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Dystonia clinical trials

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NCT ID: NCT02504905 Completed - Healthy Volunteers Clinical Trials

Propensity to Develop Plasticity in the Parieto-Motor Networks in Dystonia From the Perspective of Abnormal High-Order Motor Processing

Start date: August 20, 2015
Phase: Early Phase 1
Study type: Interventional

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.

NCT ID: NCT02468843 Completed - Dystonia Clinical Trials

Novel Stimulation Patterns for the Treatment of Dystonia

Start date: July 2015
Phase: N/A
Study type: Observational

Deep brain stimulation (DBS) is an effective surgical therapy for select Dystonia patients who are refractory to medications or who have generalized symptoms (e.g. patients with Early-Onset Primary Dystonia(DYT1) mutations and other dystonia subtypes). DBS patients typically experience significant improvement in disabling symptoms; however, detailed programming is always required, and stimulation-induced side effects commonly emerge. Clinicians may empirically vary voltage, pulse width, frequency and also the active contacts on the DBS lead to achieve observed optimal benefits. The majority of DBS patients undergo repeat surgeries to replace the implantable pulse generator (IPG) every 2.5 to 5 years. It has been demonstrated that, in dystonia patients, that higher settings are required for adequate symptomatic control, and that neurostimulators have a considerably shorter life when compared to neurostimulators from patients with essential tremor or Parkinson's disease. Additionally, several smaller studies have suggested that alternative pulse stimulation properties and pulse shape modifications can lower IPG battery consumption. Newer patterns of stimulation (regularity of pulses and shapes of pulses) have not been widely tested in clinical practice, and are not part of the current FDA device labeling. Novel patterns of stimulation do however, have the potential to improve symptoms, reduce side effects, and to preserve the neurostimulator life. The current research proposal will prospectively study biphasic pulse stimulation paradigms and its effects on dystonic symptoms. The investigators aim to demonstrate that we can tailor DBS settings to address dystonia symptoms, improve the safety profile, characterize distinct clinical advantages, and carefully document the safety and neurostimulator battery consumption profile for biphasic stimulation.

NCT ID: NCT02420106 Completed - Cervical Dystonia Clinical Trials

Effect of Osteopathic Manipulative Medicine on Motor Function and Quality of Life in Cervical Dystonia

Start date: February 2014
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02334683 Completed - Spasticity Clinical Trials

Compare Two Guidance Techniques for Botulinum Toxin Injections for the Treatment of Limb Spasticity and Focal Dystonia

Start date: October 28, 2015
Phase: N/A
Study type: Interventional

This study seeks to compare the use of ultrasound and electrophysiologic techniques to target muscles for the treatment of spasticity and focal dystonia of the limbs. The purpose of this study is to investigate the use of two ways of locating the muscle for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity. Electrophysiologic guidance, using electrical stimulation, and ultrasound are the standard ways of locating muscles during a treatment of BoNT injection.

NCT ID: NCT02326818 Completed - Dystonia Clinical Trials

Comparison of Electrophysiologic and Ultrasound Guidance for Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia and Spasticity

Start date: January 20, 2016
Phase: Phase 3
Study type: Interventional

Background: - It is hard for people with arm spasticity and focal hand dystonia to control their arm and hand muscles. They are often treated with botulinum toxin (BoNT) injections. Electromyography with electrical stimulation (e-stim) and ultrasound are used to find muscles for BoNT injection. Researchers want to learn which method is faster and more comfortable. Objective: - To compare 2 ways of finding muscles for BoNT injection for the treatment of focal hand dystonia and upper limb spasticity. Eligibility: - Adults 18 and older with focal hand dystonia or arm spasticity who have been getting onabotulinumtoxin-A injections in protocol 85-N-0195. Design: - Participants will be screened with medical history and physical exam. - Participants will push or pull on a device that measures arm strength. They will have a neurologic exam. Women will have a pregnancy test. - Participants will have a BoNT injection using either e-stim or ultrasound. - For e-stim, sticky pads will be placed on the arm. A needle will be placed in the muscle. A small electric shock will be given through the needle. Then the injection will be given. - For ultrasound, a probe will be moved across the skin. A screen will show an image of the muscles. Then the injection will be given. - Participants will have a second injection 3 months later. They will have the method that was not used for their first injection. - After each session, participants will rate their experience. - Participants will have follow-up visits 1 month after each injection. They will be examined and asked about their response to treatment. Arm strength will be measured.

