Treating Intention In Aphasia: Neuroplastic Substrates

Cerebrovascular Accident Clinical Trial

Official title:

Treating Intention In Aphasia: Neuroplastic Substrates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567242
• Other study ID #: R01DC007387-01A1
• Secondary ID: R01DC007387
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 30, 2007
• Last updated: April 30, 2012
• Start date: March 2007
• Est. completion date: September 2009

Study information

• Verified date: April 2012
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 95 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphasia
• Cerebrovascular Accident
• Stroke

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	Brooks Center for Rehabilitation Studies	Jacksonville	Florida
United States	University of Florida/Shands Hospital	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lateralization of Frontal Lobe (and Posterior Perisylvian) Activity During Word Production	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.	immediately post-treatment scan minus pre-treatment baseline scan	No
Secondary	Picture Naming Probe Scores (% Accuracy)	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.	trend for time series of 8 baseline + 30 treatment sessions	No
Secondary	Category Member Generation Probe Scores (% Accuracy)	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.	trend for time series of 8 baseline + 30 treatment sessions	No

External Links

•   Brain Imaging, Rehabilitation, and Cognition laboratory website