Reward Circuit Targeted iTBS

NCT05468853 | Completed Results FDA Device

• 2 other identifiers: STUDY00002776R21MH129653
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to examine the effect of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting the reward circuit.

Conditions

Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (6)

• Change in Anhedonia Post-intervention and Washout

  change in self-reported anhedonia from baseline averaged across post-intervention and post-washout measured using the score on the Dimensional Anhedonia Rating Scale (DARS); score range is 0-68 with higher scores meaning better outcomes (less anhedonia)

  baseline, one-hour post-intervention, one-week post-intervention

• Change in Anhedonia Post-intervention

  change in self-reported anhedonia from baseline immediately following the intervention measured using the score on the Dimensional Anhedonia Rating Scale (DARS); score range is 0-68 with higher scores meaning better outcomes (less anhedonia)

  baseline, 1 hour post-intervention

• Change in Anhedonia Post-washout

  change in self-reported anhedonia from baseline following a week of washout post-intervention measured using the score on the Dimensional Anhedonia Rating Scale (DARS); score range is 0-68 with higher scores meaning better outcomes (less anhedonia)

  baseline, 1 week post-intervention

• Change in RewP Post-intervention and Washout Measured Via EEG

  change in reward positivity from baseline averaged across immediately post-intervention and post-washout assessed via the EEG event-related potential (ERP) to feedback over FCz in microvolts

  baseline, immediately post-intervention, one-week post-intervention

• Change in RewP Post-intervention Measured Via EEG

  change in reward positivity from baseline immediately following the intervention assessed via the EEG event-related potential (ERP) to feedback over FCz in microvolts

  baseline, immediately post-intervention

• Change in RewP Post-washout Measured Via EEG

  change in reward positivity from baseline immediately following a week of washout post-intervention assessed via the EEG event-related potential (ERP) to feedback over FCz in microvolts

  baseline, 1 week post-intervention

Secondary Outcomes (2)

• Change in Reward Activation Measured Via fMRI

  baseline, 15 minutes post-intervention

• Change in Reward Connectivity Measured Via fMRI

  baseline, 15 minutes post-intervention

Study Arms (2)

rmPFC-iTBS

EXPERIMENTAL

Transcranial magnetic stimulation delivered to the rostral medial prefrontal cortex. 600 pulses delivered in 50 Hz bursts every 5 Hz for 2 seconds followed by 8 seconds of no stimulation repeated 20 times at 80% of resting motor threshold. Repeated daily for 5 consecutive days.

Device: transcranial magnetic stimulation

Inion-iTBS

ACTIVE COMPARATOR

Transcranial magnetic stimulation delivered to the inion. 600 pulses delivered in 50 Hz bursts every 5 Hz for 2 seconds followed by 8 seconds of no stimulation repeated 20 times at 80% of resting motor threshold. Repeated daily for 5 consecutive days.

Device: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation DEVICE

Transcranial magnetic stimulation delivered to the scalp targeting medial prefrontal cortex

rmPFC-iTBS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Right-handed
• Native English speaker or fluent by the age of 6
• Elevated self-reported anhedonia

You may not qualify if:

• Left-handed
• Metal in head
• Brain tumor, stroke, aneurysm, multiple sclerosis
• Active substance use disorder in last 3 months
• Dementia or other cognitive disorder making unable to engage in treatment
• History or diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, or other psychiatic illness that precludes safe participation in trial
• Suicidal risk that precludes safe participation
• obsessive-compulsive disorder
• Inability to stop taking any mediation that significant lowers the seizure threshold (e.g. tricyclic antidepressants, clozapine, etc.)
• Severe traumatic brain injury
• Non-English speaker

Sponsors & Collaborators

• Florida State University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

FSU MRI Facility

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Limitations and Caveats

Due to a programming error, the rmPFC was mistargeted in 55 participants. For these participants, stimulation of the rmPFC was weaker than intended. This issue may have undermined the efficacy of the intervention.

Results Point of Contact

• Title: Derek Nee
• Organization: Florida State University

dnee@fsu.edu

8506441963

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 21, 2022
• Study Start: June 28, 2022
• Primary Completion: September 18, 2024
• Study Completion: September 18, 2024
• Last Updated: January 27, 2026
• Results First Posted: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Within a year following publication of findings
• Access Criteria: Behavioral and imaging data will be accessible from https://nda.nih.gov/edit\ collection.html?id=4341 by NDA users

Locations

US (1)