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Individualized Closed Loop TMS for Working Memory Enhancement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04402294
Recruitment Status : Suspended (COVID-19 Restrictions)
First Posted : May 26, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
The study is investigating working memory brain states by using transcranial magnetic stimulation (TMS) in combination with functional magnetic resonance imaging (fMRI). The study uses a novel, individualized targeting approach for TMS based on each subject's individual multi-modal fMRI data. Next, the individualized target will be stimulated in a TMS/ fMRI imaging session to investigate working memory states and optimal stimulation frequencies.

Condition or disease Intervention/treatment Phase
Working Memory in Healthy Participants Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Intervention Model: Crossover Assignment
Intervention Model Description:

Task and resting fMRI will be used to determine an individualized brain target for each participant. In a subsequent session, participants will complete a task fMRI with repetitive TMS neuromodulation; during this session, various stimulation protocols will be interleaved with working memory task blocks to result in online brain readouts of the degree in which modulation affected the brain state in regards to working memory performance.

Based on this testing, an optimal and sub-optimal TMS stimulation frequency will be determined for each individual participant. Each frequency will be administered separately across three stimulation days using a crossover design, with the order of frequencies being randomized and counterbalanced. Therefore, each subject will receive six days of TMS stimulation: three using the optimal frequency, and three using the sub-optimal frequency. The initial TMS/ task fMRI testing session will be completed at the midpoint and end of the study.

Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: Individualized Closed Loop Transcranial Magnetic Stimulation (TMS) for Working Memory Enhancement
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory


Intervention Details:
  • Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
    The investigators will create individualized TMS targets using deep learning methods on task and resting fMRI data to target working memory augmentation. The individualized target will be stimulated in a subsequent fMRI scan involving working memory task performance interleaved with repetitive TMS (rTMS) delivered at a variety of stimulation frequencies. Based on activation readouts in response to rTMS, an optimal and sub-optimal brain state frequency to impact working memory performance will be selected for each participant. Participants will receive rTMS at each frequency separately for three days (six days total), with the order of frequency randomly assigned and counterbalanced. Following each three day protocol, another fMRI working memory readout will be conducted to support the targeting and frequency selection algorithms.


Primary Outcome Measures :
  1. fMRI Classifier Fit [ Time Frame: Baseline ]
    Using deep learning classification methods, an 'optimal' brain state will be identified from baseline task and resting fMRI. This will be the target during future interleaved TMS/fMRI brain readouts.

  2. Effect of Individualized Stimulation Frequency on Working Memory [ Time Frame: Baseline, Immediately After the Intervention ]
    Overall, the investigators will be assessing whether there is a significant change in working memory performance using neuromodulation at the individual's optimal stimulation frequency versus sub-optimal frequency, as determined by performance during fMRI/ rTMS sessions and rTMS behavioral sessions.


Secondary Outcome Measures :
  1. Working Memory Performance in MRI Sessions [ Time Frame: Baseline, After approx. 1 month, After approx. 2 months ]
    During rounds of interleaved rTMS with fMRI recordings, participants will be engaging in a working memory task. Online block-wise performance will be evaluated for both speed and accuracy as an indicator of the effect of the neuromodulation train preceding it.

  2. Working Memory Performance in Behavior Sessions [ Time Frame: Baseline, Immediately after the Intervention ]
    During each offline working memory rTMS session, participants' speed and accuracy on a working memory task will be evaluated as an indicator of the degree to which the neuromodulation is affecting performance.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-60 years old
  • Right handed
  • No current or lifetime history of any DSM-V diagnosis
  • No history of neurological disorder or traumatic brain injury (other than mild)
  • No current psychoactive medication use
  • Normal cognition
  • Female patients must attest to not being pregnant
  • Capacity to give informed consent and follow study procedures
  • Sufficient command of English language to understand and respond to written as well as verbal instructions

Exclusion Criteria:

  • Unable to have an MRI scan, including current or prior medical condition that could interfere with the collection or interpretation of MRI data
  • Implanted devices, such as an aneurysm clip or cardiac pacemaker
  • History of stroke, epilepsy, or brain scarring
  • Cognitive impairment
  • Recent use of psychoactive medications, as determined by investigators
  • People who are unwilling/unable to abstain from medications that substantially reduce the seizure threshold to TMS under PI discretion
  • Otherwise determined by investigator to be unfit for study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04402294


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04402294    
Other Study ID Numbers: 832891
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Pennsylvania:
memory
healthy
TMS