N/A N=21 Randomized Triple-blind Basic Science

Noninvasive Modulation of Motivational Brain Regions in Healthy Volunteers

Traumatic Brain Injury

Bottom Line

View on ClinicalTrials.gov: NCT04972786 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2024

Primary outcome: Primary: dACC BOLD Signal (After Active rTMS Session) — -1.14; -1.27 Percentage of BOLD signal change

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Repetitive Transcranial Magnetic Stimulation (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of New Mexico
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY dACC BOLD Signal (After Active rTMS Session)	-1.14; -1.27	—
PRIMARY Immediate Expected Value (IEV; After Active rTMS Visit)	1.22; 1.62	—
PRIMARY Effort-Based Discounting (After Active rTMS)	0.35; -0.62	—
PRIMARY dACC BOLD Signal (After Sham rTMS Session)	-1.18; -0.96	—
PRIMARY Immediate Expected Value (IEV; After Sham rTMS Visit)	1.06; 1.32	—
PRIMARY Effort-Based Discounting (After Sham rTMS)	0.08; 0.13	—

Summary

21 healthy control participants will be recruited. On Day 1 they will complete reward-guided decision making tasks and questionnaires followed by a functional magnetic resonance imaging (fMRI) scan. On Days 2 and 3 they will receive repetitive transcranial magnetic stimulation (rTMS) targeting a specific part of the brain called the dorsal anterior cingulate cortex (dACC) or sham stimulation, and will then repeat a subset of the same decision making tasks and fMRI sequences. If brain stimulation modifies decision making and dACC activity, it could represent a novel way of treating patients with neural circuit deficits that impede motivated behavior. Of particular relevance to the current trial, this rTMS study will run in parallel with a study of apathy (i.e., diminished motivation) in patients with traumatic brain injury (TBI), with the goal of eventually leading to a patient-centered trial of rTMS treatment for this disruptive neuropsychiatric symptom.

Eligibility Criteria

Inclusion Criteria

12 or more years of education
ability to provide informed consent independently

Exclusion Criteria

Non-fluency in English
Prior history of seizure
contraindications to MRI (metal in the body)
history of substance abuse (excluding moderate alcohol/cannabis usage)
medical diagnosis of psychosis or mania

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04972786). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.