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Deep Brain Stimulation clinical trials

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NCT ID: NCT05065151 Recruiting - Parkinson Disease Clinical Trials

Understanding Motivation in Parkinson's Patients Through Neurophysiology

MPPN
Start date: October 30, 2021
Phase: N/A
Study type: Interventional

The study's aim is to better understand motivation and value-based decision making in Parkinson's patients through neurophysiology using Medtronic's Percept PC DBS device.

NCT ID: NCT05022147 Recruiting - Parkinson Disease Clinical Trials

Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease

ENGAGE-PD
Start date: October 4, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess how alternating-frequency Deep Brain Stimulation (DBS) works to improve postural instability and gait, while also treating other motor symptoms of Parkinson Disease (PD).

NCT ID: NCT05003206 Recruiting - Parkinson's Disease Clinical Trials

Predictive Value of Multimodal MRI in Parkinson's Disease

Start date: June 19, 2021
Phase: N/A
Study type: Interventional

Deep brain stimulation (DBS) is recognized as the most safe and effective neurosurgical method for the treatment of advanced Parkinson's disease. However, the mechanism of relieving motor and non-motor symptoms of Parkinson's disease has not been fully clarified, and the prognosis is significantly different. This study is based on multimodal MRI technique to clarify the mechanism of DBS in relieving motor and non-motor symptoms of Parkinson's disease, and to explore imaging indicators that can predict prognosis, so as to guide the individual and accurate treatment of Parkinson's disease (PD).

NCT ID: NCT04965727 Recruiting - Clinical trials for Deep Brain Stimulation

Deep Brain Stimulation of the Lateral Hypothalamus to Augment Motor Function of Patients With Spinal Cord Injury

HoT-DBS
Start date: June 14, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate safety of Deep Brain Stimulation (DBS) of the lateral hypothalamus (LH) and whether the use of DBS can increase motor performance in patients with chronic spinal cord injury (SCI). The hypothesis, based on preclinical findings, is that DBS of the lateral hypothalamus can acutely augment leg motor function after SCI, and that the use of lateral hypothalamus DBS can be an adjunct during rehabilitation to promote recovery and long-term neuroplasticity.

NCT ID: NCT04922411 Recruiting - Parkinson Disease Clinical Trials

Cortical Network Modulation by Subthalamic Nucleus DBS

Start date: April 23, 2021
Phase: N/A
Study type: Interventional

Deep brain stimulation of the subthalamic nucleus (STN DBS) in Parkinson's disease (PD) can provide substantial motor benefit yet can also produce unwanted mood and cognitive side effects. Although the neural mechanisms underlying benefits and side effects are not well understood, current hypotheses center on the potentially measurable yet currently undefined effects within downstream cortical networks. Limitations of current tools have impeded attempts to assess network connectivity directly and dynamically in humans with implanted DBS; PET lacks the necessary temporal resolution while fMRI is neither optimal nor safe for patients with implanted DBS. In this proposal, to overcome these significant limitations, the investigators apply high-density diffuse optical tomography (HD-DOT) methods to investigate how STN DBS modulates cortical functional networks and behavior in PD patients. HD-DOT uses a collection of functional near-infrared spectroscopy (fNIRS) measurements, free of radiation exposure concerns, and without electrical/metal artifacts or contraindications or safety concerns for DBS. However, common fNIRS systems are critically hampered by typically sparse measurement distributions that lead to poor anatomical specificity, unreliable image quality due to crosstalk with scalp signals, poor spatial resolution, limited field of view, unstable point spread functions, and uneven spatial coverage. HD-DOT solves these problems by using high-density interlaced source and detector imaging arrays that support densely overlapping measurements and anatomical head models that together result in higher spatial resolution, stable point spread functions, and greatly improved isolation of brain signals from scalp signals. The investigators have demonstrated that HD-DOT accurately maps functional connectivity (FC) within and between cortical resting state networks (RSNs) in the outer ~1cm of cortex with comparable temporal and spatial resolution to fMRI. Preliminary data in older controls and STN DBS patients that directly establish validity and feasibility for the proposed studies are provided. A recent comprehensive evaluation of FC in PD (without DBS) using fMRI found reduced within-network FC in visual, somatomotor, auditory, thalamic and cerebellar networks and reduced between-network FC involving predominantly cortical RSNs (somatomotor, sensory and association), some of which correlated with cognitive and motor dysfunction in PD. Notably, striatal RSNs were not abnormal. These data suggest that PD affects the interrelationships of cortical networks in a behaviorally meaningful way, far downstream of focal subcortical neuropathology. STN DBS is known to alter activity in downstream cortical regions that function as nodes within these dynamic cortical networks supporting movement and cognition. Thus, cortical network FC may play a critical role in mediating the impact of STN DBS on motor and non-motor behavior. Location of the stimulating contact may further modulate these downstream effects, due to the complex functional organization of the STN region. Study procedures include motor and cognitive tests, questionnaires, HD-DOT scanning, and MRI scans. The investigators propose to investigate how STN DBS influences downstream cortical network FC using HD-DOT. This information could lead to more efficient clinical optimization of DBS, identify potential cortical targets for less invasive neuromodulation, and lay the groundwork for future more complex experimental manipulations to determine the full range of STN DBS-induced cortical network responses to up-stream focal electrical perturbations, revealing fundamental properties of functional network plasticity.

