HealthyNCT05917002
MPFC Theta Burst Stimulation as a Tool to Affect Rational Decision Making
A study testing Real TBS to mPFC in people with Healthy, run by Medical University of South Carolina.
Trial summary
This is a study to investigate if a device that temporarily changes brain activity (repetitive transcranial magnetic stimulation, rTMS) might be used to change how healthy participants make decisions. This study involves 2 visits to MUSC that will each take between 2-3 hours. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Real TBS to mPFC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Aug 2025
- 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
- Is able to read consent document and provide informed consent
- English is first or primary language
Who cannot join
- • Current psychiatric disorder (as defined by DSM-5 and determined using standardized self-report instruments)
- Suicide attempt in the past year
- Lifetime diagnosis of psychotic disorder or bipolar mania
- Presence of neurological disorder that contraindicates TMS or neurophysiological recording:
- Seizure disorder
- Lifetime history of traumatic brain injury with loss of consciousness
Show all 15Show fewer
- Neurodegenerative disorder (e.g., Alzheimer's Disease, Parkinson's Disease, Frontotemporal Dementia)
- Presence of standard contraindications for rTMS
- Currently pregnant
- Significant sensitivity to noise
- Medical treatments or conditions that lower seizure threshold
- History of severe brain injury
- History of seizures/epilepsy
- Currently taking chronic opiate medications or substances
- Inability or unwillingness of subject to give informed consent
About this study
This is a study to investigate if a device that temporarily changes brain activity (repetitive transcranial magnetic stimulation, rTMS) might be used to change how healthy participants make decisions. This study involves 2 visits to MUSC that will each take between 2-3 hours. This study is not a treatment study, but it could help inform studies investigating treatment in the future. Participants in this study will be compensated for their time.
Read the detailed description
This study aims to investigate whether a single session of excitatory repetitive transcranial magnetic stimulation (rTMS) compared to electrical sham stimulation to the medial prefrontal cortex (mPFC) facilitates rational decision making. Our prior data suggests that decisions are biased depending on if the available options are presented with a negative or positive connotation (even in the case of mathematical equivalence). Work by us and others has demonstrated that even if both options are equal, the negatively framed choice is most often avoided.
- Conditions
- Healthy
- Being tested
- Real TBS to mPFC, Sham TBS to mPFC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real TBS to mPFCDevice
This will be delivered with the Magventure MagPro System; (double blinded using the integrated active sham system).
Sham TBS to mPFCDevice
This will be delivered with the Magventure MagPro System; (double blinded using the integrated active sham system). The Magventure MagPro system has an integrated active sham that passes current through two surface electrodes placed on the scalp. The electrodes are placed on the left frontalis muscle under the coil for both the real and sham stimulation sessions.
| Study group | Role | What they receive |
|---|---|---|
| Real TBS to the mPFC | Experimental | The type of stimulation to be used will be intermittent theta burst (iTBS) stimulation to the mPFC with a figure 8 coil (Coil Cool-B65 A/P). Participants will receive three 3-minute sessions of iTBS (600 pulses; 190s; 120% resting motor threshold) with 10-15-minute breaks in between each session or more per participant preference. Receives: Device: Real TBS to mPFC |
| Sham TBS to the mPFC | Sham comparator | The MagVenture MagPro system has an integrated, active sham which passes current through two surface electrodes placed on the scalp. The electrodes will be placed on the left frontalis muscle for all sessions. A patient identification card will randomize participants to receive either sham or active stimulation in the first session.This system maintains blinding by a gyroscope in the coil which indicates to the clinical staff whether the coil should be rotated up or down for this participant once the card is entered into the machine. One side of the coil is active, the other is sham. The integrity of the double blind procedure will be assessed by asking the patients and study personnel rate their confidence regarding whether they thought they received real or sham. (Scale 1-10) Receives: Device: Sham TBS to mPFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baratt Impulsiveness Scale
Change in 30-item self-report scale that is commonly used to measure impulsiveness. Participants respond to each item using a 4-point Likert scale: 1 (rarely/never), 2 (occasionally), 3 (often), and 4 (almost always/always).
