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Dystonia clinical trials

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NCT ID: NCT04755192 Active, not recruiting - Healthy Volunteers Clinical Trials

Data Analysis of Protocol 04-N-0188: Neurophysiological Markers in Patients With Craniofacial Dystonia and Their Relatives

Start date: February 11, 2021
Phase:
Study type: Observational

Study Description: We want to analyze the data collected under Protocol 04-N-0188. Objectives: To assess the eye blink rate (EBR) during different behavioral conditions. Study Population: No new subjects will be enrolled. Adult (greater than or equal to 18 years old) subjects in Protocol 04-N-0188 included the following: 1. patients with craniofacial dystonia, 2. first degree relatives of patients with craniofacial dystonia, 3. age matched control group. Description of Sites/Facilities conducting research: All data analysis will take place either on the NIH Main campus or remotely using NIH-provided computers and laptops. Study Duration: 12 months.

NCT ID: NCT04727177 Recruiting - Clinical trials for Transcranial Magnetic Stimulation

Precision-targeted Transcranial Magnetic Stimulation in the Treatment of Primary Dystonia

Start date: November 1, 2020
Phase: Early Phase 1
Study type: Interventional

In this scheme, TMS treatment of Primary dystonia is planned by precise magnetic resonance positioning.

NCT ID: NCT04712552 Completed - Parkinson Disease Clinical Trials

In Vivo Measurement of the Accuracy of the "Neurolocate" Module of the Neurosurgical Robot "Neuromate" in Its Application to Deep Brain Stimulation

NEUROLOCATE
Start date: January 26, 2021
Phase:
Study type: Observational

The purpose of this study is to evaluate the accuracy of the Neurolocate recording system of the neurosurgical robot Neuromate, marketed by Renishaw, in order to optimize surgical procedures, costs and patient comfort.

NCT ID: NCT04707638 Withdrawn - Parkinson Disease Clinical Trials

Neurophysiological Characteristics of Subthalamic Deep-brain Stimulation (STN-DBS)

Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

The intraoperative neuroelectrophysiological signals were collected from patients undergoing STN-DBS under general anesthesia in the Neurosurgery Department of Wuhan union Hospital, and their preoperative conditions and postoperative efficacy will be evaluated.

NCT ID: NCT04692285 Completed - Focal Dystonia Clinical Trials

Electrophysiological and Neuroimaging Correlates of the Effect of Zolpidem in Patients With Focal Dystonia

Start date: September 30, 2017
Phase: Phase 1
Study type: Interventional

To study electrophysiological and imaging correlations of the clinical effectiveness of zolpidem in task-specific dystonia and to elucidate mechanisms underlying its therapeutic effects, patients with focal dystonia will be clinically evaluated and will undergo transcranial magnetic stimulation and FDG-PET CT brain imaging after a single 5 mg dose of zolpidem and placebo, in two separate sessions. Resting motor threshold (RMT), active motor threshold (AMT), resting and active input/output (IO) curve, short-interval intracortical inhibition (SICI) curve, long interval intracortical inhibition (LICI), intracortical facilitation (ICF), and cortical silent period (CSP) will be measured. Objective clinical improvement will be rated using Burke-Fahn-Marsden Dystonia Rating Scale-movement (BFM-M) and writer's cramp rating scale (WCRS). Subjective improvement will be measured using the visual analog scale (VAS). Only a subset of patients (10 patients) will undergo positron emission tomography with 18F-2-fluoro-2-deoxy-D-glucose (18F-FDG PET) brain imaging after a single 5 mg dose of zolpidem and placebo.

NCT ID: NCT04650958 Recruiting - Dystonia Clinical Trials

SUNDYS: A Multicenter, Randomized, Double-blind, Sham-controlled, Parallel-group Trial

