Clinical trial NCT05917002: MPFC Theta Burst Stimulation as a Tool to Affect Rational Decision Making
Official title: MPFC Theta Burst Stimulation as a Tool to Affect Rational Decision Making
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Brain Stimulation Lab MUSC
First posted: 2023-06-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Baratt Impulsiveness Scale
timeFrame: Change assessed at visit 1 (day 1) and visit 2 (day 2)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Lisa McTeague, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: