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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01098864
Other study ID # 109639
Secondary ID
Status Withdrawn
Phase N/A
First received January 19, 2010
Last updated March 3, 2015
Start date May 2011
Est. completion date January 2014

Study information

Verified date March 2015
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The main objective of this study is to examine the effects of magnetic stimulation on the prefrontal cortex. We plan to use low frequency, repeated transcranial magnetic stimulation (1 Hz rTMS) to temporarily inhibit activity in the prefrontal cortex and measure the resulting effect on two decision-making tasks. The prefrontal cortex is thought to mediate or control cognitive functions like decision-making, planning, memory, and inhibit impulsive behavior.Previous research has indicated that rTMS over the right dorsal lateral prefrontal cortex will lead to preferences for riskier alternatives. Our hypothesis is that rTMS over the right DLPFC will lead to greater preference for the riskier alternative and greater temporal discounting.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Healthy participants willing to give informed consent to participate

- complete the Transcranial magnetic stimulation Adult Safety Screen

- have a MRI scan

- wear ear plugs during rTMS

- receive rTMS over the designated course of days

- complete cognitive assessments and decision making tasks.

- return for post-testing on all tasks after completing all rTMS sessions

Exclusion Criteria:

- Diagnosed neurological and/or psychiatric disorders requiring hospitalization or medication

- pregnancy or the possibility of pregnancy at the time of consent

- a history of tinnitus

- metal implants in head or neck or a pacemaker

- poorly-controlled migraines

- a history of head injury, stroke, previous brain neurosurgery, or loss of consciousness due to head injury lasting greater than 10 minutes

- a personal or family history of epilepsy or seizures

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Device:
transcranial magnetic stimulation
low frequency (1 Hz) repeated transcranial magnetic stimulation will be delivered to the dorsal lateral prefrontal cortex (DLPFC) area for a period of 15 minutes to test for effect on executive function (e.g., decision choice and subjective value). Four sessions will be conducted per subject; 2 active stimulations,(1 left DLPFC, 1 right DLPFC) and 2 sham stimulations (1 left DLPFC, 1 right DLPFC) with a minimum of 48 hours between every stimulation. Pre and post stimulations measures of cognitive and executive function will be collected and analyzed for significant differences.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Arkansas

Outcome

Type Measure Description Time frame Safety issue
Primary The k metric of a hyperbolic function for delayed discounting 12-18 weeks No
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