Clinical trial NCT00567242: Treating Intention In Aphasia: Neuroplastic Substrates
Official title: Treating Intention In Aphasia: Neuroplastic Substrates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Aphasia
Cerebrovascular Accident
Keywords: aphasia
therapies, investigational
rehabilitation of speech and language disorders
magnetic resonance imaging, functional
language
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2007-12-04
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Lateralization of Frontal Lobe (and Posterior Perisylvian) Activity During Word Production
timeFrame: immediately post-treatment scan minus pre-treatment baseline scan
Secondary outcomes:
measure: Picture Naming Probe Scores (% Accuracy)
timeFrame: trend for time series of 8 baseline + 30 treatment sessions
measure: Category Member Generation Probe Scores (% Accuracy)
timeFrame: trend for time series of 8 baseline + 30 treatment sessions
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: University of Florida/Shands Hospital
state: Florida
city: Jacksonville
country: United States
facility: Brooks Center for Rehabilitation Studies
state: Florida
Study officials:
affiliation: University of Florida
name: Bruce Crosson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1017/S1355617707070737. Epub 2007 May 18.
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. doi: 10.1007/s11065-007-9024-z. Epub 2007 May 25.
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.
citation: 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.