StrokeEarly Phase 1STARTNCT04816799
Efficacy of START (Startle Rehabilitation Therapy) in the Treatment Stroke-induced Aphasia/Apraxia
A Early Phase 1 study testing Startle Adjuvant Rehabilitation Therapy (START) in people with Stroke and Aphasia, run by Arizona State University at 1 site in United States.
Trial summary
A stratified, parallel-group, double-blind, randomized controlled trial of remotely delivered START treatment to individuals with severe-to-moderate stroke (with recruitment focused on individuals with low SES) will be conducted. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke, Aphasia, Apraxia of Speech
- What is being tested?
- Startle Adjuvant Rehabilitation Therapy (START)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2020to Aug 2022
- Phase
- Early Phase 1
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old
- Native English Speakers
- Capacity to provide informed consent
- Right-handed
- Corrected to normal vision
- Left hemisphere cerebral stroke at least 6 months prior to testing
- Presence of severe-to-moderate, non-fluent aphasia, i.e. Aphasia Quotients of 0-50 on the Western Aphasia Battery-Revised (PsychCorp, 2007)
- Corrected pure tone threshold (octave frequencies 250- 4000 Hz) norms for their age and gender41,42 NOTE: Audiometry data will be collected for all participants by lab personnel trained by an audiologist in a sound-attenuated booth. Based on our ongoing aphasia studies, we expect that ~30% of participants will use hearing aids; we will not exclude these individuals but rather include hearing aid use as a covariate in analyses.
Who cannot join
- Severe concurrent uncontrolled medical problems (e.g. cardiorespiratory impairment).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Arizona State University
Tempe, Arizona, 85287
Claire F Honeycutt, PhD, 480-965-8453, claire.honeycutt@asu.edu
About this study
A stratified, parallel-group, double-blind, randomized controlled trial of remotely delivered START treatment to individuals with severe-to-moderate stroke (with recruitment focused on individuals with low SES) will be conducted. Subjects and assessors will be blinded to the condition making the experiment double blind. Specifically, subjects will be told that we are exploring a new therapy that using different sounds to improve therapy. Parallel group design will ensure that subjects in the Control group are unaware that their "sounds" are softer than the START group. Trainers may become aware that a loud sound is present thus a unique Assessor will evaluate clinical performance before and after training making the study double-blind. Fifty-four subjects will undergo baseline testing in the laboratory to establish their capacity for functional and expressive speech as well as their self-reported health-related quality of life (power analysis below). Next, subjects will participate in a high-frequency, word-picture verification/ auditory-repetition treatment, 2 hr/day for 5 consecutive days focusing on expression of words of functional significance (e.g., water, fall). Subjects will either receive training with START or without (Control). Subjects will be re-tested immediately following training as well as one-month post to assess retention. Aim 1 will evaluate capacity of START to enhance SLT outcomes by assessing the % change in clinical assessment of functional and expressive speech. Our preliminary data points to a robust response [details]. Aim 2 will focus on the capacity of these changes to 1) be retained and 2) impact subject's reported quality of life. NOTE: While we are planning in-person baseline, end, and retention testing, in response to COVID, we have established remote clinical screening using peer-reviewed validated techniques for WAB and ABA-2 (see Alternative Solutions). All preliminary data collected for this proposal were collected remotely via no-contact protocols.
- Conditions
- Stroke, Aphasia, Apraxia of Speech
- Being tested
- Startle Adjuvant Rehabilitation Therapy (START)
- Medical subject headings
- Stroke, Aphasia, Apraxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Startle Adjuvant Rehabilitation Therapy (START)Behavioural
Exposure to loud acoustic stimulus during training of motor task (in this case speech).
| Study group | Role | What they receive |
|---|---|---|
| START | Experimental | START (startle adjuvant rehabilitation therapy) will be applied. Receives: Behavioral: Startle Adjuvant Rehabilitation Therapy (START) |
| Control | No intervention | Subjects will train but without START |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Aphasia Battery
(WAB) will be administered to determine aphasia severity via its aphasia quotient, as well as aphasia type. Severe non-fluent aphasia will be defined as an aphasia quotient < 50 and a classification of Broca's, global, or transcortical motor aphasia.
Measured: end of training
Western Aphasia Battery Retention
(WAB) will be administered to determine aphasia severity via its aphasia quotient, as well as aphasia type. Severe non-fluent aphasia will be defined as an aphasia quotient < 50 and a classification of Broca's, global, or transcortical motor aphasia.
Measured: one month post
Apraxia Battery for adults
(ABA-2) will be collected to identify presence and severity of apraxia of speech (AOS) via its six subtests: diadochokinetic rate, increasing word length, limb and oral apraxia, and latency and utterance for polysyllabic words, repeated trials, and inventory of articulation characteristics.
Measured: end of training
Apraxia Battery for adults Retention
(ABA-2) will be collected to identify presence and severity of apraxia of speech (AOS) via its six subtests: diadochokinetic rate, increasing word length, limb and oral apraxia, and latency and utterance for polysyllabic words, repeated trials, and inventory of articulation characteristics.
Measured: one-month post
Stroke Impact Scale
(SIS) is a self-report scale of disability and health-related quality of life. We will use the subdomains of Communication, ADL/LDL, Life participation, Quality of life, Social Relationships, Depression.
Measured: Baseline, end of training, one-month post
Stroke Impact Scale Retention
(SIS) is a self-report scale of disability and health-related quality of life. We will use the subdomains of Communication, ADL/LDL, Life participation, Quality of life, Social Relationships, Depression.
