Targeting Fronto-Striatal Neural Circuitry Using Repetitive Transcranial Magnetic Stimulation to Reduce Irritability

NCT07678060 | Active Not Recruiting FDA Device

• 1 other identifier: HHC-2024-0180
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This pilor study will use repetitive Transcranial Magnetic Stimulation (rTMS) as a noninvasive circuit-based neural modulation to test frontostriatal circuitry as a potential target to reduce irritability.

Conditions

Irritability; Mental Health

Outcome Measures

Primary Outcomes (3)

• Frontostriatal connectivity

  Frontostriatal connectivity easured using fMRI during a frustration task. The unit of measure is degrees of functional connectivity.

  Day 1-3

• Grip force (an index of motor activity)

  Grip force measured using a dynamometer during a frustration task. The unit of measure is pounds of force.

  Day 1-3

• Self-reported frustration and unhappiness

  Self-reported frustration and unhappiness measured using self-rated Likert scales from 1 to 9 during a frustration task. Total score range 1-9 with higher scores indicating more frustration and unhappiness.

  Day 1-3

Study Arms (1)

rTMS participants

EXPERIMENTAL

Participants will be asked to complete a 3-day within-participant active and sham rTMS crossover study and perform tasks pre and post sessions while fMRI data is collected. Each will receive an active and sham rTMS.

Device: repetitive transcranial magnetic stimulation (rTMS); Diagnostic Test: fMRI

Interventions

repetitive transcranial magnetic stimulation (rTMS) DEVICE

Transcranial magnetic stimulation (TMS) is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction. To administer TMS, a stimulator equipped with a figure-8 coil will be used. Two separate coils will be used that are similar in appearance and acoustic properties. One active, unblinded, coil will be used to determine resting motor threshold (RMT) and deliver pulses for the recruitment curves; the other coil will be used to deliver rTMS. rTMS stimulation will be targeted to l-dlPFC.

rTMS participants

fMRI DIAGNOSTIC_TEST

fMRI will be performed pre- and post rTMS

rTMS participants

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• able to give informed consent in English
• elevated levels of irritability, defined as scoring ≥5 on the Affective Reactivity Index (ARI)
• Absence of cognitive impairment. Must have an IQ equivalent of ≥ 70 on the WASI
• Absence of MRI or TMS contraindications

You may not qualify if:

• History of any neurological disorder that would increase seizure risk from rTMS such as stroke, brain lesions, previous neurosurgery, any history of seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than one month.
• First-degree family history of any neurological disorder with a potentially hereditary basis, including epilepsy or multiple sclerosis.
• Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps or sensors, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object in the body that precludes rTMS or MRI administration.
• Current use of any investigational drug or of anti or pro-convulsive action.
• Use of benzodiazepines.
• Lifetime history of schizophrenia, bipolar disorder, mania, autism spectrum disorder, intellectual disability, hypomania, or post-traumatic stress disorder.
• History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack.
• Participation in any TMS session less than 2 weeks prior to admission. (No TMS exposure for treatment purposes in the last 6 months.)
• History or current substance use disorder, excluding cannabis use disorder.
• Major medical illnesses.
• An acute risk of hurting themselves or others.
• Pregnant or lactating women.
• Participant-reported history of severe claustrophobia.
• Excessive weight beyond the MRI limit (\> 450 lbs)

Sponsors & Collaborators

• Yale University: lead
• Yale Center for Brain and Mind Health: collaborator

Study Sites (1)

Hartford Healthcare

Hartford, Connecticut, 06102, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Transcranial Magnetic Stimulation; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Vaughn R Steele, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 1, 2026
• Study Start: September 1, 2024
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)