CognitionNCT04123496
rTMS to Enhance Cognitive Performance and Promote Resilience
A study testing rTMS in people with Cognition and Stress Reaction, run by Medical University of South Carolina at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 22 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition, Stress Reaction
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2019to 27 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29401-5799
About this study
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
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).
Read the 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.
- Conditions
- Cognition, Stress Reaction
- Being tested
- rTMS
- Keywords
- cognition, adult, prefrontal cortex, Transcranial Magnetic Stimulation, Stress, Psychological, memory, attention
- Medical subject headings
- Fractures, Stress, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Post-treatment (within 1 month of completing rTMS)
Secondary outcomes (15)
Mean Score of Stress Resilience as Assessed by Connor Davidson Resilience Scale
Participants would complete a series of questionnaires Connor Davidson Resilience Scale is a self-reported scale consisting of 10-items measuring resilience. Respondents rate items on a 5-point Likert scale, ranging from 0 (not true at all) to 4 (true nearly all the time). Each item has a minimum score of 0 and a maximum score of 4. The minimum value is a 0 and the maximum value is a 100. A higher score indicates higher resilience, which indicates a better outcome.
-Questions are rated on a scale from 0-4, where a higher score reflects greater resilience.
Measured: Baseline (Day 1)
Mean Score of Stress Resilience as Assessed by Perceived Stress Scale-10
The investigators will use the Perceived Stress Scale 10 (PSS-10) to assess perceived stress using a 5-point Likert scale.
Scoring Instructions: Total score is determined by adding together the scores of each of the four items. Questions 2 and 3 are reverse coded. Questions 1 and 4: 0 = Never; 1 = Almost never; 2 = Sometimes; 3 = Fairly often; 4 = Very often Questions 2 and 3: 4 = Never; 3 = Almost never; 2 = Sometimes; 1 = Fairly often; 0 = Very often.
Scores range from 0 to 40 with higher scores indicating more stress.
Measured: Baseline (Day 1)
Mean Score of Stress Resilience as Assessed by Inventory of Depression and Anxiety Symptoms-II
The Inventory of Depression and Anxiety Symptoms-II (IDAS-II) is a 99-item self-report questionnaire assessing emotional and psychological symptoms across 18 subscales. Each item is rated on a 5-point Likert scale from 1 ("Not at all") to 5 ("Extremely").
In this study, a composite score was calculated by summing responses across multiple relevant subscales (e.g., Dysphoria, Panic, Insomnia, Well-Being) to assess overall emotional distress and stress resilience.
Minimum possible score: 99 (if all items scored 1) Maximum possible score: 495 (if all items scored 5) Higher scores indicate greater symptom severity and worse outcomes. Lower scores reflect better emotional functioning and greater resilience.
Measured: Baseline (Day 1)
Mean Score of Stress Resilience as Assessed by Connor Davidson Resilience Scale
The Connor Davidson Resilience Scale (CD-RISC 10) is a unidimensional self-reported scale consisting of 10-items measuring resilience. Respondents rate items on a 5-point Likert scale, ranging from 0 (not true at all) to 4 (true nearly all the time). Each item has a minimum score of 0 and a maximum score of 4. The minimum value is a 0 and the maximum value is a 100. A higher score indicates higher resilience, which indicates a better outcome.
Measured: Post-treatment (within 1 week of completing rTMS)
Mean Score of Stress Resilience as Assessed by Perceived Stress Scale-10
The investigators will use the Perceived Stress Scale 10 (PSS-10) to assess perceived stress using a 5-point Likert scale.
Scoring Instructions: Total score is determined by adding together the scores of each of the four items. Questions 2 and 3 are reverse coded. Questions 1 and 4: 0 = Never; 1 = Almost never; 2 = Sometimes; 3 = Fairly often; 4 = Very often Questions 2 and 3: 4 = Never; 3 = Almost never; 2 = Sometimes; 1 = Fairly often; 0 = Very often.
Scores range from 0 to 40 with higher scores indicating more stress.
Measured: Post-treatment (within 1 week of completing rTMS)
Mean Score of Stress Resilience as Assessed by Inventory of Depression and Anxiety Symptoms-II
The Inventory of Depression and Anxiety Symptoms-II (IDAS-II) is a 99-item self-report questionnaire assessing emotional and psychological symptoms across 18 subscales. Each item is rated on a 5-point Likert scale from 1 ("Not at all") to 5 ("Extremely").
In this study, a composite score was calculated by summing responses across multiple relevant subscales (e.g., Dysphoria, Panic, Insomnia, Well-Being) to assess overall emotional distress and stress resilience.
Minimum possible score: 99 Maximum possible score: 495 Higher scores indicate greater symptom severity and worse outcomes. Lower scores reflect better emotional functioning and greater resilience.
Measured: Post-treatment (within 1 week of completing rTMS)
Mean Score of Stress Resilience as Assessed by Connor Davidson Resilience Scale
The Connor Davidson Resilience Scale (CD-RISC 10) is a unidimensional self-reported scale consisting of 10-items measuring resilience. Respondents rate items on a 5-point Likert scale, ranging from 0 (not true at all) to 4 (true nearly all the time). Each item has a minimum score of 0 and a maximum score of 4. The minimum value is a 0 and the maximum value is a 100. A higher score indicates higher resilience, which indicates a better outcome.
Measured: Post-treatment (within 1 month of completing rTMS)
Mean Score of Stress Resilience as Assessed by Perceived Stress Scale-10
The investigators will use the Perceived Stress Scale 10 (PSS-10) to assess perceived stress using a 5-point Likert scale.
Scoring Instructions: Total score is determined by adding together the scores of each of the four items. Questions 2 and 3 are reverse coded. Questions 1 and 4: 0 = Never; 1 = Almost never; 2 = Sometimes; 3 = Fairly often; 4 = Very often Questions 2 and 3: 4 = Never; 3 = Almost never; 2 = Sometimes; 1 = Fairly often; 0 = Very often.
Scores range from 0 to 40 with higher scores indicating more stress.
Measured: Post-treatment (within 1 month of completing rTMS)
Mean Score of Stress Resilience as Assessed by Inventory of Depression and Anxiety Symptoms-II
The Inventory of Depression and Anxiety Symptoms-II (IDAS-II) is a 99-item self-report questionnaire assessing emotional and psychological symptoms across 18 subscales. Each item is rated on a 5-point Likert scale from 1 ("Not at all") to 5 ("Extremely").
In this study, a composite score was calculated by summing responses across multiple relevant subscales (e.g., Dysphoria, Panic, Insomnia, Well-Being) to assess overall emotional distress and stress resilience.
Minimum possible score: 99 Maximum possible score: 495 Higher scores indicate greater symptom severity and worse outcomes. Lower scores reflect better emotional functioning and greater resilience.
Measured: Post-treatment (within 1 month of completing rTMS)
Mean Score of Neurocognitive Performance (WINSCAT Composite)
The WINSCAT battery includes 5 subtests: Code Substitution (CDS), Code Substitution Delayed Recognition (CDD), Delayed Matching to Sample (MSP), Mathematical Processing (MTH), and Running Memory Continuous Performance (CPT). Each subtest produces a standardized score (range: 0-100). Composite score is the sum of all subtests (range: 0-500). Higher scores indicate better cognitive performance. Baseline scores reflect initial neurocognitive status. WINSCAT assesses attention, memory, visual processing, and executive function.
