MPFC Theta Burst Stimulation as a Tool to Affect Rational Decision Making

Early Phase 1

Not yet recruiting

• Conditions: Healthy

• Registration Number: NCT05917002
• Lead Sponsor: Medical University of South Carolina

Brief 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. 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 Timeline

• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-06-20
• Study First Posted: 2023-06-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Study Start: 2025-08-12
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Is able to read consent document and provide informed consent
• English is first or primary language

Exclusion Criteria

• • 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
  • 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Baratt Impulsiveness Scale	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).