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Clinical Trials/NCT04242810
NCT04242810
Withdrawn
Not Applicable

Effects of rTMS on Human Brain Activity Measured With fMRI

Duke University1 site in 1 countryDecember 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Repetitive Transcranial Magnetic Stimulation (rTMS)
Sponsor
Duke University
Locations
1
Primary Endpoint
Effect of a rTMS session on the performance for a memory task, as measured by accuracy (in percentage of correct responses)
Status
Withdrawn
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this study is to investigate how repetitive transcranial magnetic stimulation (rTMS) affects brain networks measured by functional magnetic resonance imaging (fMRI).

Participants will undergo a screening that includes a psychiatric and medical history screening, TMS and MRI safety screening, and urine screening. If participants pass the screening procedure, they will be introduced to transcranial magnetic stimulation (TMS), magnetic resonance imaging (MRI), and a task that involves viewing words, sentences, or pictures. There will be up to seven visits and each visit will take less than 3 hours.

MRI can be dangerous for people that have medical devices, metal objects, or metal debris in their bodies. TMS procedures are associated with a very low risk of seizures, "muscle-tension" type headache, ear damage, numbness of the face, fainting, dizziness, memory impairment, trouble concentrating, and acute mood changes. This study will use only levels of TMS that are within safety guidelines. There is also a risk of potential loss of confidentiality.

Registry
clinicaltrials.gov
Start Date
December 2021
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age restrictions: between 18-35 years old
  • Use of effective method of birth control for women of childbearing capacity.
  • Willing to provide informed consent.

Exclusion Criteria

  • Current or recent (within the past 6 months) substance abuse or dependence, excluding nicotine and caffeine (urine test)
  • Current serious medical illness (self-report)
  • History of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by rTMS or MRI (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
  • Subjects are unable or unwilling to give informed consent
  • Diagnosed any Axis I DSM-IV disorder (MINI, DSM-IV)
  • Subjects with a clinically defined neurological disorder including, but not limited to:
  • Any condition likely to be associated with increased intracranial pressure
  • Space occupying brain lesion.
  • History of stroke.
  • Transient ischemic attack within two years.

Outcomes

Primary Outcomes

Effect of a rTMS session on the performance for a memory task, as measured by accuracy (in percentage of correct responses)

Time Frame: up to 1 month

An effect of a rTMS session on fMRI brain representation for a memory task, as measured by BOLD signal

Time Frame: up to 1 month

An effect of a rTMS session on the performance for a memory task, as measured by reaction time (in ms)

Time Frame: Time frame: up to 1 month

Study Sites (1)

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