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Establishing Functional Biomarkers for Spaced Theta-Burst Stimulation

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ClinicalTrials.gov Identifier: NCT03687892
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : March 25, 2021
Sponsor:
Information provided by (Responsible Party):
Nolan R, Stanford University

Brief Summary:
The investigators plan to use functional magnetic resonance imaging (fMRI) methods to assess brain changes following spaced theta burst stimulation (TBS), a new form of repetitive transcranial magnetic stimulation (rTMS), in 10 healthy participants. The investigators will measure the effects of both excitatory (intermittent, iTBS) and inhibitory (continuous, cTBS) TBS applied to the motor cortex, a system that when stimulated produces a readily observable behavioral response (e.g., movement of a given body regions). In addition to brain activity, we will assess the effects of TBS on motor responses and pain perception. The goal is to determine how brain activity and blood flow during tasks and at rest change following the applications of spaced cTBS and iTBS. Additionally, the aim is to determine the duration of the spaced TBS effects on brain activity and behavior. This study will provide an understanding of the functional brain and behavioral changes that occur following spaced TBS to the motor cortex and has implications for reducing the long treatment schedules associated with classical rTMS protocols.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Device: continuous Theta Burst Stimulation Device: intermittent Theta Burst Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Establishing Functional Biomarkers for Spaced Theta-Burst Stimulation
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2023

Arm Intervention/treatment
Experimental: continuous Theta Burst Stimulation
The investigators will perform two applications of 40s of continuous Theta Burst Stimulation (cTBS) form of rTMS at 80% resting motor threshold (previously determined), with a 15 minute intersession interval. The standardized treatment location for the left motor cortex will be determined by Localite Neuronavigation. The baseline structural scan obtained during the scan 1 will be utilized for this localization process.
Device: continuous Theta Burst Stimulation
Continuous Theta Burst Simulation will be applied in a continuous manner resulting in cortical excitability.
Other Name: cTBS

Experimental: intermittent Theta Burst Stimulation
The investigators will perform two applications of 40s of intermittent Theta Burst Stimulation (iTBS) form of rTMS at 80% resting motor threshold (previously determined), with a 15 minute intersession interval. The standardized treatment location for the left motor cortex will be determined by Localite Neuronavigation. The baseline structural scan obtained during the scan 1 will be utilized for this localization process.
Device: intermittent Theta Burst Stimulation
Intermittent Theta Burst Stimulation will be applied in an intermittent manner resulting in cortical inhibition.
Other Name: iTBS




Primary Outcome Measures :
  1. Changes in Motor Evoked Potential [ Time Frame: Prior to and and immediately after TBS sessions on each day (separated by 3+ days) ]
    To determine the duration of effect of an application of a spaced TBS stimulation session (both inhibitory, cTBS and excitatory, iTBS) as measured by duration of change in motor evoked potential.


Secondary Outcome Measures :
  1. Change from baseline resting-state functional connectivity between the M1 hotspot and other motor areas immediately post-TBS [ Time Frame: Prior to and and immediately after TBS sessions on each day (separated by 3+ days) ]
    To determine the resting state functional connectivity changes that result from an application of spaced TBS stimulations (both inhibitory, cTBS and excitatory, iTBS).

  2. Change from baseline motor cortex activity as assessed by the BOLD signal immediately post-TBS [ Time Frame: Prior to and and immediately after TBS sessions on each day (separated by 3+ days) ]
    To determine the TMS-BOLD (over M1) changes that result from an application of spaced TBS stimulations (both inhibitory, cTBS and excitatory, iTBS).

  3. Changes in arterial perfusion [ Time Frame: Prior to and and immediately after TBS sessions on each day (separated by 3+ days) ]
    To determine the arterial perfusion changes that result from an application of spaced TBS stimulations (both inhibitory, cTBS and excitatory, iTBS) as measured by ASL.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Right-handed
  • Agree to having fMRI scan
  • Willingness to suspend use of analgesic drugs or cough suppressants for 24 hours prior to the scans
  • Proficiency in English sufficient to complete questionnaires/follow instructions during fMRI assessments
  • US Citizen or resident able to receive payment legally

Exclusion Criteria:

  • A medical condition that would contraindicate the use of rTMS
  • Any condition that would contraindicate MRI (like ferromagnetic metal in the body)
  • Pregnancy or breast feeding
  • Any significant neurologic disease, including dementia, multi-infarct dementia, Parkinson's or Huntington's disease, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, history of significant head trauma
  • Current antidepressant use (must be washed out for two weeks prior to starting protocol)
  • Inability to stop taking medication contraindicated with treatment

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): NCT03687892


Contacts
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Contact: Romina Nejad, M.Sc (650)736-2233 rnejad@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94305
Contact: Romina Nejad, M.Sc    650-736-2233    rnejad@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Nolan Williams, M.D. Stanford University
Publications:

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Responsible Party: Nolan R, Instructor of Psychiatry and Behavioral Sciences, Stanford University
ClinicalTrials.gov Identifier: NCT03687892    
Other Study ID Numbers: 39234
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: March 25, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided.

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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 Nolan R, Stanford University:
repetitive Transcranial Magnetic Stimulation
functional MRI
Theta Burst Stimulation