rTMS to Enhance Cognitive Performance and Promote Resilience

Cognition Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04123496
• Other study ID #: 00084982
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 21, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2021
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognition
• Fractures, Stress
• Stress Reaction

Intervention

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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Aeronautics and Space Administration (NASA), The Translational Research Institute for Space Health (TRISH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Baseline Structural MRI - FLAIR	FLAIR sequences	Baseline (Day 1)
Other	Baseline Structural MRI - Diffusion	Diffusion sequences	Baseline (Day 1)
Other	Baseline Structural MRI - T2	T2 sequences	Baseline (Day 1)
Other	Baseline Structural MRI - Volumetric	Volumetric sequences	Baseline (Day 1)
Other	Change from baseline in structural MRI at 1 week post treatment - FLAIR	FLAIR sequences	Post-treatment (within 1 week of completing rTMS)
Other	Change from baseline in structural MRI at 1 week post treatment - Diffusion	Diffusion sequences	Post-treatment (within 1 week of completing rTMS)
Other	Change from baseline in structural MRI at 1 week post treatment - T2	T2 sequences	Post-treatment (within 1 week of completing rTMS)
Other	Change from baseline in structural MRI at 1 week post treatment - Volumetric	Volumetric sequences	Post-treatment (within 1 week of completing rTMS)
Primary	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.	Baseline (Day 1)
Primary	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.	Post-treatment (within 1 week of completing rTMS)
Primary	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.	Post-treatment (within 1 month of completing rTMS)
Secondary	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.	Baseline (Day 1)
Secondary	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.	Baseline (Day 1)
Secondary	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	Baseline (Day 1)
Secondary	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.	Post-treatment (within 1 week of completing rTMS)
Secondary	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.	Post-treatment (within 1 week of completing rTMS)
Secondary	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	Post-treatment (within 1 week of completing rTMS)
Secondary	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.	Post-treatment (within 1 month of completing rTMS)
Secondary	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.	Post-treatment (within 1 month of completing rTMS)
Secondary	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	Post-treatment (within 1 month of completing rTMS)