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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
38
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.
Medical University of South Carolina
Charleston, South Carolina, United States
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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Post-treatment (within 1 month of completing rTMS)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Post-treatment (within 1 month of completing rTMS)