Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID05322239

Novel Electric-field Modelling Approach to Quantify Changes in Resting State Functional Connectivity Following Theta Burst Stimulation

Led by Nicholas Balderston, PhD · Updated on 2026-01-07

200

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how transcranial magnetic stimulation (TMS) affects brain connectivity across the whole brain in healthy adults. This study aims to develop and validate a model that predicts changes in resting state functional connectivity based on the electric current distribution in the brain's cortex following TMS. The study focuses on two types of theta burst stimulation (intermittent and continuous) and their impact on brain network changes, which is relevant to improving treatments for mental health disorders like depression and obsessive-compulsive disorder. Participants will receive multiple doses of either intermittent theta burst stimulation (iTBS) or continuous theta burst stimulation (cTBS) delivered to the left dorsolateral prefrontal cortex. Each participant will undergo three stimulation days with five sessions per day, spaced 30 minutes apart. The stimulation targets are individualized using functional MRI data collected during a working memory task. The study uses a Magventure MagPro 100X device with a figure-8 coil for these sessions. During the study, participants will have resting state brain scans and working memory assessments before and 24 hours after each dose to measure changes in brain connectivity. Researchers will track how well their electric-field model predicts these changes. The study lasts through three doses, with detailed monitoring of brain function and symptoms. Safety screenings and exclusion criteria ensure participants do not have conditions that increase risk with TMS or MRI. Overall, the study lasts several weeks, focusing on brain connectivity outcomes after TMS.

CONDITIONS

Brief Title

Resting State Changes Following Theta Burst Stimulation

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to give their consent
  • Right-handed
  • Age between 18 and 60 years
Not Eligible

You will not qualify if you...

  • Non-english speaking
  • Any significant medical problems
  • Current or past Axis I psychiatric disorder(s)
  • Active or history of active suicidal ideation
  • Alcohol/drug problems in the past year or lifetime alcohol or drug dependence
  • Medications that act on the central nervous system
  • History of seizure
  • History of epilepsy or other neurological problems
  • Increased risk of seizure for any reason
  • Pregnancy
  • Any medical condition that increases risk for fMRI or TMS
  • Any metal in their body which would make having an MRI scan unsafe
  • Any sort of medical implants
  • Claustrophobia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 3 days

Participants receive either intermittent or continuous theta burst stimulation (iTBS or cTBS) delivered to the left dorsolateral prefrontal cortex across 3 stimulation days. Each day includes 5 sessions of stimulation spaced 30 minutes apart.

15 stimulation sessions over 3 days (in-person)

Monitoring

Duration - Up to 9 days following stimulation (24 hours after each of the 3 doses)

Participants undergo resting state and working memory fMRI assessments before and 24 hours after each dose of stimulation to measure functional connectivity changes.

6 visits for fMRI assessments (in-person)

Trial Site Locations

Total: 1 location

1

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

Loading map...

Research Team

N

Nicholas L Balderston

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

Similar Trials

Investigating the Effects of Transcranial Direct Current Sti...

Transcranial Direct Current Stimulation

Actively Recruiting

1 location

Evaluation of Brain Connectivity Function in Predicting Ther...

Constipation - Functional

Actively Recruiting

3 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Proof of concept study to develop a novel connectivity-based electric-field modelling approach for individualized targeting of transcranial magnetic stimulation treatment.

Nicholas L Balderston, Joanne C Beer, Darsol Seok...

https://pubmed.ncbi.nlm.nih.gov/34321597