StrokeNCT03770377
Laryngeal Adaptation for Speech and Swallowing
A study testing Intermittent Perturbation to Continuous Perturbation and Continuous Perturbation to Intermittent Perturbation in people with Stroke and Spinocerebellar Ataxia, run by University of Florida.
Trial summary
This study will test laryngeal adaptation in speech and swallowing function in healthy adults, in patients with cerebral stroke, and in patients with spinocerebellar ataxia type 6. Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Spinocerebellar Ataxia, Cerebral Stroke
- What is being tested?
- Intermittent Perturbation to Continuous Perturbation and Continuous Perturbation to Intermittent Perturbation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 24 Aug 2018to 30 Aug 2019
- Phase
- Interventional
- 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 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Patient Inclusion Criteria:
All stroke and ataxia
Ataxia
- DNA diagnosis of SCA6 and phenotype consistent with the DNA diagnosis
- No recessive, X-linked or mitochondrial
Stroke
- Bilateral or unilateral middle cerebral artery (MCA) stroke
- No structural abnormalities (i.e. nodules)
- Dysphagia involving laryngeal dysfunction
Stroke and ataxia with speech and swallowing disorders
- no structural abnormalities
- dysphagia involving laryngeal dysfunction
Patient Exclusion Criteria:
- Montreal Cognitive Assess. <24
- Moderate to severe hearing loss
- Barium allergy
- Other confounding speech disorder (i.e. stuttering)
- Chemo-radiation, surgical head and neck treatment
- Smoking Hx in the past 5 yrs or >5 years at any one time
- Twenty one years of age or older
- Breathing disorders or diseases
About this study
This study will test laryngeal adaptation in speech and swallowing function in healthy adults, in patients with cerebral stroke, and in patients with spinocerebellar ataxia type 6. The findings from this proposal will be the first step toward implementing rehabilitation techniques that help patients to prevent speech and swallowing errors before they occur.
- Conditions
- Stroke, Spinocerebellar Ataxia, Cerebral Stroke, Dysphagia, Dysarthria
- Being tested
- Intermittent Perturbation to Continuous Perturbation, Continuous Perturbation to Intermittent Perturbation
- Keywords
- speech, swallowing, rehabilitation, stroke, deglutition, dysphagia, dysarthria, laryngeal, ataxia
- Medical subject headings
- Stroke, Spinocerebellar Ataxias, Deglutition Disorders, Dysarthria, Speech, Laryngeal Diseases, Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Perturbation to Continuous PerturbationDevice
Also called I to C Paradigm
Manipulate the Movement Planning Period (MPP), by interrupting sensory predictions by removing e-stim during the inter-trial interval (Intermittent Perturbation), followed by a washout/de-adaptation period.
Continuous Perturbation to Intermittent PerturbationDevice
Also called C to I Paradigm
Manipulate the Movement Planning Period (MPP), by keep sensory input about the perturbation constant by maintaining e-stim during the inter-trial interval.
| Study group | Role | What they receive |
|---|---|---|
| Stroke without Dysarthria | Experimental | Examine laryngeal adaptation across all study groups: (1) baseline measures of speech or swallowing , (2) a clinical examination of disease/condition severity and (3) the experimental paradigm. Receives: Device: Intermittent Perturbation to Continuous Perturbation; Device: Continuous Perturbation to Intermittent Perturbation |
| Stroke with Dysarthria | Experimental | Examine laryngeal adaptation across all study groups: (1) baseline measures of speech or swallowing , (2) a clinical examination of disease/condition severity and (3) the experimental paradigm. Receives: Device: Intermittent Perturbation to Continuous Perturbation; Device: Continuous Perturbation to Intermittent Perturbation |
| SCA6 without Dysarthria | Experimental | Examine laryngeal adaptation across all study groups: (1) baseline measures of speech or swallowing , (2) a clinical examination of disease/condition severity and (3) the experimental paradigm. Receives: Device: Intermittent Perturbation to Continuous Perturbation; Device: Continuous Perturbation to Intermittent Perturbation |
| SCA6 with Dysarthria | Experimental | Examine laryngeal adaptation across all study groups: (1) baseline measures of speech or swallowing , (2) a clinical examination of disease/condition severity and (3) the experimental paradigm. Receives: Device: Intermittent Perturbation to Continuous Perturbation; Device: Continuous Perturbation to Intermittent Perturbation |
| Age-Matched Controls | Active comparator | Examine laryngeal adaptation across all study groups: (1) baseline measures of speech or swallowing , (2) a clinical examination of disease/condition severity and (3) the experimental paradigm. Receives: Device: Intermittent Perturbation to Continuous Perturbation; Device: Continuous Perturbation to Intermittent Perturbation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laryngeal Adaptation in Speech
To differentiate laryngeal adaptation during speech among cerebral stroke, SCA6, and healthy controls when vocal loudness is perturbed with expiratory loading.
