AphasiaSPTNCT02046941
Brain Biomarkers of Response to Treatment for Apraxia of Speech
A study testing Speech Production Treatment in people with Aphasia and Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The study will use MRI brain imaging to identify brain changes associated in stroke patients after they receive speech-language treatment for their speech difficulties. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- What is being tested?
- Speech Production Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2014to 30 Jun 2018
- Phase
- Interventional
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary English speaker since < age 5
- a history of a single left hemisphere stroke
- at least 1 year post-stroke
- at least 12 years of education
- pre-morbidly right-handed (Edinburgh Handedness Questionnaire)
- within normal limits on the Test of Non-Verbal Intelligence
Who cannot join
- Exclusion criteria will include a pre-morbid neurologic or psychiatric history
- history/current substance abuse disorder
- MRI contraindications
- other motor speech disorders (e.g., dysarthria)
- current or recent (<2 months) speech/language therapy
- prior SPT
Show all 9Show fewer
- pre-morbid history of speech/language disorders
- significant hearing disabilities (based on a pure-tone audiological screen at 35 dB HL at 500, 1K, and 2K Hz for at least one ear)
- aphasia severity resulting in <30th percentile performance on the Porch Index of Communicative Ability-R
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Northern California Health Care System, Mather, CA
Sacramento, California, 95655
About this study
The study will use MRI brain imaging to identify brain changes associated in stroke patients after they receive speech-language treatment for their speech difficulties.
Read the detailed description
The goals of the current study are to identify grey and white matter regions that are predictive of speech treatment response and measure neural plasticity in response to speech treatment, using state-of-the-art neuroimaging and statistical processing techniques in a group of well-characterized left hemisphere patients meeting strict inclusionary criteria. Specifically, the investigators will use voxel-based lesion symptom mapping to identify lesion sites most predictive of a positive response to speech treatment and advanced diffusion imaging techniques to map changes in the integrity of white matter tracts from pre- to post-treatment.
- Being tested
- Speech Production Treatment
- Keywords
- aphasia, stroke, Magnetic Resonance Imaging, Diffusion Magnetic Resonance Imaging
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech Production TreatmentBehavioural
This treatment employs a response-contingent hierarchy made up of verbal modeling/repetition, graphic cueing, integral stimulation, and articulatory placement instruction.
| Study group | Role | What they receive |
|---|---|---|
| Speech Production Treatment | Experimental | This treatment employs a response-contingent hierarchy made up of verbal modeling/repetition, graphic cueing, integral stimulation, and articulatory placement instruction. The investigators chose this treatment for the following reasons: 1) rigor of development demonstrated across multiple studies, 2) large and predictable effects with published, quantified effect sizes, 3) a demonstrated pattern of generalization to untrained items, illustrating experimental control, 4) an established multi-modal stimulation protocol, and 5) use of repeated practice, which is associated with neural plasticity. Receives: Behavioral: Speech Production Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Percent of Trained Items Correctly Repeated
For each participant, three target sounds were chosen: single consonants, vowels, or clusters at the word level. Based on these target sounds, 10 word items were generated for each target sound that served as Trained Items. Participants were tested on lists of Trained Items (probe trials) during repeated sessions in pre-intervention stage to establish baseline performance (percent of each word list repeated correctly) and during every other treatment session (again, percent of each word list repeated correctly). The change in percent correct list repetition from pre-intervention (5 probe trials) to the end of intervention (final 3 probe trials) was calculated as individual treatment effect sizes using the Busk \& Serlin (1992) d2 statistic, which involves subtracting the difference between mean performance at end of the intervention minus pre-intervention, divided by the pooled standard deviation of the two phases. The larger the d2 effect size, the larger the effect of the treatment.
Measured: 8 weeks
Change From Baseline in Percent of Untrained Items Correctly Repeated
To test generalization, we assessed the change in performance (percent correct repetition) on lists of 10 Untrained Items that had the same speech production targets as each patient's lists of 10 Trained Items, balanced for syllabic structure, word frequency, grammatical form class, and stress pattern. Just as for Trained Items, participants were tested on the lists of Untrained Items (probe trials) during repeated sessions in the pre-intervention stage to establish baseline performance and during every other treatment session (percent of each word list repeated correctly). The change in percent correct list repetition from pre-intervention (5 probe trials) to end of intervention (final 3 probe trials) was calculated as individual treatment effect sizes using the d2 statistic: the difference between mean performance at end of the intervention minus pre-intervention, divided by the pooled standard deviation. The larger the d2 effect size, the larger the effect of the treatment.