Measured: Baseline (Day 1)
Mean Score of Neurocognitive Performance (WINSCAT Composite)
The WINSCAT battery includes 5 subtests: Code Substitution (CDS), Code Substitution Delayed Recognition (CDD), Delayed Matching to Sample (MSP), Mathematical Processing (MTH), and Running Memory Continuous Performance (CPT). Each subtest produces a standardized score (range: 0-100). Composite score is the sum of all subtests (range: 0-500). Higher scores indicate better cognitive performance. This measure reflects post-treatment neurocognitive status following rTMS. Scores are compared to baseline to assess improvement. WINSCAT evaluates attention, memory, visual processing, and executive function.
Measured: Post-treatment (within 1 week of completing rTMS)
Mean Score of Neurocognitive Performance (WINSCAT Composite)
The WINSCAT battery includes 5 subtests: Code Substitution (CDS), Code Substitution Delayed Recognition (CDD), Delayed Matching to Sample (MSP), Mathematical Processing (MTH), and Running Memory Continuous Performance (CPT). Each subtest produces a standardized score (range: 0-100). Composite score is the sum of all subtests (range: 0-500). Higher scores indicate better cognitive performance. This measure reflects neurocognitive status 1 month after rTMS treatment. Scores are compared to baseline and 1-week post-treatment to assess sustained or enhanced cognitive improvement. WINSCAT evaluates attention, memory, visual processing, and executive function.
Measured: Post-treatment (within 1 month of completing rTMS)
Mean Score of Neurocognitive Performance (Stress Total Score)
is a 99-item self-report questionnaire assessing emotional and psychological symptoms across 18 subscales. For this outcome, a subset of items was used to assess stress resilience, likely drawn from the Well-Being or related subscales.
Each item is rated on a 5-point Likert scale from 1 ("Not at all") to 5 ("Extremely"). Scores were summed across selected items.
Minimum possible score: 0 Maximum possible score: 15 Lower scores indicate greater resilience and better emotional functioning. Higher scores indicate greater symptom severity and worse outcomes.
Measured: Baseline (Day 1)
Mean Score of Neurocognitive Performance (Stress Total Score)
is a 99-item self-report questionnaire assessing emotional and psychological symptoms across 18 subscales. For this outcome, a subset of items was used to assess stress resilience, likely drawn from the Well-Being or related subscales.
Each item is rated on a 5-point Likert scale from 1 ("Not at all") to 5 ("Extremely"). Scores were summed across selected items.
Minimum possible score: 0 Maximum possible score: 15 Lower scores indicate greater resilience and better emotional functioning. Higher scores indicate greater symptom severity and worse outcomes.
Measured: Post-treatment (within 1 week of completing rTMS)
Mean Score of Neurocognitive Performance (Stress Total Score)
is a 99-item self-report questionnaire assessing emotional and psychological symptoms across 18 subscales. For this outcome, a subset of items was used to assess stress resilience, likely drawn from the Well-Being or related subscales.
Each item is rated on a 5-point Likert scale from 1 ("Not at all") to 5 ("Extremely"). Scores were summed across selected items.
Minimum possible score: 0 Maximum possible score: 15 Lower scores indicate greater resilience and better emotional functioning. Higher scores indicate greater symptom severity and worse outcomes.
