View clinical trials related to Deep Brain Stimulation.
Filter by:Op-TICS is a clinical investigation of the use of Deep Brain Stimulation (DBS), with a CE marked implantable device, to reduce severe motor and vocal tics in patients who suffer from Tourette Syndrome (TS). It is a randomised, double-blind, crossover clinical investigation for 20 patients. Op-TICS will be performed at the National Hospital for Neurology & Neurosurgery. Following DBS surgery, participants will first enter an open adjustment phase, of 6 months, where the electrical stimulation settings of the device are optimised. Participants will then enter the double-blind phase that will include successively up to 2 weeks with stimulation on and up to 2 weeks with the stimulation off in a randomised order. The primary outcome measure is the tic severity score measured by the Yale Global Tic Severity Scale -Total Tic Score after two weeks OFF-stimulation versus two weeks ON-stimulation in the double-blind randomised crossover phase
The goal of this single-center prospective, randomized, open-label clinical trial is to compare the effectiveness of imaging-based DBS programming with threshold assessment-based DBS programming in patients with Parkinson's disease and motor response fluctuations. The main question the study aims to answer is: Is the improvement of motor symptoms in the OFF-drug phase following STN DBS for Parkinson's disease, using imaging-based DBS programming only, non-inferior to the improvement of motor symptoms following DBS programming with threshold assessment at six months follow-up? Participants will be randomized to imaging-based programming or to threshold assessment-based programming. The main clinical outcome is motor symptoms; secondary outcomes are level of physical disability and quality of life, among others.
This is a multi-center, single arm, prospective, open-label, extendable study for the efficacy and safety of combo-stim deep brain stimulation for treatment-refractory mental disorders (obsessive-compulsive disorder, schizophrenia, bipolar with depression, anorexia nervosa, gambling disorder and adult autism).
This study aims to conduct a randomized controlled study to compare the efficacy of remote programming (RP) on the improvement of motor function after DBS surgery in PD patients with standard programming (SP).
Rationale: Deep brain stimulation (DBS) of the thalamus is an effective surgical treatment for patients with disabling essential tremor, despite optimal pharmacological treatment. To date, the standard DBS procedure is performed under local anesthesia which is very burdensome for patients. It is now possible to directly visualize the target (motor) area in the thalamus due to advances in modern imaging techniques. DBS surgery could be performed under general anesthesia (asleep). Objective: The primary objective of the study is to determine whether asleep thalamic DBS surgery provides an equal tremor reduction compared to awake thalamic DBS surgery, measured by the clinically validated Essential Tremor Rating Assessment Scale after six months of DBS. Secondary outcomes are: disease related daily functioning, adverse effects, operation time, quality of life, patient satisfaction with treatment outcome and patient evaluation of treatment burden. Study design: The study will be a multicentre prospective randomized open label blinded (PROBE) endpoint trial comparing thalamic DBS under general versus local anesthesia. Study population: A total of 110 patients with disabling essential tremor despite optimal pharmacological treatment will be randomized. Intervention (if applicable): Patients will be randomized for asleep DBS or awake DBS. According to the standard DBS procedure, two brain-electrodes are connected to an implanted neurostimulator, which is placed subcutaneously in the subclavicular area Main study parameter/endpoints: The primary outcome measure is the change in tremor score on the Essential Tremor Rating Assessment Scale after 6 months of thalamic DBS. The secondary outcome measures are the Amsterdam Linear Disability Score for functional health status, Quality of Life in Essential Tremor Questionnaire, patient satisfaction with the treatment, patient evaluation of treatment burden, operating time, hospitalization time, change of tremor medication, side effects and complications. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Awake DBS at present is very burdensome and by many patients and health care providers considered to be an overly invasive treatment for essential tremor. Through this trial, we aim to investigate whether asleep DBS in essential tremor can become the new treatment standard. This is expected to increase the accessibility for DBS and subsequently would allow more people with essential tremor to be helped, as well as in an earlier stage of their disease than currently; more patients will benefit for a longer time period from DBS. Asleep DBS will have a shorter procedure length. The proposed research project involves treatment options that are standard care in daily practice. The therapies will not be combined with other research products. Both treatments have a low risk of serious complications and a higher risk of minor side effects. Regular follow up will be used. Participation in this study constitutes moderate risk according to NFU criteria for human research.
