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| Name | Class |
|---|---|
| National Center of Neuromodulation for Rehabilitation | OTHER |
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The goal of this pilot study is to determine whether a high-dose form of non-invasive brain stimulation is a promising and safe treatment for Mild Cognitive Impairment (MCI). Transcranial magnetic stimulation (TMS) is an FDA approved treatment for depression. In studies of TMS for depression and other disorders, individuals have experienced improved cognitive function. Thus, the current study is testing whether TMS is safe, feasible and effective in improving cognition in individuals with MCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose accelerated rTMS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dose accelerated rTMS | Device | A MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System will be utilized. All participants will receive open-label treatment for approximately eight, 3-minute sessions of intermittent theta burst rTMS on each of three days within an eight-day span. A single session = 600 pulses at 120% resting motor threshold (rMT), intermittent Theta Burst Stimulation (iTBS) triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 s to left dorsolateral prefrontal cortex. Total pulses = 14,400. To enable adherence and retention, the days do not need to be contiguous. Same day sessions will be separated by 10-15 minutes, but more accounting for participant comfort. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Structural Brain Change on T1- and T2-weighted Magnetic Resonance Imaging (MRI) | Clinically significant structural brain change were determined by a board-certified neuroradiologist who reviewed both the pre-treatment and post-treatment structural (T1- and T2-weighted) MRI scans to identify the presence of any changes from pre- to post-treatment based on their clinical read of the images. | Baseline prior to treatment and at follow-up within 1 week post-treatment |
| Change From Baseline Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA) | The MoCA is a psychometrist-administered brief cognitive assessment tool with raw total scores ranging from 0 to 30, with higher values indicating better cognition. For this analysis raw total scores were converted to age- and education-adjusted Z-scores using published norms (Rossetti et al., 2011). Z-scores have a mean of 0 and a standard deviation of 1. Lower scores indicate worse performance. The outcome measure reported below is the mean Z-score score at the 1-week post-treatment assessment. The statistical analysis compares this mean score to the mean score at Baseline. | Baseline prior to treatment and at follow-up within 1 week post-treatment |
| Change in the Review of Systems Criteria Compared to Baseline | A review of systems questionnaire will be administered to rate the subjective symptom (headache, scalp pain, arm/hand pain, other pain(s), numbness/tingling, other sensation(s), weakness, loss of dexterity, vision/hearing change(s), ear ringing, nausea/vomiting, appetite loss, rash, skin change(s) or any other symptom(s)) on a scale of 0 to 5 (none, minimal, mild, moderate, marked, severe). | Baseline prior to treatment and at follow-up within 1 week post-treatment |
| Patient Perception of Treatment Acceptability | A 15-item study-specific questionnaire of rTMS treatment acceptability, with each item rated on a scale from 1 to 5 (1 = not at all, 3 = somewhat, 5 = very much so). Higher scores indicate better acceptability for the first 10 items, lower scores indicate better acceptability for the last 5 items. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Depression, as Measured by the Hamilton Depression Rating Scale (HAM-D) | The Hamilton Depression Rating Scale (Ham-D) is a 17-item interviewer-administered structured questionnaire designed to assess symptoms of depression with scores ranging from 0 to 53, with higher scores indicating more depressive symptoms. The outcome measure reported below is the mean score at the 1-week post-treatment assessment. The statistical analysis compares this mean score to the mean score at Baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreana Benitez, PhD | Medical University of South Carolina | Principal Investigator |
| Lisa McTeague, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38719432 | Derived | Aghamoosa S, Lopez J, Rbeiz K, Fleischmann HH, Horn O, Madden K, Caulfield KA, Antonucci MU, Revuelta G, McTeague LM, Benitez A. A phase I trial of accelerated intermittent theta burst rTMS for amnestic MCI. J Neurol Neurosurg Psychiatry. 2024 Oct 16;95(11):1036-1045. doi: 10.1136/jnnp-2023-332680. |
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Of the 67 participants assessed for eligibility, 10 did not meet inclusion criteria, 15 met exclusion criteria, 17 declined to participate, and 1 was excluded for other reasons. 24 participants were assigned to treatment.
