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Trial registered on ANZCTR

Registration number

ACTRN12617000469314

Ethics application status

Approved

Date submitted

14/03/2017

Date registered

31/03/2017

Date last updated

23/10/2020

Date data sharing statement initially provided

25/09/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Do measures of brain activity predict recovery of the ability to communicate after stroke and predict response to speech therapy?

Scientific title

An examination of whether measures of brain function and structure in subacute post-stroke aphasia predict language recovery (naming and comprehension) and word retrieval treatment response at 3 months and 6 months post stroke-onset.

Secondary ID [1]

NHMRC - APP1104194

Universal Trial Number (UTN)

Trial acronym

PAPAR

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Aphasia post stroke

Condition category

Condition code

Stroke

Ischaemic

Stroke

Haemorrhagic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The patient cohort will be randomly assigned to either treatment or a usual care control condition (stratified based on severity of language deficit).

Prior to receiving treatment or usual care, all participants will undertake a neuroimaging scan, including a language-based functional MRI, which will be used as a predictor for language recovery.

Therapy group:
- The therapy provided to participants in the therapy group of the study will include individual word retrieval treatment focused primarily on the phonological (sound) representation
- The word retrieval treatment will be delivered individually at 1 month post-stroke onset (following scanning) by qualified speech pathologists over 3 x 1 hour sessions a week for a period of 8 weeks.
- Stimuli (nouns) will be selected for treatment based on pre-test performance indicating difficulties with naming individual items. 2 sets of items will be selected (matched for relevant psycholinguistic variables), with one set treated and the other untreated to test for generalisation.
- The content of treatment is based on evidence for the effectiveness of word retrieval treatments that include repetition, phonological cueing, and phonological judgments (e.g., Nickels, 2000; Van Hees et al., 2013). In accordance with Leonard et al. (2008) and our work (Van Hees et al., 2013), patients are asked to attempt to name the item. They are then asked to produce the features of the item according to each cue word in a matrix. The cues include: first sound, syllables, last sound, association, and rhyme. If a participant is unable to produce a response, the clinician provides a response both orally and in written form. After all the features are produced, the participant is asked to name the item again. Another component of treatment will involve repetition of the name in the presence of its picture.
- Treatment will also include computer-based therapy (guided by the clinician, approximately 20% of each session), including picture naming for word retrieval, reading aloud for reading comprehension and script practice. Additional activities focused on phrase-level production may be included if impairments are identified (Rodriguez et al., 2013). Homework tasks may also be provided as part of the individualised treatment.
- Patients may receive usual care for other speech and communication impairments.
- Intervention adherence/fidelity will be assessed by recording a sample from a treatment session that will then be reviewed by one of the principal investigators. Strategies used to maintain/improve fidelity will include meetings with research therapists to discuss therapy provision.

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Other

Comparator / control treatment

Control group:
- 20 healthy age and gender matched controls will be scanned once to identify key regions normally activated in fMRI studies. This data will be critical for determining regions-of-interest and will determine whether normal or novel patterns of activity are observed in patients at each time-point.
- The control participants will also be screened using a brief (5-10 minute) cognitive assessment, the Montreal Cognitive Assessment (MoCA), to rule out cognitive impairment.

Usual Care treatment group:
- The usual care condition will comprise standard speech pathology intervention delivered at the frequency available in each specific health service in which the patient is recruited.
- Frequency and type of usual care intervention may be dependent on setting (e.g., acute hospital, inpatient rehabilitation, outpatient rehabilitation, community based) and will likely be influenced by clinician expertise, and by whether care is delivered in a private or a public health service setting. It may include individual sessions, computer-based therapy, and group sessions.
- Usual care therapy will be documented by the usual care therapists in the various health services, and participants (or their family members) will also keep a diary of therapy activities to assist with data checking by the research team.
- Usual care is unlikely to exceed on average 1-2 sessions of 45 minutes per week.

Control group

Active

Outcomes

Primary outcome [1]

Change in naming (Philadelphia Naming Test) at 3 months post stroke onset compared to baseline, as predicted by functional MRI of language-related brain activity at baseline (2-6 weeks post-stroke onset).

Timepoint [1]

Baseline (2-6 weeks) to 3 months post stroke onset

Primary outcome [2]

Change in comprehension (Comprehensive Aphasia Test) at 3 months post stroke onset compared to baseline, as predicted by functional MRI of language-related brain activity at baseline (2-6 weeks post-onset).

Timepoint [2]

Baseline (2-6 weeks) to 3 months post stroke onset

Secondary outcome [1]

Change in naming (Philadelphia Naming Test) at 6 months post stroke onset compared to baseline, as predicted by functional MRI of language-related brain activity at baseline (2-6 weeks post-stroke onset).

Timepoint [1]

Baseline (2-6 weeks) to 6 months post stroke onset

Secondary outcome [2]

Change in comprehension (Comprehensive Aphasia Test) at 6 months post stroke onset compared to baseline, as predicted by functional MRI of language-related brain activity at baseline (2-6 weeks post-stroke onset).

Timepoint [2]

Baseline (2-6 weeks) to 6 months post stroke onset

Secondary outcome [3]

Change in functional MRI measure of language-related brain activity at baseline (2-6 weeks post-stroke onset) to 3 and 6 months post-stroke onset

Timepoint [3]

Baseline (2-6 weeks) to 6 months post stroke onset

Secondary outcome [4]

Change in naming (Philadelphia Naming Test) at 3, 6 months post stroke onset compared to baseline.

Timepoint [4]

Baseline (2-6 weeks) to 3 and 6 months post stroke onset

Secondary outcome [5]

Change in comprehension (Comprehensive Aphasia Test) at 3, 6 months post stroke onset compared to baseline.

Timepoint [5]

Baseline (2-6 weeks) to 3 and 6 months post stroke onset

Secondary outcome [6]

Change in Western Aphasia Battery - Revised Aphasia Quotient at 3 months and 6 months post stroke onset compared to baseline

Timepoint [6]