Aphasia, AcquiredPhase 2NCT04488029
PCT for Speech, Language, and Cognitive Intervention in Stroke Patients
A Phase 2 study testing PCT and Workbooks in people with Aphasia, Acquired, run by The Learning Corp at 1 site in United States.
Trial summary
Given the evolving uses of technology in rehabilitation, the investigators aimed to measure the change in aphasia severity using PCT App, a digital therapeutic adapted from Constant Therapy (CT), a dynamic, personalized therapy program for people with cognitive, speech, or language disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphasia, Acquired
- What is being tested?
- PCT and Workbooks
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2019to 20 Feb 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have diagnosis of stroke involving a hemorrhage or ischemic event, resulting in speech, language, and/or cognitive deficits
- Have time post-stroke of at least 4 months prior to enrollment
- Have been discharged from rehabilitation hospital
- Are adults (aged 18 years or older) at the time of consent
- Exhibit clinically confirmed speech, language, and/or cognitive deficits based on medical records
- Are fluent English speakers
- Have confirmed aphasia using the WAB-R Aphasia Quotient (score of 90 or lower; 93.8 is cutoff for normal scores)
- Have a presence of a family member or caregiver who is willing and able to provide assistance during the duration of study period
Who cannot join
- Have comorbid neurological conditions that could impair study participation in the opinion of the investigator, such as dementia or Parkinson's disease
- Currently require inpatient care or acute care
- Are currently undergoing related one-on-one individual therapy at a hospital, rehabilitation facility, university, or at home
- Exhibit severe apraxia of speech or severe dysarthria of speech, as verified by a clinician and confirmed by the WAB-R (and the Screen for Dysarthria and Apraxia of Speech if necessary), and/or medical records
- Have comorbid psychiatric conditions that could impair study participation in the opinion of the investigator, including such as schizophrenia or major depressive disorder, as indicated by medical records
- Have uncorrected hearing or vision loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Parallel, Virtual, Randomized Trial of PCT for Speech, Language, and Cognitive Intervention in Stroke Patients
Given the evolving uses of technology in rehabilitation, the investigators aimed to measure the change in aphasia severity using PCT App, a digital therapeutic adapted from Constant Therapy (CT), a dynamic, personalized therapy program for people with cognitive, speech, or language disorders.
The entire study, including recruitment, enrollment, assessment and treatment were conducted remotely.
Read more
The proposed pilot study seeks to compare performance of PCT therapy vs. conventional workbook intervention for stroke patients. The investigators hypothesize that the experimental (PCT) group will experience greater gains on the WAB-AQ at follow-up compared to baseline compared to a control (workbook) group.
Subjects were prospectively assigned to an experimental or active control group in a random order with both groups balanced for their baseline level of speech, language and/or cognitive ability:
- Experimental Group: Participants were instructed to use PCT for at least 30 minutes/day, 5 days/week. Performance and usage data were automatically reported by the PCT software to the treating clinician and was used to modify task assignment over time and monitor participant adherence to the treatment program.
- Active Control Group: Participants were provided with a standard regime of paper workbooks (e.g. Workbook for Aphasia; Brubaker, 2006) that are typically used by clinicians with persons with aphasia (PWA) for at least 30 minutes/day, 5 days/week. Notably, the control procedure employed here is similar to a large-scale study examining technology as a treatment option by Palmer and colleagues (2015).
The treatment period was 10 weeks. All participants received a bimonthly check-in through video-chat with a member of the research staff during the treatment period.
- Conditions
- Aphasia, Acquired
- Being tested
- PCT, Workbooks
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCTOther
PCT is designed to deliver similar therapy as is conventionally provided in-clinic by a Speech Language Pathologist (SLP), which the patient can access from any location using the application installed on a supported tablet. The device functions by allowing clinicians to create a personalized therapy program for each patient from 75 categories of clinical therapies, which patients may access from their tablet device remotely. The PCT software is comprised primarily of authentication and an algorithm that suggests advancement of the therapy program based on observed patient deficits and progress.
