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Showing 1-20 of 34 trials
NCT02689466
Background: Dystonia is a movement disorder in which a person s muscles contract on their own. This causes different parts of the body to twist or turn. The cause of this movement is unknown. Researchers think it may have to do with a chemical called acetylcholine. They want to learn more about why acetylcholine in the brain doesn t work properly in people with dystonia. Objective: To better understand how certain parts of the brain take up acetylcholine in people with dystonia. Eligibility: Adults at least 18 years old who have DYT1 dystonia or cervical dystonia. Healthy adult volunteers. Design: Participants will be screened with a medical history, physical exam, and pregnancy test. Study visit 1: Participants will have a magnetic resonance imaging (MRI) scan of the brain. The MRI scanner is a metal cylinder in a strong magnetic field that takes pictures of the brain. Participants will lie on a table that slides in and out of the cylinder. Study visit 2: Participants will have a positron emission tomography (PET) scan. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. A small amount of a radioactive chemical that can be detected by the PET scanner will be given through an IV line to measure how the brain takes up acetylcholine. ...
NCT06937931
The purpose of this study is to evaluate the efficacy and safety of the study drug, IPN10200, and to assess how well it works when compared with placebo in treating Cervical Dystonia (CD) in adults. CD can cause a series of abnormalities and symptoms in the head and neck that can lead to neck pain and stiffness, and headaches. CD is believed to involve deep parts within the brain that control movement, but genetic factors, environmental factors, and abnormalities in the brain may also play a role. The usual treatment for CD includes injecting BoNT into the affected muscles, but the treatment only lasts about 3 months. IPN10200 is designed to last for a longer period. The study will consist of two periods: 1. A Screening Period of up to 4 weeks (28 days) to assess whether a participant can take part in the study and requires at least one visit. 2. A Treatment Period of 36 weeks. On Day 1 of the treatment period, participants will receive either IPN10200 Dose A or Dose B (additional participants may receive IPN10200 Dose C) of the study drug, or placebo distributed into different muscles in the head, neck and shoulders. Participants may continue some other medications, but details need to be recorded. There will be 10 visits to the clinic in person and one remote visits (phone call) (12 visits to the clinic for participants who receive Dose C). Participants will undergo blood samplings, urine collections, physical/neurological examinations, and clinical evaluations. Participants will also need to complete questionnaires throughout the study. The total study duration for a participant will be up to 40 weeks (approximately 9 months).
NCT06328114
This study aims to investigate the impact of accelerated transcranial magnetic stimulation (TMS) on brain function and behavior in patients with focal cervical dystonia. Previous research demonstrated that individualized TMS improved writing behavior in focal hand dystonia after one session. In this study, we aim to expand the application on TMS on focal cervical dystonia. The current study administers four TMS sessions in a day. The research involves 9 in-person visits. The effect of TMS will be assessed using functional MRI brain scans and behavioral measurements. The risk of TMS includes seizures; the potential risk of seizures from TMS is mitigated through careful screening, adhering to safety guidelines. The study's main benefit is enhancing dystonic behavior and deepening the understanding of brain changes caused by TMS in cervical dystonia, paving the way for further advancements in clinical therapy for this condition.
NCT03938363
Efficient gait requires effective postural control, both static and dynamic. Hence, postural disorders may affect gait. Yet, very little is known about the specific effects of focal postural disorders such as cervical dystonia (CD) and blepharospasm (BS) on patients' mobility. The present research therefore aims at analyzing gait characteristics in patients presenting with these conditions in order to document possible gait alterations. In addition, the investigators will explore the effect of botulinum toxin treatment, which the most frequently used therapeutic option, on the patients' gait characteristics. Indeed, while the treatment improves both dystonia and pain, and therefore quality of life, its influence on gait is presently unknown. the investigators aim at filling this knowledge gap
NCT02504905
Background: \- People with dystonia have muscle contractions they can t control. These cause slow, repeated motions or abnormal postures. People with dystonia have abnormalities in certain parts of the brain. Researchers want to study the activity of two different brain areas in people with writer s cramp and cervical dystonia. Objective: \- To compare brain activity in people with dystonia to that in healthy people. Eligibility: * Right-handed people ages of 18-65 with cervical dystonia or writer s cramp. * Healthy volunteers the same ages. Design: * Participants will be screened with a physical exam. They will answer questions about being right- or left-handed. * At study visit 1, participants will:\<TAB\> * Have a neurological exam. * Answer questions about how their disease impacts their daily activities. * Have a structural magnetic resonance imaging (MRI) scan. Participants will lie on a table that can slide \<TAB\>in and out of a metal cylinder. This is surrounded by a strong magnetic field. * Do 2 simple computer tasks. * At study visit 2: * Participants will have transcranial magnetic stimulations (TMS) at 2 places on the head. Two wire coils will be held on the scalp. A brief electrical current creates a magnetic pulse that affects brain activity. Muscles of the face, arm, or leg might twitch. Participants may have to tense certain muscles or do simple tasks during TMS. They may be asked to rate any discomfort caused by TMS. * Muscle activity in the right hand will be recorded by electrodes stuck to the skin of that hand.