NCT ID: NCT04855344 Recruiting - Clinical trials for Deep Brain Stimulation

Deep Brain Stimulation Therapy and Intestinal Microbiota

Start date: April 15, 2021
Phase:
Study type: Observational

This study aims to observe the changes of intestinal microbiota after deep brain stimulation (DBS) therapy for Parkinson's disease, and explore the role of intestinal microbiota in the neuroprotective effect of DBS.

NCT ID: NCT04725773 Recruiting - Parkinson Disease Clinical Trials

Apraxia in Parkinson's Disease Patients With Deep Brain Stimulation

Apraxia DBS
Start date: June 1, 2021
Phase:
Study type: Observational

Deep brain stimulation (DBS) of the subthalamic nucleus or globus pallidus internus can improve motor symptoms Parkinson's disease (PD). However, it is not known whether DBS can help reduce the signs and symptoms of the limb-kinetic, ideomotor or ideational apraxia associated with PD or if apraxia can exist as a stimulation induced side effect from DBS therapy. In this study, we look to conduct a pilot study to examine the feasibility of characterizing the prevalence of apraxia in PD patients with chronic, stable DBS.

NCT ID: NCT04716296 Completed - Clinical trials for Deep Brain Stimulation

Ketamine in Deep Brain Stimulation (DBS) Surgery

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

Deep brain stimulation (DBS) is a well-established and effective treatment for motor symptoms resulting from idiopathic Parkinson's disease (PD). During the DBS surgery , a brain electrode is implanted in the basal ganglia, which is involved in the pathophysiology of the disease. The surgery consists of three steps: 1. Opening the skin, drilling the skull bone and inserting a temporary electrode. 2. Recording electrical activity of the brain, electrical stimulation of the brain which guide the implantation of the electrode.3 Transferring wires and implanting a subcutaneous pacemaker battery in the chest area. Today, standard treatment protocols consist undergoing the second stage (or first and second stage, depending on the treatment center protocol) of the surgery awake (under local anesthesia only). As systemic anesthetics affect cerebral electrical activity and prevent patient cooperation, they inhibit precise identification of the cerebral target under 'physiological navigation' guided by electrical recording and brain stimulation. As a result, the accuracy of electrode implantation decreases. However, undergoing surgery in an awake format often causes severe patient discomfort and anxiety necessitating shortening the length of surgery or aborting the surgery. As such there is a need for establishing an alternative anesthesia protocol for DBS surgeries. Ketamine is considered a unique anesthetic due to its hypnotic properties, analgesia, and possible amnesia. Standard doses of ketamine are currently used worldwide to treat patients with various injuries and brain diseases. Research from monkeys has shown that ketamine (in low dose) does not affect electrical brain activity used for physiological navigation. The investigators therefore propose a prospective , randomized , blinded study to evaluate the utility of low dose of ketamine in the second stage of DBS surgeries for increasing patient satisfaction and cooperation without detracting from the accuracy of physiological navigation to the cerebral target. This study will compare two treatment arms : Treatment arm consisting of patients randomized to receive a low dose of ketamine for the second stage of DBS surgery. Control arm consisting of patients randomized to receive sham control of saline during the second stage of DBS surgery.

NCT ID: NCT04578678 Recruiting - Parkinson's Disease Clinical Trials

Can Subthalamic Stimulation Using Directional Electrodes Improve Postoperative Management in Parkinson's Disease

Steeropt
Start date: August 9, 2019
Phase:
Study type: Observational

The primary objective of the study is to determine if subthalamic nucleus (STN) deep brain stimulation (DBS) using the Vercise directional leads improves neuropsychiatric state and neuropsychiatric fluctuations 12 months after surgery in a large consecutive series of STN-DBS Parkinson's disease (PD) patients.

NCT ID: NCT04530942 Active, not recruiting - Clinical trials for Major Depressive Disorder

The Efficacy and Prediction of Deep Brain Stimulation for Treatment-resistant Depression

Start date: March 29, 2021
Phase: N/A
Study type: Interventional

Several open-label trials have shown the therapeutic promise of deep brain stimulation (DBS) targeted to striatal and surrounding capsular areas in treatment-resistant depression (TRD). However, the results of placebo-controlled trials have been mixed, with one showing a large difference between active and sham DBS and another finding no difference. Main aim of this study is establishing whether active DBS results in more treatment responders than sham DBS. Secondary aims are establishing an adverse events profile, establishing effects on quality of life,neuropsychological and neuroimaging measures, and finding predictors of response.