Treating Intention In Aphasia: Neuroplastic Substrates
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine if an "intentional act" improves treatment response for patients with nonfluent aphasia. The treatment involves naming pictures and saying members of categories. The "intentional act" requires initiating picture naming or category member trials with a left-hand movement sequence. Nonfluent aphasia is a disorder of language production in which patients with damage to the brain's language system have trouble initiating and maintaining spoken communication. All patients participating in the study take part in functional MRI scans to determine how treatments affect brain systems.
| Condition | Intervention | Phase |
|---|---|---|
|
Aphasia Cerebrovascular Accident |
Behavioral: Word-finding with intention component Behavioral: Word-finding with no intention component |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Treating Intention In Aphasia: Neuroplastic Substrates |
- Lateralization of Frontal Lobe (and Posterior Perisylvian) Activity During Word Production [ Time Frame: immediately post-treatment scan minus pre-treatment baseline scan ] [ Designated as safety issue: No ]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.
- Picture Naming Probe Scores (% Accuracy) [ Time Frame: trend for time series of 8 baseline + 30 treatment sessions ] [ Designated as safety issue: No ]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.
- Category Member Generation Probe Scores (% Accuracy) [ Time Frame: trend for time series of 8 baseline + 30 treatment sessions ] [ Designated as safety issue: No ]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.
| Enrollment: | 14 |
| Study Start Date: | March 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Word-finding with intention component
Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
|
Behavioral: Word-finding with intention component
Word-finding trials (picture-naming) with intention manipulation (initiating word-finding trials with a complex left-hand movement). 8 (or more) baseline sessions over 4 days followed by 30 treatment sessions (2 sessions/day, 5 days/week for 3 weeks).
Other Name: Intention Treatment
|
|
Active Comparator: Word-finding with no intention component
Word-finding trials similar to intention mediated treatment, but without intention manipulation
|
Behavioral: Word-finding with no intention component
Word-finding trials with no intention manipulation. 8 (or more) baseline sessions in 4 days followed by 30 treatment sessions (2 sessions/day, 5 days/week for 3 weeks).
Other Name: Control Treatment
|
Detailed Description:
A new treatment manipulating intention substrates for language production in "nonfluent" aphasia patients was developed. The intention component involves initiating word-finding trials with a complex left-hand movement. The study addresses (1) whether or not the intention manipulation (complex left-hand movement) makes a unique contribution to treatment outcome and (2) whether or not the intention manipulation helps to shift word production mechanisms from the left to the right frontal lobe. All study participants take part in functional magnetic resonance imaging (fMRI) scans of word-finding before and after treatment and at 3-month follow-up to measure changes in lateralization of frontal lobe activity during word finding. Only patients with a substantial degree of left frontal activity on the pre-treatment fMRI scan can participate. There are three specific aims: (1) to determine if repetitive initiation of word production with a complex left-hand movement leads to increased right-hemisphere lateralization of frontal activity and if these changes can be attributed to the intention component of treatment, (2) to determine whether activity in posterior perisylvian cortices that is entrained to right frontal activity shows a greater increase in right-hemisphere lateralization from pre- to post-treatment fMRI when the intention component is included in treatment, and (3) to determine whether onset of hemodynamic responses (HDRs) in right motor/premotor cortex becomes more closely associated with the temporal onset of participants' spoken responses across treatment when the intention component is included in treatment. If successful, the treatment can provide a new treatment vehicle for increasing language function in patients with "nonfluent" aphasia.
Eligibility| Ages Eligible for Study: | 21 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Nonfluent aphasia caused by stroke
- Moderate to severe word-finding problems
- 6 or more months post stroke
- Right handed prior to stroke
- All strokes in left hemisphere
- Native English speaker
- Capable of following verbal directions
Exclusion Criteria:
- Severe impairment of word comprehension
- Brain injury or disease in addition to stroke
- Drug or alcohol abuse within past 6 months
- Schizophrenia or other psychiatric disorder necessitating hospitalization
- History of learning disability
- Claustrophobia
- Cardiac pace-maker
- Ferrous metal implants not attached to bone, metal fragments in body
- Profound hearing loss
Contacts and Locations| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| University of Florida/Shands Hospital | |
| Jacksonville, Florida, United States, 32209 | |
| Brooks Center for Rehabilitation Studies | |
| Jacksonville, Florida, United States, 32216 | |
| Principal Investigator: | Bruce Crosson, PhD | University of Florida |
More Information
Additional Information:
Publications:
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT00567242 History of Changes |
| Other Study ID Numbers: | R01DC007387-01A1, R01DC007387 |
| Study First Received: | November 30, 2007 |
| Results First Received: | March 6, 2012 |
| Last Updated: | April 30, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Florida:
|
aphasia therapies, investigational rehabilitation of speech and language disorders magnetic resonance imaging, functional language |
Additional relevant MeSH terms:
|
Aphasia Cerebral Infarction Stroke Speech Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013