Hemifacial Spasm

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Found 7 Actively Recruiting clinical trials

A

RECRUITING

Patients who suffered a stroke, cranial traumatism, medullar lesions or multiple sclerosis can present spastic muscular complications, which is particularly impairing if it concerns muscles of the leg. Muscular spastic complications of the legs can alter significantly the ability to walk because it clinically manifests itself by a stiffness of the leg, thus generating a complication called "Stif Knee Gait" (SKG). It means that the femoro-patello-tibial articulation cannot be mobilized as it should because it stays spastic instead of being mobile. However, it remains possible to treat this kind of medical condition by using Botulinum toxin injections in the target muscle, in particular the rectus femoris (which is part of the quadriceps). As a reminder, botulinum toxin, sold under the international common denomination "Botox®", is a neurotoxin of 150 kDa produced by the bacteria "Clostridium Botulinum" and is the most powerful natural poison known to humankind, with its DL50 between 1 and 2 nanogramms / kg in humans. This toxin works by entering the neuro-muscular synaptic junctions and by linking itself to a proteic complex called SNARE. The link between the toxin and the SNARE complex inhibits the fusion of the acetylcholinergic synaptic vesicles with the plasmic membrane of the pre-synaptic axone. The Botox® blocks the exocytosis of the acetycholin (Ach) vesicle in the inter-synaptic space at the neuro-muscular junction and blocks the nervous transmission, thus generating muscular flaccid paralysis. This kind of intoxication is caused directly by an infection by Clostridium Botulinum and is called Botulism. It manifests itself clinically by flaccid paralysis, swelling, diarrhea tiredness, respiratory failure, vomiting etc… Despite its highly toxic properties, Botox® can be used as a therapeutic tool against number of medical conditions (strabismus, hyperhidrosis, migraines etc…) and even as a cosmetic tool (anti face-wrinkles). It can be used against spastic muscular paralysis, especially like the ones encountered in the patients of this study. The current Standard Of Care (SOC) against SKG is to inject Botox into the rectus femoris in order to counter its spasticity. It has been shown to upgrade the walking ability of SKG patients by enhancing the leg kinetics. More precisely, it has been shown to improve the fluidity of the movement of the spastic leg in SKG patients, especially the knee flexion. However, the rectus femoris' contractility remains necessary to be able to stand up statically and to stay balanced during the walk and everyday-activity and the myorelaxant properties of Botox® may be problematic and alter the leg biomechanics despite its utility. To this day, no study has been published to compare the static and dynamic balance troubles before and after Botox injections in the rectus femoris. The medical bibliography does not report any augmentation of the risk of fall in the case of Botox injection in the rectus femoris. However, we consider the hypothesis along which those injections can enhance the risk of fall. Therefore, we decided to conduct a monocentric, prospective observational clinical study to compare the state of the static and dynamic balance before and after Botox injections in the rectus femoris (in SKG patients) by using balance scores. In order to complete this objective, we compared the following parameters before and after the Botox injection in SKG patients : * Time Up and Go test(in seconds) : primary evaluation criteria * Berg Balance Scale (BBS) : secondary evaluation criteria * Stair climb and descent time test (SCT) : secondary evaluation criteria. * Number of falls.

18+ yearsAll Genders
1 location
B

RECRUITING

While deep brain stimulation (DBS) targeting the subthalamic nucleus (STN) or the globus pallidus interna (GPi) has shown moderate efficacy, incomplete symptom relief and high stimulation thresholds with associated side effects remain significant limitations. Emerging evidence suggests that dual-target neuromodulation combining STN with ventralis oralis (VO) nucleus stimulation may synergistically modulate hyperactive basal ganglia-thalamocortical circuits, potentially enhancing therapeutic outcomes.The study will involve patients diagnosed with Meige syndrome who are eligible for DBS therapy. Participants will be randomly assigned to one of two groups.The primary outcome measure is the improvement in motor symptoms, assessed using the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) before and after treatment. Secondary outcomes will include changes in quality of life, anxiety and depression scores, and any adverse effects related to the DBS procedure.The results of this study will be used to guide future clinical trials and inform the treatment options for patients with Meige syndrome.

