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NCT05945615
After an episode of facial paralysis, as nerves recover, they aberrantly regenerate and send additional branches to the incorrect muscles in addition to the intended muscle. This leads to what is known as Aberrant Regeneration Syndrome, Post-paralysis Synkinesis, or Nonflaccid Facial Paralysis. It is characterized by poor facial symmetry and function, hypertonic facial muscles at rest, and abnormal facial movements. One sequela is acquired blepharoptosis causing a smaller ocular aperture, visual field obstruction, cosmetic deformity, and abnormal periocular spasms. This study aims to evaluate an FDA approved medication for acquired blepharoptosis due to synkinesis/hyperkinesis as an adjunct to treatment.
NCT06335719
A research study to find out if brief intraoperative electrical stimulation therapy improves nerve regeneration and smile outcomes following two-stage cross face nerve graft facial reanimation surgery.
NCT05997199
Patients aged between 18-65 who visit the Physical Medicine and Rehabilitation outpatient clinic diagnosed with Bell Palsy will be included in the study. The patients' Bell Palsy grade will be evaluated by Houseman Brahman (HB) Scale and their disability level will be evaluated by Facial Disability Index (FDI). Their serum vitamin D level will be noted. The patients having vitamin D deficiency will be randomized into two groups. Group 1 will be given 50.000 IU/week vitamin D replacement for 8 weeks. All the patients will be included in a standard physical therapy and home exercise program. Both groups will be asked for a control visit at weeks 8.Their clinical recovery will be evaluated by HB staging and FDI by the Physical Medicine and Rehabilitation specialist who is blind to the randomization.
NCT06742580
In the etıology of Idıopathıc Acute Perıpheral Facıal Palsy, known as bell palsy, many causes have been descrıbed, such as specıfıc ımmune, ıchemıc, ınfectıous and heredıal factors. ın our study, we have observed the blood homocysteıne level that causes thrombotıc dısorders ın paralysıs patıents.
NCT06615297
70 stroke patients with central facial paralysis will be included and their demographic data will be questioned and facial nerve thickness, depressor labi inferior, depressor anguli oris, buccinator and risorius muscles will be evaluated.
NCT06538103
Facial synkinesis (FS) is a distressing sequela of facial palsy (FP) characterized by involuntary, simultaneous movements of facial muscles occurring during voluntary facial expressions. Treatment of synkinesis is challenging, and preventive methods are needed. This study evaluates the efficacy of physical facial nerve rehabilitation (PFNR) therapy alone versus PNFR with eyelid surgery to correct lagophthalmos and prevent the onset of synkinesis. 25 outpatients are randomized to receive either PFNR alone (neuromuscular retraining and Kabat proprioceptive neuromuscular facilitation) or PNFR and early (90 days after FP onset) eyelid surgery (involving a conservative oculoplastic correction for lagophthalmos with epiphora or ectropion). Comprehensive otolaryngological assessments and Magnetic Resonance Imaging (MRI) will be conducted. Synkinesis progression was measured using Another Disease Scale (ADS) at baseline, 3 months 6 months, 12 months, and 24-months post-treatment. The data were analyzed with ANOVA, t-test, Chi-Square analyses.
NCT06532903
This is a controlled, single-blind (hybrid) clinical investigation that aims to analyze the process of recovery of muscle function in people with peripheral facial paralysis who receive kinesthetic treatment with electrostimulation compared to those who receive treatment without electrostimulation, in the UNNE University Kinesiology Service, during the period 2023-2025, to promote early reintegration into their social activities of daily life. An initial evaluation will be carried out, the movements that cause the requested gestures will be observed and recorded and recorded on a monitoring sheet and on video. The House Brackman and Sunnybrook scale will be used to measure functional outcomes. The initial and final evaluations will be external and blind. Patients will sign informed consent approved by Resolution No 04/23 of the Health Sciences Research Bioethics Committee. The following inclusion criteria will be taken into account: patients with a medical referral that indicates a diagnosis of peripheral facial paralysis, Bell's palsy, frigori facial paralysis, idiopathic facial paralysis, who have not received previous kinesic treatment. Patients with central facial paralysis (associated with stroke), with peripheral facial paralysis of more than 6 months of evolution, who present dermal lesions that interfere with the application of electrical currents (open wounds, lacerations or burns) will be excluded from the study. ) In addition, those patients who attend with a medical prescription that advises in writing against the use of electrostimulation will be excluded.
NCT06393231
Bell's palsy itself has a certain self-healing tendency. Therefore, it is recommended to leave a bit of Bell's palsy for self-recovery without treatment. If complete recovery is achieved after treatment, complications such as stiffness, contracture and even hemifacial inversion may occur as time moves. Therefore, this study aims to evaluate the optimal end time of acupuncture for facial paralysis.
NCT04153916
Artificial eye blinking stimulation following damage to the facial nerve. Group 1 - Patients with a persistent unilateral facial paralysis (palsy) that underwent an operation for facial reanimation Group 2 - Patients with temporary unilateral facial paralysis, secondary to unilateral Bell's palsy. Primary objective: To evaluate whether the Neurotigger device can elicit a complete or a partial eyelid closure of the affected eye. Secondary objective: To optimize the location of the Neurotrigger's electrodes, and define the level of the pain generated, if any, during device implementation and stimulation, as well as the method for the personal adjustment of the precise pattern of stimulation (strength, intensity, other features) to achieve eye blinking for different patients.
NCT03996525
After nerve injury and facial palsy, many patients have permanent muscle and sensory dysfunction. Electrical stimulation (ES) of injured nerves may speed up axon growth and improve recovery. This study will assess if ES accelerates motor axon regeneration and improves muscle recovery in patients undergoing two-staged facial reanimation for facial palsy. This study of ES in these patients will investigate: i) nerve regeneration over long distances; ii) direct evidence of changes in nerve regeneration with nerve samples from the second procedure; and iii) changes in functional outcomes in a patient population with much less variability. Our study will provide evidence about the effect of ES in improving outcomes in patients with nerve injuries.
NCT03115203
The problem posed is the possibility of objectively assessing facial muscle mobility. Today, in patients with facial paralysis, the assessment of the deficit is carried out using a subjective scale such as the House Brackman \[1\] or EMG scale of the facial nerve but does not distinguish each muscle individually . Objective measurements of skin muscles such as thickness and volume, in preoperative assessment of a facial paralysis rehabilitation surgery, would be useful in order to choose the most appropriate surgical technique. Indeed, too much amyotrophy will contraindicate hypoglosso-facial anastomosis (VII-XII) and it will be preferable to propose a temporal elongation myoplasty or a reinfused free muscle flap. Similarly, it would be useful to be able to objectively evaluate the recovery of muscle function after facial allo-transplantation. Although electromyography has been developed since the work of Duchenne de Boulogne, little research has been carried out on the development of noninvasive methods to objectively characterize in vivo skin muscles (variation, position, orientation, morphometry). The main morphometric data of the skin muscles come from anatomical dissections. Imaging of the skin muscles has not been specifically developed. Some studies have been carried out to visualize these muscles in MRI 1.5 Tesla in pathologies such as myasthenia gravis, facial paralysis, and labio-alveolo-palatine clefts for example. The originality of the project is to develop a method allowing to establish a quantitative correlation between the movements of the face and the muscular changes. This correlation will be achieved by associating muscular morphological data derived from MRI acquisitions and cutaneous deformations resulting from clinical examinations. This non-invasive approach should make it possible to establish objective and reproducible indicators in patients with facial paralysis sequelae.
NCT05585333
Objective: Facial paralysis can be caused by a variety of etiological factors, complete palsy continues for two months, the chance of full recovery is reduced to zero. The aim of this study was to evaluate the effectiveness of photobiomodulation therapy (PBMT) in the in patients undergoing facial paralysis over 8 weeks. Methods: This study was an open-label, not concurrent control study including 54 patients that underwent facial paralysis over 8 weeks. Patients were assigned to the PBMT group and control group, with 27 patients in each group. Laser treatments were applied 3 days a week after recruited. PBMT was delivered using a class IV Multi-wave Locked System that combines with a simultaneous 808 nm continuous emission and 905 nm pulse emission and the maximum peak power was 25 W. Clinical outcome measure comprised the House-Brackmann grading system, Facial Clinimetric Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), and electrophysiological testing, including Electroneuronography (ENoG), Electromyography (EMG) and Blink Reflex. All the measurements were collected at the first day and at the end of study. All reported P values were two-sided and were declared statistically significant when less than 0.05.
NCT03284125
The facial paralysis is a frequent disease causing important functionals swallowing dysfunctions. The purpose of our study was to evaluate the improvement of the swallowing disorders after surgery by lengthening temporalis myoplasty (LTM) in the facial paralysis. This prospective study has realised on the following of patients affected by facial paralysis treated by LTM. Self-administered questionnaires and clinics tests had realized to analyze three components oh the oral phase of the swallowing ( drooling, mastication and handicap). The evaluations was realized before the surgery and at 3 and 6 months after .
NCT03974763
This study will be unique for the rehabilitation of patients with facial paralysis in that the focus is to generate novel 3D facial soft tissue measures to characterize the condition and temporal changes, and on the generation of future testable hypotheses to optimize surgical interventions and outcomes. In addition, the investigators will extend our previous work, beyond the facial circumoral and lip areas/zones, to characterize additional facial zones specific for facial paralysis. The approach for facial mapping of soft tissue movement, when validated through this proposed study, can be used for both surgical planning and to support the development and training of implantable facial pacing devices. Mapping both normal facial movements and movements of patients with unilateral facial paralysis are vital to describe the temporal and spatial course of the recovery process. Ultimately, this information can be used to inform clinicians on the precise placement of these devices and the signal strength needed to facilitate movements in the required 'paralyzed' facial zones until the recovery process has been completed.
NCT02892864
Facial palsy can be divided into supranuclear lesion (central facial palsy) and infranuclear lesion such as Bell's Palsy, an idiopathic disease. The peripheral facial paralysis (PFP) is a frequent but little-known pathology (20 / 100 000 inhabitants in France a year). Oro-facial functions and the ability to convey emotional facial information are seriously affected by facial palsy, thereby reducing patient's quality of life. The PFP can have several repercussions on the functional, aesthetic, social, occupational and psychological levels. Evolution and prognosis depend not only on its etiology and gravity, but also on the precocity and the quality of the medical and paramedical care. It is essential to assess functional and psychological issues before beginning an adapted global therapeutic care. If these depressive symptoms can be explained by multiple factors, the inability to smile would be one of the triggering factors of depression. The facial feedback hypothesis could be one of many explications because smiling induces a positive emotional state and a feeling of well-being. In PFP, patients must cope with their difficulties to smile. Their facial behaviour affected their own emotional experiences. The main purpose of the present study is to determine if virtual rehabilitation program is relevant compared to standard therapy. The second aim is to characterize the efficiency by analysing the time required to obtain a stable score of 4 in the Sunnybrook test. A secondary objective will be to decrease the functional and social repercussions of the facial paralysis with an intensive and targeted therapy of the smile. Furthermore, a virtual rehabilitation program will be implemented in an interactive platform. To this end, a parallel randomized controlled trial (RCT) of the two groups will be conducted: standard therapy versus virtual rehabilitation program. RCT involves a treatment in which active participation of the patient is necessary so only the assessment will be blinded. Facial motor skills (tongue, mouth and face motricity) are measured using electronic devices, objective and subjective evaluation with pragmatic fields such as communication, emotion and quality of life. The severity of patient's facial paralysis is appraised by the House and Brackmann scale. This global assessment will be conducted before the beginning of the therapy and every 3 months during 18 months. The patients will be recruited within the Ear, Nose, and Throat (ENT) service after a baseline assessment. Simple randomization will be used in order to establish both therapeutic groups with 45 patients in each group. Group A: Patients taken care in consultation within the ENT service which provides oro-myo-functional classical rehabilitation. Group B: Patients taken care in external consultation who receive oro-myo-functional rehabilitation through a virtual rehabilitation program targeted at the smile, in their place of living in virtual conditions. The patients must have been diagnosed with unilateral peripheral facial palsy, according to House and Brackmann international classification. Inclusion time : 18 months Between-two-groups analysis will be conducted in order to compare a targeted and intensive implementation-intention rehabilitation such as virtual rehabilitation program to standard therapy. This virtual therapy will consist in repeating mentally movement desired, so that it will be more spontaneously executed in the every-day-life situation.
NCT01537952
Objective: Microbiologic etiologies of facial palsy in children were investigated. Study design: Prospective clinical study. Methods: Forty-six children aged 0-16 years with facial palsy comprised the study group. Paired serum samples and cerebrospinal fluid were tested to find indications (antibodies, growth of the microbe, or nucleic acids) of microbes putatively associated with facial palsy. The microbes tested were herpes simplex virus-1 and -2, varicella-zoster virus, human herpesvirus-6, Mycoplasma pneumoniae, Borrelia burgdorferi, influenza A and B-, picorna-, cytomegalo-, parainfluenza-, respiratory syncytial-, coxsackie B5-, adeno-, and enteroviruses, Chlamydia psittaci, and Toxoplasma gondii. Besides the routine tests in clinical practice, serum and cerebrospinal fluid samples were tested with a highly sensitive microarray assay for DNA of herpes simplex virus-1 and -2, human herpesvirus-6A , -6B, -7, Epstein-Barr-, cytomegalo-, and varicella-zoster viruses.
NCT00989209
Objective: Quantify the benefits of myofunctional therapy associated to botulinum toxin injection in patients with long standing facial unilateral palsy.
NCT00903669
The current study sought to determine the reliability of the rehabilitation protocol using the labial commissure angle (LCA) as an indicator of both muscle tonus and therapeutic success. The investigators hypothesized that this measurement would provide objective data regarding the efficacy of rehabilitation for these challenging patients.