search
Back to results

Treating Intention In Aphasia: Neuroplastic Substrates

Primary Purpose

Aphasia, Cerebrovascular Accident

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Word-finding with intention component
Word-finding with no intention component
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring aphasia, therapies, investigational, rehabilitation of speech and language disorders, magnetic resonance imaging, functional, language

Eligibility Criteria

21 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida
  • University of Florida/Shands Hospital
  • Brooks Center for Rehabilitation Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Word-finding with intention component

Word-finding with no intention component

Arm Description

Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)

Word-finding trials similar to intention mediated treatment, but without intention manipulation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 30, 2007
Last Updated
April 30, 2012
Sponsor
University of Florida
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
search

1. Study Identification

Unique Protocol Identification Number
NCT00567242
Brief Title
Treating Intention In Aphasia: Neuroplastic Substrates
Official Title
Treating Intention In Aphasia: Neuroplastic Substrates
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Cerebrovascular Accident
Keywords
aphasia, therapies, investigational, rehabilitation of speech and language disorders, magnetic resonance imaging, functional, language

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Word-finding with intention component
Arm Type
Experimental
Arm Description
Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
Arm Title
Word-finding with no intention component
Arm Type
Active Comparator
Arm Description
Word-finding trials similar to intention mediated treatment, but without intention manipulation
Intervention Type
Behavioral
Intervention Name(s)
Word-finding with intention component
Other Intervention Name(s)
Intention Treatment
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Word-finding with no intention component
Other Intervention Name(s)
Control Treatment
Intervention Description
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).
Primary Outcome Measure Information:
Title
Lateralization of Frontal Lobe (and Posterior Perisylvian) Activity During Word Production
Description
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.
Time Frame
immediately post-treatment scan minus pre-treatment baseline scan
Secondary Outcome Measure Information:
Title
Picture Naming Probe Scores (% Accuracy)
Description
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.
Time Frame
trend for time series of 8 baseline + 30 treatment sessions
Title
Category Member Generation Probe Scores (% Accuracy)
Description
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.
Time Frame
trend for time series of 8 baseline + 30 treatment sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Crosson, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Florida/Shands Hospital
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Brooks Center for Rehabilitation Studies
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17521480
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.
Results Reference
background
PubMed Identifier
17525865
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.
Results Reference
background
PubMed Identifier
18465746
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.
Results Reference
background
PubMed Identifier
18577292
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.
Results Reference
background

Learn more about this trial

Treating Intention In Aphasia: Neuroplastic Substrates

We'll reach out to this number within 24 hrs