SUNDYS
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Dystonia is a group of movement disorders characterized by twisting, repetitive movements, or abnormal postures caused by involuntary muscle contractions and is characterized by a young age of onset and a high disability rate. Early intervention can reduce disability incidence, improve the patient's quality of life, and reduce the burden on families and society. Multiple international guidelines on dystonia have found deep brain stimulation (DBS) to be a safe and effective treatment for refractory dystonia. The globus pallidal internus (GPi) is the mostly widely used target for dystonia. However, there are limitations on the GPi DBS treatment, including slow onset of beneficial effects, poor improvement of axis symptoms, and potential stimulation-related side effects. Previous studies have described the highly successful use of subthalamic nucleus deep brain stimulation (STN DBS) in patients with refractory dystonia, suggesting that STN DBS is an effective and persisting alternative to pallidal deep brain stimulation. However, all STN DBS treated cases have been analyzed in open-label uncontrolled cohort studies, leading to limited data with a high level of evidence on the STN DBS in dystonia. Further, the investigators hypothesized STN has potentially more effectiveness when compared with GPi, and may be more power-saving and quick-acting. In this study, the investigators will organize a prospective randomized, double-blind, parallel-group, multicenter study comparing active versus sham stimulation in isolated segmental or generalized dystonia to evaluate the effectiveness and safety of STN DBS by measuring the impact on motor status, mental status, quality of life, the rate of response of the patients (the number of patients with ≥30% improvement in the movement score on the Burke-Fahn-Marsden Dystonia Rating Scale) and the rate of adverse events during the trial.

NCT ID: NCT04618887 Active, not recruiting - Blepharospasm Clinical Trials

A Comparative Study of GPI's DBS and Pallidotomy in the Treatment of Meige Syndrome

Start date: January 1, 2020
Phase:
Study type: Observational

In this study, we will compare the degree of postoperative symptom improvement, postoperative complication rate, postoperative quality of life improvement degree of patients with Meige syndrome undergoing pallidotomy (unilateral globus palliotomy) and deep brain stimulation (unilateral globus pallidus) ,in order to get the conclusion of the comparison of the clinical efficacy of the two surgical plans. In addition, possible predictive factors such as age, gender, age of onset, length of disease course, scale baseline score, preoperative brain PET-CT function analysis and other possible predictive factors are added for analysis, in order to find predictive factors that can guide the choice of surgical options.

NCT ID: NCT04582929 Completed - Cervical Dystonia Clinical Trials

Neubotulinum Toxin Injection in Cerivical Dystonia

NTCD
Start date: January 3, 2019
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT04568681 Completed - Dystonia Clinical Trials

Deep Brain Stimulation Effects in Dystonia

Start date: November 5, 2020
Phase:
Study type: Observational

Deep Brain Stimulation (DBS) is an effective therapy for patients with medically refractory primary dystonia. However, DBS programming for dystonia is not standardized and multiple clinic visits are frequently required to adequately control symptoms. We aim to longitudinally record brain signals from patients using a novel neurostimulator that can record brain signals. We will correlate brain signals to clinical severity scores to identify pathological rhythms in the absence of DBS, and we will study the effects of DBS on these signals in order to guide clinical programming. We are going to recruit patients who receive the Medtronic Percept device, which allows for brain signal recordings (this feature is FDA approved). The investigators will be conducting an observational study using this device to collect data that the subjects receive as standard of care.

NCT ID: NCT04560101 Recruiting - Dystonia, Focal Clinical Trials

Motor and Non-motor Symptoms in Cervical Dystonia

Royal
Start date: August 1, 2020
Phase:
Study type: Observational

In this monocenter, observational, non-interventional, prospective, open label study investigators will enrol 43 CD patients from the outpatient Movement Disorders Clinic of the Department of Human Neurosciences, Sapienza University of Rome. As this is a non-interventional study, no diagnostic, therapeutic or experimental intervention is involved. Subjects will receive clinical assessments, medications and treatments solely as determined by their study physician. The BoNT-A injection will be performed in CD patients at baseline. As this is an observational, non-interventional study, the injection protocol for BoNT-A treatment is upon physicians' decision. All CD patients will undergo up to three evaluations of motor and non-motor symptoms: before (baseline) and 1 month and 3 months after botulinum toxin treatment. Both evaluations will be carried out under the same conditions. Motor symptoms will be assessed in all CD using the Comprehensive Cervical Dystonia Rating scale (CCDRS) (Comella et al, 2015). Non-motor symptoms including psychiatric, psychological and sleep disorders will be investigated. Psychiatric symptoms will be assessed with CCDS, Hamilton Rating Scale for Anxiety (HAM-A) and the Hamilton Rating Scale for Depression (HAM-D); the psychological symptoms will be assessed with the demoralization scale (Kissane et al, 2004) and the Italian Perceived Disability Scale (Innamorati et al,2009). Sleep disorders will be investigated with the Pittisburg Sleep Quality Index (PSQI) (Buysse et al, 1989).