Trial Outcomes & Findings for Effects of rTMS on Brain Activation in Aphasia (NCT NCT03292471)

Last Updated: 2022-12-20

Results Overview

The Philadelphia Naming Test is a performance-based measure commonly used to assess naming (word production) ability among adults with aphasia. The minimum raw score is 0 and the maximum is 175 (higher scores reflect more accurate naming/better naming ability).

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

Pre- to post treatment (an average of 3 weeks), and at 2 month follow-up

Results posted on

2022-12-20

Participant Flow

Prior to group assignment, participants completed the Comprehensive Aphasia Test to determine aphasia severity, as groups were pseudorandomized on this basis (groups were balanced for average aphasia severity). In addition, participants completed an MRI screener and medical records were reviewed to screen for the presence of contraindications to MRI and/or rTMS.

Participant milestones

Participant milestones
Measure	Inhibitory Only Inhibitory 1Hz rTMS was applied continuously for 1200 pulses (20 minutes) 5 days per week across 2 weeks (10 sessions total).	Excitatory Primed The inhibitory sequence (1Hz rTMS was applied continuously for 1200 pulses) was preceded for each session by priming stimulation which consisted of intermittent 6-Hz rTMS applied in 5 second trains with 25 second intervals between trains for a total 600 pulses (10 minutes).
Overall Study STARTED	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of rTMS on Brain Activation in Aphasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inhibitory Only n=8 Participants Inhibitory 1Hz rTMS was applied continuously for 1200 pulses (20 minutes) 5 days per week across 2 weeks (10 sessions total).	Excitatory Primed n=8 Participants The inhibitory sequence (1Hz rTMS was applied continuously for 1200 pulses) was preceded for each session by priming stimulation which will consist of intermittent 6-Hz rTMS applied in 5 second trains with 25 second intervals between trains for a total 600 pulses (10 minutes).	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Aphasia Severity (Comprehensive Aphasia Severity Mean Modality T-Score)	53.56 T-Score STANDARD_DEVIATION 5.25 • n=5 Participants	53.86 T-Score STANDARD_DEVIATION 4.29 • n=7 Participants	53.64 T-Score STANDARD_DEVIATION 4.67 • n=5 Participants

PRIMARY outcome

Timeframe: Pre- to post treatment (an average of 3 weeks), and at 2 month follow-up

Population: 5 participants in each group were able to return for 2-month follow up testing

Outcome measures

Outcome measures
Measure	Inhibitory Only n=8 Participants Inhibitory 1Hz rTMS was applied continuously for 1200 pulses (20 minutes) 5 days per week across 2 weeks (10 sessions total).	Excitatory Primed n=8 Participants The inhibitory sequence (1Hz rTMS was applied continuously for 1200 pulses) was preceded for each session by priming stimulation which will consist of intermittent 6-Hz rTMS applied in 5 second trains with 25 second intervals between trains for a total 600 pulses (10 minutes).
Change in Philadelphia Naming Test (PNT) Performance Pre-treatment	122.125 Score on a scale Standard Deviation 27.18	130.875 Score on a scale Standard Deviation 22.86
Change in Philadelphia Naming Test (PNT) Performance Post-treatment	132.5 Score on a scale Standard Deviation 28.65	142.125 Score on a scale Standard Deviation 16.71
Change in Philadelphia Naming Test (PNT) Performance Follow-up	115.6 Score on a scale Standard Deviation 21.85	133.6 Score on a scale Standard Deviation 26.84

SECONDARY outcome

Timeframe: Pre- to post treatment (an average of 3 weeks), and at 2 month follow-up

Population: 5 participants in each group were able to return for follow-up testing

The Comprehensive Aphasia Test is a performance-based measure of language processing across multiple language domains commonly used to assess language-processing ability among adults with aphasia. CAT mean modality T-Score (average of all language subscale T-scores of the Comprehensive Aphasia Test) is a measure of overall aphasia severity. A T-score of 50 reflects mean performance for the CAT normative sample of individuals with aphasia, with a standard deviation of 10 (higher scores reflect better performance/less severe aphasia).

Outcome measures

Outcome measures
Measure	Inhibitory Only n=8 Participants Inhibitory 1Hz rTMS was applied continuously for 1200 pulses (20 minutes) 5 days per week across 2 weeks (10 sessions total).	Excitatory Primed n=8 Participants The inhibitory sequence (1Hz rTMS was applied continuously for 1200 pulses) was preceded for each session by priming stimulation which will consist of intermittent 6-Hz rTMS applied in 5 second trains with 25 second intervals between trains for a total 600 pulses (10 minutes).
Change in Comprehensive Aphasia Test (CAT) Performance Post-treatment	54.54 T-Score Standard Deviation 5.45	55.71 T-Score Standard Deviation 4.59
Change in Comprehensive Aphasia Test (CAT) Performance Pre-treatment	53.56 T-Score Standard Deviation 5.25	53.875 T-Score Standard Deviation 4.29
Change in Comprehensive Aphasia Test (CAT) Performance Follow-up	52.5 T-Score Standard Deviation 4.04	56.7 T-Score Standard Deviation 5.3

Adverse Events

Inhibitory Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Excitatory Primed

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Inhibitory Only n=8 participants at risk Inhibitory 1Hz rTMS was applied continuously for 1200 pulses (20 minutes) 5 days per week across 2 weeks (10 sessions total).	Excitatory Primed n=8 participants at risk The inhibitory sequence (1Hz rTMS was applied continuously for 1200 pulses) was preceded for each session by priming stimulation which consisted of intermittent 6-Hz rTMS applied in 5 second trains with 25 second intervals between trains for a total 600 pulses (10 minutes).
General disorders Mild Headache	0.00% 0/8 • Approximately 3 months An adverse event reporting form was completed at each assessment and treatment visit	12.5% 1/8 • Number of events 3 • Approximately 3 months An adverse event reporting form was completed at each assessment and treatment visit

Additional Information

Dr. Michelle Gravier

VA Pittsburgh/California State University, East Bay

Phone: 510 885-3215

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place