Normal Physiology Clinical Trial
Official title:
The Effect of Transcranial Magnetic Stimulation on Learning With Reward in Healthy Humans
Verified date | June 23, 2017 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background:
- Two areas on the surface of the brain, the dorsolateral prefrontal cortex (DLPFC) and motor
cortex (MC), play a key role during learning. Researchers are interested in determining the
effect that transcranial magnetic stimulation (TMS) on the DLPFC and MC has on participants'
performance of learning tasks. By studying the effect of TMS on reaction time, learning, and
memory, researchers hope to better understand how to treat conditions such as Parkinson's
disease and traumatic brain injury that affect these parts of the brain.
Objectives:
- To study the effects of transcranial magnetic stimulation on the dorsolateral prefrontal
cortex and motor cortex.
- To learn which areas of the brain are used to perform certain learning and memory tasks.
Eligibility:
- Healthy, right-handed individuals between 18 and 70 years of age.
Design:
- Participants will be screened with a physical and neurological examination and a medical
and psychiatric history.
- Participants will be asked to take part in one of five different parts of this study.
Most participants will have four 2-hour visits to the National Institutes of Health
Clinical Center. Some participants (those involved in Part 5) will have only one 2-hour
visit.
- Parts 1 and 2 (four visits): Participants will have TMS, and then do a learning task
that may provide a small monetary reward. On the first visit, before the TMS,
participants will take an intelligence test based on reading aloud the words given on a
card. Participants who have not had a routine magnetic resonance imaging (MRI) scan of
the brain within the past year will also have a scan.
- Parts 3 and 4 (four visits): Participants will have a functional MRI scan while doing a
learning task that may provide a small monetary reward. On the first visit, before the
functional MRI, participants will take an intelligence test based on reading aloud the
words given on a card. Participants who have not had a routine magnetic resonance
imaging (MRI) scan of the brain within the past year will also have a scan.
- Part 5 (one visit): Participants will take an intelligence test based on reading aloud
the words given on a card. Then, participants will have TMS followed by a functional MRI
scan. During the functional MRI, participants will do a button-pressing task that may
provide a small monetary reward.
- Participants will also be asked to provide a small blood sample for genetic analysis.
Status | Terminated |
Enrollment | 174 |
Est. completion date | June 23, 2017 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
- Participants will be 272 healthy volunteers drawn from the population in the NIH
clinical research volunteer program. INCLUSION CRITERIA: Healthy Right-handed Ages 18-70 (inclusive) Have completed high school or college in an English speaking country. All participants must have had a neurological examination by a NINDS physician within the last two years. All participants in the fMRI experiments must also have had a clinical MRI within the last year. EXCLUSION CRITERIA: Individuals with conditions that could pose a risk relating to the safety of the MRI procedure will be excluded from the protocol such as: Those with ferromagnetic metal in the cranial cavity or eye, e.g. aneurysm clip, implanted neural stimulator, cochlear implant, ocular foreign body. Those with an implanted cardiac pacemaker or auto-defibrillator. Those with an insulin pump. Those with an irremovable body piercing. Pregnant women Individuals with conditions that could pose a risk relating to the safety of the TMS procedure will be excluded from the protocol such as: - Those with significant abnormality on neurological examination. - Those with metal in the cranial cavity or eye, e.g. aneurysm clip, implanted neural stimulator, cochlear implant, ocular foreign body. - Those with an implanted cardiac pacemaker or auto-defibrillator. - Those with an insulin pump. - Pregnant women Individuals with conditions that could compromise our interpretation of the TBS and fMRI results will be excluded such as: - Those with significant abnormality on neurological examination. - Those who have a significant psychiatric illness or have a history of psychiatric illness. - Those using medication affecting the DA system, such as phenothiazine antihistamines (promethazine), antiemetics or decongestants within the last month. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Arancio O, Chao MV. Neurotrophins, synaptic plasticity and dementia. Curr Opin Neurobiol. 2007 Jun;17(3):325-30. Epub 2007 Apr 6. Review. — View Citation
Aron AR, Gluck MA, Poldrack RA. Long-term test-retest reliability of functional MRI in a classification learning task. Neuroimage. 2006 Feb 1;29(3):1000-6. Epub 2005 Sep 1. — View Citation
Badgaiyan RD, Fischman AJ, Alpert NM. Striatal dopamine release in sequential learning. Neuroimage. 2007 Nov 15;38(3):549-56. Epub 2007 Aug 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | We will examine the effects of reward and TBS and their interaction on measures of learning. | One hour | ||
Secondary | Secondary outcome measures will be how TBS and reward interact to alter the pattern of BOLD activation on MRI and the effects of relevant genetic variation on learning variables and BOLD activation. | One hour |
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