Trial Outcomes & Findings for Transmagnetic Stimulation Pilot in Early Stage Alzheimer's Disease (NCT NCT05292222)
NCT ID: NCT05292222
Last Updated: 2025-01-07
Results Overview
Assessed by calculating the difference and standard deviation between follow-up and baseline of number of abnormal connections of the TGd parcellation. Range: 0-378. There are 378 possible connections of the parcellation. Higher values indicate more abnormal connections of the TGd parcellation pre and post-treatment. The change in the number of abnormal connections of the parcellation is reported.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
9 weeks
Results posted on
2025-01-07
Participant Flow
4 participants screen failed with a low MMSE, 1 participant withdrew before receiving any treatment.
Participant milestones
| Measure |
Intermittent Theta Burst Stimulation
All subjects will receive treatment with intermittent theta burst stimulation (iTBS). There will be a total of 5 treatments over a 2-week period. All subjects will receive iTBS to the right TGd region. TBS treatment will also be provided for two additional sites within the large-scale brain networks (LSBNs) that is found to contain the greatest number of connectivity anomalies. Total participation will be 10-12 weeks.
Intermittent theta burst stimulation: MagVenture TMS Therapy with theta burst stimulation. Resting motor threshold: 80%; Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz
|
|---|---|
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Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transmagnetic Stimulation Pilot in Early Stage Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Intermittent Theta Burst Stimulation
n=10 Participants
All subjects will receive treatment with intermittent theta burst stimulation (iTBS). There will be a total of 5 treatments over a 2-week period. All subjects will receive iTBS to the right TGd region. TBS treatment will also be provided for two additional sites within the large-scale brain networks (LSBNs) that is found to contain the greatest number of connectivity anomalies. Total participation will be 10-12 weeks.
Intermittent theta burst stimulation: MagVenture TMS Therapy with theta burst stimulation. Resting motor threshold: 80%; Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz
|
|---|---|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Mini Mental Status Examination (MMSE)
|
26.3 units on a scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Clinical Dementia Rating (CDR) Scale
|
0.5 units on a scale
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Education Level
Bachelors/Associates
|
6 Participants
n=5 Participants
|
|
Education Level
Masters/PhD
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 weeksAssessed by calculating the difference and standard deviation between follow-up and baseline of number of abnormal connections of the TGd parcellation. Range: 0-378. There are 378 possible connections of the parcellation. Higher values indicate more abnormal connections of the TGd parcellation pre and post-treatment. The change in the number of abnormal connections of the parcellation is reported.
Outcome measures
| Measure |
Intermittent Theta Burst Stimulation
n=10 Participants
All subjects will receive treatment with intermittent theta burst stimulation (iTBS). There will be a total of 5 treatments over a 2-week period. All subjects will receive iTBS to the right TGd region. TBS treatment will also be provided for two additional sites within the large-scale brain networks (LSBNs) that is found to contain the greatest number of connectivity anomalies. Total participation will be 10-12 weeks.
Intermittent theta burst stimulation: MagVenture TMS Therapy with theta burst stimulation. Resting motor threshold: 80%; Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz
|
|---|---|
|
Change in Connectivity Measure of the TGd Parcellations.
|
0.5 abnormal connections
Standard Deviation 25
|
Adverse Events
Intermittent Theta Burst Stimulation
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intermittent Theta Burst Stimulation
n=10 participants at risk
All subjects will receive treatment with intermittent theta burst stimulation (iTBS). There will be a total of 5 treatments over a 2-week period. All subjects will receive iTBS to the right TGd region. TBS treatment will also be provided for two additional sites within the large-scale brain networks (LSBNs) that is found to contain the greatest number of connectivity anomalies. Total participation will be 10-12 weeks.
Intermittent theta burst stimulation: MagVenture TMS Therapy with theta burst stimulation. Resting motor threshold: 80%; Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Facial or jaw twitching at RTGd site
|
100.0%
10/10 • 9 weeks
|
|
General disorders
Headache
|
10.0%
1/10 • 9 weeks
|
|
Eye disorders
tearing of the eye
|
10.0%
1/10 • 9 weeks
|
|
Musculoskeletal and connective tissue disorders
facial twitching at other sites
|
20.0%
2/10 • 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Scalp pain
|
10.0%
1/10 • 9 weeks
|
|
General disorders
Altered consciousness
|
10.0%
1/10 • 9 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place