Participants were referred by neurologists and neuropsychologists at MUSC's outpatient memory disorders and neuropsychology clinics. They were recruited between 12/22/2020 and 5/5/2022. The first participant was enrolled on 4/12/2021 and the last participant was enrolled on 6/1/2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | High-dose Accelerated rTMS | High-dose accelerated rTMS: A MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System will be utilized. All participants will receive open-label treatment for approximately eight, 3-minute sessions of intermittent theta burst rTMS on each of three days within an eight-day span. A single session = 600 pulses at 120% rMT, intermittent Theta Burst Stimulation (iTBS) triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 s to left dorsolateral prefrontal cortex. Total pulses = 14,400. To enable adherence and retention, the days do not need to be contiguous. Same day sessions will be separated by 10-15 minutes, but more accounting for participant comfort. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High-dose Accelerated rTMS | High-dose accelerated rTMS: A MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System will be utilized. All participants will receive open-label treatment for approximately eight, 3-minute sessions of intermittent theta burst rTMS on each of three days within an eight-day span. A single session = 600 pulses at 120% rMT, intermittent Theta Burst Stimulation (iTBS) triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 s to left dorsolateral prefrontal cortex. Total pulses = 14,400. To enable adherence and retention, the days do not need to be contiguous. Same day sessions will be separated by 10-15 minutes, but more accounting for participant comfort. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Clinically Significant Structural Brain Change on T1- and T2-weighted Magnetic Resonance Imaging (MRI) | Clinically significant structural brain change were determined by a board-certified neuroradiologist who reviewed both the pre-treatment and post-treatment structural (T1- and T2-weighted) MRI scans to identify the presence of any changes from pre- to post-treatment based on their clinical read of the images. | Participants who completed both the pre- and post-treatment assessments were included in this analysis. | Posted | Count of Participants | Participants | Baseline prior to treatment and at follow-up within 1 week post-treatment |
|
6 weeks
In this study, other (i.e., non-serious) adverse events were defined as those that were 1) unexpected, 2) related or possibly related to study participation, AND 3) serious or more prevalent than expected. This definition was approved by our local Institutional Review Board (IRB).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-dose Accelerated rTMS | High-dose accelerated rTMS: A MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System will be utilized. All participants will receive open-label treatment for approximately eight, 3-minute sessions of intermittent theta burst rTMS on each of three days within an eight-day span. A single session = 600 pulses at 120% rMT, intermittent Theta Burst Stimulation (iTBS) triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 s to left dorsolateral prefrontal cortex. Total pulses = 14,400. To enable adherence and retention, the days do not need to be contiguous. Same day sessions will be separated by 10-15 minutes, but more accounting for participant comfort. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andreana Benitez PhD | Medical University of South Carolina | (843) 876-8479 | benitez@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 28, 2022 | Aug 7, 2023 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 29, 2021 | Aug 7, 2023 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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|
| Administered at post-treatment |
| Retention Rate | Percentage of participants who completed the study (n=21) relative to all participants who initiated treatment (n=22). | Baseline prior to treatment and at follow-up within 1 week post-treatment |
| Baseline prior to treatment and at follow-up within 1 week post-treatment |
| Change From Baseline Depression, as Measured by the Geriatric Depression Scale (GDS) | The Geriatric Depression Scale (GDS) is a 30-item scale that evaluates the severity of depressive symptoms in older adults with scores ranging from 0 to 30, with higher scores indicating more depressive symptoms. The outcome measure reported below is the mean score at the 1-week post-treatment assessment. The statistical analysis compares this mean score to the mean score at Baseline. | Baseline prior to treatment and at follow-up within 1 week post-treatment |
