Trial Outcomes & Findings for Transcranial Magnetic Stimulation (TMS) for Primary Progressive Apraxia of Speech (PPAOS) (NCT NCT03028324)

NCT ID: NCT03028324

Last Updated: 2020-05-26

Results Overview

Apraxia of Speech Rating Scale has a total range from 0-64, with lower scores indicating lower impairment and higher scores indicating higher impairment.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 4 participants
• Primary outcome timeframe: Baseline, 4 weeks
• Results posted on: 2020-05-26

Participant Flow

Participant milestones

Measure	Transcranial Magnetic Stimulation (TMS) Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period. Transcranial Magnetic Stimulation (TMS): Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transcranial Magnetic Stimulation (TMS) for Primary Progressive Apraxia of Speech (PPAOS)

Baseline characteristics by cohort

Measure	Transcranial Magnetic Stimulation (TMS) n=4 Participants Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period. Transcranial Magnetic Stimulation (TMS): Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.
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	3 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 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	1 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

PRIMARY outcome

Timeframe: Baseline, 4 weeks

Apraxia of Speech Rating Scale has a total range from 0-64, with lower scores indicating lower impairment and higher scores indicating higher impairment.

Outcome measures

Measure	Transcranial Magnetic Stimulation (TMS) n=4 Participants Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period. Transcranial Magnetic Stimulation (TMS): Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.
Change in Speech Performance	-8.75 score on a scale Standard Deviation 8.06

SECONDARY outcome

Timeframe: Baseline, 4 weeks

Population: The change in motor excitability data is not available due to the fact that post intervention data was not collected.

Motor cortex excitability will be assessed with single-pulse TMS

Outcome measures

Outcome data not reported

Adverse Events

Transcranial Magnetic Stimulation (TMS)

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

Joyce Rios Gomes-Osman

University of Miami

Phone: 305-284-2632

Email: j.gomes@miami.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place