Measured: one-month post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start22 Jul 2020
- Primary completionMar 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claire Honeycutt, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816799
- Sponsor's protocol ID
- STUDY00005229
- Acronym
- START
- Status last verified
- Feb 2022
- First submitted
- 23 Mar 2021
- Last updated
- 22 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Swann Z, Tesman N, Rogalsky C, Honeycutt CF. Word Repetition Paired With Startling Stimuli Decreases Aphasia and Apraxia Severity in Severe-to-Moderate Stroke: A Stratified, Single-Blind, Randomized, Phase 1 Clinical Trial. Am J Speech Lang Pathol. 2023 Nov 6;32(6):2630-2653. doi: 10.1044/2023_AJSLP-22-00296. Epub 2023 Sep 12.
PubMed 37699161
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of START (Startle Rehabilitation Therapy) in the Treatment Stroke-induced Aphasia/Apraxia
- ClinicalTrials.gov ID
- NCT04816799
- Acronym / sponsor ID
- START / STUDY00005229
- Conditions
- Stroke, Aphasia, Apraxia of Speech
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 25 Mar 2021 (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.
A stratified, parallel-group, double-blind, randomized controlled trial of remotely delivered START treatment to individuals with severe-to-moderate stroke (with recruitment focused on individuals with low SES) will be conducted. Subjects and assessors will be blinded to the condition making the experiment double blind. Specifically, subjects will be told that we are exploring a new therapy that using different sounds to improve therapy. Parallel group design will ensure that subjects in the Control group are unaware that their "sounds" are softer than the START group. Trainers may become aware that a loud sound is present thus a unique Assessor will evaluate clinical performance before and after training making the study double-blind. Fifty-four subjects will undergo baseline testing in the laboratory to establish their capacity for functional and expressive speech as well as their self-reported health-related quality of life (power analysis below). Next, subjects will participate in a high-frequency, word-picture verification/ auditory-repetition treatment, 2 hr/day for 5 consecutive days focusing on expression of words of functional significance (e.g., water, fall). Subjects will either receive training with START or without (Control). Subjects will be re-tested immediately following training as well as one-month post to assess retention. Aim 1 will evaluate capacity of START to enhance SLT outcomes by assessing the % change in clinical assessment of functional and expressive speech. Our preliminary data points to a robust response [details]. Aim 2 will focus on the capacity of these changes to 1) be retained and 2) impact subject's reported quality of life. NOTE: While we are planning in-person baseline, end, and retention testing, in response to COVID, we have established remote clinical screening using peer-reviewed validated techniques for WAB and ABA-2 (see Alternative Solutions). All preliminary data collected for this proposal were collected remotely via no-contact protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| START | Experimental | Behavioral: Startle Adjuvant Rehabilitation Therapy (START)START (startle adjuvant rehabilitation therapy) will be applied. |
| Control | No intervention | –Subjects will train but without START |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years old
- Native English Speakers
- Capacity to provide informed consent
- Right-handed
- Corrected to normal vision
Key exclusion criteria (1 listed)
- Severe concurrent uncontrolled medical problems (e.g. cardiorespiratory impairment).
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 |
|---|---|---|
| Startle Adjuvant Rehabilitation Therapy (START)Exposure to loud acoustic stimulus during training of motor task (in this case speech). | Behavioural | START |
Primary outcome
Western Aphasia Battery
Time frame: end of training
(WAB) will be administered to determine aphasia severity via its aphasia quotient, as well as aphasia type. Severe non-fluent aphasia will be defined as an aphasia quotient < 50 and a classification of Broca's, global, or transcortical motor aphasia.
Western Aphasia Battery Retention
Time frame: one month post
(WAB) will be administered to determine aphasia severity via its aphasia quotient, as well as aphasia type. Severe non-fluent aphasia will be defined as an aphasia quotient < 50 and a classification of Broca's, global, or transcortical motor aphasia.
Apraxia Battery for adults
Time frame: end of training
(ABA-2) will be collected to identify presence and severity of apraxia of speech (AOS) via its six subtests: diadochokinetic rate, increasing word length, limb and oral apraxia, and latency and utterance for polysyllabic words, repeated trials, and inventory of articulation characteristics.
Apraxia Battery for adults Retention
Time frame: one-month post
(ABA-2) will be collected to identify presence and severity of apraxia of speech (AOS) via its six subtests: diadochokinetic rate, increasing word length, limb and oral apraxia, and latency and utterance for polysyllabic words, repeated trials, and inventory of articulation characteristics.
Stroke Impact Scale
Time frame: Baseline, end of training, one-month post
(SIS) is a self-report scale of disability and health-related quality of life. We will use the subdomains of Communication, ADL/LDL, Life participation, Quality of life, Social Relationships, Depression.
Stroke Impact Scale Retention
Time frame: one-month post
(SIS) is a self-report scale of disability and health-related quality of life. We will use the subdomains of Communication, ADL/LDL, Life participation, Quality of life, Social Relationships, Depression.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Derived from this study: PubMed 37699161Swann Z, Tesman N, Rogalsky C, Honeycutt CF. Word Repetition Paired With Startling Stimuli Decreases Aphasia and Apraxia Severity in Severe-to-Moderate Stroke: A Stratified, Single-Blind, Randomized, Phase 1 Clinical Trial. Am J Speech Lang Pathol. 2023 Nov 6;32(6):2630-2653. doi: 10.1044/2023_AJSLP-22-00296. Epub 2023 Sep 12.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Startle Adjuvant Rehabilitation Therapy (START) in people with Stroke and Aphasia, run by Arizona State University 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 1 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: status not confirmed, as of the sponsor's last update on 22 Feb 2022. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire F Honeycutt, PhD (4809658453, claire.honeycutt@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Aphasia Battery (time frame: end of training). The study lists 6 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 NCT04816799, which also lists 1 linked publication.
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 22 Feb 2022.