Measured: 8 weeks
Secondary outcomes (1)
Percentage Change in Fractional Anisotropy (FA)
To measure neuroplasticity associated with the speech treatment protocol, the investigators calculated the percent change in fractional anisotropy (FA) from pre- to post-treatment for each of the eight fiber tracts in the left hemisphere. The average percentage change in FA across all eight fiber tracts was calculated, which could thus range from 0-100%. A positive change indicates an increase in white matter integrity, and a negative change indicates a decrease in white matter integrity. A number close to 0 indicates minimal/no significant change.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study start1 Mar 2014
- Primary completion8 Jan 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Juliana V. Baldo, PhD, Principal investigator, VA Northern California Health Care System, Mather, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046941
- Sponsor's protocol ID
- C1532-I
- Acronym
- SPT
- Status last verified
- Jul 2019
- First submitted
- 24 Jan 2014
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Biomarkers of Response to Treatment for Apraxia of Speech
- ClinicalTrials.gov ID
- NCT02046941
- Acronym / sponsor ID
- SPT / C1532-I
- Keywords
- aphasia, stroke, Magnetic Resonance Imaging, Diffusion Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will use MRI brain imaging to identify brain changes associated in stroke patients after they receive speech-language treatment for their speech difficulties.
Detailed description
The goals of the current study are to identify grey and white matter regions that are predictive of speech treatment response and measure neural plasticity in response to speech treatment, using state-of-the-art neuroimaging and statistical processing techniques in a group of well-characterized left hemisphere patients meeting strict inclusionary criteria. Specifically, the investigators will use voxel-based lesion symptom mapping to identify lesion sites most predictive of a positive response to speech treatment and advanced diffusion imaging techniques to map changes in the integrity of white matter tracts from pre- to post-treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Speech Production Treatment | Experimental | Behavioral: Speech Production TreatmentThis treatment employs a response-contingent hierarchy made up of verbal modeling/repetition, graphic cueing, integral stimulation, and articulatory placement instruction. The investigators chose this treatment for the following reasons: 1) rigor of development demonstrated across multiple studies, 2) large and predictable effects with published, quantified effect sizes, 3) a demonstrated pattern of generalization to untrained items, illustrating experimental control, 4) an established multi-modal stimulation protocol, and 5) use of repeated practice, which is associated with neural plasticity. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- primary English speaker since < age 5
- a history of a single left hemisphere stroke
- at least 1 year post-stroke
- at least 12 years of education
- pre-morbidly right-handed (Edinburgh Handedness Questionnaire)
Key exclusion criteria (9 listed)
- Exclusion criteria will include a pre-morbid neurologic or psychiatric history
- history/current substance abuse disorder
- MRI contraindications
- other motor speech disorders (e.g., dysarthria)
- current or recent (<2 months) speech/language therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech Production TreatmentThis treatment employs a response-contingent hierarchy made up of verbal modeling/repetition, graphic cueing, integral stimulation, and articulatory placement instruction. | Behavioural | Speech Production Treatment |
Primary outcome
Change From Baseline in Percent of Trained Items Correctly Repeated
Time frame: 8 weeks
For each participant, three target sounds were chosen: single consonants, vowels, or clusters at the word level. Based on these target sounds, 10 word items were generated for each target sound that served as Trained Items. Participants were tested on lists of Trained Items (probe trials) during repeated sessions in pre-intervention stage to establish baseline performance (percent of each word list repeated correctly) and during every other treatment session (again, percent of each word list repeated correctly). The change in percent correct list repetition from pre-intervention (5 probe trials) to the end of intervention (final 3 probe trials) was calculated as individual treatment effect sizes using the Busk \& Serlin (1992) d2 statistic, which involves subtracting the difference between mean performance at end of the intervention minus pre-intervention, divided by the pooled standard deviation of the two phases. The larger the d2 effect size, the larger the effect of the treatment.
Change From Baseline in Percent of Untrained Items Correctly Repeated
Time frame: 8 weeks
To test generalization, we assessed the change in performance (percent correct repetition) on lists of 10 Untrained Items that had the same speech production targets as each patient's lists of 10 Trained Items, balanced for syllabic structure, word frequency, grammatical form class, and stress pattern. Just as for Trained Items, participants were tested on the lists of Untrained Items (probe trials) during repeated sessions in the pre-intervention stage to establish baseline performance and during every other treatment session (percent of each word list repeated correctly). The change in percent correct list repetition from pre-intervention (5 probe trials) to end of intervention (final 3 probe trials) was calculated as individual treatment effect sizes using the d2 statistic: the difference between mean performance at end of the intervention minus pre-intervention, divided by the pooled standard deviation. The larger the d2 effect size, the larger the effect of the treatment.
1 secondary outcome
Percentage Change in Fractional Anisotropy (FA)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliana V. Baldo, PhD principal investigator
VA Northern California Health Care System, Mather, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech Production Treatment in people with Aphasia and Stroke, run by VA Office of Research and Development at 1 site 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 6 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2019). 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?
Change From Baseline in Percent of Trained Items Correctly Repeated (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2019.