WorkbooksOther
Subjects in this group will be provided with a standard regime of paper workbooks (e.g. Workbook for Aphasia: Exercises for Expressive and Receptive Language Functioning; Brubaker, 2006) that are typically used by clinicians to practice therapy tasks with individuals. Notably, the control procedure employed here is similar to that employed on a large-scale study examining technology as a treatment option and involved usual care control group by Palmer and colleagues (2015).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | At the start of the study, subjects will be provided with a tablet with videoconferencing software and the PCT app pre-installed. Research staff will remotely setup a PCT account for the subjects, and provide instructions for logging into the PCT application. During the treatment period, patients will be instructed to use PCT for at least 30 minutes a day and at least 5 days a week. Performance data (accuracy and latency) will be reported by the PCT software to the treating clinician and will be used to modify task assignment over time. PCT tracks usage of the program so that research staff can access automated reporting of subject use to monitor participant adherence to the treatment program. Receives: Other: PCT |
| Control Group 1 [Conventional Workbook Therapy] | Active comparator | At the start of the study, subjects will be provided with a tablet with videoconferencing software and the PCT app pre-installed. Subjects in the control group will be told they will have access to 3-months of PCT after their participation in the study has concluded. Subjects in this group will be provided with a standard regime of paper workbooks and instructions to complete approximately 30 minutes a day at least 5 days a week. Receives: Other: Workbooks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Aphasia Battery Revised, Aphasia Quotient (WAB-AQ)
The WAB-R is a standardized tool that assesses language and cognitive skills and provides scores quantifying the impact of a stroke on those skills. The Aphasia Quotient from the WAB-R includes segments from Part 1 of the assessment, evaluating spontaneous speech including fluency and information content, auditory comprehension, naming, and repetition.
Measured: Baseline assessment
Western Aphasia Battery Revised, Aphasia Quotient (WAB-AQ)
The WAB-R is a standardized tool that assesses language and cognitive skills and provides scores quantifying the impact of a stroke on those skills. The Aphasia Quotient from the WAB-R includes segments from Part 1 of the assessment, evaluating spontaneous speech including fluency and information content, auditory comprehension, naming, and repetition.
Measured: Follow-up assessment 10-12 weeks post baseline
Secondary outcomes (8)
Western Aphasia Battery Revised, Cortical Quotient (WAB-CQ)
The Cortical Quotient as obtained from the WAB-R Parts 1 and 2 was utilized as secondary outcome measures. Part 2 of the WAB-R includes reading, writing, apraxia, constructional, visuospatial, and calculation sections.
Measured: Baseline assessment
Western Aphasia Battery Revised, Cortical Quotient (WAB-CQ)
The Cortical Quotient as obtained from the WAB-R Parts 1 and 2 was utilized as secondary outcome measures. Part 2 of the WAB-R includes reading, writing, apraxia, constructional, visuospatial, and calculation sections.
Measured: Follow-up assessment 10-12 weeks post baseline
Western Aphasia Battery Revised, Language Quotient (WAB-LQ)
The Language Quotient as obtained from the WAB-R Parts 1 and 2 was utilized as secondary outcome measures. Part 2 of the WAB-R informing the Language Quotients includes reading and writing sections.
Measured: Baseline assessment
Western Aphasia Battery Revised, Language Quotient (WAB-LQ)
The Language Quotient as obtained from the WAB-R Parts 1 and 2 was utilized as secondary outcome measures. Part 2 of the WAB-R informing the Language Quotients includes reading and writing sections.
Measured: Follow-up assessment 10-12 weeks post baseline
Brief Test of Adult Cognition by Telephone (BTACT)
The BTACT is a brief, remote, cognitive assessment that evaluates memory for and judgments about words and numbers. It includes tasks such as recall tasks, both immediate and short term, category fluency, and number reasoning and manipulation tasks.
Measured: Baseline assessment
Brief Test of Adult Cognition by Telephone (BTACT)
The BTACT is a brief, remote, cognitive assessment that evaluates memory for and judgments about words and numbers. It includes tasks such as recall tasks, both immediate and short term, category fluency, and number reasoning and manipulation tasks.
Measured: Follow-up assessment 10-12 weeks post baseline
Stroke and Aphasia Quality of Life Scale 39 (SAQOL-39)
The SAQOL-39 is a structured quality of life questionnaire administered to either a patient or a caregiver. It assesses the impact of a stroke on daily activities, communication, emotions, and family and social life by asking patients or caregivers to complete a 5 point rating scale in response to specific questions focusing on the past week alone.
