Treating Intention In Aphasia: Neuroplastic Substrates
2 other identifiers
interventional
14
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2007
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 30, 2007
CompletedFirst Posted
Study publicly available on registry
December 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
May 1, 2012
CompletedMay 3, 2012
April 1, 2012
2.5 years
November 30, 2007
March 6, 2012
April 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Picture Naming Probe Scores (% Accuracy)
trend for time series of 8 baseline + 30 treatment sessions
Category Member Generation Probe Scores (% Accuracy)
trend for time series of 8 baseline + 30 treatment sessions
Study Arms (2)
Word-finding with intention component
EXPERIMENTALTreats 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
ACTIVE COMPARATORWord-finding trials similar to intention mediated treatment, but without intention manipulation
Interventions
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 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).
Eligibility Criteria
You may qualify if:
- Nonfluent aphasia caused by stroke
- Moderate to severe word-finding problems
- or more months post stroke
- Right handed prior to stroke
- All strokes in left hemisphere
- Native English speaker
- Capable of following verbal directions
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Florida
Gainesville, Florida, 32610, United States
University of Florida/Shands Hospital
Jacksonville, Florida, 32209, United States
Brooks Center for Rehabilitation Studies
Jacksonville, Florida, 32216, United States
Related Publications (4)
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.
PMID: 17521480BACKGROUNDCrosson 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.
PMID: 17525865BACKGROUNDGopinath 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.
PMID: 18465746BACKGROUNDConway 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.
PMID: 18577292BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
1. Patients who had aphasia were enrolled. Groups were equated for anomia severity, but not type of aphasia. Aphasia types were not evenly distributed between groups which may affect results. 2. Intention subjects were older than Control Subjects.
Results Point of Contact
- Title
- Bruce Crosson, PhD / Professor
- Organization
- University of Florida
Study Officials
- PRINCIPAL INVESTIGATOR
Bruce Crosson, PhD
University of Florida
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2007
First Posted
December 4, 2007
Study Start
March 1, 2007
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
May 3, 2012
Results First Posted
May 1, 2012
Record last verified: 2012-04