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rTMS to Enhance Cognitive Performance and Promote Resilience

Primary Purpose

Cognition, Stress Reaction

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
rTMS
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cognition focused on measuring cognition, adult, prefrontal cortex, Transcranial Magnetic Stimulation, Stress, Psychological, memory, attention

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose 1

Dose 2

Dose 3

Dose 4

Dose 5

Dose 6

Dose 7

Dose 8

Dose 9

Dose 10

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Mean Score of Neurocognitive Performance
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.
Change from baseline in Neurocognitive Performance at 1 week post treatment
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.
Change from baseline in Neurocognitive Performance at 1 month post treatment
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

Mean Score of Stress Resilience as assessed by Connor Davidson Resilience Scale
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.
Mean Score of Stress Resilience as assessed by Perceived Stress Scale-10
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.
Mean Score of Stress Resilience as assessed by Inventory of Depression and Anxiety Symptoms-II
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
Mean Score of Stress Resilience as assessed by Connor Davidson Resilience Scale
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.
Mean Score of Stress Resilience as assessed by Perceived Stress Scale-10
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.
Mean Score of Stress Resilience as assessed by Inventory of Depression and Anxiety Symptoms-II
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
Mean Score of Stress Resilience as assessed by Connor Davidson Resilience Scale
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.
Mean Score of Stress Resilience as assessed by Perceived Stress Scale-10
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.
Mean Score of Stress Resilience as assessed by Inventory of Depression and Anxiety Symptoms-II
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

Full Information

First Posted
October 9, 2019
Last Updated
October 25, 2021
Sponsor
Medical University of South Carolina
Collaborators
National Aeronautics and Space Administration (NASA), The Translational Research Institute for Space Health (TRISH)
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1. Study Identification

Unique Protocol Identification Number
NCT04123496
Brief Title
rTMS to Enhance Cognitive Performance and Promote Resilience
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 21, 2019 (Actual)
Primary Completion Date
September 27, 2021 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Aeronautics and Space Administration (NASA), The Translational Research Institute for Space Health (TRISH)

4. Oversight

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

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognition, Stress Reaction
Keywords
cognition, adult, prefrontal cortex, Transcranial Magnetic Stimulation, Stress, Psychological, memory, attention

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose 3
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose 4
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose 5
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose 6
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose 7
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose 8
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose 9
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose 10
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Score of Neurocognitive Performance
Description
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.
Time Frame
Baseline (Day 1)
Title
Change from baseline in Neurocognitive Performance at 1 week post treatment
Description
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.
Time Frame
Post-treatment (within 1 week of completing rTMS)
Title
Change from baseline in Neurocognitive Performance at 1 month post treatment
Description
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.
Time Frame
Post-treatment (within 1 month of completing rTMS)
Secondary Outcome Measure Information:
Title
Mean Score of Stress Resilience as assessed by Connor Davidson Resilience Scale
Description
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.
Time Frame
Baseline (Day 1)
Title
Mean Score of Stress Resilience as assessed by Perceived Stress Scale-10
Description
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.
Time Frame
Baseline (Day 1)
Title
Mean Score of Stress Resilience as assessed by Inventory of Depression and Anxiety Symptoms-II
Description
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
Time Frame
Baseline (Day 1)
Title
Mean Score of Stress Resilience as assessed by Connor Davidson Resilience Scale
Description
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.
Time Frame
Post-treatment (within 1 week of completing rTMS)
Title
Mean Score of Stress Resilience as assessed by Perceived Stress Scale-10
Description
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.
Time Frame
Post-treatment (within 1 week of completing rTMS)
Title
Mean Score of Stress Resilience as assessed by Inventory of Depression and Anxiety Symptoms-II
Description
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
Time Frame
Post-treatment (within 1 week of completing rTMS)
Title
Mean Score of Stress Resilience as assessed by Connor Davidson Resilience Scale
Description
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.
Time Frame
Post-treatment (within 1 month of completing rTMS)
Title
Mean Score of Stress Resilience as assessed by Perceived Stress Scale-10
Description
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.
Time Frame
Post-treatment (within 1 month of completing rTMS)
Title
Mean Score of Stress Resilience as assessed by Inventory of Depression and Anxiety Symptoms-II
Description
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
Time Frame
Post-treatment (within 1 month of completing rTMS)
Other Pre-specified Outcome Measures:
Title
Baseline Structural MRI - FLAIR
Description
FLAIR sequences
Time Frame
Baseline (Day 1)
Title
Baseline Structural MRI - Diffusion
Description
Diffusion sequences
Time Frame
Baseline (Day 1)
Title
Baseline Structural MRI - T2
Description
T2 sequences
Time Frame
Baseline (Day 1)
Title
Baseline Structural MRI - Volumetric
Description
Volumetric sequences
Time Frame
Baseline (Day 1)
Title
Change from baseline in structural MRI at 1 week post treatment - FLAIR
Description
FLAIR sequences
Time Frame
Post-treatment (within 1 week of completing rTMS)
Title
Change from baseline in structural MRI at 1 week post treatment - Diffusion
Description
Diffusion sequences
Time Frame
Post-treatment (within 1 week of completing rTMS)
Title
Change from baseline in structural MRI at 1 week post treatment - T2
Description
T2 sequences
Time Frame
Post-treatment (within 1 week of completing rTMS)
Title
Change from baseline in structural MRI at 1 week post treatment - Volumetric
Description
Volumetric sequences
Time Frame
Post-treatment (within 1 week of completing rTMS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: No history of mental or physical illness No implanted metal in the body College graduates (Associates degree or higher) Negative urine pregnancy test, if female subject of childbearing potential Able to read and understand questionnaires and informed consent Exclusion Criteria: Any current psychiatric diagnosis or current Clinical Global Impression ratings of psychiatric illness > 1 Current physical illness History of CNS disease, concussion, overnight hospitalization, tumors, seizures, meningitis, encephalitis, abnormal CT/MRI of the brain Moderate to severe traumatic brain injury (TBI) History of a continuing significant laboratory finding Frequent or severe headaches Any history of psychotropic medication prior to study enrollment Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control. active participation or plan for enrollment in another evidence-based clinical trial affecting psychosocial function repeated abuse or dependence upon drugs (excluding nicotine and caffeine) implanted devices/ferrous metal of any kind
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Roberts, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5799
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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rTMS to Enhance Cognitive Performance and Promote Resilience

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