| Change From Baseline Cognition, as Measured by the Fluid Cognition Composite Score From the NIH Toolbox Cognition Battery | Fluid cognition was measured using the iPad-administered NIH Toolbox Cognition Battery (NIHTB-CB). Fluid Cognition Composite scores were calculated by averaging the demographically adjusted (age, education, sex, race/ethnicity; Casaletto et al., 2015) T-scores for 4 NIHTB-CB tests: the flanker inhibitory control, list sorting working memory, pattern comparison processing speed, and dimensional change card sort tests. T-Scores have a mean of 50 and a standard deviation of 10. Lower scores indicate worse performance. The outcome measure reported below is the mean T-score at the 1-week post-treatment assessment. The statistical analysis compares this mean score to the mean score at Baseline. | Baseline prior to treatment and at follow-up within 1 week post-treatment |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Montreal Cognitive Assessment (MoCA) | The MoCA is a psychometrist-administered brief cognitive assessment tool with raw total scores ranging from 0 to 30, with higher values indicating better cognition. For this analysis raw total scores were converted to age- and education-adjusted Z-scores using published norms (Rossetti et al., 2011). Z-scores have a mean of 0 and a standard deviation of 1. Lower scores indicate worse performance. | This includes only participants with both pre- and post-treatment data. | Mean | Standard Deviation | Z-score |
|
| Hamilton Depression Rating Scale (HAM-D) | The Hamilton Depression Rating Scale (Ham-D) is a 17-item interviewer-administered structured questionnaire designed to assess symptoms of depression with scores ranging from 0 to 53, with higher scores indicating more depressive symptoms. | This includes only participants with both pre- and post-treatment data. | Mean | Standard Deviation | scores on a scale |
|
| Geriatric Depression Scale (GDS) | The Geriatric Depression Scale (GDS) is a 30-item scale that evaluates the severity of depressive symptoms in older adults with scores ranging from 0 to 30, with higher scores indicating more depressive symptoms. | This includes only participants with both pre- and post-treatment data. | Mean | Standard Deviation | scores on a scale |
|
| Fluid Cognition Composite | Fluid cognition was measured using the iPad-administered NIH Toolbox Cognition Battery (NIHTB-CB). Fluid Cognition Composite scores were calculated by averaging the demographically adjusted (age, education, sex, race/ethnicity; Casaletto et al., 2015) T-scores for 4 NIHTB-CB tests: flanker inhibitory control, list sorting working memory, pattern comparison processing speed, and dimensional change card sort. T-Scores have a mean of 50 and a standard deviation of 10. Lower scores indicate worse performance. | This includes only participants with both pre- and post-treatment data. | Mean | Standard Deviation | T-score |
|
|
|
| Primary | Change From Baseline Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA) | The MoCA is a psychometrist-administered brief cognitive assessment tool with raw total scores ranging from 0 to 30, with higher values indicating better cognition. For this analysis raw total scores were converted to age- and education-adjusted Z-scores using published norms (Rossetti et al., 2011). Z-scores have a mean of 0 and a standard deviation of 1. Lower scores indicate worse performance. The outcome measure reported below is the mean Z-score score at the 1-week post-treatment assessment. The statistical analysis compares this mean score to the mean score at Baseline. | Participants who completed both the pre- and post-treatment assessments were included in this analysis. | Posted | Mean | Standard Deviation | Z-score | Baseline prior to treatment and at follow-up within 1 week post-treatment |
|
|
|
|
| Primary | Change in the Review of Systems Criteria Compared to Baseline | A review of systems questionnaire will be administered to rate the subjective symptom (headache, scalp pain, arm/hand pain, other pain(s), numbness/tingling, other sensation(s), weakness, loss of dexterity, vision/hearing change(s), ear ringing, nausea/vomiting, appetite loss, rash, skin change(s) or any other symptom(s)) on a scale of 0 to 5 (none, minimal, mild, moderate, marked, severe). | Participants who completed both the pre- and post-treatment assessments were included in this analysis. | Posted | Count of Participants | Participants | Baseline prior to treatment and at follow-up within 1 week post-treatment |
|
|
|
| Primary | Patient Perception of Treatment Acceptability | A 15-item study-specific questionnaire of rTMS treatment acceptability, with each item rated on a scale from 1 to 5 (1 = not at all, 3 = somewhat, 5 = very much so). Higher scores indicate better acceptability for the first 10 items, lower scores indicate better acceptability for the last 5 items. | Participants who completed both the pre- and post-treatment assessments were included in this analysis. | Posted | Median | Inter-Quartile Range | score on a scale | Administered at post-treatment |
|
|
|
| Primary | Retention Rate | Percentage of participants who completed the study (n=21) relative to all participants who initiated treatment (n=22). | All participants who initiated treatment were included in this analysis. | Posted | Count of Participants | Participants | Baseline prior to treatment and at follow-up within 1 week post-treatment |
