Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE May 4, 2020
First Posted Date  ICMJE May 26, 2020
Last Update Posted Date May 26, 2020
Estimated Study Start Date  ICMJE August 2020
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2020)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Individualized Closed Loop TMS for Working Memory Enhancement
Official Title  ICMJE Individualized Closed Loop Transcranial Magnetic Stimulation (TMS) for Working Memory Enhancement
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Working Memory in Healthy Participants
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: May 22, 2020)
38
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2025
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04402294
Other Study ID Numbers  ICMJE 832891
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Pennsylvania
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP