Effect of Neuromuscular Electrical Stimulation on Unilateral Central Facial Palsy

NCT07325604 | Recruiting DMC FDA Device

• 2 other identifiers: 9550872501205
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Facial Palsy; Stroke

Keywords

NMES; Central facial palsy; Multicenter RCT; Stroke; Facial symmetry

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at four weeks"

Secondary Outcomes (2)

• Iowa Oral Performance Instrument (IOPI)

  From enrollment to the end of treatment at four weeks

• Facial Clinimetric Evaluation (FACE)

  From enrollment to three months follow-up after the intervention

Study Arms (2)

NMES

EXPERIMENTAL

NMES is provided as an add-on to usual care

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.

Other: Usual Care

Interventions

Neuromuscular electrical stimulation (NMES) DEVICE

Electrical stimulation of facial muscles.

NMES

Usual Care OTHER

This arm receives usual care of facial palsy without NMES. Usual care encompass mimical exercises, facio oral sensory input, and kinesio taping.

NMES; Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Central facial palsy
• First time stroke
• \>=18 years
• Able to provide written consent

You may not qualify if:

• Not able to cooperate for mimical exercises
• Contraindications for NMES
• Admitted for three weeks assessment stay at the hospital

Sponsors & Collaborators

• University of Aarhus: lead
• Danish Association of Occupational Therapist: collaborator
• Hammel Neurorehabilitation Centre and University Research Clinic: collaborator
• Hospital of Central Denmark Region, Denmark: collaborator

Study Sites (1)

Hammel neurorehabilitation centre and university research clinic

Hammel, 8450, Denmark

RECRUITING

MeSH Terms

Conditions

Facial Paralysis; Stroke

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jesper Fabricius, PhD

  Hammel Neurorehabilitation Centre and University Research Clinic & Department of clinical medicine, Aarhus University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesper Fabricius, PhD

CONTACT

+4578419051; jesperjm@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 8, 2026
• Study Start: February 27, 2026
• Primary Completion (Estimated): December 15, 2030
• Study Completion (Estimated): December 15, 2030
• Last Updated: March 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)