Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-12-31
2021-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Active rTMS
rTMS applied over memory task-based brain target
rTMS
TMS will be applied over task-based target at an intensity up of 130% rMT. The optimal coil placement during stimulation will be guided using the BrainSight neuronavigation system.
MRI scan
Participants will undergo an MRI scan directly after rTMS stimulation that will last less than 120 minutes. During the scan, subjects will encode and retrieve object pictures.
Sham rTMS
Sham rTMS applied over memory task-based brain target
Sham rTMS
An electrical sham coil that produces the same auditory and somatosensory stimulations, without a significant magnetic field, will be used as an active control.
MRI scan
Participants will undergo an MRI scan directly after rTMS stimulation that will last less than 120 minutes. During the scan, subjects will encode and retrieve object pictures.
Interventions
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rTMS
TMS will be applied over task-based target at an intensity up of 130% rMT. The optimal coil placement during stimulation will be guided using the BrainSight neuronavigation system.
Sham rTMS
An electrical sham coil that produces the same auditory and somatosensory stimulations, without a significant magnetic field, will be used as an active control.
MRI scan
Participants will undergo an MRI scan directly after rTMS stimulation that will last less than 120 minutes. During the scan, subjects will encode and retrieve object pictures.
Eligibility Criteria
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Inclusion Criteria
* Use of effective method of birth control for women of childbearing capacity.
* Willing to provide informed consent.
Exclusion Criteria
* 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.
* Cerebral aneurysm.
* Dementia.
* Parkinson's disease.
* Huntington's disease.
* Multiple sclerosis.
* Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold
* Subjects with cochlear implants
* Subjects not willing to tolerate the confinement associated with being in the MRI scanner
* Women who are pregnant or breast-feeding (urine test)
18 Years
35 Years
ALL
Yes
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Robert Cabeza
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00102980
Identifier Type: -
Identifier Source: org_study_id
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