|
|
|
| Secondary | Change From Baseline Depression, as Measured by the Hamilton Depression Rating Scale (HAM-D) | The Hamilton Depression Rating Scale (Ham-D) is a 17-item interviewer-administered structured questionnaire designed to assess symptoms of depression with scores ranging from 0 to 53, with higher scores indicating more depressive symptoms. The outcome measure reported below is the mean score at the 1-week post-treatment assessment. The statistical analysis compares this mean score to the mean score at Baseline. | Participants who completed both the pre- and post-treatment assessments were included in this analysis. | Posted | Mean | Standard Deviation | scores on a scale | Baseline prior to treatment and at follow-up within 1 week post-treatment |
|
|
|
|
| Secondary | Change From Baseline Depression, as Measured by the Geriatric Depression Scale (GDS) | The Geriatric Depression Scale (GDS) is a 30-item scale that evaluates the severity of depressive symptoms in older adults with scores ranging from 0 to 30, with higher scores indicating more depressive symptoms. The outcome measure reported below is the mean score at the 1-week post-treatment assessment. The statistical analysis compares this mean score to the mean score at Baseline. | Participants who completed both the pre- and post-treatment assessments were included in this analysis. Of the 21 participants who completed treatment, one was missing a GDS score. | Posted | Mean | Standard Deviation | scores on a scale | Baseline prior to treatment and at follow-up within 1 week post-treatment |
|
|
|
|
| Secondary | Change From Baseline Cognition, as Measured by the Fluid Cognition Composite Score From the NIH Toolbox Cognition Battery | Fluid cognition was measured using the iPad-administered NIH Toolbox Cognition Battery (NIHTB-CB). Fluid Cognition Composite scores were calculated by averaging the demographically adjusted (age, education, sex, race/ethnicity; Casaletto et al., 2015) T-scores for 4 NIHTB-CB tests: the flanker inhibitory control, list sorting working memory, pattern comparison processing speed, and dimensional change card sort tests. T-Scores have a mean of 50 and a standard deviation of 10. Lower scores indicate worse performance. The outcome measure reported below is the mean T-score at the 1-week post-treatment assessment. The statistical analysis compares this mean score to the mean score at Baseline. | Participants who completed both the pre- and post-treatment assessments were included in this analysis. | Posted | Mean | Standard Deviation | T-score | Baseline prior to treatment and at follow-up within 1 week post-treatment |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
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| Headache: Post-Treatment |
|
| Scalp pain: Treatment day 1 (Baseline) |
|
| Scalp pain: Post-Treatment |
|
| Arm/hand pain: Treatment day 1 (Baseline) |
|
| Arm/hand pain: Post-Treatment |
|
| Other pain: Treatment day 1 (Baseline) |
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| Other pain: Post-Treatment |
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| Weakness: Treatment day 1 (Baseline) |
|
| Weakness: Post-Treatment |
|
| Loss of dexterity: Treatment day 1 (Baseline) |
|
| Loss of dexterity: Post-Treatment |
|
| Vision changes: Treatment day 1 (Baseline) |
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| Vision changes: Post-Treatment |
|
| Hearing changes: Treatment day 1 (Baseline) |
|
| Hearing changes: Post-Treatment |
|
| Ear ringing: Treatment day 1 (Baseline) |
|
| Ear ringing: Post-Treatment |
|
| Nausea/Vomiting: Treatment day 1 (Baseline) |
|
| Nausea/Vomiting: Post-Treatment |
|
| Appetite loss: Treatment day 1 (Baseline) |
|
| Appetite loss: Post-Treatment |
|
| Rash: Treatment day 1 (Baseline) |
|
| Rash: Post-Treatment |
|
| Skin changes: Treatment day 1 (Baseline) |
|
| Skin changes: Post-Treatment |
|
|
| "I understand the purpose of the treatment and how it could help my symptoms." |
|
| "I would be open to completing another course of rTMS treatment in the future, if needed." |
|
| "The rTMS treatment helped improve my ability to cope with daily challenges." |
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| Paraphrased: Condensed treatment was preferable to conventional treatment course |
|
| "The staff members were attentive and sensitive to my needs during treatment." |
|
| "The staff members explained all procedures to me and answered my questions." |
|
| "There was plenty of flexibility in scheduling rTMS sessions around my other obligations." |
|
| "At times I wanted to quit treatment." |
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| "Treatment sessions were stressful." |
|
| "It was hard to stay awake during the rTMS sessions." |
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| "I experienced pain and discomfort during treatment that was difficult to tolerate." |
|
| "Completing multiple rTMS sessions in each day was at times tiring." |
|