Recruiting

Theta Burst Stimulation

Sponsor:

Nicholas Balderston, PhD

Code:

NCT05322239

Conditions

Brain Connectivity

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Intermittent Theta Burst Stimulation

Continuous Theta Burst Stimulation

Study Details

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.

Conditions

Brain Connectivity

Study ID

NCT05322239

Start date

Nov 17, 2022

Status verified date

Jan, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Intermittent Theta Burst Stimulation

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.

experimental: Continuous Theta Burst Stimulation

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.

Interventions

Intermittent Theta Burst Stimulation

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).

Continuous Theta Burst Stimulation

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.

Primary outcome measure

  • Resting state - dose 1 [ Time Frame: 24 hours ]
  • Resting state - dose 2 [ Time Frame: 24 hours ]
  • Resting state - dose 3 [ Time Frame: 24 hours ]
  • Working memory - dose 1 [ Time Frame: 24 hours ]
  • Working memory - dose 2 [ Time Frame: 24 hours ]
  • Working memory - dose 3 [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Nicholas L Balderston

2157463058nicholas.balderston@pennmedicine.upenn.edu

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Nicholas l Balderston, PhD

215-746-3058nicholas.balderston@pennmedicine.upenn.edu

More Information

Sponsor

Nicholas Balderston, PhD

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Nicholas Balderston, PhD on 2026-01-07.