Treating Intention In Aphasia: Neuroplastic Substrates

• ClinicalTrials.gov Identifier: NCT00567242
• Recruitment Status: Completed
• First Posted: December 4, 2007
• Results First Posted: May 1, 2012
• Last Update Posted: May 3, 2012
• Sponsor: University of Florida
• Collaborator: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Information provided by (Responsible Party): University of Florida

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Aphasia; Cerebrovascular Accident	Behavioral: Word-finding with intention component; Behavioral: Word-finding with no intention component	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Treating Intention In Aphasia: Neuroplastic Substrates
• Study Start Date: March 2007
• Actual Primary Completion Date: September 2009
• Actual Study Completion Date: September 2009

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Lateralization of Frontal Lobe (and Posterior Perisylvian) Activity During Word Production [ Time Frame: 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 :

1. Picture Naming Probe Scores (% Accuracy) [ Time Frame: 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.
2. Category Member Generation Probe Scores (% Accuracy) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 95 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

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

Sponsors and Collaborators

University of Florida

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

• Principal Investigator: Bruce Crosson, PhD; University of Florida

More Information

Publications:

Crosson B, Fabrizio KS, Singletary F, Cato MA, Wierenga CE, Parkinson RB, Sherod ME, Moore AB, Ciampitti M, Holiway B, Leon S, Rodriguez A, Kendall DL, Levy IF, Rothi LJ. Treatment of naming in nonfluent aphasia through manipulation of intention and attention: a phase 1 comparison of two novel treatments. J Int Neuropsychol Soc. 2007 Jul;13(4):582-94. Epub 2007 May 18.

Crosson B, McGregor K, Gopinath KS, Conway TW, Benjamin M, Chang YL, Moore AB, Raymer AM, Briggs RW, Sherod MG, Wierenga CE, White KD. Functional MRI of language in aphasia: a review of the literature and the methodological challenges. Neuropsychol Rev. 2007 Jun;17(2):157-77. Epub 2007 May 25. Review.

Gopinath K, Crosson B, McGregor K, Peck K, Chang YL, Moore A, Sherod M, Cavanagh C, Wabnitz A, Wierenga C, White K, Cheshkov S, Krishnamurthy V, Briggs RW. Selective detrending method for reducing task-correlated motion artifact during speech in event-related FMRI. Hum Brain Mapp. 2009 Apr;30(4):1105-19. doi: 10.1002/hbm.20572.

Conway T, Heilman KM, Gopinath K, Peck K, Bauer R, Briggs RW, Torgesen JK, Crosson B. Neural substrates related to auditory working memory comparisons in dyslexia: an fMRI study. J Int Neuropsychol Soc. 2008 Jul;14(4):629-39. doi: 10.1017/S1355617708080867.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT00567242
• Other Study ID Numbers: R01DC007387-01A1 ( U.S. NIH Grant/Contract ); R01DC007387 ( U.S. NIH Grant/Contract )
• First Posted: December 4, 2007
• Results First Posted: May 1, 2012
• Last Update Posted: May 3, 2012
• Last Verified: April 2012

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; Stroke; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases