Changes in brain connectivity after theta burst stimulation
Novel Electric-field Modelling Approach to Quantify Changes in Resting State Functional Connectivity Following Theta Burst Stimulation
NA · University of Pennsylvania · NCT05322239
This study tests how a specific type of brain stimulation can change the way different parts of the brain connect and communicate in healthy people.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Pennsylvania (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05322239 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcranial magnetic stimulation (TMS) on brain connectivity by developing a comprehensive model that predicts changes in resting state functional connectivity following TMS. The research will involve healthy volunteers receiving either intermittent or continuous theta burst stimulation, with the aim of understanding how the current density at the cortex influences these connectivity changes. By measuring brain connectivity before and after TMS, the study seeks to validate a whole-brain model that can generalize across various conditions and predict psychiatric symptom changes. This work addresses a critical gap in the understanding of TMS effects on brain network architecture.
Who should consider this trial
Good fit: Ideal candidates for this study are right-handed healthy volunteers who can provide informed consent.
Not a fit: Patients with significant medical problems, psychiatric disorders, or those who are non-English speaking will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved TMS treatment protocols for mental health conditions by providing insights into how brain connectivity changes can predict treatment outcomes.
How similar studies have performed: While there have been studies on TMS effects, this approach of developing a generalized model for brain connectivity changes is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Able to give their consent * Right-handed Exclusion Criteria * 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
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Nicholas L Balderston — University of Pennsylvania
- Study coordinator: Nicholas L Balderston
- Email: nicholas.balderston@pennmedicine.upenn.edu
- Phone: 2157463058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brain Connectivity