Task Augmentation of Transcranial Magnetic Stimulation (TMS)

NCT04586205 | Completed Results

• 1 other identifier: 832232
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot, within-subjects, randomized proof-of-concept study investigates the effects of activating the DLPFC promotion system on TMS treatment outcomes. Twenty-five healthy volunteers will participate in four sessions involving either active or sham repetitive transcranial magnetic stimulation (rTMS). Using anatomically guided TMS paired with cognitive tasks, the study tests the hypothesis that cognitive paired associative stimulation enhances cortical responses. For this pilot study, we are focusing only on the augmentation of TMS with the IASP task.

Conditions

Healthy

Keywords

TMS; fMRI; dlPFC

Outcome Measures

Primary Outcomes (2)

• Sternberg Sorting Task (SST) at Baseline

  This Sternberg Sorting Task (SST) task is designed to assess how individuals store and retrieve random information from short-term memory. This task was administered to all participants before they were randomized into one of two groups (active TMS first then sham TMS or sham TMS first then active TMS). 0's were recorded for incorrect responses and 1's were recorded for correct responses. Therefore, the mean represents the accuracy percentage for each group.

  Baseline (Visit 1)

• International Affective Picture System (IAPS)

  International Affective Picture System (IAPS): an emotional task using IAPS picture that will also compare low load and high load conditions. The number of images will vary by condition load, but for both the high-load \& low-load conditions, participants will look at IAPS pictures and answer questions about the images. Further, jittered within this design will be both neutral and negative blocks of IAPS pictures: Baseline measurement before randomizing participants into Active or Sham groups. 0's were recorded for incorrect responses and 1's were recorded for correct responses. Therefore, the mean represents the accuracy percentage for each group.

  Baseline

Secondary Outcomes (2)

• International Affective Picture System (IAPS) at Post-intervention (Active/Sham)

  post-intervention (Active/Sham) (Week 6 Final Visit)

• Comparing the Impact of Sternberg Sort Task (SST), the Working Memory Task and International Affective Picture System (IAPS) Emotional Task on TMS-Induced DLPFC Activation; Post-intervention (Active/Sham)

  post-intervention (Active/Sham) (Week 6 Final Visit)

Study Arms (2)

Active rTMS + IASP

ACTIVE COMPARATOR

Participants perform the IASP emotional task Receive active rTMS

Device: active TMS; Behavioral: IASP Task; Behavioral: SST Task; Other: MRI

Sham rTMS + IASP

SHAM COMPARATOR

Participants perform the IASP emotional task Receive Sham rTMS

Device: sham TMS; Behavioral: IASP Task; Behavioral: SST Task; Other: MRI

Interventions

active TMS DEVICE

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.

Active rTMS + IASP

sham TMS DEVICE

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.

Sham rTMS + IASP

IASP Task BEHAVIORAL

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.

Active rTMS + IASP; Sham rTMS + IASP

SST Task BEHAVIORAL

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.

Active rTMS + IASP; Sham rTMS + IASP

MRI OTHER

Participants undergo MRI sessions to measure DLPFC cortical reactivity and connectivity.

Active rTMS + IASP; Sham rTMS + IASP

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Gender, inclusive
• 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

You may not qualify if:

• Pregnancy (Female participants)
• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Center for Neuromodulation in Depression and Stress

Philadelphia, Pennsylvania, 19104, United States

Location

Results Point of Contact

• Title: Yvette Sheline
• Organization: University of Pennsylvania

sheline@pennmedicine.upenn.edu

215-573-0082

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Neuromodulation in Depression and Stress (CNDS)

Model Details: A within-subjects design was used. Healthy participants between the ages of 18 and 60 who met basic eligibility criteria were invited to participate. 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.

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 14, 2020
• Study Start: April 7, 2019
• Primary Completion: March 4, 2020
• Study Completion: March 11, 2024
• Last Updated: May 31, 2025
• Results First Posted: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)