Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Theta Burst Transcranial Magnetic Stimulation of Fronto-parietal Networks: Modulation by Mental State (TMScogMod)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010461
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : January 23, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Stephan F. Taylor, University of Michigan

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The purpose of this study is to improve understanding of the way transcranial magnetic stimulation (TMS), a form of non-invasive brain stimulation, affects the brain. The study hypothesis that when theta burst stimulation (TBS) is applied during a controlled mental state, network changes will be facilitated, compared to stimulation when mental state is uncontrolled. This study will focus on the dorsolateral prefrontal cortex (dlPFC) and the associated frontoparietal network (FPN), which subserves cognitive control - the ability to flexibly adapt and regulate behavior, an ability known to be impaired in neuropsychiatric conditions such as depression and dementia.

Healthy volunteers that qualify for this study will have psychological assessments and cognitive measures, as well as functional Magnetic Resonance Imaging (fMRI) scans, completed after administration of TMS. Participants will be asked to come in for a total of five visits that include; a screening and assessment visit; a baseline functional magnetic resonance imaging (fMRI) scan, followed by TMS session; Visits 3, 4, and 5 will be the experimental TMS session, followed by fMRI scan.


Condition or disease Intervention/treatment Phase
Healthy Device: TMS Behavioral: n-back working memory task Not Applicable

Detailed Description:
Please note the collaborator (NIMH) is requesting that an NCT number be obtained prior to receiving the award.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: All participants will have 3 MRI sessions subsequent to the baseline visit and these will occur in a counterbalanced order.
Masking: Single (Participant)
Masking Description: All subjects will receive all interventions in a cross-over design. The three intervention sessions (visits 3, 4 & 5) will be given in counter-balanced order, stratified by gender. Subjects will be blind to the nature of the questions being asked; however, they will be told that different stimulation paradigms will be used, which will be evident to the subjects as they go through the procedures.
Primary Purpose: Basic Science
Official Title: Theta Burst Transcranial Magnetic Stimulation of Fronto-parietal Networks: Modulation by Mental State
Actual Study Start Date : November 11, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : September 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: TMS to dlPFC, without a concurrent task
TMS (intermittent theta burst stimulation) will be applied to the dlPFC, when subjects are in a resting state
 Device: TMS
Intermittent theta burst stimulation TMS applied to the cortex to excite cerebral cortex
Other Name: intermittent theta burst stimulation (iTBS)

Behavioral: n-back working memory task
Subjects perform an executive function task, in which they view the serial presentation of letters and decide whether or not a letter matches a letter presented 'n' letters back (3 letters or 1 letter)
Experimental: TMS to vertex, without concurrent task
TMS (intermittent theta burst stimulation) will be applied to the cerebral vertex, when subjects are in a resting state
 Device: TMS
Intermittent theta burst stimulation TMS applied to the cortex to excite cerebral cortex
Other Name: intermittent theta burst stimulation (iTBS)

Behavioral: n-back working memory task
Subjects perform an executive function task, in which they view the serial presentation of letters and decide whether or not a letter matches a letter presented 'n' letters back (3 letters or 1 letter)
Experimental: TMS to dlPFC, during task
TMS (intermittent theta burst stimulation) will be applied to the dlPFC, when subjects are engaged in the n-back working memory task
 Device: TMS
Intermittent theta burst stimulation TMS applied to the cortex to excite cerebral cortex
Other Name: intermittent theta burst stimulation (iTBS)

Behavioral: n-back working memory task
Subjects perform an executive function task, in which they view the serial presentation of letters and decide whether or not a letter matches a letter presented 'n' letters back (3 letters or 1 letter)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 3-back minus 1-back Blood Oxygen Level-Dependent (BOLD) activation, voxelwise in FPN [ Time Frame: 60 minutes after TMS during fMRI ]
    Fronto-parietal network defined by BOLD change while subject performs the n-back working memory task, contrasting high (3-back) versus low (1-back) loads.