Measured: Change assessed at visit 1 (day 1) and visit 2 (day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Aug 2025
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Why it stopped: Trainee Investigator did not come to institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomly assigned to receive active or sham stimulation either first or second. All participants will receive active and sham during the study, only the order will be randomized.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa McTeague, Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917002
- Sponsor's protocol ID
- Pro00126644
- Status last verified
- Sep 2025
- First submitted
- 29 Mar 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MPFC Theta Burst Stimulation as a Tool to Affect Rational Decision Making
- ClinicalTrials.gov ID
- NCT05917002
- Acronym / sponsor ID
- Pro00126644
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trainee Investigator did not come to institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 23 Jun 2023 (actual)
- 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.
This is a study to investigate if a device that temporarily changes brain activity (repetitive transcranial magnetic stimulation, rTMS) might be used to change how healthy participants make decisions. This study involves 2 visits to MUSC that will each take between 2-3 hours. This study is not a treatment study, but it could help inform studies investigating treatment in the future. Participants in this study will be compensated for their time.
Detailed description
This study aims to investigate whether a single session of excitatory repetitive transcranial magnetic stimulation (rTMS) compared to electrical sham stimulation to the medial prefrontal cortex (mPFC) facilitates rational decision making. Our prior data suggests that decisions are biased depending on if the available options are presented with a negative or positive connotation (even in the case of mathematical equivalence). Work by us and others has demonstrated that even if both options are equal, the negatively framed choice is most often avoided.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to receive active or sham stimulation either first or second. All participants will receive active and sham during the study, only the order will be randomized.
| Arm | Type | Receives |
|---|---|---|
| Real TBS to the mPFC | Experimental | Device: Real TBS to mPFCThe type of stimulation to be used will be intermittent theta burst (iTBS) stimulation to the mPFC with a figure 8 coil (Coil Cool-B65 A/P). Participants will receive three 3-minute sessions of iTBS (600 pulses; 190s; 120% resting motor threshold) with 10-15-minute breaks in between each session or more per participant preference. |
| Sham TBS to the mPFC | Sham comparator | Device: Sham TBS to mPFCThe MagVenture MagPro system has an integrated, active sham which passes current through two surface electrodes placed on the scalp. The electrodes will be placed on the left frontalis muscle for all sessions. A patient identification card will randomize participants to receive either sham or active stimulation in the first session.This system maintains blinding by a gyroscope in the coil which indicates to the clinical staff whether the coil should be rotated up or down for this participant once the card is entered into the machine. One side of the coil is active, the other is sham. The integrity of the double blind procedure will be assessed by asking the patients and study personnel rate their confidence regarding whether they thought they received real or sham. (Scale 1-10) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Is able to read consent document and provide informed consent
- English is first or primary language
Key exclusion criteria (15 listed)
- • Current psychiatric disorder (as defined by DSM-5 and determined using standardized self-report instruments)
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 |
|---|---|---|
| Real TBS to mPFCThis will be delivered with the Magventure MagPro System; (double blinded using the integrated active sham system). | Device | Real TBS to the mPFC |
| Sham TBS to mPFCThis will be delivered with the Magventure MagPro System; (double blinded using the integrated active sham system). The Magventure MagPro system has an integrated active sham that passes current through two surface electrodes placed on the scalp. The electrodes are placed on the left frontalis muscle under the coil for both the real and sham stimulation sessions. | Device | Sham TBS to the mPFC |
Primary outcome
Baratt Impulsiveness Scale
Time frame: Change assessed at visit 1 (day 1) and visit 2 (day 2)
Change in 30-item self-report scale that is commonly used to measure impulsiveness. Participants respond to each item using a 4-point Likert scale: 1 (rarely/never), 2 (occasionally), 3 (often), and 4 (almost always/always).
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 8 Sep 2025.
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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.
Lisa McTeague, Ph.D. principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing Real TBS to mPFC in people with Healthy, run by Medical University of South Carolina.
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 2 inclusion and 15 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 8 Sep 2025. 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. Some participants in this study may receive a placebo. 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?
Baratt Impulsiveness Scale (time frame: Change assessed at visit 1 (day 1) and visit 2 (day 2)). 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 8 Sep 2025.