Trial Outcomes & Findings for Transmagnetic Stimulation Pilot in Primary Progressive Aphasia (NCT NCT05860647)
NCT ID: NCT05860647
Last Updated: 2025-06-03
Results Overview
The difference and corresponding 95% confidence interval between follow-up and baseline connectivity measures of the TGd parcellations. Range: -1 to 1. Positive values indicate areas where connectivity is higher than healthy controls from the Human Connectome Project.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
6 weeks
Results posted on
2025-06-03
Participant Flow
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 8-10 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
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transmagnetic Stimulation Pilot in Primary Progressive Aphasia
Baseline characteristics by cohort
| Measure |
Intermittent Theta Burst Stimulation
n=3 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 8-10 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, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 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
|
3 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 State Examination (MMSE)
|
25.3 units on a scale
STANDARD_DEVIATION 3.21 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe difference and corresponding 95% confidence interval between follow-up and baseline connectivity measures of the TGd parcellations. Range: -1 to 1. Positive values indicate areas where connectivity is higher than healthy controls from the Human Connectome Project.
Outcome measures
| Measure |
Intermittent Theta Burst Stimulation
n=3 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 8-10 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
|
|---|---|
|
Connectivity Measures of the Left TGd, 55b, and STV Parcellations at Baseline and Post-treatment
L55b
|
-.06 correlation
Interval -0.07 to -0.04
|
|
Connectivity Measures of the Left TGd, 55b, and STV Parcellations at Baseline and Post-treatment
LTgD
|
.03 correlation
Interval 0.02 to 0.05
|
|
Connectivity Measures of the Left TGd, 55b, and STV Parcellations at Baseline and Post-treatment
LSTV
|
-.01 correlation
Interval -0.02 to 0.01
|
POST_HOC outcome
Timeframe: 6 weeksAssessed by calculating the difference and standard deviation between follow-up and baseline of number of abnormal connections of the parcellations. Range: 0-378. There are 378 possible connections of the parcellation. Higher values indicate more abnormal connections of the 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=3 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 8-10 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 Abnormal Connections of Parcellations
L55b
|
7 abnormal connections
Standard Deviation 13.7
|
|
Change in Abnormal Connections of Parcellations
LTgD
|
2 abnormal connections
Standard Deviation 7
|
|
Change in Abnormal Connections of Parcellations
LSTV
|
3.6 abnormal connections
Standard Deviation 10.7
|
Adverse Events
Intermittent Theta Burst Stimulation
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intermittent Theta Burst Stimulation
n=3 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 8-10 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 Twitching
|
100.0%
3/3 • Number of events 97 • 1 month
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Number of events 2 • 1 month
|
Additional Information
Bhavani Kashyap, MBBS, PhD
HealthPartners Institute Neuroscience Research Center
Phone: 651-495-6565
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place