Trial Outcomes & Findings for Treating Intention In Aphasia: Neuroplastic Substrates (NCT NCT00567242)
NCT ID: NCT00567242
Last Updated: 2012-05-03
Results Overview
Functional MRI laterality indices (LIs)were calculated for lateral frontal, medial frontal, and posterior perisylvian cortex regions of interest (ROIs): L=number of active voxels in left hemisphere ROI and R=number of active voxels in right hemisphere ROI using the following formula: (L-R)/(L+R). LIs could vary from -1 (completely right lateralized) to +1 (completely left lateralized). Then, change in LIs was calculated by subtracting the pre-treatment from the post-treatment and 3-mo follow-up LI. It was expected the intention manipulation would show a rightward shift in LI.
COMPLETED
PHASE1/PHASE2
14 participants
immediately post-treatment scan minus pre-treatment baseline scan
2012-05-03
Participant Flow
Subjects were recruited from December 2006 through August 2009. Fourteen subjects with minimally nonfluent aphasia, anomia, and at least some degree of frontal lesion participated in the study.
Prior to trial assignment, subjects underwent a functional MRI scan to determine degree of lateralization of frontal activity during word generation. Subjects with a high degree of right frontal lateralization of activity were excluded. Further, patients whose naming scores indicated that they were no more than minimally anomic were excluded.
Participant milestones
| Measure |
Word-finding With Intention Manipulation
Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
|
Word-finding With no Intention Manipulation
Word-finding trials similar to intention mediated treatment, but without intention manipulation
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treating Intention In Aphasia: Neuroplastic Substrates
Baseline characteristics by cohort
| Measure |
Word-finding With Intention Manipulation
n=7 Participants
Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
|
Word-finding With no Intention Manipulation
n=7 Participants
Word-finding trials similar to intention mediated treatment, but without intention manipulation
|
Total
n=14 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
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age Continuous
|
70.86 years
STANDARD_DEVIATION 12.35 • n=5 Participants
|
63.00 years
STANDARD_DEVIATION 9.22 • n=7 Participants
|
66.93 years
STANDARD_DEVIATION 11.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: immediately post-treatment scan minus pre-treatment baseline scanPopulation: Data for all subjects completing the protocol for their respective arm were analyzed.
Functional MRI laterality indices (LIs)were calculated for lateral frontal, medial frontal, and posterior perisylvian cortex regions of interest (ROIs): L=number of active voxels in left hemisphere ROI and R=number of active voxels in right hemisphere ROI using the following formula: (L-R)/(L+R). LIs could vary from -1 (completely right lateralized) to +1 (completely left lateralized). Then, change in LIs was calculated by subtracting the pre-treatment from the post-treatment and 3-mo follow-up LI. It was expected the intention manipulation would show a rightward shift in LI.
Outcome measures
| Measure |
Word-finding With Intention Manipulation
n=7 Participants
Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
|
Word-finding With no Intention Manipulation
n=7 Participants
Word-finding trials similar to intention mediated treatment, but without intention manipulation
|
|---|---|---|
|
Lateralization of Frontal Lobe (and Posterior Perisylvian) Activity During Word Production
|
-0.2802 laterality index
Standard Deviation 0.1077
|
-0.1832 laterality index
Standard Deviation 0.2768
|
SECONDARY outcome
Timeframe: trend for time series of 8 baseline + 30 treatment sessionsPopulation: Data from all subjects completing their respective arms were analyzed, with the exception that one control subject was eliminated because of an unstable baseline measure.
Improvement for the time series from 8 baseline sessions through 30 treatment sessions for naming probes was computed with the C statistic using Tryon's (1982, 1983) formula for each subject. C statistics were converted to Z scores, using the formula provided by Tryon (1982). Z scores indicated treatment change for each subject, with a positive and significant Z score indicating substantive treatment gains. Z scores were then compared between groups with a t statistic. It was expected that the intention manipulation would lead to greater treatment gains than when it was not used.
Outcome measures
| Measure |
Word-finding With Intention Manipulation
n=7 Participants
Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
|
Word-finding With no Intention Manipulation
n=6 Participants
Word-finding trials similar to intention mediated treatment, but without intention manipulation
|
|---|---|---|
|
Picture Naming Probe Scores (% Accuracy)
|
3.68 Z score
Standard Deviation 1.61
|
3.92 Z score
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: trend for time series of 8 baseline + 30 treatment sessionsPopulation: Data from all subjects completing their respective arms were analyzed, with the exception of one control subject whose baseline was not stable.
Improvement for the time series from 8 baseline sessions through 30 treatment sessions for naming probes was computed with the C statistic using Tryon's (1982, 1983) formula for each subject. C statistics were converted to Z scores, using the formula provided by Tryon (1982). Z scores indicated treatment change for each subject, with a positive and significant Z score indicating substantive treatment gains. Z scores were then compared between groups with a t statistic. It was expected that the intention manipulation would lead to greater treatment gains than when it was not used.
Outcome measures
| Measure |
Word-finding With Intention Manipulation
n=7 Participants
Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
|
Word-finding With no Intention Manipulation
n=6 Participants
Word-finding trials similar to intention mediated treatment, but without intention manipulation
|
|---|---|---|
|
Category Member Generation Probe Scores (% Accuracy)
|
3.50 Z score
Standard Deviation 0.83
|
1.94 Z score
Standard Deviation 1.75
|
Adverse Events
Word-finding With Intention Manipulation
Word-finding With no Intention Manipulation
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