Facial PalsyNCT07325604
Effect of Neuromuscular Electrical Stimulation on Unilateral Central Facial Palsy
A study testing Neuromuscular electrical stimulation (NMES) in people with Facial Palsy and Stroke, run by University of Aarhus at 1 site in Denmark.
Trial summary
Background Central facial palsy (CFP) is a common condition in stroke, with an estimated prevalence of 45%. CFP can lead to facial asymmetry, problems with mouth closure and food processing, bite marks on the cheek, social isolation, and reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Palsy, Stroke
- What is being tested?
- Neuromuscular electrical stimulation (NMES)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Feb 2026to 15 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Central facial palsy
- First time stroke
- >=18 years
- Able to provide written consent
Who cannot join
- Not able to cooperate for mimical exercises
- Contraindications for NMES
- Admitted for three weeks assessment stay at the hospital
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Hammel neurorehabilitation centre and university research clinic
Hammel, 8450
Jesper Fabricius, PhD, +4578419051, jesperjm@hotmail.com
jesperjm@hotmail.com
About this study
Official title: Effect of Neuromuscular Electrical Stimulation on Unilaterial Central Facial Palsy: An Assesorblinded Randomized Controlled Trial
Background Central facial palsy (CFP) is a common condition in stroke, with an estimated prevalence of 45%. CFP can lead to facial asymmetry, problems with mouth closure and food processing, bite marks on the cheek, social isolation, and reduced quality of life. CFP is seen as an important area of rehabilitation, and training is therefore often carried out to reduce the consequences of CFP. In a recent systematic review conducted by the principal investigator, the results showed that very few studies have been conducted that have investigated the effect of training for CFP, and there is currently no scientific evidence to support the effect of the various training interventions.
Objective To investigate the effect of Neuromuscular electrical stimulation (NMES) on facial symmetry compared to usual practice, in participants with CFP as a result of stroke.
Read more
Hypothesis: Participants who receive training with NMES together with usual training for facial paralysis have greater improvement in facial symmetry than participants who only receive usual training for facial paralysis.
Trial design Randomized controlled trial (RCT) with a nested pilot trial. A pilot trial/RCT will be conducted in order to power calculation in an RCT. The protocol for the pilot trial and RCT will be the same, and participants from the pilot trial and their outcome data are thus expected to be included in the RCT.
- Conditions
- Facial Palsy, Stroke
- Being tested
- Neuromuscular electrical stimulation (NMES), Usual Care
- Keywords
- NMES, Central facial palsy, Multicenter RCT, Stroke, Facial symmetry
- Medical subject headings
- Facial Paralysis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulation (NMES)Device
Electrical stimulation of facial muscles.
Usual CareOther
This arm receives usual care of facial palsy without NMES. Usual care encompass mimical exercises, facio oral sensory input, and kinesio taping.
| Study group | Role | What they receive |
|---|---|---|
| NMES | Experimental | NMES is provided as an add-on to usual care Receives: Device: Neuromuscular electrical stimulation (NMES); Other: Usual Care |
| Usual care | Active comparator | This arm receives usual care of facial palsy without NMES. Usual care encompass mimical exercises, facio oral sensory input, and kinesio taping. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
My Facial Quantification (MyFacialQ)
MyFacialQ quantifies degree of unilateral facial palsy through video recordings of mimical exercises. The development and validation study for MyFacialQ is in review.
