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AphasiaPhase 1/2NCT00567242

Treating Intention In Aphasia: Neuroplastic Substrates

A Phase 1/2 study testing Word-finding with intention component and Word-finding with no intention component in people with Aphasia and Cerebrovascular Accident, run by University of Florida at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 95 years
Conditions the study is for
Aphasia, Cerebrovascular Accident
What is being tested?
Word-finding with intention component and Word-finding with no intention component
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
3 sitesUnited States
Study dates
Mar 2007to Sep 2009
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Cardiac pace-maker
  • Ferrous metal implants not attached to bone, metal fragments in body
  • Profound hearing loss

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Florida

    Gainesville, Florida, 32610

  • University of Florida/Shands Hospital

    Jacksonville, Florida, 32209

  • Brooks Center for Rehabilitation Studies

    Jacksonville, Florida, 32216

Other trials in United States

About this study

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.

Read the 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.

Being tested
Word-finding with intention component, Word-finding with no intention component
Keywords
aphasia, therapies, investigational, rehabilitation of speech and language disorders, magnetic resonance imaging, functional, language
Medical subject headings
Aphasia, Stroke, Language Disorders, Language

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Word-finding with intention componentBehavioural

    Also called Intention Treatment

    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 with no intention componentBehavioural

    Also called Control Treatment

    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).

Study groups in NCT00567242
Study groupRoleWhat they receive
Word-finding with intention componentExperimentalTreats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
Receives: Behavioral: Word-finding with intention component
Word-finding with no intention componentActive comparatorWord-finding trials similar to intention mediated treatment, but without intention manipulation
Receives: Behavioral: Word-finding with no intention component

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: immediately post-treatment scan minus pre-treatment baseline scan

Secondary outcomes (2)

  1. 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.

    Measured: trend for time series of 8 baseline + 30 treatment sessions

  2. 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.

    Measured: trend for time series of 8 baseline + 30 treatment sessions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionSep 2009
  4. Study completionSep 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00567242
Sponsor's protocol ID
R01DC007387-01A1
Other IDs
R01DC007387
Status last verified
Apr 2012
First submitted
30 Nov 2007
Last updated
3 May 2012
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17521480

  • 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.

    PubMed 17525865

  • 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.

    PubMed 18465746

  • 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.

    PubMed 18577292

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Word-finding with intention component and Word-finding with no intention component in people with Aphasia and Cerebrovascular Accident, run by University of Florida at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lateralization of Frontal Lobe (and Posterior Perisylvian) Activity During Word Production (time frame: immediately post-treatment scan minus pre-treatment baseline scan). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00567242, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2012.

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