Dysphagia Following Cerebral InfarctionPhEEDNCT03358810
Pharyngeal Electrical Stimulation Evaluation for Dysphagia After Stroke
A study testing PES in people with Dysphagia Following Cerebral Infarction, run by Phagenesis Ltd. at 1 site in United States.
Trial summary
This is a randomized, sham-controlled, patient masked, outcome assessor-blinded study to assess a Pharyngeal Electrical Stimulation (PES) Catheter for treatment of oropharyngeal dysphagia following a stroke. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dysphagia Following Cerebral Infarction
- What is being tested?
- PES
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2018to 1 May 2020
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 90 years.
- Acute ischemic or hemorrhagic cerebral stroke within 7-28 days of baseline VFSS.
- Score of 0 or 1 on NIHSS question 1a, Level of Consciousness.
- Moderate to severe dysphagia (PAS >4) on baseline VFSS (Baseline VFSS must meet the threshold criteria of demonstrating a PAS of ≥ 4, in three of the six boli (5 mL/1 tsp/bolus), during swallowing "thin liquid" barium media as assessed by the clinical staff administering the VFSS.).
- Willing and able to have the Phagenyx® Catheter placed transnasally.
- Willing and able to provide informed consent.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
Who cannot join
- Brainstem stroke.
- Evidence of traumatic brain injury or subarachnoid hemorrhage.
- Other known brain abnormalities documented by history and/or imaging (e.g., tumor, abnormal white matter, inflammatory neuropathy, myelin delamination, hydrocephalus).
- Dysphagia from conditions other than stroke.
- Pre-stroke history of swallowing complaints or treatment or history of diseases known to be associated with swallowing problems (other neurological, head and neck cancer.
- Distorted oropharyngeal anatomy (e.g., pharyngeal pouch, major pharyngeal surgery or head /neck surgery)
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- Currently being treatment for pneumonia.
- Mute, global aphasia; no usable speech or auditory comprehension (scores 3 on NIHSS question 9, Best Language)
- NIHSS score of >25
- Presence of a tracheostomy
- Any active implanted device (e.g., cochlear implant, ICD)
- Any progressive neurological disorder (e.g., Parkinson's Disease, Multiple Sclerosis)
- Cognitive impairment that prevents compliance with protocol-specific instructions and assessments
- Unstable cardiopulmonary condition, i.e., not on maintenance therapy.
- Currently participating in another investigational study
- Pregnant or planning to become pregnant while participating in the clinical study -Known Allergy to oral radiographic contrast media (specifically barium) -
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized, sham-controlled, patient masked, outcome assessor-blinded study to assess a Pharyngeal Electrical Stimulation (PES) Catheter for treatment of oropharyngeal dysphagia following a stroke.
Read the detailed description
Randomization will be stratified at each site in a 1:1 fashion. All patients will have the Phagenyx® Catheter placed prior to randomization, and will receive either an active treatment of Pharyngeal Electrical Stimulation (PES) or a sham treatment performed by a health care professional (HCP) that is un-blinded to treatment assignment. All other speech pathology standard dysphagia care will be provided by a speech language pathologist (SLP) that is blinded to treatment assignment. Administration of all protocol-specific assessments will be conducted by personnel blinded to treatment assignment.
The study will follow an adaptive group sequential design with unblinded sample size re-assessment. To ensure 180 evaluable patients with 7-day data and assuming a 20% dropout rate, 225 patients will be enrolled initially. An interim analysis for futility will occur after the first 60 patients complete their 7-day visits and another interim analysis will be performed for efficacy and futility after 120 patients complete their 7-day visits. The total sample size may be increased up to 338 patients after the second interim analysis to ensure up to 270 evaluable patients. Up to 15 investigational centers across the US and possibly Europe will participate in this study. The enrollment period is expected to be approximately 24 months and patient participation will last for approximately 11 weeks. Patients will be assessed at the following intervals: baseline, 48 hours, 7 days, 14 days or at discharge, whichever is first, and 11 weeks after completion of the study treatments.
- Conditions
- Dysphagia Following Cerebral Infarction
- Being tested
- PES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PESDevice
Also called Pharyngeal Electrical Stimulation
The PES system is a two-part neurostimulation system. It is composed of a durable component called the Base Station and the single-use sterile disposable Phagenyx® Catheter. The Base Station acts as the user interface and provides the means to generate, optimize and monitor the delivery of electrical stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | patients randomized to receive active PES Receives: Device: PES |
| Sham treatmment | Sham comparator | Patients randomized to sham will not receive any PES. Receives: Device: PES |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of treatment in reducing the severity of unsafe swallows based on PAS(Penetration Aspiration Scale)of each swallow during VFSS
VFSS (Vidoeflouroscopic Swallow Study) Swallowing safety of a bolus of thin and nectar consistency determined by a videofluoroscopic swallowing study.The PAS provides a scoring mechanism for airway closure and clearance during the VFSS. The PAS is a validated 8-point scale that measures penetration and aspiration. Scores are determined primarily by the depth to which material passes into the airway.
