Transcranial Magnetic Stimulation of the Prefrontal Cortex: Effects on Risky Decision Making and Temporal Discounting.

This study has been withdrawn prior to enrollment.
(Study was withdrawn prior to the first subject being enrolled due to the Co-Investigator leaving the university)
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01098864
First received: January 19, 2010
Last updated: April 12, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Decision Making
Device: transcranial magnetic stimulation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Transcranial Magnetic Stimulation of the Prefrontal Cortex: Effects on Risky Decision Making and Temporal Discounting.

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • The k metric of a hyperbolic function for delayed discounting [ Time Frame: 12-18 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: Magstim Super Rapid 2 Stimulator w/ 70mm figure eight stimulating coil
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01098864

Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Mark S Mennemeier, PhD Universtiy of Arkansas for Medical Sciences
  More Information

No publications provided

Responsible Party: Mark Mennemeier, PhD / Principal Investigator, UAMS
ClinicalTrials.gov Identifier: NCT01098864     History of Changes
Other Study ID Numbers: 109639
Study First Received: January 19, 2010
Last Updated: April 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arkansas:
Behavior
Impulsivity
Transcranial Magnetic Stimulation

ClinicalTrials.gov processed this record on October 20, 2014