Measured: Day 1
Laryngeal Adaptation in Swallowing
To differentiate laryngeal adaptation among cerebral stroke, SCA6, and healthy controls when swallowing is perturbed with neck surface electrical stimulation to restrict laryngeal elevation.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start24 Aug 2018
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Why it stopped: IRB Closure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A cross-sectional study design will be used to examine laryngeal adaptation across all study groups.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770377
- Sponsor's protocol ID
- IRB201702917 -A
- Other IDs
- R01DC016275-01A1, OCR19032, 5R01DC016275-02
- Status last verified
- Jun 2021
- First submitted
- 29 Nov 2018
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal Adaptation for Speech and Swallowing
- ClinicalTrials.gov ID
- NCT03770377
- Acronym / sponsor ID
- IRB201702917 -A
- Conditions
- Stroke, Spinocerebellar Ataxia, Cerebral Stroke, Dysphagia, Dysarthria
- Keywords
- speech, swallowing, rehabilitation, stroke, deglutition, dysphagia, dysarthria, laryngeal
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB Closure
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 10 Dec 2018 (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.
This study will test laryngeal adaptation in speech and swallowing function in healthy adults, in patients with cerebral stroke, and in patients with spinocerebellar ataxia type 6. The findings from this proposal will be the first step toward implementing rehabilitation techniques that help patients to prevent speech and swallowing errors before they occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- A cross-sectional study design will be used to examine laryngeal adaptation across all study groups.
| Arm | Type | Receives |
|---|---|---|
| Stroke without Dysarthria | Experimental | Device: Intermittent Perturbation to Continuous Perturbation, Device: Continuous Perturbation to Intermittent PerturbationExamine laryngeal adaptation across all study groups: (1) baseline measures of speech or swallowing , (2) a clinical examination of disease/condition severity and (3) the experimental paradigm. |
| Stroke with Dysarthria | Experimental | Device: Intermittent Perturbation to Continuous Perturbation, Device: Continuous Perturbation to Intermittent PerturbationExamine laryngeal adaptation across all study groups: (1) baseline measures of speech or swallowing , (2) a clinical examination of disease/condition severity and (3) the experimental paradigm. |
| SCA6 without Dysarthria | Experimental | Device: Intermittent Perturbation to Continuous Perturbation, Device: Continuous Perturbation to Intermittent PerturbationExamine laryngeal adaptation across all study groups: (1) baseline measures of speech or swallowing , (2) a clinical examination of disease/condition severity and (3) the experimental paradigm. |
| SCA6 with Dysarthria | Experimental | Device: Intermittent Perturbation to Continuous Perturbation, Device: Continuous Perturbation to Intermittent PerturbationExamine laryngeal adaptation across all study groups: (1) baseline measures of speech or swallowing , (2) a clinical examination of disease/condition severity and (3) the experimental paradigm. |
| Age-Matched Controls | Active comparator | Device: Intermittent Perturbation to Continuous Perturbation, Device: Continuous Perturbation to Intermittent PerturbationExamine laryngeal adaptation across all study groups: (1) baseline measures of speech or swallowing , (2) a clinical examination of disease/condition severity and (3) the experimental paradigm. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Intermittent Perturbation to Continuous PerturbationAlso: I to C ParadigmManipulate the Movement Planning Period (MPP), by interrupting sensory predictions by removing e-stim during the inter-trial interval (Intermittent Perturbation), followed by a washout/de-adaptation period. | Device | Age-Matched Controls, SCA6 with Dysarthria, SCA6 without Dysarthria, Stroke with Dysarthria, Stroke without Dysarthria |
| Continuous Perturbation to Intermittent PerturbationAlso: C to I ParadigmManipulate the Movement Planning Period (MPP), by keep sensory input about the perturbation constant by maintaining e-stim during the inter-trial interval. | Device | Age-Matched Controls, SCA6 with Dysarthria, SCA6 without Dysarthria, Stroke with Dysarthria, Stroke without Dysarthria |
Primary outcome
Laryngeal Adaptation in Speech
Time frame: Day 1
To differentiate laryngeal adaptation during speech among cerebral stroke, SCA6, and healthy controls when vocal loudness is perturbed with expiratory loading.
Laryngeal Adaptation in Swallowing
Time frame: Day 1
To differentiate laryngeal adaptation among cerebral stroke, SCA6, and healthy controls when swallowing is perturbed with neck surface electrical stimulation to restrict laryngeal elevation.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Perturbation to Continuous Perturbation and Continuous Perturbation to Intermittent Perturbation in people with Stroke and Spinocerebellar Ataxia, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Laryngeal Adaptation in Speech (time frame: Day 1). 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 15 Jun 2021.