rTMS to Enhance Cognitive Performance and Promote Resilience

Sponsor

Medical University of South Carolina (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04123496

Collaborator

National Aeronautics and Space Administration (NASA) (U.S. Fed), The Translational Research Institute for Space Health (TRISH) (Other)

Enrollment

Location

Arms

25.3

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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).

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

Study Type:

Interventional

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 :

Nov 21, 2019

Actual Primary Completion Date :

Sep 27, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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

Primary Outcome Measures

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

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

Baseline Structural MRI - FLAIR [Baseline (Day 1)]
FLAIR sequences
Baseline Structural MRI - Diffusion [Baseline (Day 1)]
Diffusion sequences
Baseline Structural MRI - T2 [Baseline (Day 1)]
T2 sequences
Baseline Structural MRI - Volumetric [Baseline (Day 1)]
Volumetric sequences
Change from baseline in structural MRI at 1 week post treatment - FLAIR [Post-treatment (within 1 week of completing rTMS)]
FLAIR sequences
Change from baseline in structural MRI at 1 week post treatment - Diffusion [Post-treatment (within 1 week of completing rTMS)]
Diffusion sequences
Change from baseline in structural MRI at 1 week post treatment - T2 [Post-treatment (within 1 week of completing rTMS)]
T2 sequences
Change from baseline in structural MRI at 1 week post treatment - Volumetric [Post-treatment (within 1 week of completing rTMS)]
Volumetric sequences

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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