Measured: From enrollment to the end of treatment at four weeks"
Secondary outcomes (2)
Iowa Oral Performance Instrument (IOPI)
Measurement of lip strength
Measured: From enrollment to the end of treatment at four weeks
Facial Clinimetric Evaluation (FACE)
Patient reported outcome on facial palsy
Measured: From enrollment to three months follow-up after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start27 Feb 2026
- Primary completion15 Dec 2030 (estimated)
- Study completion15 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial PalsyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Association of Occupational Therapist, Hammel Neurorehabilitation Centre and University Research Clinic, Hospital of Central Denmark Region, Denmark
- Responsible party
- Sponsor
- Investigators
- Jesper Fabricius, PhD, Principal investigator, Hammel Neurorehabilitation Centre and University Research Clinic & Department of clinical medicine, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325604
- Sponsor's protocol ID
- 955087
- Other IDs
- 2501205
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD raw data is mainly video recordings, and these will not be shared. However aggregated measures from the video recordings may be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromuscular Electrical Stimulation on Unilaterial Central Facial Palsy: An Assesorblinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07325604
- Acronym / sponsor ID
- 955087
- Conditions
- Facial Palsy, Stroke
- Keywords
- NMES, Central facial palsy, Multicenter RCT, Stroke, Facial symmetry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Danish Association of Occupational Therapist, Hammel Neurorehabilitation Centre and University Research Clinic, Hospital of Central Denmark Region, Denmark
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- 15 Dec 2030 (estimated)
- Study completion
- 15 Dec 2030 (estimated)
- First posted
- 8 Jan 2026 (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.
Background Central facial palsy (CFP) is a common condition in stroke, with an estimated prevalence of 45%. CFP can lead to facial asymmetry, problems with mouth closure and food processing, bite marks on the cheek, social isolation, and reduced quality of life. CFP is seen as an important area of rehabilitation, and training is therefore often carried out to reduce the consequences of CFP. In a recent systematic review conducted by the principal investigator, the results showed that very few studies have been conducted that have investigated the effect of training for CFP, and there is currently no scientific evidence to support the effect of the various training interventions.
Objective To investigate the effect of Neuromuscular electrical stimulation (NMES) on facial symmetry compared to usual practice, in participants with CFP as a result of stroke.
Hypothesis: Participants who receive training with NMES together with usual training for facial paralysis have greater improvement in facial symmetry than participants who only receive usual training for facial paralysis.
Trial design Randomized controlled trial (RCT) with a nested pilot trial. A pilot trial/RCT will be conducted in order to power calculation in an RCT. The protocol for the pilot trial and RCT will be the same, and participants from the pilot trial and their outcome data are thus expected to be included in the RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMES | Experimental | Device: Neuromuscular electrical stimulation (NMES), Other: Usual CareNMES is provided as an add-on to usual care |
| Usual care | Active comparator | Other: Usual CareThis arm receives usual care of facial palsy without NMES. Usual care encompass mimical exercises, facio oral sensory input, and kinesio taping. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Central facial palsy
- First time stroke
- >=18 years
- Able to provide written consent
Key exclusion criteria (3 listed)
- Not able to cooperate for mimical exercises
- Contraindications for NMES
- Admitted for three weeks assessment stay at the hospital
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 |
|---|---|---|
| Neuromuscular electrical stimulation (NMES)Electrical stimulation of facial muscles. | Device | NMES |
| Usual CareThis arm receives usual care of facial palsy without NMES. Usual care encompass mimical exercises, facio oral sensory input, and kinesio taping. | Other | NMES, Usual care |
Primary outcome
My Facial Quantification (MyFacialQ)
Time frame: From enrollment to the end of treatment at four weeks"
MyFacialQ quantifies degree of unilateral facial palsy through video recordings of mimical exercises. The development and validation study for MyFacialQ is in review.
2 secondary outcomes
Iowa Oral Performance Instrument (IOPI)
Time frame: From enrollment to the end of treatment at four weeks
Facial Clinimetric Evaluation (FACE)
Time frame: From enrollment to three months follow-up after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No. IPD raw data is mainly video recordings, and these will not be shared. However aggregated measures from the video recordings may be shared.
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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.
Jesper Fabricius, PhD principal investigator
Hammel Neurorehabilitation Centre and University Research Clinic & Department of clinical medicine, Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation (NMES) in people with Facial Palsy and Stroke, run by University of Aarhus at 1 site in Denmark.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Mar 2026. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jesper Fabricius, PhD (+4578419051, jesperjm@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
My Facial Quantification (MyFacialQ) (time frame: From enrollment to the end of treatment at four weeks"). 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 9 Mar 2026.