rTMS to Enhance Cognitive Performance and Promote Resilience

NCT04123496 | Completed Results FDA Device

• 1 other identifier: 00084982
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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).

Conditions

Cognition; Stress Reaction

Keywords

cognition; adult; prefrontal cortex; Transcranial Magnetic Stimulation; Stress, Psychological; memory; attention

Outcome Measures

Primary Outcomes (3)

• Mean Score of Neurocognitive Performance (Fluid Cognition)

  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. This composite includes all the tests noted above that are fluid ability measures: Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting and Pattern Comparison. This composite score is derived by averaging the standard scores of each of the measures, and then deriving standard scores based on this new distribution. Higher values (positive changes from baseline) indicate better performance. The T-score has a mean of 50 in the general population and a SD of 10. Scores higher than the mean indicate better performance.

  Baseline (Day 1)

• Change From Baseline in Neurocognitive Performance at 1 Week Post Treatment (Fluid Cognition)

  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. This composite includes all the tests noted above that are fluid ability measures: Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting and Pattern Comparison. This composite score is derived by averaging the standard scores of each of the measures, and then deriving standard scores based on this new distribution. The T-score has a mean of 50 in the general population and a SD of 10. Scores higher than the mean indicate better performance.

  Post-treatment (within 1 week of completing rTMS)

• Change From Baseline in Neurocognitive Performance at 1 Month Post Treatment (Fluid Cognition)

  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. This composite includes all the tests noted above that are fluid ability measures: Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting and Pattern Comparison. This composite score is derived by averaging the standard scores of each of the measures, and then deriving standard scores based on this new distribution. The T-score has a mean of 50 in the general population and a SD of 10. Scores higher than the mean indicate better performance.

  Post-treatment (within 1 month of completing rTMS)

Secondary Outcomes (15)

• 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)

Study Arms (10)

Dose 1

EXPERIMENTAL

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

Dose 2

EXPERIMENTAL

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

Dose 3

EXPERIMENTAL

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

Dose 4

EXPERIMENTAL

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

Dose 5

EXPERIMENTAL

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

Dose 6

EXPERIMENTAL

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

Dose 7

EXPERIMENTAL

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

Dose 8

EXPERIMENTAL

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

Dose 9

EXPERIMENTAL

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

Dose 10

EXPERIMENTAL

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

Interventions

rTMS DEVICE

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.

Dose 1; Dose 10; Dose 2; Dose 3; Dose 4; Dose 5; Dose 6; Dose 7; Dose 8; Dose 9

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Aeronautics and Space Administration (NASA): collaborator
• The Translational Research Institute for Space Health (TRISH): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29401-5799, United States

Location

MeSH Terms

Conditions

Fractures, Stress; Stress, Psychological

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Donna Robers, MD
• Organization: Medical University of South Carolina

Robertdr@musc.edu

843-792-9343

Study Officials

• Donna Roberts, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 11, 2019
• Study Start: November 21, 2019
• Primary Completion: September 27, 2021
• Study Completion: October 27, 2021
• Last Updated: October 16, 2025
• Results First Posted: October 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)