Measured: Baseline assessment
Stroke and Aphasia Quality of Life Scale 39 (SAQOL-39)
The SAQOL-39 is a structured quality of life questionnaire administered to either a patient or a caregiver. It assesses the impact of a stroke on daily activities, communication, emotions, and family and social life by asking patients or caregivers to complete a 5 point rating scale in response to specific questions focusing on the past week alone.
Measured: Follow-up assessment 10-12 weeks post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start18 Mar 2019
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Aphasia, AcquiredStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Final study eligibility will be assessed after administration of the Western Aphasia Battery, Revised (WAB-R). Eligible subjects will be pseudorandomly assigned to the experimental group OR the control group, while trying to balance for aphasia severity (WAB-R Aphasia Quotient, WAB-AQ). Subjects in the experimental group will receive therapy via the PCT app during the treatment period. Subjects in the control arm will receive conventional workbook therapy. Subjects in both groups will be asked to refrain from obtaining one-on-one individual aphasia or cognitive therapy. Subjects may participate in organized social groups, such as community aphasia groups.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Learning Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Michelle Braley, The Learning Corp
- Investigators
- Swathi Kiran, PhD, CCC-SLP, Study director, The Learning Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488029
- Sponsor's protocol ID
- TLC-PCT-Pilot
- Status last verified
- Jul 2020
- First submitted
- 22 Jul 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified, aggregate only. Data will be available at the request of other investigators for purposes of replicating procedures and results. Anonymized data will be shared by request from any qualified investigator.
Publications
Palmer R, Witts H, Chater T. What speech and language therapy do community dwelling stroke survivors with aphasia receive in the UK? PLoS One. 2018 Jul 10;13(7):e0200096. doi: 10.1371/journal.pone.0200096. eCollection 2018.
PubMed 29990345Tun PA, Lachman ME. Telephone assessment of cognitive function in adulthood: the Brief Test of Adult Cognition by Telephone. Age Ageing. 2006 Nov;35(6):629-32. doi: 10.1093/ageing/afl095. Epub 2006 Aug 30. No abstract available.
PubMed 16943264Dekhtyar M, Braun EJ, Billot A, Foo L, Kiran S. Videoconference Administration of the Western Aphasia Battery-Revised: Feasibility and Validity. Am J Speech Lang Pathol. 2020 May 8;29(2):673-687. doi: 10.1044/2019_AJSLP-19-00023. Epub 2020 Mar 19.
PubMed 32191122Caute A, Northcott S, Clarkson L, Pring T, Hilari K. Does mode of administration affect health-related quality-of-life outcomes after stroke? Int J Speech Lang Pathol. 2012 Aug;14(4):329-37. doi: 10.3109/17549507.2012.663789. Epub 2012 Apr 4.
PubMed 22472032Braley M, Pierce JS, Saxena S, De Oliveira E, Taraboanta L, Anantha V, Lakhan SE, Kiran S. A Virtual, Randomized, Control Trial of a Digital Therapeutic for Speech, Language, and Cognitive Intervention in Post-stroke Persons With Aphasia. Front Neurol. 2021 Feb 12;12:626780. doi: 10.3389/fneur.2021.626780. eCollection 2021.
PubMed 33643204
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel, Virtual, Randomized Trial of PCT for Speech, Language, and Cognitive Intervention in Stroke Patients
- ClinicalTrials.gov ID
- NCT04488029
- Acronym / sponsor ID
- TLC-PCT-Pilot
- Conditions
- Aphasia, Acquired
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- The Learning CorpIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Given the evolving uses of technology in rehabilitation, the investigators aimed to measure the change in aphasia severity using PCT App, a digital therapeutic adapted from Constant Therapy (CT), a dynamic, personalized therapy program for people with cognitive, speech, or language disorders.
The entire study, including recruitment, enrollment, assessment and treatment were conducted remotely.
The proposed pilot study seeks to compare performance of PCT therapy vs. conventional workbook intervention for stroke patients. The investigators hypothesize that the experimental (PCT) group will experience greater gains on the WAB-AQ at follow-up compared to baseline compared to a control (workbook) group.