  2. FPN connectivity to dlPFC TBS stimulation target [ Time Frame: 60 minutes after TMS during fMRI ]
    Resting-state connectivity of low frequency BOLD fluctuations for a seed at the dlPFC

  3. rCBF at stimulation target [ Time Frame: 60 minutes after TMS during fMRI ]
    Regional cerebral blood flow measured at the site of TBS stimulation

  4. Accuracy to 3-back [ Time Frame: 60 minutes after TMS during fMRI ]
    Correct responses to letter stimuli, as a percentage of all responses


Secondary Outcome Measures :
  1. 3-back minus 1-back BOLD activation, voxelwise in whole brain [ Time Frame: 60 minutes after TMS during fMRI ]
    Fronto-parietal network defined by BOLD change while subject performs the n-back working memory task, contrasting high (3-back) versus low (1-back) loads.

  2. Measure cerebral blood flow (rCBF) in FPN [ Time Frame: 60 minutes after TMS during fMRI ]
    Regional cerebral blood flow measured in the FPN

  3. Median Reaction Time (RT) to 3-back [ Time Frame: 60 minutes after TMS during fMRI ]
    Median reaction time for subjects responding in the n-back task, for correct responses

  4. d-prime in 3-back [ Time Frame: 60 minutes after TMS during fMRI ]
    d-prime measure, including all hits, misses, false alarms and 'correct rejections'


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women of child bearing age can not be pregnant or trying to become pregnant
  • Ability to tolerate small, enclosed spaces without anxiety
  • Size compatible with scanner gantry, e. g. men over 6 feet tall that weigh more than 250 lbs, men under 6 feet tall that weigh over 220 lbs, women over 5'11" tall that weigh more than 220 lbs, or women under 5'10" tall that weigh more than 200 lbs. Subjects of these weights or greater typically have difficult fitting into the fMRI scanner properly
  • Ability and willingness to give informed consent to participate
  • Alcohol or drug dependence (if in remission for greater than 5 years)

Exclusion Criteria

  • History of past or current mental illness (except simple phobias)
  • History of closed head injury, for example, loss of consciousness > approximately 5 minutes, hospitalization, neurological sequela;
  • Metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition (for example; aneurysm clips, retained particles or metal workers with exposures, neurostimulators, foil-backed transdermal patches, carotid or cerebral stents, cerebral spinal fluid (CSF) shunts; magnetic dental implants, ferromagnetic ocular implants, pacemakers, and automatic implantable defibrillators).
  • Prescription or non-prescription, with psychotropic effects (birth control medications allowed)
  • First-degree family members with a history of epilepsy
  • History of serious neurological illness or current medical condition that could compromise brain function, such as liver failure
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04010461


Contacts
Layout table for location contacts
Contact: Pan Gu 734-936-4958 TMScogMod-study@med.umich.edu
Contact: Laura Stchur, MSW 734-936-1323 lmarine@med.umich.edu

Locations
Layout table for location information
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48170
Contact: Laura Stchur, MSW    734-936-1323    lmarine@med.umich.edu   
Sponsors and Collaborators
University of Michigan
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Stephan Taylor, MD University of Michigan
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Stephan F. Taylor, Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT04010461    
Other Study ID Numbers: HUM00165239
R21MH120633-01 ( U.S. NIH Grant/Contract )
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The PI will share information about this/these trial(s) via timely registration, updates, and results reporting in ClinicalTrials.gov in accordance with NIH policy.

The PI will also upload data gathered in this proposal to an National Institute of Mental Health (NIMH)-designated central data, NIMH Data Archive (NDA), as prescribed by NOT-MH-15-012, working with NIMH program to determine the timing and extent of data sharing. This includes formulation of an enrollment strategy that will obtain the information necessary to generate a Global Unique Identifier (GUID) for each participant.

The consent form will include language indicating the intention to upload de-identified data into the central archive, and permission will be obtained from University of Michigan Institutional Review Board to do so. The budget includes a data manager to cover the costs of managing the data, building the data dictionary and harmonizing it with data structures.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: De-identified data will be entered into the NDA within 1 year of the conclusion of the study.
Access Criteria: No additional access restrictions will be placed on the de-identified data beyond those that are standard for the NDA.
URL: https://nda.nih.gov

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Stephan F. Taylor, University of Michigan:
functional magnetic resonance imaging
Transcranial Magnetic Stimulation
dorsolateral prefrontal cortex