Treating Intention In Aphasia: Neuroplastic Substrates

Phase 1

Completed

Conditions: Aphasia
Cerebrovascular Accident

Interventions: Behavioral: Word-finding with intention component
Behavioral: Word-finding with no intention component

Registration Number: NCT00567242

Lead Sponsor: University of Florida

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 14

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Word-finding with intention component	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)
Word-finding with no intention component	Word-finding with no intention component	Word-finding trials similar to intention mediated treatment, but without intention manipulation

Primary Outcome Measures

Name	Time	Method
Lateralization of Frontal Lobe (and Posterior Perisylvian) Activity During Word Production	immediately post-treatment scan minus pre-treatment baseline scan	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.

Secondary Outcome Measures

Name	Time	Method
Picture Naming Probe Scores (% Accuracy)	trend for time series of 8 baseline + 30 treatment sessions	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)	trend for time series of 8 baseline + 30 treatment sessions	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.

Trial Locations

Locations (3): University of Florida
🇺🇸
Gainesville, Florida, United States
University of Florida/Shands Hospital
🇺🇸
Jacksonville, Florida, United States
Brooks Center for Rehabilitation Studies
🇺🇸
Jacksonville, Florida, United States