NCT06748846
This pilot study aims to evaluate the effectiveness of Vibration Muscle Stimulation (VMS) in reducing pain and improving quality of life in patients with primary cervical dystonia (CD), a focal dystonia characterized by involuntary and often painful muscle contractions in the neck. The study will involve patients who have been treated with botulinum toxin and are candidates for an integrated rehabilitation program, which includes physiotherapy and occupational therapy. Participants will be randomized into two groups: an experimental group receiving therapeutic VMS (80 Hz frequency, 0.5 mm vibration amplitude) and a control group receiving sham VMS. Both groups will undergo a 10-session rehabilitation program combining 45 minutes of physiotherapy and 15 minutes of VMS (or sham), followed by 30 minutes of occupational therapy. The primary outcome measure will be pain and disability as assessed by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and the McGill Pain Questionnaire. Secondary outcomes will include improvements in quality of life and clinical severity of dystonia. The results are expected to provide insights into the potential role of VMS in enhancing rehabilitation outcomes for patients with cervical dystonia.
NCT05884528
The goal of this retrospective, international, multi-center chart abstraction is to learn about the long-term impact of product-specific immunogenicity-related factors in different botulinum neurotoxin type A formulations in patients suffering from cervical dystonia. The main question it aims to answer is: Do complex-containing (CC) botulinum toxin formulations impact the long-term clinical outcome in cervical dystonia patients compared to a complex-free (CF) formulation? Researchers will compare differences observed in years 2 and 7 between two toxin groups, i.e., botulinum neurotoxins type A containing complexing proteins (CC) and without complexing proteins (CF).
NCT04849988
This Phase 2 trial will evaluate the safety and efficacy of ABP-450 for the treatment of cervical dystonia in adults. The study will enroll 60 patients across approximately 30 sites in the United States. Study subjects will be divided evenly across a low dose group, a medium dose group, a high dose group, and a placebo group for one treatment cycle.
NCT04348669
The purpose of this study is to investigate the effect of yoga delivered remotely on adults with dystonia. This work will have implications related to physical interventions symptom management and quality of life as well as implications related to the role of tele-therapy.
NCT03617367
Phase 3, open-label, multi-center trial to evaluate the long-term safety, efficacy, and immunogenicity of up to four continuous treatment cycles of daxibotulinumtoxinA (DAXI) for injection.
NCT02877836
The aim of this study is to evaluate the organization of the motor circuit in a group of patients suffering from dystonia compared with a group of healthy controls. Deep Brain stimulation is a functional neurosurgery technique consisting in neuromodulation of the motor circuit that has been applied to dystonia. The efficiency of this technique depends on the relative preservation of the function and the structure of the motor network . The assessment of neuronal circuit by advanced techniques of functional neuroimaging in this study might contribute to expand our understanding of the abnormalities in motor circuit activation and the integrity of CNS structure underlying dystonia. This study might contribute therefore to the refinement of Deep brain stimulation indications and techniques in complex dystonia syndromes
NCT04582929
24-Week Prospective, Double-Blinded, Randomized, Cross-over design in Multicenter Study of 50 unit of Neubotulinum Toxin Type A (Neuronox) and 100 unit of Neubotulinum Toxin Type A (Neuronox) injection for Cervical Dystonia in patient diagnosed with cervical dystonia according to clinical diagnosis. It was designed to evaluate the efficacy, safety, tolerability, quality of life and the comparesion the improvement after treatment by of 50 unit of Neubotulinum Toxin Type A (Neuronox) and 100 unit of Neubotulinum Toxin Type A (Neuronox) injection.
NCT01314365
The purpose of the protocol is to determine typical patient response to Dysport in the treatment of adult cervical dystonia (CD).
NCT01753349
The purpose of the study is to document long-term response in real-life practice after injection cycles with BoNT-A in subjects suffering from idiopathic cervical dystonia (Long-term clinical and pharmaco-economic data).
NCT02662530
This study investigates the use of a kinematic measurement device to quantify the abnormal head movements and postures in patients with cervical dystonia (CD) in order to individualize and optimize botulinum toxin type A (BoNT-A) injection therapy. A single sensor captures five degrees of freedom of the neck and head that distinguish which muscle(s) contribute to CD and the amount of BoNT-A to inject into these muscle(s). The efficacy, relief and improvements in social, occupation and function by injections will be investigated. The efficacy of BoNT-A therapy using either BoNT-A injection parameters from clinical-based assessments and kinematically-based assessments will be investigated in CD patients. Individuals clinically diagnosed with CD will be randomized for two treatment conditions: A) injection parameters from a kinematic assessment only, or B) injection parameters from a clinical assessment only.
NCT03471923
This study will examine the prevalence of four previously identified non-motor markers in a population of cervical dystonia patients, unaffected family members, and healthy volunteers in an attempt to identify a distinct combination of non-motor symptoms that may be indicative of disease development.
NCT02175693
Investigation of the clinical condition and safety in patients with cervical dystonia
NCT01753336
The purpose of the protocol is to assess the long term safety of repeat treatment cycles of Dysport® 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia. This is an extension study to study A-TL-52120-169 (hereafter referred to as Study 169).
NCT02420106
The purpose of the proposed research is to determine if Osteopathic manipulative medicine (OMM) used alone or in combination with the standard treatment of botulinum toxin intramuscular injections improves motor function and quality of life amongst people with cervical (neck) dystonia.
NCT03905304
The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of Cervical Dystonia.