Decision MakingNCT01098864
Transcranial Magnetic Stimulation of the Prefrontal Cortex: Effects on Risky Decision Making and Temporal Discounting.
A study testing transcranial magnetic stimulation in people with Decision Making, run by University of Arkansas.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Decision Making
- What is being tested?
- transcranial magnetic stimulation
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Decision Making
- Being tested
- transcranial magnetic stimulation
- Keywords
- Behavior, Impulsivity, Transcranial Magnetic Stimulation
- Medical subject headings
- Behavior, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulationDevice
Also called Magstim Super Rapid 2 Stimulator w/ 70mm figure eight stimulating coil
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The k metric of a hyperbolic function for delayed discounting
Measured: 12-18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2010 (estimated)
- Study startMay 2011
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Why it stopped: Study was withdrawn prior to the first subject being enrolled due to the Co-Investigator leaving the university
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decision MakingStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Investigators
- Mark S Mennemeier, PhD, Principal investigator, Universtiy of Arkansas for Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098864
- Sponsor's protocol ID
- 109639
- Status last verified
- Mar 2015
- First submitted
- 19 Jan 2010
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation of the Prefrontal Cortex: Effects on Risky Decision Making and Temporal Discounting.
- ClinicalTrials.gov ID
- NCT01098864
- Acronym / sponsor ID
- 109639
- Conditions
- Decision Making
- Keywords
- Behavior, Impulsivity, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn prior to the first subject being enrolled due to the Co-Investigator leaving the university
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 5 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial magnetic stimulationAlso: Magstim Super Rapid 2 Stimulator w/ 70mm figure eight stimulating coillow 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. | Device | – |
Primary outcome
The k metric of a hyperbolic function for delayed discounting
Time frame: 12-18 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark S Mennemeier, PhD principal investigator
Universtiy of Arkansas for Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic stimulation in people with Decision Making, run by University of Arkansas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The k metric of a hyperbolic function for delayed discounting (time frame: 12-18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2015.