Measured: Post-treatment (within 1 month of completing rTMS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start21 Nov 2019
- Primary completion27 Sep 2021
- Study completion27 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CognitionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Aeronautics and Space Administration (NASA), The Translational Research Institute for Space Health (TRISH)
- Responsible party
- Sponsor
- Investigators
- Donna Roberts, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123496
- Sponsor's protocol ID
- 00084982
- Status last verified
- Sep 2025
- First submitted
- 9 Oct 2019
- Last updated
- 16 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04123496
- Acronym / sponsor ID
- 00084982
- Conditions
- Cognition, Stress Reaction
- Keywords
- cognition, adult, prefrontal cortex, Transcranial Magnetic Stimulation, Stress, Psychological, memory, attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Aeronautics and Space Administration (NASA), The Translational Research Institute for Space Health (TRISH)
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 11 Oct 2019 (actual)
- Results
- Posted 16 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Device: rTMSAll 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. |
| Dose 2 | Experimental | Device: rTMSAll 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. |
| Dose 3 | Experimental | Device: rTMSAll 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. |
| Dose 4 | Experimental | Device: rTMSAll 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. |
| Dose 5 | Experimental | Device: rTMSAll 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. |
| Dose 6 | Experimental | Device: rTMSAll 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. |
| Dose 7 | Experimental | Device: rTMSAll 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. |
| Dose 8 | Experimental | Device: rTMSAll 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. |
| Dose 9 | Experimental | Device: rTMSAll 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. |
| Dose 10 | Experimental | Device: rTMSAll 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. |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMSDevice: 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. | Device | Dose 1, Dose 10, Dose 2, Dose 3, Dose 4, Dose 5, Dose 6, Dose 7, Dose 8, Dose 9 |
Primary outcome
Mean Score of Neurocognitive Performance (Fluid Cognition)
Time frame: Baseline (Day 1)
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.
Change From Baseline in Neurocognitive Performance at 1 Week Post Treatment (Fluid Cognition)
Time frame: Post-treatment (within 1 week of completing rTMS)
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.
Change From Baseline in Neurocognitive Performance at 1 Month Post Treatment (Fluid Cognition)
Time frame: Post-treatment (within 1 month of completing rTMS)
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.
15 secondary outcomes
Mean Score of Stress Resilience as Assessed by Connor Davidson Resilience Scale
Time frame: Baseline (Day 1)
Mean Score of Stress Resilience as Assessed by Perceived Stress Scale-10
Time frame: Baseline (Day 1)
Mean Score of Stress Resilience as Assessed by Inventory of Depression and Anxiety Symptoms-II
Time frame: Baseline (Day 1)
Mean Score of Stress Resilience as Assessed by Connor Davidson Resilience Scale
Time frame: Post-treatment (within 1 week of completing rTMS)
Mean Score of Stress Resilience as Assessed by Perceived Stress Scale-10
Time frame: Post-treatment (within 1 week of completing rTMS)
Mean Score of Stress Resilience as Assessed by Inventory of Depression and Anxiety Symptoms-II
Time frame: Post-treatment (within 1 week of completing rTMS)
Mean Score of Stress Resilience as Assessed by Connor Davidson Resilience Scale
Time frame: Post-treatment (within 1 month of completing rTMS)
Mean Score of Stress Resilience as Assessed by Perceived Stress Scale-10
Time frame: Post-treatment (within 1 month of completing rTMS)
Mean Score of Stress Resilience as Assessed by Inventory of Depression and Anxiety Symptoms-II
Time frame: Post-treatment (within 1 month of completing rTMS)
Mean Score of Neurocognitive Performance (WINSCAT Composite)
Time frame: Baseline (Day 1)
Mean Score of Neurocognitive Performance (WINSCAT Composite)
Time frame: Post-treatment (within 1 week of completing rTMS)
Mean Score of Neurocognitive Performance (WINSCAT Composite)
Time frame: Post-treatment (within 1 month of completing rTMS)
Mean Score of Neurocognitive Performance (Stress Total Score)
Time frame: Baseline (Day 1)
Mean Score of Neurocognitive Performance (Stress Total Score)
Time frame: Post-treatment (within 1 week of completing rTMS)
Mean Score of Neurocognitive Performance (Stress Total Score)
Time frame: Post-treatment (within 1 month of completing rTMS)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cognition
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Recruiting
Neurobehavioral Changes Following Spaceflight Stressors
Stressor, Individual, Alcohol Impairment
RecruitingPhase 4
Testing Healthy Participants for Drowsiness After Single Dosing of Two Different Doses of Muscle Relaxer
Healthy Participants
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Roberts, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Cognition and Stress Reaction, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Score of Neurocognitive Performance (Fluid Cognition) (time frame: Baseline (Day 1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.