ClinicalTrials.gg
WithdrawnNCT03770377Updated Jun 15, 2021

Laryngeal Adaptation for Speech and Swallowing

An interventional study of Intermittent Perturbation to Continuous Perturbation and Continuous Perturbation to Intermittent Perturbation in Stroke, Spinocerebellar Ataxia and Cerebral Stroke, sponsored by University of Florida. Withdrawn. Open to participants aged 21 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-15.

Sponsored by University of Florida · Not applicable, Interventional, and Treatment

Why this study was withdrawn
IRB Closure

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Aug 2018, registered Nov 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
21 Years to 100 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Stroke
  • Spinocerebellar Ataxia
  • Cerebral Stroke
  • Dysphagia
  • Dysarthria

Keywords

  • speech
  • swallowing
  • rehabilitation
  • stroke
  • deglutition
  • dysphagia
  • dysarthria
  • laryngeal
  • ataxia
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

Browse Stroke studies →

Lead sponsor

University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.

Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Stroke without Dysarthria

    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.

    Device: Intermittent Perturbation to Continuous Perturbation · Device: Continuous Perturbation to Intermittent Perturbation

  • Experimental
    Stroke with Dysarthria

    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.

    Device: Intermittent Perturbation to Continuous Perturbation · Device: Continuous Perturbation to Intermittent Perturbation

  • Experimental
    SCA6 without Dysarthria

    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.

    Device: Intermittent Perturbation to Continuous Perturbation · Device: Continuous Perturbation to Intermittent Perturbation

  • Experimental
    SCA6 with Dysarthria

    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.

    Device: Intermittent Perturbation to Continuous Perturbation · Device: Continuous Perturbation to Intermittent Perturbation

  • Active comparator
    Age-Matched Controls

    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.

    Device: Intermittent Perturbation to Continuous Perturbation · Device: Continuous Perturbation to Intermittent Perturbation

Interventions

  • DeviceIntermittent Perturbation to Continuous Perturbation

    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.

    Also known as: I to C Paradigm

  • DeviceContinuous Perturbation to Intermittent Perturbation

    Manipulate the Movement Planning Period (MPP), by keep sensory input about the perturbation constant by maintaining e-stim during the inter-trial interval.

    Also known as: C to I Paradigm

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1

  2. 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.

    Time frame: Day 1

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2018 to primary completion in Aug 2019, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2018
First posted
Dec 10, 2018
StartActual
Aug 24, 2018
Primary completionActual
Aug 30, 2019
CompletionActual
Aug 30, 2019
Last update
Jun 15, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03770377
Responsible party
Sponsor
First posted
Dec 10, 2018
Start date
Aug 24, 2018
Primary completion
Aug 30, 2019
Completion
Aug 30, 2019
Last update
Jun 15, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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