Facial Nerve ParesisNCT04457492
Functional Electrical Stimulation for Facial Muscles
A study testing Application of FES to the Face in people with Facial Nerve Paresis, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Partial or complete facial paralysis is the weakness of muscles of facial expression. Facial paralysis causes physical, social and emotional problems. Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated, causing them to contract This study is… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Facial Nerve Paresis
- What is being tested?
- Application of FES to the Face
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2021to 16 Mar 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients experiencing unilateral facial nerve paralysis Brackmann 5/6 or 6/6.
Who cannot join
- History of epilepsy or seizures.
- Individuals with metal orthopedic implants in the mouth (e.g. plates or screws).
- Individuals suffering from fibromyalgia.
- Individuals currently receiving any form of transcranial brain stimulation (e.g. rTMS, ECT, or MST).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Applying Functional Electrical Stimulation to Facial Muscles After Acute Paralysis
Partial or complete facial paralysis is the weakness of muscles of facial expression. Facial paralysis causes physical, social and emotional problems. Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated, causing them to contract This study is designed to help patients with facial nerve weakness.
- Conditions
- Facial Nerve Paresis
- Being tested
- Application of FES to the Face
- Keywords
- Facial Nerve Paralysis, Functional Electrical Stimulation, Rehabilitation
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of FES to the FaceOther
Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated.
| Study group | Role | What they receive |
|---|---|---|
| Acute Facial Nerve Injury with Intact Facial Nerve | Experimental | 40 sessions of FES (in a 14 week period)
Assessments will be taken during the beginning, middle, and end of each study arm. Receives: Other: Application of FES to the Face |
| Facial Nerve Grafting After Surgical Excision | Experimental | 40 sessions of FES (in a 14 week period)
Assessments will be taken during the beginning, middle, and end of each study arm. Receives: Other: Application of FES to the Face |
| Standard of Care Group | No intervention | No FES Assessments will be taken at the same intervals as the interventions group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lagophthalmos Over 14 weeks
Change in ability to close eyelids, measured in mm
Measured: Measured at week 0, 7 and 14
Change in Elevation of Corner of Mouth Over 14 weeks
Change in ability to raise corner of mouth, measured in mm
Measured: Measured at week 0, 7 and 14
Change House-Brackmann Scale Measurement Over 14 weeks
The House-Brackmann facial nerve grading scale is a measure of facial nerve impairment. The scale ranges from values 1 to 6, with larger values indicating greater facial nerve impairment.
Measured: Measured at week 0, 7 and 14
FaCE Questionnaire
Patient-based instrument to measure both facial impairment and disability. This will be used to identify patient's perceived change in facial impairment for the duration of the study period.
Measured: Administered at week 0, 7 and 14
Change in Facial Movements Over 14 weeks
A video will be taken of the patient undergoing standard facial movements
Measured: Measured at week 0, 7 and 14
Study Interview
A structured interview questionnaire administered by a study team member to identify any changes to the therapy that may be needed before further studies are conducted
Measured: Administered at week 0, 7 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Nov 2021
- Primary completion16 Mar 2023
- Study completion16 Mar 2023
Why it stopped: PI Relocation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Nerve ParesisStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas Chepeha, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457492
- Sponsor's protocol ID
- 19-5743
- Status last verified
- Mar 2024
- First submitted
- 8 Jun 2020
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Functional Electrical Stimulation to Facial Muscles After Acute Paralysis
- ClinicalTrials.gov ID
- NCT04457492
- Acronym / sponsor ID
- 19-5743
- Conditions
- Facial Nerve Paresis
- Keywords
- Facial Nerve Paralysis, Functional Electrical Stimulation, Rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI Relocation
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 7 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.
Partial or complete facial paralysis is the weakness of muscles of facial expression. Facial paralysis causes physical, social and emotional problems. Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated, causing them to contract This study is designed to help patients with facial nerve weakness.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute Facial Nerve Injury with Intact Facial Nerve | Experimental | Other: Application of FES to the Face40 sessions of FES (in a 14 week period) Assessments will be taken during the beginning, middle, and end of each study arm. |
| Facial Nerve Grafting After Surgical Excision | Experimental | Other: Application of FES to the Face40 sessions of FES (in a 14 week period) Assessments will be taken during the beginning, middle, and end of each study arm. |
| Standard of Care Group | No intervention | –No FES Assessments will be taken at the same intervals as the interventions group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients experiencing unilateral facial nerve paralysis Brackmann 5/6 or 6/6.
Key exclusion criteria (4 listed)
- History of epilepsy or seizures.
- Individuals with metal orthopedic implants in the mouth (e.g. plates or screws).
- Individuals suffering from fibromyalgia.
- Individuals currently receiving any form of transcranial brain stimulation (e.g. rTMS, ECT, or MST).
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 |
|---|---|---|
| Application of FES to the FaceFunctional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated. | Other | Acute Facial Nerve Injury with Intact Facial Nerve, Facial Nerve Grafting After Surgical Excision |
Primary outcome
Change in Lagophthalmos Over 14 weeks
Time frame: Measured at week 0, 7 and 14
Change in ability to close eyelids, measured in mm
Change in Elevation of Corner of Mouth Over 14 weeks
Time frame: Measured at week 0, 7 and 14
Change in ability to raise corner of mouth, measured in mm
Change House-Brackmann Scale Measurement Over 14 weeks
Time frame: Measured at week 0, 7 and 14
The House-Brackmann facial nerve grading scale is a measure of facial nerve impairment. The scale ranges from values 1 to 6, with larger values indicating greater facial nerve impairment.
FaCE Questionnaire
Time frame: Administered at week 0, 7 and 14
Patient-based instrument to measure both facial impairment and disability. This will be used to identify patient's perceived change in facial impairment for the duration of the study period.
Change in Facial Movements Over 14 weeks
Time frame: Measured at week 0, 7 and 14
A video will be taken of the patient undergoing standard facial movements
Study Interview
Time frame: Administered at week 0, 7 and 14
A structured interview questionnaire administered by a study team member to identify any changes to the therapy that may be needed before further studies are conducted
Results and safety
The study was stopped early (reason given: PI Relocation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
Related trials for Facial Nerve Paresis
RecruitingObservational study
Genetic Studies of Strabismus, Congenital Cranial Dysinnervation Disorders (CCDDs), and Their Associated Anomalies
Congenital Fibrosis of Extraocular Muscles, Duane Retraction Syndrome
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.
Douglas Chepeha, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of FES to the Face in people with Facial Nerve Paresis, run by University Health Network, Toronto at 1 site in Canada.
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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 20 Mar 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 Canada. 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.
Are results available for this study?
The study was stopped early (reason given: PI Relocation). Results are not available in the source record.
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?
Change in Lagophthalmos Over 14 weeks (time frame: Measured at week 0, 7 and 14). 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?
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 Mar 2024.