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rTMS to Enhance Cognitive Performance and Promote Resilience

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: NCT04123496
Recruitment Status : Active, not recruiting
First Posted : October 11, 2019
Last Update Posted : November 1, 2021
Sponsor:
Collaborators:
National Aeronautics and Space Administration (NASA)
The Translational Research Institute for Space Health (TRISH)
Information provided by (Responsible Party):
Donna Roberts, Medical University of South Carolina

Study Description
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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 determine the most effective dose of brief, non-invasive brain stimulation (repetitive transcranial magnetic stimulation, rTMS) for improving cognitive functions such as attention and memory as well as to improve the ability to recover from stressful situations (stress resilience).

Condition or disease Intervention/treatment Phase
Cognition Stress Reaction Device: rTMS Phase 1

Detailed Description:
Repetitive transcranial magnetic stimulation (rTMS) works by rapidly turning a focused magnetic field on-and-off repeatedly over your head, which passes directly through your hair, scalp, and skull and onto your brain, and can temporarily increase brain activity under the magnetic field. Repetitive transcranial magnetic stimulation (rTMS) is an FDA approved treatment for depression, and is used commonly to treat people for their depression. The rTMS treatment regime used in this study is different from the FDA approved treatment because you will receive up to ten treatments per day over five days instead of the FDA approved rTMS treatment regime of 25 treatments over 25 days. This sort of accelerated or high dose protocol has been shown to be safe and effective in the treatment of depression. We are hoping to find out if this treatment can be used as a treatment for improving cognitive function and stress resilience.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Safety and Efficacy of an Accelerated Protocol of Intermittent Theta Burst Transcranial Magnetic Stimulation (TMS) to Enhance Performance and Promote Resilience in Astronauts: Study 1
Actual Study Start Date : November 21, 2019
Actual Primary Completion Date : September 27, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Dose 1
All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is 5 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
 Device: rTMS
Device: Repetitive Transcranial Magnetic Stimulation (rTMS) MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.
Experimental: Dose 2
All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 2 is 10 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
 Device: rTMS
Device: Repetitive Transcranial Magnetic Stimulation (rTMS) MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.
Experimental: Dose 3
All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 3 is 15 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
 Device: rTMS
Device: Repetitive Transcranial Magnetic Stimulation (rTMS) MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.
Experimental: Dose 4
All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 4 is 20 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
 Device: rTMS
Device: Repetitive Transcranial Magnetic Stimulation (rTMS) MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.
Experimental: Dose 5
All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 5 is 25 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
 Device: rTMS
Device: Repetitive Transcranial Magnetic Stimulation (rTMS) MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.
Experimental: Dose 6
All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 6 is 30 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
 Device: rTMS
Device: Repetitive Transcranial Magnetic Stimulation (rTMS) MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.
Experimental: Dose 7
All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 7 is 35 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
 Device: rTMS
Device: Repetitive Transcranial Magnetic Stimulation (rTMS) MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.
Experimental: Dose 8
All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 8 is 40 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
 Device: rTMS
Device: Repetitive Transcranial Magnetic Stimulation (rTMS) MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.
Experimental: Dose 9
All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 9 is 45 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
 Device: rTMS
Device: Repetitive Transcranial Magnetic Stimulation (rTMS) MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.
Experimental: Dose 10
All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 10 is 50 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
 Device: rTMS
Device: Repetitive Transcranial Magnetic Stimulation (rTMS) MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.


Outcome Measures
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Primary Outcome Measures :
  1. Mean Score of Neurocognitive Performance [ Time Frame: Baseline (Day 1) ]
    Participants would complete a computerized batteries (Penn Computerized Neuropsychological Battery and NIH Cognition Battery). Tasks would assess the following domains: information-processing speed, executive function, sustained attention/vigilance, verbal memory, working-memory capacity, inhibition/impulsivity, and sensorimotor function.

  2. Change from baseline in Neurocognitive Performance at 1 week post treatment [ Time Frame: Post-treatment (within 1 week of completing rTMS) ]
    Participants would complete a computerized batteries (Penn Computerized Neuropsychological Battery and NIH Cognition Battery). Tasks would assess the following domains: information-processing speed, executive function, sustained attention/vigilance, verbal memory, working-memory capacity, inhibition/impulsivity, and sensorimotor function.

  3. Change from baseline in Neurocognitive Performance at 1 month post treatment [ Time Frame: Post-treatment (within 1 month of completing rTMS) ]
    Participants would complete a computerized batteries (Penn Computerized Neuropsychological Battery and NIH Cognition Battery). Tasks would assess the following domains: information-processing speed, executive function, sustained attention/vigilance, verbal memory, working-memory capacity, inhibition/impulsivity, and sensorimotor function.


Secondary Outcome Measures :
  1. Mean Score of Stress Resilience as assessed by Connor Davidson Resilience Scale [ Time Frame: Baseline (Day 1) ]

    Participants would complete a series of questionnaires

    1. Connor Davidson Resilience Scale

    -Questions are rated on a scale from 0-4, where a higher score reflects greater resilience.


  2. Mean Score of Stress Resilience as assessed by Perceived Stress Scale-10 [ Time Frame: Baseline (Day 1) ]

    Participants would complete a series of questionnaires

    2. Perceived Stress Scale-10

    -Questions are rated on a scale from 0-4, where a higher score reflects a higher perceived stress.


