NCT01098864

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2011

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 5, 2010

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

March 4, 2015

Status Verified

March 1, 2015

Enrollment Period

2.7 years

First QC Date

January 19, 2010

Last Update Submit

March 3, 2015

Conditions

Keywords

BehaviorImpulsivityTranscranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

  • The k metric of a hyperbolic function for delayed discounting

    12-18 weeks

Interventions

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.

Also known as: Magstim Super Rapid 2 Stimulator w/ 70mm figure eight stimulating coil

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

BehaviorImpulsive Behavior

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Mark S Mennemeier, PhD

    Universtiy of Arkansas for Medical Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2010

First Posted

April 5, 2010

Study Start

May 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

March 4, 2015

Record last verified: 2015-03