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

rTMS to Enhance Cognitive Performance and Promote Resilience

Sponsors

Lead sponsor: Medical University of South Carolina

Collaborator: National Aeronautics and Space Administration (NASA)
The Translational Research Institute for Space Health (TRISH)

Source Medical University of South Carolina
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.

Overall Status Recruiting
Start Date November 21, 2019
Completion Date May 1, 2021
Primary Completion Date May 1, 2021
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean Score of Neurocognitive Performance Baseline (Day 1)
Change from baseline in Neurocognitive Performance at 1 week post treatment At baseline and 1 week post treatment
Change from baseline in Neurocognitive Performance at 1 month post treatment Post-treatment (within 1 month of completing rTMS)
Secondary Outcome
Measure Time Frame
Mean Score of Stress Resilience as assessed by Connor Davidson Resilience Scale Baseline (Day 1)
Mean Score of Stress Resilience as assessed by Perceived Stress Scale-10 Baseline (Day 1)
Mean Score of Stress Resilience as assessed by Inventory of Depression and Anxiety Symptoms-II Baseline (Day 1)
Mean Score of Stress Resilience as assessed by Connor Davidson Resilience Scale Post-treatment (within 1 week of completing rTMS)
Mean Score of Stress Resilience as assessed by Perceived Stress Scale-10 Post-treatment (within 1 week of completing rTMS)
Mean Score of Stress Resilience as assessed by Inventory of Depression and Anxiety Symptoms-II Post-treatment (within 1 week of completing rTMS)
Mean Score of Stress Resilience as assessed by Connor Davidson Resilience Scale Post-treatment (within 1 month of completing rTMS)
Mean Score of Stress Resilience as assessed by Perceived Stress Scale-10 Post-treatment (within 1 month of completing rTMS)
Mean Score of Stress Resilience as assessed by Inventory of Depression and Anxiety Symptoms-II Post-treatment (within 1 month of completing rTMS)
Enrollment 50
Condition
Intervention

Intervention type: Device

Intervention name: rTMS

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.

Eligibility

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 lifetime psychiatric diagnosis

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

Gender: All

Minimum age: 25 Years

Maximum age: 55 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Donna Roberts, MD Principal Investigator Medical University of South Carolina
Overall Contact

Last name: Claire Cox

Phone: 843-792-2872

Email: [email protected]

Location
facility status contact contact_backup Medical University of South Carolina Claire Cox 843-792-2872 [email protected]
Location Countries

United States

Verification Date

December 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Medical University of South Carolina

Investigator full name: Donna Roberts

Investigator title: Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 10
Arm Group

Arm group label: Dose 1

Arm group type: Experimental

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 group label: Dose 2

Arm group type: Experimental

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 group label: Dose 3

Arm group type: Experimental

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 group label: Dose 4

Arm group type: Experimental

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 group label: Dose 5

Arm group type: Experimental

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 group label: Dose 6

Arm group type: Experimental

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 group label: Dose 7

Arm group type: Experimental

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 group label: Dose 8

Arm group type: Experimental

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 group label: Dose 9

Arm group type: Experimental

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 group label: Dose 10

Arm group type: Experimental

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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: Single (Participant)

Source: ClinicalTrials.gov