NCT ID: NCT02263417 Completed - Dystonia Clinical Trials

A Randomized Controlled Trail Comparing Subthalamic and Pallidal Deep Brain Stimulation for Dystonia

Start date: July 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study was to compare the subthalamic nucleus(STN) with the globus pallidus internus(GPi) as a stimulation target for deep brian stimulation(DBS) for medically refractory dystonia.

NCT ID: NCT02245958 Completed - Cervical Dystonia Clinical Trials

A Retrospective Chart Review of BOTOX® and Xeomin® for the Management of Cervical Dystonia and Blepharospasm

Start date: August 2015
Phase: Phase 4
Study type: Observational

This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of Cervical Dystonia and Blepharospasm in clinical practice.

NCT ID: NCT02199509 Completed - Clinical trials for Oromandibular Dystonia

Efficacy of Levetiracetam in Oromandibular and Cranial Dystonia

Start date: July 2014
Phase: Phase 2
Study type: Interventional

Background: - People with dystonia cannot control their muscle contractions. This disorder can affect different body areas. When it affects the face, tongue, and jaw, it is called oromandibular dystonia (OMD) or cranial dystonia (CD). Researchers want to find out if a drug that treats seizures may help people with this kind of dystonia. Objective: - To see if levetiracetam can improve symptoms of jaw or face dystonia. Eligibility: - Adults ages 18 70 with OMD or CD. Design: - Participants will be screened with a medical history and physical exam. Researchers will test how severe their dystonia is. - Participants will have blood drawn through a needle in the arm. - Participants will be assigned to take either levetiracetam or placebo. - Phase 1: - Participants will start with one 500-mg tablet twice daily. The dose will be increased by 500 mg every 3 days. The maximum dose will be 4000 mg a day over 3 weeks. Participants who cannot tolerate that will take the highest dose they can. - Participants will return for study visits at weeks 3 and 6. They will be asked about their health, side effects, and symptoms of depression. They will have a neurological examination and test of their dystonia. - After the week 6 visit, participants will taper and stop the study drug over about 1 week. - Phase 2 begins one week later. Participants will repeat phase 1, but with the other drug. - After phase 2, participants will return to their usual clinics. They will be told how to stop taking the drug. They will have a follow-up phone call 2 weeks later.

NCT ID: NCT02177617 Completed - Cervical Dystonia Clinical Trials

Neurotoxin and Physical Therapy

Start date: December 2014
Phase: Phase 4
Study type: Interventional

This study aims to compare Botox injections without Physical Therapy sessions to Botox injections combined with Physical Therapy sessions for treatment of Cervical Dystonia. It is expected that Botox combined with Physical Therapy will improve Cervical Dystonia symptoms and quality of life more than Botox alone. It is also expected that Botox combined with Physical Therapy will enhance neuroplasticity, or the ability of the brain to make new connections, more than Botox alone at 4-5 weeks, and remain improved at 12 weeks, after Botox injection.

NCT ID: NCT02175719 Completed - Cervical Dystonia Clinical Trials

Post-marketing Surveillance of Administration of Botulinum Toxin Type B(NerBloc)-Investigation of the Clinical Condition in Patients With Change From Botulinum Toxin Type A

Start date: April 16, 2013
Phase:
Study type: Observational

Investigation of the clinical condition in patients with cervical dystonia by Toronto Western Spasmodic Torticollis Scale (TWSTRS)