Sleep-wake disturbances are a major factor associated with reduced quality of life of individuals with Parkinson's disease (PD), a progressive neurological disorder affecting millions of people in the U.S and worldwide. The brain mechanisms underlying these sleep disorders, and the effects of therapeutic interventions such as deep brain stimulation on sleep-related neuronal activity and sleep behavior, are not well understood. Results from this study will provide a better understanding of the brain circuitry involved in disordered sleep in PD and inform the development of targeted therapeutic interventions to treat sleep disorders in people with neurodegenerative disease.
Fifteen PwPD who have undergone DBS surgery and utilize the Percept system will complete a FE and VE exercise session on a stationary cycle while Off antiparkinsonian medication. Bilateral neural activity of the STN will be continuously recorded for 130 minutes (pre-, during FE or VE and post-exercise). The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III Motor Exam and upper extremity force-tracking task will be used to determine motor response to exercise.
Variable Frequency Stimulation(VFS) is a stimulation pattern applied in Deep Brain Stimulation(DBS) therapy for Parkinson's disease(PD). Peking Union Medical College Hospital was the first centre conducting research on VFS. The studies in the past have resembled conclusion that VFS provides improvement not only in the major symptoms such as tremor and rigidity, but also in gait and balance disorder. However, the best programming strategy of VFS has not met agreement. The random-controlled double blinded crossover study is designed for participants who underwent DBS surgery in bilateral subthalamic nucleus for parkinson's disease. The investigators study several strategies on programming and observe the improvement of symptom to look for the best one. A 4-month follow-up is designed to observe a relatively long-term effectiveness of VFS. The study intends to gather more clinical evidence to guide further studies on VFS application.
This is a multi-center, single arm, prospective, open-label, extendable study for the efficacy and safety of dual-target deep brain stimulation for treatment-resistant alcohol use disorder.
Rationale: Deep brain stimulation (DBS) of the nucleus subthalamicus (STN) is an effective surgical treatment for the patients with advanced Parkinson's disease, despite optimal pharmacological treatment. However, individual improvement after DBS remains variable and 50% of patients show insufficient benefit. To date, DBS-electrode placement and settings in the highly connected STN are based on 1,5-Tesla or 3-Tesla MR-images. These low resolution and solely structural modalities are unable to visualize the multiple brain networks to this small nucleus and prevent electrode activation directed at its cortical projections. By using structural 7-Tesla MRI (7T MRI) connectivity to visualize (malfunctioning) brain networks, DBS-electrode placement and activation can be individualized. Objective: Primary objective of the study is to determine whether visualisation of cortical projections originating in the STN and the position of the DBS electrode relative to these projections using 7T MRI improves motor symptoms as measured by the disease-specific Unified Parkinson's Disease Rating Scale (UPDRS-III). Secondary outcomes are: disease related daily functioning, adverse effects, operation time, quality of life, patient satisfaction with treatment outcome and patient evaluation of treatment burden. Study design: The study will be a single center prospective observational study. Study population: Enrollment will be ongoing from April 2023. Intervention (if applicable): No intervention will be applied. Application of 7T MRI for DBS is standard care and outcome scores used will be readily accessible from the already existing advanced electronic DBS database. Main study parameters/endpoints: The primary outcome measure is the change in motor symptoms as measured by the disease-specific Unified Parkinson's Disease Rating Scale (UPDRS-III). This is measured after 6 months of DBS as part of standard care. The secondary outcome measures are the Amsterdam Linear Disability Score for functional health status, Parkinson's Disease Questionnaire 39, Starkstein apathy scale, patient satisfaction with the treatment, patient evaluation of treatment burden, operating time, hospitalization time, change of tremor medication, side effects and complications. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The proposed observational research project involves treatment options that are standard care in daily practice. The therapies will not be combined with other research products. Participation in this study constitutes negligible risk according to NFU criteria for human research.