Trial Outcomes & Findings for Plasticity Using Stimulation and Habit: A Pilot Open-label rTMS Study for MCI (NCT NCT04503096)
NCT ID: NCT04503096
Last Updated: 2023-09-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Baseline prior to treatment and at follow-up within 1 week post-treatment
Results posted on
2023-09-07
Participant Flow
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.
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.
Participant milestones
| Measure |
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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|---|---|
|
Overall Study
STARTED
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24
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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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|---|---|
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Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
This includes only participants with both pre- and post-treatment data.
Baseline characteristics by cohort
| Measure |
High-dose Accelerated rTMS
n=24 Participants
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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|---|---|
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Age, Continuous
|
74.1 years
STANDARD_DEVIATION 5.71 • n=24 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=24 Participants
|
|
Montreal Cognitive Assessment (MoCA)
|
-1.25 Z-score
STANDARD_DEVIATION 1.38 • n=21 Participants • This includes only participants with both pre- and post-treatment data.
|
|
Hamilton Depression Rating Scale (HAM-D)
|
.24 scores on a scale
STANDARD_DEVIATION .77 • n=21 Participants • This includes only participants with both pre- and post-treatment data.
|
|
Geriatric Depression Scale (GDS)
|
4.55 scores on a scale
STANDARD_DEVIATION 3.14 • n=20 Participants • This includes only participants with both pre- and post-treatment data.
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|
Fluid Cognition Composite
|
40.25 T-score
STANDARD_DEVIATION 8.07 • n=21 Participants • This includes only participants with both pre- and post-treatment data.
|
PRIMARY outcome
Timeframe: Baseline prior to treatment and at follow-up within 1 week post-treatmentPopulation: Participants who completed both the pre- and post-treatment assessments were included in this analysis.
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.
Outcome measures
| Measure |
High-dose Accelerated rTMS
n=21 Participants
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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|---|---|
|
Number of Participants With Clinically Significant Structural Brain Change on T1- and T2-weighted Magnetic Resonance Imaging (MRI)
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline prior to treatment and at follow-up within 1 week post-treatmentPopulation: Participants who completed both the pre- and post-treatment assessments were included in this analysis.
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.
Outcome measures
| Measure |
High-dose Accelerated rTMS
n=21 Participants
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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|---|---|
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Change From Baseline Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA)
|
-1.20 Z-score
Standard Deviation 1.18
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PRIMARY outcome
Timeframe: Baseline prior to treatment and at follow-up within 1 week post-treatmentPopulation: Participants who completed both the pre- and post-treatment assessments were included in this analysis.
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).
Outcome measures
| Measure |
High-dose Accelerated rTMS
n=21 Participants
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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|---|---|
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Change in the Review of Systems Criteria Compared to Baseline
Headache: Treatment day 1 (Baseline) · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Headache: Treatment day 1 (Baseline) · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Headache: Treatment day 1 (Baseline) · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Headache: Post-Treatment · Minimal/none (0-1)
|
20 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Headache: Post-Treatment · Mild/moderate (2-3)
|
1 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Headache: Post-Treatment · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Scalp pain: Treatment day 1 (Baseline) · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Scalp pain: Treatment day 1 (Baseline) · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Scalp pain: Treatment day 1 (Baseline) · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Scalp pain: Post-Treatment · Minimal/none (0-1)
|
19 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Scalp pain: Post-Treatment · Mild/moderate (2-3)
|
2 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Scalp pain: Post-Treatment · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Arm/hand pain: Treatment day 1 (Baseline) · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Arm/hand pain: Treatment day 1 (Baseline) · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Arm/hand pain: Treatment day 1 (Baseline) · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Arm/hand pain: Post-Treatment · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Arm/hand pain: Post-Treatment · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Arm/hand pain: Post-Treatment · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Other pain: Treatment day 1 (Baseline) · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Other pain: Treatment day 1 (Baseline) · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Other pain: Treatment day 1 (Baseline) · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Other pain: Post-Treatment · Minimal/none (0-1)
