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

Sponsor

Medical University of South Carolina (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05917002

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: Real TBS to mPFC Device: Sham TBS to mPFC	Early Phase 1

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

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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 (Participant, Investigator)

Masking Description:

This study is double blinded. Both the investigators and the participants will be blinded as to which method of stimulation they receive first.

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Real TBS to the mPFC 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.	Device: Real TBS to mPFC This will be delivered with the Magventure MagPro System; (double blinded using the integrated active sham system).
Sham Comparator: Sham TBS to the mPFC 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)	Device: 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.

Arm

Intervention/Treatment

Experimental: Real TBS to the mPFC

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.

Device: Real TBS to mPFC

This will be delivered with the Magventure MagPro System; (double blinded using the integrated active sham system).

Sham Comparator: Sham TBS to the mPFC

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)

Device: 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.

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medical University of South Carolina

Investigators

Principal Investigator: Lisa McTeague, Ph.D., Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lisa McTeague, PhD, Assistant Professor-Faculty, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT05917002

Other Study ID Numbers:

Pro00126644

First Posted:

Jun 23, 2023

Last Update Posted:

Jun 23, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 23, 2023