18+ yearsAll GendersNA
1 location
E

RECRUITING

Healthy Volunteer

This will be a single-arm, crossover study, in which each patient is their own historical control using a 2:1 conversion ratio of Daxxify to Botox units. Study participants will be selected through the electronic medical records of ophthalmologists at Montefiore Medical Center. Medical documentation on each patient will include information on age, sex, race, Benign Essential Blepharospasm (BEB) diagnosis year and duration, Hemifacial Spasms (HFS) diagnosis year and duration, and past treatments. The immediate effects (desired or undesired) of Daxxify observed within 48-72 hours, will be defined as (1) complete relief of spasms (2) partial relief to a tolerable level (3) mild to moderate ocular irritation (4) ptosis. Overall efficacy will be evaluated using the base to peak efficacy (recorded in changes to Jankovic Rating Scale (JRS) scores) and be defined as (1) excellent (resolution of signs and symptoms, only requiring injections \> 5-6 months (2) moderate (improvement in signs and symptoms but requiring repeated injections within \< 5 months (3) poor (no improvement in signs and symptoms). Adverse side effects will be documented, and Daxxify will be discontinued in any patients who develop significant side effects that outweigh the benefits.

18+ yearsAll GendersPHASE4
1 location
E

RECRUITING

Trismus is a common side effect in head and neck cancer patients after radiation therapy. This project aims to explore the therapeutic effect of Botulinum toxin (Botox) injection to the masticatory muscles in the above-mentioned patients. In this project, Botulinum toxin will be injected into the masticatory muscles (medial pterygoid and masticatory muscles), combined with oral rehabilitation exercises, to reduce the patient's masticatory muscle tension and spasm. Patient's mouth opening range, quality of life, trismus condition and pain will be evaluated to understand its efficacy.

18+ yearsAll GendersPHASE4
1 location
E

RECRUITING

Acute facial nerve palsy occur in 10-20/100 000 children/year in Sweden. About 20 % of these children will have persistent symptoms with excessive tear secretion, drooling and social problems due to asymmetry in the face. Studies on cortisone treatment to adult patients with acute facial nerve palsy have shown beneficial effects, but no studies with strong quality have been performed in children. Investigators will perform a double-blind randomized placebo-controlled multicenter trial on children with acute facial nerve palsy. Participants will be recruited consecutively at 9-12 study centers in Sweden during 2019-2020. Oral cortisone (prednisolone) 1 mg/kg x 1 in 10 days (or placebo) will be started on admission. Clinical data, including recovery will be followed-up until 12 months. The primary outcome is defined as total recovery of the facial nerve palsy, measured with the House-Brackmann scale (grade 1) at 12-months follow-up. The overall purpose is to assess the utility of cortisone treatment given to children with acute facial nerve palsy in this study. If the total recovery rate is significantly improved in the prednisolone group as compared to the placebo group, prednisolone treatment will be introduced in clinical practice for children with acute facial nerve palsy in order to reduce the risk of persistent symptoms.

1-17 yearsAll GendersPHASE4
15 locations
M

RECRUITING

Temporomandibular disorders (TMD) are common chronic musculoskeletal pain conditions among orofacial pain, consisting of a group of conditions associated with pain and dysfunction of the temporomandibular joint (TMJ) and masticatory muscles. Temporomandibular joint displacement, also known as internal disc derangement, is an abnormal relationship between the articular disc, the mandibular condyle, and the mandibular fossa. The most frequent displacement of the disc is anterior to the mandibular condyle however, in rare cases it can be posteriorly. Occlusal splint treatment is generally considered to be a basic treatment for Temporomandibular disorders. It could promote correction of the vertical dimension, maxillo-mandibular realignment, temporomandibular joint repositioning and cognitive awareness. Although various splints are currently available, the most used are stabilization splints and anterior repositioning splints. Injection of BTX-A in LP muscle, considering the different methods, frequencies and injection dosages used in different studies, would decrease the clicks and other TMJ-related disorders such as pain, hyperactivity, and dysfunction. Based on the present review, most studies about the injection of botulinum toxin in LP muscle reported cases or were done as quasi-experimental studies.

18-40 yearsAll GendersNA
1 location
S

RECRUITING

The International Headache Society's Headache Classification Committee recognizes three broad categories of headaches: primary headaches, secondary headaches, and a third catchall category called "painful cranial neuropathies, other facial pain, and other headaches." Migraines fall into the primary headache category. Sphenopalatine ganglion (SPG), or the pterygopalatine ganglion (PPG), is a large extracranial parasympathetic ganglion with multiple neural connections, including autonomic and motor. The botulinum toxin (BOTOX®), which can exert a paralytic effect by binding to presynaptic cholinergic nerve terminals at the neuromuscular junction, is produced by the Gram-positive, rod-shaped, spore-forming, anaerobic bacterium Clostridium botulinum. It internalizes and inhibits the exocytosis of the neurotransmitter acetylcholine by decreasing the frequency of acetylcholine release

18-65 yearsAll GendersNA
1 location