- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01098864
Transcranial Magnetic Stimulation of the Prefrontal Cortex: Effects on Risky Decision Making and Temporal Discounting.
March 3, 2015 updated by: University of Arkansas
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The k metric of a hyperbolic function for delayed discounting
Time Frame: 12-18 weeks
|
12-18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mark S Mennemeier, PhD, Universtiy of Arkansas for Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (ANTICIPATED)
January 1, 2014
Study Completion (ANTICIPATED)
January 1, 2014
Study Registration Dates
First Submitted
January 19, 2010
First Submitted That Met QC Criteria
April 2, 2010
First Posted (ESTIMATE)
April 5, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
March 4, 2015
Last Update Submitted That Met QC Criteria
March 3, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 109639
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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