|
20 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Other pain: Post-Treatment · Mild/moderate (2-3)
|
1 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Other pain: Post-Treatment · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Weakness: Treatment day 1 (Baseline) · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Weakness: Treatment day 1 (Baseline) · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Weakness: Treatment day 1 (Baseline) · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Weakness: Post-Treatment · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Weakness: Post-Treatment · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Weakness: Post-Treatment · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Loss of dexterity: Treatment day 1 (Baseline) · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Loss of dexterity: Treatment day 1 (Baseline) · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Loss of dexterity: Treatment day 1 (Baseline) · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Loss of dexterity: Post-Treatment · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Loss of dexterity: Post-Treatment · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Loss of dexterity: Post-Treatment · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Vision changes: Treatment day 1 (Baseline) · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Vision changes: Treatment day 1 (Baseline) · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Vision changes: Treatment day 1 (Baseline) · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Vision changes: Post-Treatment · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Vision changes: Post-Treatment · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Vision changes: Post-Treatment · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Hearing changes: Treatment day 1 (Baseline) · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Hearing changes: Treatment day 1 (Baseline) · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Hearing changes: Treatment day 1 (Baseline) · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Hearing changes: Post-Treatment · Minimal/none (0-1)
|
19 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Hearing changes: Post-Treatment · Mild/moderate (2-3)
|
2 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Hearing changes: Post-Treatment · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Ear ringing: Treatment day 1 (Baseline) · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Ear ringing: Treatment day 1 (Baseline) · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Ear ringing: Treatment day 1 (Baseline) · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Ear ringing: Post-Treatment · Minimal/none (0-1)
|
20 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Ear ringing: Post-Treatment · Mild/moderate (2-3)
|
1 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Ear ringing: Post-Treatment · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Nausea/Vomiting: Treatment day 1 (Baseline) · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Nausea/Vomiting: Treatment day 1 (Baseline) · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Nausea/Vomiting: Treatment day 1 (Baseline) · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Nausea/Vomiting: Post-Treatment · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Nausea/Vomiting: Post-Treatment · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Nausea/Vomiting: Post-Treatment · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Appetite loss: Treatment day 1 (Baseline) · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Appetite loss: Treatment day 1 (Baseline) · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Appetite loss: Treatment day 1 (Baseline) · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Appetite loss: Post-Treatment · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Appetite loss: Post-Treatment · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Appetite loss: Post-Treatment · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Rash: Treatment day 1 (Baseline) · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Rash: Treatment day 1 (Baseline) · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Rash: Treatment day 1 (Baseline) · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Rash: Post-Treatment · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Rash: Post-Treatment · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Rash: Post-Treatment · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Skin changes: Treatment day 1 (Baseline) · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Skin changes: Treatment day 1 (Baseline) · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Skin changes: Treatment day 1 (Baseline) · Marked/severe (4-5)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Skin changes: Post-Treatment · Minimal/none (0-1)
|
21 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Skin changes: Post-Treatment · Mild/moderate (2-3)
|
0 Participants
|
|
Change in the Review of Systems Criteria Compared to Baseline
Skin changes: Post-Treatment · Marked/severe (4-5)
|
0 Participants
|
PRIMARY outcome
Timeframe: Administered at post-treatmentPopulation: Participants who completed both the pre- and post-treatment assessments were included in this analysis.
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.