Subjects were prospectively assigned to an experimental or active control group in a random order with both groups balanced for their baseline level of speech, language and/or cognitive ability:
- Experimental Group: Participants were instructed to use PCT for at least 30 minutes/day, 5 days/week. Performance and usage data were automatically reported by the PCT software to the treating clinician and was used to modify task assignment over time and monitor participant adherence to the treatment program.
- Active Control Group: Participants were provided with a standard regime of paper workbooks (e.g. Workbook for Aphasia; Brubaker, 2006) that are typically used by clinicians with persons with aphasia (PWA) for at least 30 minutes/day, 5 days/week. Notably, the control procedure employed here is similar to a large-scale study examining technology as a treatment option by Palmer and colleagues (2015).
The treatment period was 10 weeks. All participants received a bimonthly check-in through video-chat with a member of the research staff during the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Final study eligibility will be assessed after administration of the Western Aphasia Battery, Revised (WAB-R). Eligible subjects will be pseudorandomly assigned to the experimental group OR the control group, while trying to balance for aphasia severity (WAB-R Aphasia Quotient, WAB-AQ). Subjects in the experimental group will receive therapy via the PCT app during the treatment period. Subjects in the control arm will receive conventional workbook therapy. Subjects in both groups will be asked to refrain from obtaining one-on-one individual aphasia or cognitive therapy. Subjects may participate in organized social groups, such as community aphasia groups.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: PCTAt the start of the study, subjects will be provided with a tablet with videoconferencing software and the PCT app pre-installed. Research staff will remotely setup a PCT account for the subjects, and provide instructions for logging into the PCT application. During the treatment period, patients will be instructed to use PCT for at least 30 minutes a day and at least 5 days a week. Performance data (accuracy and latency) will be reported by the PCT software to the treating clinician and will be used to modify task assignment over time. PCT tracks usage of the program so that research staff can access automated reporting of subject use to monitor participant adherence to the treatment program. |
| Control Group 1 [Conventional Workbook Therapy] | Active comparator | Other: WorkbooksAt the start of the study, subjects will be provided with a tablet with videoconferencing software and the PCT app pre-installed. Subjects in the control group will be told they will have access to 3-months of PCT after their participation in the study has concluded. Subjects in this group will be provided with a standard regime of paper workbooks and instructions to complete approximately 30 minutes a day at least 5 days a week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have diagnosis of stroke involving a hemorrhage or ischemic event, resulting in speech, language, and/or cognitive deficits
- Have time post-stroke of at least 4 months prior to enrollment
- Have been discharged from rehabilitation hospital
- Are adults (aged 18 years or older) at the time of consent
- Exhibit clinically confirmed speech, language, and/or cognitive deficits based on medical records
Key exclusion criteria (6 listed)
- Have comorbid neurological conditions that could impair study participation in the opinion of the investigator, such as dementia or Parkinson's disease
- Currently require inpatient care or acute care
- Are currently undergoing related one-on-one individual therapy at a hospital, rehabilitation facility, university, or at home
- Exhibit severe apraxia of speech or severe dysarthria of speech, as verified by a clinician and confirmed by the WAB-R (and the Screen for Dysarthria and Apraxia of Speech if necessary), and/or medical records
- Have comorbid psychiatric conditions that could impair study participation in the opinion of the investigator, including such as schizophrenia or major depressive disorder, as indicated by medical records
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 |
|---|---|---|
| PCTPCT is designed to deliver similar therapy as is conventionally provided in-clinic by a Speech Language Pathologist (SLP), which the patient can access from any location using the application installed on a supported tablet. The device functions by allowing clinicians to create a personalized therapy program for each patient from 75 categories of clinical therapies, which patients may access from their tablet device remotely. The PCT software is comprised primarily of authentication and an algorithm that suggests advancement of the therapy program based on observed patient deficits and progress. | Other | Experimental Group |
| WorkbooksSubjects in this group will be provided with a standard regime of paper workbooks (e.g. Workbook for Aphasia: Exercises for Expressive and Receptive Language Functioning; Brubaker, 2006) that are typically used by clinicians to practice therapy tasks with individuals. Notably, the control procedure employed here is similar to that employed on a large-scale study examining technology as a treatment option and involved usual care control group by Palmer and colleagues (2015). | Other | Control Group 1 [Conventional Workbook Therapy] |
Primary outcome
Western Aphasia Battery Revised, Aphasia Quotient (WAB-AQ)
Time frame: Baseline assessment
The WAB-R is a standardized tool that assesses language and cognitive skills and provides scores quantifying the impact of a stroke on those skills. The Aphasia Quotient from the WAB-R includes segments from Part 1 of the assessment, evaluating spontaneous speech including fluency and information content, auditory comprehension, naming, and repetition.
