NCT05322239

Brief Summary

Transcranial magnetic stimulation (TMS) is increasingly being applied to effectively treat mental illness, however efforts to quantify the effects of TMS on the network architecture of the brain have largely been limited in scope and tied to specific neurologic and psychiatric disorders. The objective of the current work is to build and validate a whole-brain, domain-general model of brain connectivity changes following TMS, based on physical models of the current distribution at the cortex. PUBLIC HEALTH RELEVANCE: This work is relevant to public health because it will provide direct evidence that brain connectivity changes following neuromodulatory TMS vary as a function of the current density at the cortex, which can be used to predict psychiatric symptom change following neuromodulatory TMS.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Nov 2022Aug 2027

First Submitted

Initial submission to the registry

March 24, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

November 17, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

4.1 years

First QC Date

March 24, 2022

Last Update Submit

January 6, 2026

Conditions

Brain Connectivity

Outcome Measures

Primary Outcomes (6)

  • Resting state - dose 1

    Investigators will measure resting state functional connectivity 24 hours after first dose of continuous or intermittent theta burst stimulation.

    24 hours

  • Resting state - dose 2

    Investigators will measure resting state functional connectivity 24 hours after second dose of continuous or intermittent theta burst stimulation.

    24 hours

  • Resting state - dose 3

    Investigators will measure resting state functional connectivity 24 hours after third dose of continuous or intermittent theta burst stimulation.

    24 hours

  • Working memory - dose 1

    Investigators will measure reaction time during the Sternberg Working memory paradigm 24 hours after first dose of continuous or intermittent theta burst stimulation.

    24 hours

  • Working memory - dose 2

    Investigators will measure reaction time during the Sternberg Working memory paradigm 24 hours after second dose of continuous or intermittent theta burst stimulation.

    24 hours

  • Working memory - dose 3

    Investigators will measure reaction time during the Sternberg Working memory paradigm 24 hours after third dose of continuous or intermittent theta burst stimulation.

    24 hours

Study Arms (2)

Intermittent Theta Burst Stimulation

EXPERIMENTAL

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.

Device: Intermittent Theta Burst Stimulation

Continuous Theta Burst Stimulation

EXPERIMENTAL

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.

Device: Continuous Theta Burst Stimulation

Interventions

Intermittent Theta Burst StimulationDEVICE

iTBS parameters. A series of 20, 10 s trains will be presented over the course of the \~3.5 min session. Each train will consist of 2 s of stimulation with an 8 s ITI. During the 2 s of stimulation, 10, 50 Hz bursts will be repeated at intervals of 200 ms (5 Hz).

Intermittent Theta Burst Stimulation
Continuous Theta Burst StimulationDEVICE

cTBS parameters. A single 600 pulse cTBS train will be delivered during each stimulation session. The train will consist of 50 Hz bursts, repeated at intervals of 200 ms (5 Hz) for 40 sec.

Continuous Theta Burst Stimulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Able to give their consent
  • Right-handed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (1)

  • Balderston NL, Beer JC, Seok D, Makhoul W, Deng ZD, Girelli T, Teferi M, Smyk N, Jaskir M, Oathes DJ, Sheline YI. Proof of concept study to develop a novel connectivity-based electric-field modelling approach for individualized targeting of transcranial magnetic stimulation treatment. Neuropsychopharmacology. 2022 Jan;47(2):588-598. doi: 10.1038/s41386-021-01110-6. Epub 2021 Jul 28.

    PMID: 34321597RESULT

Study Officials

  • Nicholas L Balderston

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas L Balderston

CONTACT

2157463058nicholas.balderston@pennmedicine.upenn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Therefore, the proposed approach will be to measure the cumulative effect of TBS on resting state functional connectivity in healthy volunteers before and 24 hours after each of 3 identical doses (5 sessions/dose; 600 pulses/session) of cTBS or iTBS. Stimulation will be delivered to the left dlPFC; targeting will be individualized based on fMRI data collected during the Sternberg Working Memory (WM) paradigm.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

March 24, 2022

First Posted

April 11, 2022

Study Start

November 17, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

August 1, 2027

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Repositories receiving data and/or samples from this protocol may be open-access or restricted access. Samples and data will be stripped of identifiers and may be coded ("de-identified") or unlinked from an identifying code ("anonymized"). When coded data is shared, the key to the code will not be provided to collaborators, but will remain with the PI.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
After study completion. No less than 5 years.
Access Criteria
Data and samples may be shared with investigators and institutions with an FWA or operating under the Declaration of Helsinki (DoH) and reported to the IRB at the time of continuing review.

Locations

US(1)