Treating Intention In Aphasia: Neuroplastic Substrates

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00567242
First received: November 30, 2007
Last updated: April 30, 2012
Last verified: April 2012
  Purpose

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: Word-finding with intention component
Behavioral: Word-finding with no intention component
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Treating Intention In Aphasia: Neuroplastic Substrates

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Lateralization of Frontal Lobe (and Posterior Perisylvian) Activity During Word Production [ Time Frame: immediately post-treatment scan minus pre-treatment baseline scan ] [ Designated as safety issue: No ]
    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:
  • Picture Naming Probe Scores (% Accuracy) [ Time Frame: trend for time series of 8 baseline + 30 treatment sessions ] [ Designated as safety issue: No ]
    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.

  • Category Member Generation Probe Scores (% Accuracy) [ Time Frame: trend for time series of 8 baseline + 30 treatment sessions ] [ Designated as safety issue: No ]
    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.


Enrollment: 14
Study Start Date: March 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   21 Years to 95 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567242

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
Investigators
Principal Investigator: Bruce Crosson, PhD University of Florida
  More Information

Additional Information:
Publications:
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00567242     History of Changes
Other Study ID Numbers: R01DC007387-01A1, R01DC007387
Study First Received: November 30, 2007
Results First Received: March 6, 2012
Last Updated: April 30, 2012
Health Authority: United States: Federal Government

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
Cerebral Infarction
Stroke
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014