Clinical trial NCT04123496: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Cognition
Stress Reaction
Keywords: cognition
adult
prefrontal cortex
Transcranial Magnetic Stimulation
Stress, Psychological
memory
attention
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Aeronautics and Space Administration (NASA)
name: The Translational Research Institute for Space Health (TRISH)
First posted: 2019-10-11
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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 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

Primary outcomes:
measure: Mean Score of Neurocognitive Performance
timeFrame: Baseline (Day 1)
measure: Change from baseline in Neurocognitive Performance at 1 week post treatment
timeFrame: Post-treatment (within 1 week of completing rTMS)
measure: Change from baseline in Neurocognitive Performance at 1 month post treatment
timeFrame: Post-treatment (within 1 month of completing rTMS)
Secondary outcomes:
measure: Mean Score of Stress Resilience as assessed by Connor Davidson Resilience Scale
timeFrame: Baseline (Day 1)
measure: Mean Score of Stress Resilience as assessed by Perceived Stress Scale-10
timeFrame: Baseline (Day 1)
measure: Mean Score of Stress Resilience as assessed by Inventory of Depression and Anxiety Symptoms-II
timeFrame: Baseline (Day 1)
measure: Mean Score of Stress Resilience as assessed by Connor Davidson Resilience Scale
timeFrame: Post-treatment (within 1 week of completing rTMS)
measure: Mean Score of Stress Resilience as assessed by Perceived Stress Scale-10
timeFrame: Post-treatment (within 1 week of completing rTMS)
measure: Mean Score of Stress Resilience as assessed by Inventory of Depression and Anxiety Symptoms-II
timeFrame: Post-treatment (within 1 week of completing rTMS)
measure: Mean Score of Stress Resilience as assessed by Connor Davidson Resilience Scale
timeFrame: Post-treatment (within 1 month of completing rTMS)
measure: Mean Score of Stress Resilience as assessed by Perceived Stress Scale-10
timeFrame: Post-treatment (within 1 month of completing rTMS)
measure: Mean Score of Stress Resilience as assessed by Inventory of Depression and Anxiety Symptoms-II
timeFrame: Post-treatment (within 1 month of completing rTMS)
Other outcomes:
measure: Baseline Structural MRI - FLAIR
timeFrame: Baseline (Day 1)
measure: Baseline Structural MRI - Diffusion
timeFrame: Baseline (Day 1)
measure: Baseline Structural MRI - T2
timeFrame: Baseline (Day 1)
measure: Baseline Structural MRI - Volumetric
timeFrame: Baseline (Day 1)
measure: Change from baseline in structural MRI at 1 week post treatment - FLAIR
timeFrame: Post-treatment (within 1 week of completing rTMS)
measure: Change from baseline in structural MRI at 1 week post treatment - Diffusion
timeFrame: Post-treatment (within 1 week of completing rTMS)
measure: Change from baseline in structural MRI at 1 week post treatment - T2
timeFrame: Post-treatment (within 1 week of completing rTMS)
measure: Change from baseline in structural MRI at 1 week post treatment - Volumetric
timeFrame: Post-treatment (within 1 week of completing rTMS)
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Donna Roberts, MD
role: PRINCIPAL_INVESTIGATOR
References: