 healthy subjects, repetitive transcranial magnetic stimulation (rTMS) at 20 Hz on the left prefrontal cortex significantly improved cognitive processing, as shown by decreased P3 latencies and faster reaction times.
The study demonstrated that rTMS has a measurable effect on cognitive processing, while single TMS at 1 Hz did not show any significant impact, highlighting the efficacy of rTMS over traditional stimulation methods.
The impact of transcranial magnetic stimulation on cognitive processing: an event-related potential study.Evers, S., Böckermann, I., Nyhuis, PW.[2019]
In a study involving 15 chronic stroke patients, five sessions of low-frequency repetitive transcranial magnetic stimulation (rTMS) on the unaffected hemisphere significantly improved motor function in the affected hand for up to 2 weeks, compared to a sham treatment.
The study found that this increased rTMS treatment did not lead to any cognitive side effects or increased risk of seizures, indicating it is a safe intervention for enhancing motor recovery in stroke patients.
A sham-controlled trial of a 5-day course of repetitive transcranial magnetic stimulation of the unaffected hemisphere in stroke patients.Fregni, F., Boggio, PS., Valle, AC., et al.[2022]

References

rTMS combined with motor learning training in healthy subjects. [2007]
The impact of transcranial magnetic stimulation on cognitive processing: an event-related potential study. [2019]
A sham-controlled trial of a 5-day course of repetitive transcranial magnetic stimulation of the unaffected hemisphere in stroke patients. [2022]
Effectiveness of repetitive transcranial magnetic stimulation (rTMS) after acute stroke: A one-year longitudinal randomized trial. [2021]
Slow frequency repetitive transcranial magnetic stimulation affects reaction times, but not priming effects, in a masked prime task. [2019]
Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. [2022]
Side effects of repetitive transcranial magnetic stimulation. [2005]
Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]
Effects of a 2- to 4-week course of repetitive transcranial magnetic stimulation (rTMS) on neuropsychologic functioning, electroencephalogram, and auditory threshold in depressed patients. [2019]
Safety of repetitive transcranial magnetic stimulation in patients with implanted cortical electrodes. An ex-vivo study and report of a case. [2019]
Effect of different pulse numbers of transcranial magnetic stimulation on motor cortex excitability: Single-blind, randomized cross-over design. [2020]
[Repetitive transcranial magnetic stimulation. Possibilities, limits and safety aspects]. [2019]
Modulation of motor cortical excitability following rapid-rate transcranial magnetic stimulation. [2008]
14.United Statespubmed.ncbi.nlm.nih.gov
Intensity-dependent regional cerebral blood flow during 1-Hz repetitive transcranial magnetic stimulation (rTMS) in healthy volunteers studied with H215O positron emission tomography: II. Effects of prefrontal cortex rTMS. [2019]
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