Western Aphasia Battery Revised, Aphasia Quotient (WAB-AQ)
Time frame: Follow-up assessment 10-12 weeks post baseline
The WAB-R is a standardized tool that assesses language and cognitive skills and provides scores quantifying the impact of a stroke on those skills. The Aphasia Quotient from the WAB-R includes segments from Part 1 of the assessment, evaluating spontaneous speech including fluency and information content, auditory comprehension, naming, and repetition.
8 secondary outcomes
Western Aphasia Battery Revised, Cortical Quotient (WAB-CQ)
Time frame: Baseline assessment
Western Aphasia Battery Revised, Cortical Quotient (WAB-CQ)
Time frame: Follow-up assessment 10-12 weeks post baseline
Western Aphasia Battery Revised, Language Quotient (WAB-LQ)
Time frame: Baseline assessment
Western Aphasia Battery Revised, Language Quotient (WAB-LQ)
Time frame: Follow-up assessment 10-12 weeks post baseline
Brief Test of Adult Cognition by Telephone (BTACT)
Time frame: Baseline assessment
Brief Test of Adult Cognition by Telephone (BTACT)
Time frame: Follow-up assessment 10-12 weeks post baseline
Stroke and Aphasia Quality of Life Scale 39 (SAQOL-39)
Time frame: Baseline assessment
Stroke and Aphasia Quality of Life Scale 39 (SAQOL-39)
Time frame: Follow-up assessment 10-12 weeks post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Background: PubMed 29990345Palmer R, Witts H, Chater T. What speech and language therapy do community dwelling stroke survivors with aphasia receive in the UK? PLoS One. 2018 Jul 10;13(7):e0200096. doi: 10.1371/journal.pone.0200096. eCollection 2018.
- Background: PubMed 16943264Tun PA, Lachman ME. Telephone assessment of cognitive function in adulthood: the Brief Test of Adult Cognition by Telephone. Age Ageing. 2006 Nov;35(6):629-32. doi: 10.1093/ageing/afl095. Epub 2006 Aug 30. No abstract available.
- Background: PubMed 32191122Dekhtyar M, Braun EJ, Billot A, Foo L, Kiran S. Videoconference Administration of the Western Aphasia Battery-Revised: Feasibility and Validity. Am J Speech Lang Pathol. 2020 May 8;29(2):673-687. doi: 10.1044/2019_AJSLP-19-00023. Epub 2020 Mar 19.
- Background: PubMed 22472032Caute A, Northcott S, Clarkson L, Pring T, Hilari K. Does mode of administration affect health-related quality-of-life outcomes after stroke? Int J Speech Lang Pathol. 2012 Aug;14(4):329-37. doi: 10.3109/17549507.2012.663789. Epub 2012 Apr 4.
- Derived from this study: PubMed 33643204Braley M, Pierce JS, Saxena S, De Oliveira E, Taraboanta L, Anantha V, Lakhan SE, Kiran S. A Virtual, Randomized, Control Trial of a Digital Therapeutic for Speech, Language, and Cognitive Intervention in Post-stroke Persons With Aphasia. Front Neurol. 2021 Feb 12;12:626780. doi: 10.3389/fneur.2021.626780. eCollection 2021.
- Individual participant dataSharing planned: No. De-identified, aggregate only. Data will be available at the request of other investigators for purposes of replicating procedures and results. Anonymized data will be shared by request from any qualified investigator.
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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.
Swathi Kiran, PhD, CCC-SLP study director
The Learning Corp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PCT and Workbooks in people with Aphasia, Acquired, run by The Learning Corp 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 8 inclusion and 6 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 27 Jul 2020. 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.
What does this phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Western Aphasia Battery Revised, Aphasia Quotient (WAB-AQ) (time frame: Baseline assessment). 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?
On the ClinicalTrials.gov record for NCT04488029, which also lists 5 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 27 Jul 2020; AzTrials last refreshed its copy on 2 Nov 2026.