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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05917002
• Other study ID #: Pro00126644
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: August 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: November 2023
• Source: Medical University of South Carolina
• Contact: Samantha LaPorta
• Phone: 8432592680
• Email: laporta[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Real TBS to mPFC
This will be delivered with the Magventure MagPro System; (double blinded using the integrated active sham system).
• Sham TBS to mPFC
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change assessed at visit 1 (day 1) and visit 2 (day 2)