Outcome measures
| Measure |
High-dose Accelerated rTMS
n=21 Participants
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.
|
|---|---|
|
Patient Perception of Treatment Acceptability
"It was hard to stay awake during the rTMS sessions."
|
1 score on a scale
Interval 1.0 to 1.0
|
|
Patient Perception of Treatment Acceptability
"I was motivated to attend the rTMS sessions."
|
5 score on a scale
Interval 4.0 to 5.0
|
|
Patient Perception of Treatment Acceptability
"I was committed to completing the treatment course."
|
5 score on a scale
Interval 5.0 to 5.0
|
|
Patient Perception of Treatment Acceptability
"I was interested in the rTMS techniques and learning about them."
|
5 score on a scale
Interval 5.0 to 5.0
|
|
Patient Perception of Treatment Acceptability
"I understand the purpose of the treatment and how it could help my symptoms."
|
5 score on a scale
Interval 5.0 to 5.0
|
|
Patient Perception of Treatment Acceptability
"I would be open to completing another course of rTMS treatment in the future, if needed."
|
5 score on a scale
Interval 5.0 to 5.0
|
|
Patient Perception of Treatment Acceptability
"The rTMS treatment helped improve my ability to cope with daily challenges."
|
3 score on a scale
Interval 2.0 to 4.0
|
|
Patient Perception of Treatment Acceptability
Paraphrased: Condensed treatment was preferable to conventional treatment course
|
5 score on a scale
Interval 5.0 to 5.0
|
|
Patient Perception of Treatment Acceptability
"The staff members were attentive and sensitive to my needs during treatment."
|
5 score on a scale
Interval 5.0 to 5.0
|
|
Patient Perception of Treatment Acceptability
"The staff members explained all procedures to me and answered my questions."
|
5 score on a scale
Interval 5.0 to 5.0
|
|
Patient Perception of Treatment Acceptability
"There was plenty of flexibility in scheduling rTMS sessions around my other obligations."
|
5 score on a scale
Interval 5.0 to 5.0
|
|
Patient Perception of Treatment Acceptability
"At times I wanted to quit treatment."
|
1 score on a scale
Interval 1.0 to 1.0
|
|
Patient Perception of Treatment Acceptability
"Treatment sessions were stressful."
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Perception of Treatment Acceptability
"I experienced pain and discomfort during treatment that was difficult to tolerate."
|
1 score on a scale
Interval 1.0 to 1.0
|
|
Patient Perception of Treatment Acceptability
"Completing multiple rTMS sessions in each day was at times tiring."
|
1 score on a scale
Interval 1.0 to 2.0
|
PRIMARY outcome
Timeframe: Baseline prior to treatment and at follow-up within 1 week post-treatmentPopulation: All participants who initiated treatment were included in this analysis.
Percentage of participants who completed the study (n=21) relative to all participants who initiated treatment (n=22).
Outcome measures
| Measure |
High-dose Accelerated rTMS
n=22 Participants
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.
|
|---|---|
|
Retention Rate
|
21 Participants
|
SECONDARY outcome
Timeframe: Baseline prior to treatment and at follow-up within 1 week post-treatmentPopulation: Participants who completed both the pre- and post-treatment assessments were included in this analysis.
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.
Outcome measures
| Measure |
High-dose Accelerated rTMS
n=21 Participants
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.
|
|---|---|
|
Change From Baseline Depression, as Measured by the Hamilton Depression Rating Scale (HAM-D)
|
.33 scores on a scale
Standard Deviation .91
|
SECONDARY outcome
Timeframe: Baseline prior to treatment and at follow-up within 1 week post-treatmentPopulation: 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.
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.
Outcome measures
| Measure |
High-dose Accelerated rTMS
n=20 Participants
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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Change From Baseline Depression, as Measured by the Geriatric Depression Scale (GDS)
|
4.65 scores on a scale
Standard Deviation 3.11
|
SECONDARY outcome
Timeframe: Baseline prior to treatment and at follow-up within 1 week post-treatmentPopulation: Participants who completed both the pre- and post-treatment assessments were included in this analysis.
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.
Outcome measures
| Measure |
High-dose Accelerated rTMS
n=21 Participants
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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|---|---|
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Change From Baseline Cognition, as Measured by the Fluid Cognition Composite Score From the NIH Toolbox Cognition Battery
|
43.67 T-score
Standard Deviation 7.85
|
Adverse Events
High-dose Accelerated rTMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Andreana Benitez PhD
Medical University of South Carolina
Phone: (843) 876-8479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place