Treating Intention In Aphasia: Neuroplastic Substrates

Completed

Phase 1/2 Results

Trial Description

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.

Conditions

Interventions

  • Word-finding with intention manipulation Behavioral
    Intervention Desc: 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).
    ARM 1: Kind: Experimental
    Label: Word-finding with intention manipulation
    Description: Treats 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 manipulation Behavioral
    Intervention Desc: 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).
    ARM 1: Kind: Experimental
    Label: Word-finding with no intention manipulation
    Description: Word-finding trials similar to intention mediated treatment, but without intention manipulation
  • Word-finding with intention component Behavioral
    Other Names: Intention Treatment
    Intervention Desc: 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).
    ARM 1: Kind: Experimental
    Label: Word-finding with intention component
    Description: Treats 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 Behavioral
    Other Names: Control Treatment
    Intervention Desc: 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).
    ARM 1: Kind: Experimental
    Label: Word-finding with no intention component
    Description: Word-finding trials similar to intention mediated treatment, but without intention manipulation

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Subject)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Lateralization of frontal lobe (and posterior perisylvian) activity during word production pre-treatment, post-treatment, 3-month follow-up No
Secondary Word-finding ability (picture-naming and category member generation accuracy) pre-treatment, post-treatment, 3-month follow-up No
Secondary Picture Naming Probe Scores (% Accuracy) trend for 8 baseline + 30 treatment sessions No
Secondary Category Member Generation Probe Scores (% Accuracy) trend for 8 baseline + 30 treatment sessions No

Sponsors