rTMS to Enhance Cognitive Performance and Promote Resilience

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Stress Reaction; Cognition

Treatments: Device: rTMS

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04123496

00084982

Details and patient eligibility

About

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).

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 22 to 55 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 10 patient groups

Dose 1

Experimental group

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.

Treatment:

Device: rTMS

Dose 2

Experimental group

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.

Treatment:

Device: rTMS

Dose 3

Experimental group

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.

Treatment:

Device: rTMS

Dose 4

Experimental group

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.

Treatment:

Device: rTMS

Dose 5

Experimental group

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.

Treatment:

Device: rTMS

Dose 6

Experimental group

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.

Treatment:

Device: rTMS

Dose 7

Experimental group

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.

Treatment:

Device: rTMS

Dose 8

Experimental group

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.

Treatment:

Device: rTMS

Dose 9

Experimental group

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.

Treatment:

Device: rTMS

Dose 10

Experimental group

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.

Treatment:

Device: rTMS