Task Augmentation of Transcranial Magnetic Stimulation (TMS)
NCT ID: NCT04586205
Last Updated: 2025-05-31
Study Results
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View full resultsBasic Information
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COMPLETED
17 participants
INTERVENTIONAL
2019-04-07
2024-03-11
Brief Summary
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Detailed Description
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Another promising approach is combining TMS with concurrent cognitive activation of the dorsolateral prefrontal cortex (DLPFC). This concept, known as cognitive paired associative stimulation, builds on traditional paired associative stimulation (PAS), where coordinated stimulation enhances cortical response. In this framework, delivering TMS to the DLPFC while participants engage in a DLPFC-activating cognitive task could produce greater neural activation than either stimulus alone. Prior research suggests that the brain's cognitive or emotional state during stimulation can significantly modulate TMS effects, though it's unclear whether this enhancement depends on the type of cognitive task or the magnitude of neural activation.
Study Design and Procedure This within-subjects, mechanism-focused pilot study builds on the Research Domain Criteria (RDoC) framework for cognitive control. The primary goal is to examine how pairing rTMS with specific task conditions affects DLPFC activation and connectivity.
Participants (ages 18-60, healthy volunteers) will undergo the following:
Screening Visit (2 hours): Consent and eligibility. Visit 1 - Baseline MRI (1 hour): Participants undergo structural and functional MRI to localize the "Fitzgerald target" in the DLPFC. Data will be analyzed using FSL and neuronavigated using BrainSight.
Visit 2 - Task-Only fMRI Session (2 hours): Participants complete both the SST (cognitive task) and the IASP (emotional task) in the scanner. Each task contains high- and low-load trials, and participants complete both tasks (they are not assigned to one or the other).
Visits 3 \& 4 - TMS Sessions (2 hours each): In a randomized crossover design, participants complete the IASP task while receiving either:
Active rTMS Sham rTMS These sessions test whether pairing emotional cognitive activation with TMS enhances cortical response. Note: TMS was never delivered alone-participants always performed the IASP task during stimulation.
2-Week Break Visits 5 \& 6 - Follow-Up TMS Sessions (2 hours each): Participants repeat the IASP task with the alternate stimulation condition (sham or active). fMRI data is again collected to assess DLPFC activation and connectivity post-stimulation.
Each TMS session uses:
Stimulation Parameters: 120% resting motor threshold (RMT), triplet 50 Hz bursts at 5 Hz, 2s on / 8s off, 600 pulses per session (\~3 min 9 sec total).
Probe Scans: Single-pulse TMS (120% RMT; 77 pulses/session) inside the scanner to measure cortical reactivity.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
In the first phase, all participants completed both the Sternberg task (SST) and the International Affective Picture System (IASP) task, each containing high- and low-load trials.
In the second phase, participants completed the IASP task during two separate TMS sessions: one with active rTMS and one with sham rTMS, in a randomized crossover design. No TMS-alone condition was included. All TMS sessions were conducted in the MRI scanner, allowing investigators to collect both brain activation to single-pulse TMS probes and connectivity data.
Participants were randomized to receive either active or sham rTMS during the first session, and then crossed over to the alternate condition after a two-week break. This design allowed for within-subject comparison of cortical response during the same task across both stimulation conditions.
OTHER
DOUBLE
Study Groups
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Active rTMS + IASP
Participants perform the IASP emotional task Receive active rTMS
active TMS
Participants receive active repetitive transcranial magnetic stimulation (rTMS) while performing the International Affective Picture System (IASP). Stimulation is delivered at 120% of resting motor threshold (RMT), in triplet 50 Hz bursts, repeated at 5 Hz (2s on, 8s off), totaling 600 pulses per session.
IASP Task
Participants complete the IASP (emotional image viewing) task during each TMS session (active and sham). The task includes both high- and low-load trials, designed to activate the dorsolateral prefrontal cortex (DLPFC). Task order and load levels are consistent across both stimulation sessions.
SST Task
In a separate MRI session prior to TMS sessions, participants complete the SST which includes both high-load and low-load trials. This cognitive task is used to examine baseline DLPFC activation and to contrast cognitive vs. emotional activation profiles.
MRI
Participants undergo MRI sessions to measure DLPFC cortical reactivity and connectivity.
Sham rTMS + IASP
Participants perform the IASP emotional task Receive Sham rTMS
sham TMS
Participants receive sham rTMS while performing the IASP task. Stimulation is mimicked without actual neural activation using the same schedule and coil placement as the active condition.
IASP Task
Participants complete the IASP (emotional image viewing) task during each TMS session (active and sham). The task includes both high- and low-load trials, designed to activate the dorsolateral prefrontal cortex (DLPFC). Task order and load levels are consistent across both stimulation sessions.
SST Task
In a separate MRI session prior to TMS sessions, participants complete the SST which includes both high-load and low-load trials. This cognitive task is used to examine baseline DLPFC activation and to contrast cognitive vs. emotional activation profiles.
MRI
Participants undergo MRI sessions to measure DLPFC cortical reactivity and connectivity.
Interventions
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active TMS
Participants receive active repetitive transcranial magnetic stimulation (rTMS) while performing the International Affective Picture System (IASP). Stimulation is delivered at 120% of resting motor threshold (RMT), in triplet 50 Hz bursts, repeated at 5 Hz (2s on, 8s off), totaling 600 pulses per session.
sham TMS
Participants receive sham rTMS while performing the IASP task. Stimulation is mimicked without actual neural activation using the same schedule and coil placement as the active condition.
IASP Task
Participants complete the IASP (emotional image viewing) task during each TMS session (active and sham). The task includes both high- and low-load trials, designed to activate the dorsolateral prefrontal cortex (DLPFC). Task order and load levels are consistent across both stimulation sessions.
SST Task
In a separate MRI session prior to TMS sessions, participants complete the SST which includes both high-load and low-load trials. This cognitive task is used to examine baseline DLPFC activation and to contrast cognitive vs. emotional activation profiles.
MRI
Participants undergo MRI sessions to measure DLPFC cortical reactivity and connectivity.
Eligibility Criteria
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Inclusion Criteria
* 18 60 years of age
* Right-handed
* No history of meeting Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for any diagnosis
* Normal cognition
* Patients must be able to read and understand English
* Participants must be able to provide consent
Exclusion Criteria
* Outside age range
* Meets DSM criteria for any diagnosis
* Unable to have an MRI scan
* Medical condition that interferes with the collection or interpretation of MRI data
* Implanted devices such as: aneurysm clip or cardiac pacemaker
* History of stroke, epilepsy, or brain scarring
* Cognitive impairment
* Recent use of psychoactive medications, as determined by investigators
* Otherwise determined by investigator to be unfit for participation
18 Years
60 Years
ALL
Yes
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Yvette Sheline
Director, Center for Neuromodulation in Depression and Stress (CNDS)
Locations
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Center for Neuromodulation in Depression and Stress
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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832232
Identifier Type: -
Identifier Source: org_study_id
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