- Material does not enter airway
- Material enters the airway, remains above the vocal folds, and is ejected
- Material remains above the vocal folds, and is not ejected from airway
- Material contacts the vocal folds, and is ejected
- Material contacts the vocal folds, and is not ejected
- Material passes below the vocal folds , and is ejected out airway
- Material passes below the vocal folds, and is not ejected from trachea
- Material enters the airway , and no effort is made to eject it
Measured: 48 hours post final treatment
Secondary outcomes (1)
To evaluate the efficacy of Phagenyx® treatment in improving nutritional management
Nutritional management changes will be evaluated via:
Time from baseline to removal of enteral feeding (i.e., removal of NG tube or PEG or transition to oral feeding, or first diet upgrade,Functional Oral Intake Scale (FOIS) at 7 days, 14 days or discharge, whichever is first, and 11 weeks
Measured: 11 weeks post final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start31 Mar 2018
- Primary completion31 Jan 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphagia Following Cerebral InfarctionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phagenesis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regulatory and Clinical Research Institute Inc, Cytel Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358810
- Sponsor's protocol ID
- AHE-05
- Acronym
- PhEED
- Status last verified
- Dec 2024
- First submitted
- 21 Nov 2017
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharyngeal Electrical Stimulation Evaluation for Dysphagia After Stroke
- ClinicalTrials.gov ID
- NCT03358810
- Acronym / sponsor ID
- PhEED / AHE-05
- Conditions
- Dysphagia Following Cerebral Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Phagenesis Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Regulatory and Clinical Research Institute Inc, Cytel Inc.
- Study start
- 31 Mar 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 2 Dec 2017 (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 is a randomized, sham-controlled, patient masked, outcome assessor-blinded study to assess a Pharyngeal Electrical Stimulation (PES) Catheter for treatment of oropharyngeal dysphagia following a stroke.
Detailed description
Randomization will be stratified at each site in a 1:1 fashion. All patients will have the Phagenyx® Catheter placed prior to randomization, and will receive either an active treatment of Pharyngeal Electrical Stimulation (PES) or a sham treatment performed by a health care professional (HCP) that is un-blinded to treatment assignment. All other speech pathology standard dysphagia care will be provided by a speech language pathologist (SLP) that is blinded to treatment assignment. Administration of all protocol-specific assessments will be conducted by personnel blinded to treatment assignment.
The study will follow an adaptive group sequential design with unblinded sample size re-assessment. To ensure 180 evaluable patients with 7-day data and assuming a 20% dropout rate, 225 patients will be enrolled initially. An interim analysis for futility will occur after the first 60 patients complete their 7-day visits and another interim analysis will be performed for efficacy and futility after 120 patients complete their 7-day visits. The total sample size may be increased up to 338 patients after the second interim analysis to ensure up to 270 evaluable patients. Up to 15 investigational centers across the US and possibly Europe will participate in this study. The enrollment period is expected to be approximately 24 months and patient participation will last for approximately 11 weeks. Patients will be assessed at the following intervals: baseline, 48 hours, 7 days, 14 days or at discharge, whichever is first, and 11 weeks after completion of the study treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Device: PESpatients randomized to receive active PES |
| Sham treatmment | Sham comparator | Device: PESPatients randomized to sham will not receive any PES. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 and ≤ 90 years.
- Acute ischemic or hemorrhagic cerebral stroke within 7-28 days of baseline VFSS.
- Score of 0 or 1 on NIHSS question 1a, Level of Consciousness.
- Moderate to severe dysphagia (PAS >4) on baseline VFSS (Baseline VFSS must meet the threshold criteria of demonstrating a PAS of ≥ 4, in three of the six boli (5 mL/1 tsp/bolus), during swallowing "thin liquid" barium media as assessed by the clinical staff administering the VFSS.).
- Willing and able to have the Phagenyx® Catheter placed transnasally.
Key exclusion criteria (16 listed)
- Brainstem stroke.
- Evidence of traumatic brain injury or subarachnoid hemorrhage.
- Other known brain abnormalities documented by history and/or imaging (e.g., tumor, abnormal white matter, inflammatory neuropathy, myelin delamination, hydrocephalus).
- Dysphagia from conditions other than stroke.
- Pre-stroke history of swallowing complaints or treatment or history of diseases known to be associated with swallowing problems (other neurological, head and neck cancer.
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 |
|---|---|---|
| PESAlso: Pharyngeal Electrical StimulationThe PES system is a two-part neurostimulation system. It is composed of a durable component called the Base Station and the single-use sterile disposable Phagenyx® Catheter. The Base Station acts as the user interface and provides the means to generate, optimize and monitor the delivery of electrical stimulation. | Device | Active group, Sham treatmment |
Primary outcome
To evaluate the efficacy of treatment in reducing the severity of unsafe swallows based on PAS(Penetration Aspiration Scale)of each swallow during VFSS
Time frame: 48 hours post final treatment
VFSS (Vidoeflouroscopic Swallow Study) Swallowing safety of a bolus of thin and nectar consistency determined by a videofluoroscopic swallowing study.The PAS provides a scoring mechanism for airway closure and clearance during the VFSS. The PAS is a validated 8-point scale that measures penetration and aspiration. Scores are determined primarily by the depth to which material passes into the airway. 1. Material does not enter airway 2. Material enters the airway, remains above the vocal folds, and is ejected 3. Material remains above the vocal folds, and is not ejected from airway 4. Material contacts the vocal folds, and is ejected 5. Material contacts the vocal folds, and is not ejected 6. Material passes below the vocal folds , and is ejected out airway 7. Material passes below the vocal folds, and is not ejected from trachea 8. Material enters the airway , and no effort is made to eject it
1 secondary outcome
To evaluate the efficacy of Phagenyx® treatment in improving nutritional management
Time frame: 11 weeks post final treatment
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 20 Dec 2024.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PES in people with Dysphagia Following Cerebral Infarction, run by Phagenesis Ltd. 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 7 inclusion and 16 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 20 Dec 2024. 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. Some participants in this study may receive a placebo. 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 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?
To evaluate the efficacy of treatment in reducing the severity of unsafe swallows based on PAS(Penetration Aspiration Scale)of each swallow during VFSS (time frame: 48 hours post final treatment). 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 20 Dec 2024.