  3. Mean Score of Stress Resilience as assessed by Inventory of Depression and Anxiety Symptoms-II [ Time Frame: Baseline (Day 1) ]

    Participants would complete a series of questionnaires

    3. Inventory of Depression and Anxiety Symptoms-II

    -Questions are rated on a scale from 1-5 and covers a wide array of psychological measures


  4. Mean Score of Stress Resilience as assessed by Connor Davidson Resilience Scale [ Time Frame: Post-treatment (within 1 week of completing rTMS) ]

    Participants would complete a series of questionnaires

    1. Connor Davidson Resilience Scale

    -Questions are rated on a scale from 0-4, where a higher score reflects greater resilience.


  5. Mean Score of Stress Resilience as assessed by Perceived Stress Scale-10 [ Time Frame: Post-treatment (within 1 week of completing rTMS) ]

    Participants would complete a series of questionnaires

    2. Perceived Stress Scale-10

    -Questions are rated on a scale from 0-4, where a higher score reflects a higher perceived stress.


  6. Mean Score of Stress Resilience as assessed by Inventory of Depression and Anxiety Symptoms-II [ Time Frame: Post-treatment (within 1 week of completing rTMS) ]

    Participants would complete a series of questionnaires

    3. Inventory of Depression and Anxiety Symptoms-II

    -Questions are rated on a scale from 1-5 and covers a wide array of psychological measures


  7. Mean Score of Stress Resilience as assessed by Connor Davidson Resilience Scale [ Time Frame: Post-treatment (within 1 month of completing rTMS) ]

    Participants would complete a series of questionnaires

    1. Connor Davidson Resilience Scale

    -Questions are rated on a scale from 0-4, where a higher score reflects greater resilience.


  8. Mean Score of Stress Resilience as assessed by Perceived Stress Scale-10 [ Time Frame: Post-treatment (within 1 month of completing rTMS) ]

    Participants would complete a series of questionnaires

    2. Perceived Stress Scale-10

    -Questions are rated on a scale from 0-4, where a higher score reflects a higher perceived stress.


  9. Mean Score of Stress Resilience as assessed by Inventory of Depression and Anxiety Symptoms-II [ Time Frame: Post-treatment (within 1 month of completing rTMS) ]

    Participants would complete a series of questionnaires

    3. Inventory of Depression and Anxiety Symptoms-II

    -Questions are rated on a scale from 1-5 and covers a wide array of psychological measures



Other Outcome Measures:
  1. Baseline Structural MRI - FLAIR [ Time Frame: Baseline (Day 1) ]
    FLAIR sequences

  2. Baseline Structural MRI - Diffusion [ Time Frame: Baseline (Day 1) ]
    Diffusion sequences

  3. Baseline Structural MRI - T2 [ Time Frame: Baseline (Day 1) ]
    T2 sequences

  4. Baseline Structural MRI - Volumetric [ Time Frame: Baseline (Day 1) ]
    Volumetric sequences

  5. Change from baseline in structural MRI at 1 week post treatment - FLAIR [ Time Frame: Post-treatment (within 1 week of completing rTMS) ]
    FLAIR sequences

  6. Change from baseline in structural MRI at 1 week post treatment - Diffusion [ Time Frame: Post-treatment (within 1 week of completing rTMS) ]
    Diffusion sequences

  7. Change from baseline in structural MRI at 1 week post treatment - T2 [ Time Frame: Post-treatment (within 1 week of completing rTMS) ]
    T2 sequences

  8. Change from baseline in structural MRI at 1 week post treatment - Volumetric [ Time Frame: Post-treatment (within 1 week of completing rTMS) ]
    Volumetric sequences


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. No history of mental or physical illness
  2. No implanted metal in the body
  3. College graduates (Associates degree or higher)
  4. Negative urine pregnancy test, if female subject of childbearing potential
  5. Able to read and understand questionnaires and informed consent

Exclusion Criteria:

  1. Any current psychiatric diagnosis or current Clinical Global Impression ratings of psychiatric illness > 1
  2. Current physical illness
  3. History of CNS disease, concussion, overnight hospitalization, tumors, seizures, meningitis, encephalitis, abnormal CT/MRI of the brain
  4. Moderate to severe traumatic brain injury (TBI)
  5. History of a continuing significant laboratory finding
  6. Frequent or severe headaches
  7. Any history of psychotropic medication prior to study enrollment
  8. Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
  9. active participation or plan for enrollment in another evidence-based clinical trial affecting psychosocial function
  10. repeated abuse or dependence upon drugs (excluding nicotine and caffeine)
  11. implanted devices/ferrous metal of any kind
Contacts and Locations
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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): NCT04123496


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29401-5799
Sponsors and Collaborators
Medical University of South Carolina
National Aeronautics and Space Administration (NASA)
The Translational Research Institute for Space Health (TRISH)
Investigators
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Principal Investigator: Donna Roberts, MD Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Donna Roberts, Medical University of South Carolina:
Informed Consent Form  [PDF] January 5, 2021

More Information
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Responsible Party: Donna Roberts, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04123496    
Other Study ID Numbers: 00084982
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Donna Roberts, Medical University of South Carolina:
cognition
adult
prefrontal cortex
Transcranial Magnetic Stimulation
 Stress, Psychological
memory
attention
Additional relevant MeSH terms:
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Fractures, Stress
Fractures, Bone
Wounds and Injuries