Trial Outcomes & Findings for Dosage and Predictors of Naming Treatment Response in Aphasia (NCT NCT02005016)
NCT ID: NCT02005016
Last Updated: 2019-11-04
Results Overview
The Philadelphia Naming Test is a performance-based measure commonly used to assess naming (word production) ability among adults with aphasia. Participants are shown 175 pictures of common objects and asked to name each stimulus item within 30 seconds. Score range is from 0 to 175 (number out of 175 items that were correctly named), with higher scores representing better performance. Change in PNT score from entry to exit is the primary study outcome. Mean PNT change score measures treatment-related changes in naming ability.
COMPLETED
NA
46 participants
Baseline (at study entry) to the day after completion of intervention (after 4 weeks of behavioral therapy).
2019-11-04
Participant Flow
Participant milestones
| Measure |
Behavioral Therapy
All study participants will be assigned to this arm of this single-arm study. Participants will receive intensive behavioral therapy intended to improve their naming (word production) ability.
Naming therapy: Participants will receive behavioral therapy which is designed to stimulate semantic (meaning) representations which are required for successful naming (word production). Therapy will be administered for 4 weeks on an intensive schedule (5 days a week, approximately 4.5 hours per day).
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|---|---|
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Overall Study
STARTED
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46
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Overall Study
COMPLETED
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44
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two enrolled participants did not complete the protocol.
Baseline characteristics by cohort
| Measure |
Behavioral Therapy
n=46 Participants
All study participants will be assigned to this arm of this single-arm study. Participants will receive intensive behavioral therapy intended to improve their naming (word production) ability.
Naming therapy: Participants will receive behavioral therapy which is designed to stimulate semantic (meaning) representations which are required for successful naming (word production). Therapy will be administered for 4 weeks on an intensive schedule (5 days a week, approximately 4.5 hours per day).
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=44 Participants • Two enrolled participants did not complete the protocol.
|
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Age, Categorical
Between 18 and 65 years
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22 Participants
n=44 Participants • Two enrolled participants did not complete the protocol.
|
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Age, Categorical
>=65 years
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22 Participants
n=44 Participants • Two enrolled participants did not complete the protocol.
|
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Age, Continuous
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61.56 years
STANDARD_DEVIATION 12.64 • n=46 Participants
|
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Sex: Female, Male
Female
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5 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
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41 Participants
n=46 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=46 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=46 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=46 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=46 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=46 Participants
|
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Region of Enrollment
United States
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46 Participants
n=46 Participants
|
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Philadelphia Naming Test
|
111.96 units on a scale
STANDARD_DEVIATION 39.92 • n=46 Participants
|
PRIMARY outcome
Timeframe: Baseline (at study entry) to the day after completion of intervention (after 4 weeks of behavioral therapy).Population: The PNT was administered at two timepoints for the majority of the sample (32/44). The initial 12 participants received the PNT at study entry and abbreviated forms of the assessment during the protocol and at study exit. These abbreviated forms were found not to be reliable, so the full PNT was administered to remaining participants at exit.
The Philadelphia Naming Test is a performance-based measure commonly used to assess naming (word production) ability among adults with aphasia. Participants are shown 175 pictures of common objects and asked to name each stimulus item within 30 seconds. Score range is from 0 to 175 (number out of 175 items that were correctly named), with higher scores representing better performance. Change in PNT score from entry to exit is the primary study outcome. Mean PNT change score measures treatment-related changes in naming ability.
Outcome measures
| Measure |
Behavioral Therapy
n=32 Participants
All study participants will be assigned to this arm of this single-arm study. Participants will receive intensive behavioral therapy intended to improve their naming (word production) ability.
Naming therapy: Participants will receive behavioral therapy which is designed to stimulate semantic (meaning) representations which are required for successful naming (word production). Therapy will be administered for 4 weeks on an intensive schedule (5 days a week, approximately 4.5 hours per day).
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|---|---|
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Change From Baseline in Philadelphia Naming Test Score
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5.91 score on a scale
Standard Error 1.84
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SECONDARY outcome
Timeframe: Baseline (at study entry) to the day after completion of intervention (after 4 weeks of behavioral therapy).The Comprehensive Aphasia Test (CAT) is a performance-based measure of language processing across multiple language domains commonly used to assess language-processing ability among adults with aphasia. The CAT Modality Mean T-Score represents an measurement of overall language-processing ability (aphasia severity). Scores are on a T-score scale (mean score 50, 2 SD range from 30 to 70), with higher scores representing better performance. Change in CAT score from entry to exit (secondary outcome) measures treatment-related changes in overall aphasia severity.
Outcome measures
| Measure |
Behavioral Therapy
n=44 Participants
All study participants will be assigned to this arm of this single-arm study. Participants will receive intensive behavioral therapy intended to improve their naming (word production) ability.
Naming therapy: Participants will receive behavioral therapy which is designed to stimulate semantic (meaning) representations which are required for successful naming (word production). Therapy will be administered for 4 weeks on an intensive schedule (5 days a week, approximately 4.5 hours per day).
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|---|---|
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Change From Baseline on Comprehensive Aphasia Test Modality Mean T-Score
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0.80 units on a scale
Standard Error 0.17
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Adverse Events
Behavioral Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place