Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute on Deafness and Other Communication Disorders (NIDCD) |
---|---|
Information provided by: | National Institute on Deafness and Other Communication Disorders (NIDCD) |
ClinicalTrials.gov Identifier: | NCT00567242 |
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: Intention treatment Behavioral: Word finding |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Treating Intention In Aphasia: Neuroplastic Substrates |
Estimated Enrollment: | 14 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Word-finding trials with intention manipulation
|
Behavioral: Intention treatment
Word-finding trials are initiated with a complex left-hand movement.
|
2: Active Comparator
Word-finding trials without intention manipulation
|
Behavioral: Word finding
Word-finding trials are initiated without a complex left-hand movement.
|
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.
Ages Eligible for Study: | 21 Years to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bruce Crosson, PhD | nossorc1@phhp.ufl.edu |
United States, Florida | |
University of Florida | Recruiting |
Gainesville, Florida, United States, 32610 | |
Contact: Michelle Benjamin, M.S. 352-376-1611 ext 5395 mlb27@phhp.ufl.edu | |
Contact: Zvinka Zlatar, B.A. 352-376-1611 ext 5395 zvinka@ufl.edu | |
Principal Investigator: Bruce Crosson, Ph.D. | |
University of Florida/Shands Hospital | Recruiting |
Jacksonville, Florida, United States, 32209 | |
Contact: Joellen Gilbert, M.S. 904-244-9057 joellen.gilbert@jax.ufl.edu | |
Principal Investigator: Bruce Crosson, Ph.D. | |
Brooks Center for Rehabilitation Studies | Recruiting |
Jacksonville, Florida, United States, 32216 | |
Contact: Cecilia Brooks, M.Ed. 904-858-7260 cecilia.brooks@brookshealth.org | |
Contact: Floris Singletary, M.S. 904-306-8973 fsinglet@phhp.ufl.edu | |
Principal Investigator: Bruce Crosson, Ph.D. |
Principal Investigator: | Bruce Crosson, PhD | University of Florida |
Responsible Party: | University of Florida ( Bruce Crosson, Ph.D./Professor ) |
Study ID Numbers: | R01DC007387-01A1 |
Study First Received: | November 30, 2007 |
Last Updated: | August 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00567242 |
Health Authority: | United States: Federal Government |
aphasia therapies, investigational rehabilitation of speech and language disorders magnetic resonance imaging, functional language |
Speech Disorders Cerebral Infarction Aphasia Stroke Vascular Diseases Central Nervous System Diseases Language Disorders Ischemia Brain Diseases |
Cerebrovascular Disorders Signs and Symptoms Neurologic Manifestations Brain Ischemia Brain Infarction Infarction Neurobehavioral Manifestations Communication Disorders |
Nervous System Diseases Cardiovascular Diseases |