Medical University of South Carolina
Charleston, South Carolina, 29401-5799, United States
NCT Number: NCT04123496
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).
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Notify Me22 year–55 year
All sexes
Interventional
Not applicable
Charleston, South Carolina, 29401-5799, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Time frame: Baseline (Day 1)
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)
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)
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: Post-treatment (within 1 week of completing rTMS)
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)
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)
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)
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)
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)
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: Baseline (Day 1)
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: Post-treatment (within 1 week of completing rTMS)
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 month of completing rTMS)
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: Baseline (Day 1)
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)
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)
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.
Medical University of South Carolina
Other
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
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