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Neuromodulation

Theta Burst Stimulation for Brain Connectivity Changes

N/A

Recruiting

Led By Nicholas L Balderston

Research Sponsored by Nicholas Balderston, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

Study Summary

This trial seeks to build and validate a whole-brain, domain-general model of brain connectivity changes following transcranial magnetic stimulation (TMS), based on physical models of the current density at the cortex. The objective is to provide direct evidence that brain connectivity changes following TMS vary as a function of the current density at the cortex, which can be used to predict psychiatric symptom change following TMS.

Who is the study for?

This trial is for right-handed individuals who can consent to participate. It's not suitable for those with recent alcohol/drug issues, medical conditions affecting fMRI or TMS safety, metal implants, claustrophobia, severe psychiatric disorders, epilepsy, pregnancy, non-English speakers, CNS medications use or any significant health problems.Check my eligibility

What is being tested?

The study tests how brain connectivity changes after two types of Transcranial Magnetic Stimulation (TMS): Intermittent and Continuous Theta Burst Stimulation. The goal is to create a model predicting changes in brain networks that could help treat psychiatric symptoms.See study design

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site on the scalp, headache, lightheadedness or dizziness. Rarely seizures might occur due to the magnetic stimulation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Resting state - dose 1

Resting state - dose 2

Resting state - dose 3

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Intermittent Theta Burst StimulationExperimental Treatment1 Intervention

TBS. A Magventure MagPro 100X stimulator with a B65 figure-8 coil will be used for the TBS sessions. On each of the 3 stimulation days, 5 iTBS sessions will be administered at 30 min intervals.

Group II: Continuous Theta Burst StimulationExperimental Treatment1 Intervention

TBS. A Magventure MagPro 100X stimulator with a B65 figure-8 coil will be used for the TBS sessions. On each of the 3 stimulation days, 5 cTBS sessions will be administered at 30 min intervals.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intermittent Theta Burst Stimulation

2020

N/A

~50

Continuous Theta Burst Stimulation

2020

N/A

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Nicholas Balderston, PhDLead Sponsor

Nicholas L BalderstonPrincipal InvestigatorUniversity of Pennsylvania

1 Previous Clinical Trials

5 Total Patients Enrolled

Media Library

Continuous Theta Burst Stimulation (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT05322239 — N/A

Brain Connectivity Research Study Groups: Intermittent Theta Burst Stimulation, Continuous Theta Burst Stimulation

Brain Connectivity Clinical Trial 2023: Continuous Theta Burst Stimulation Highlights & Side Effects. Trial Name: NCT05322239 — N/A

Continuous Theta Burst Stimulation (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05322239 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of this research endeavor?

"Affirmative. Per the information located on clinicaltrials.gov, this experiment is recruiting participants as it was initially advertised on November 1st 2022 and recently updated in October 7th 2022. The study requires 200 patients to be enrolled at one medical site."

Answered by AI

Are there still opportunities to enroll in this research trial?

"The clinical trial is still open to patient enrollment, as per the information posted on clinicaltrials.gov. The listing was initially published on November 1st 2022 and last adjusted October 7th 2022."

Answered by AI

Is the age range of this research encompassing those above 20 years?

"According to the conditions of this study, individuals must be at least 18 years old and cannot exceed 60 in order to participate."

Answered by AI

What class of individuals is ideal to recruit for this experiment?

"Prospective participants will need to qualify on the basis of age (18-60) and brain health. Approximately 200 patients are being considered for enrolment in this study."

Answered by AI

Recent research and studies

NeuropsychopharmacologyJournal

Proof of Concept Study to Develop a Novel Connectivity-based Electric-field Modelling Approach for Individualized Targeting of Transcranial Magnetic Stimulation Treatment

Balderston, Nicholas L., Joanne C. Beer, Darsol Seok, Walid Makhoul, Zhi-De Deng, Tommaso Girelli, Marta Teferi, et al.. 2021. “Proof of Concept Study to Develop a Novel Connectivity-based Electric-field Modelling Approach for Individualized Targeting of Transcranial Magnetic Stimulation Treatment”. Neuropsychopharmacology. Springer Science and Business Media LLC. doi:10.1038/s41386-021-01110-6.

clinicaltrials.govStudy

Resting State Changes Following Theta Burst Stimulation

Nicholas Balderston, PhD 2022. "Resting State Changes Following Theta Burst Stimulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05322239.