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Deep Brain Stimulation clinical trials

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NCT ID: NCT05550714 Recruiting - Dexmedetomidine Clinical Trials

Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease

CHAMPION
Start date: October 15, 2022
Phase: N/A
Study type: Interventional

Subthalamic nucleus (STN)-deep brain stimulation (DBS) under general anesthesia has been applied to PD patients who cannot tolerate awake surgery, but general anesthesia will affect the electrical signal in microelectrode recording (MER) to some degree. This study is a prospective randomized controlled, noninferiority study, open label, endpoint outcome evaluator blinded, two-arm study. Parkinson's disease patients undergoing STN-DBS are randomly divided into a conscious sedation group (dexmedetomidine) and a general anesthesia group (desflurane). Normalized root mean square (NRMS) is used to compare the difference of neuronal activity between the two groups. The primary outcome is the percentage of high NRMS recorded by the MER signal (with the average NRMS recorded by MER after entering the STN greater than 2.0). The secondary outcomes are the NRMS, length of the STN, number of MER tracks, and differences in clinical outcomes 6 months after the operation.

NCT ID: NCT05493722 Recruiting - Clinical trials for Deep Brain Stimulation

Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy

Start date: September 15, 2023
Phase: Early Phase 1
Study type: Interventional

Deep brain stimulation (DBS) is used to treat epilepsy in cases where patients are medically refractory and are not candidates for surgical resection. This therapy has been shown to be effective in seizure reduction, yet very few patients achieve the ultimate goal of seizure freedom. Implantable neural stimulators (INSs) have many parameters that may be adjusted, and could be tuned to achieve very patient specific therapies. This study will develop a platform for stimulation setting optimization based on power spectral density (PSD) measures.

NCT ID: NCT05417555 Recruiting - Clinical trials for Mild Cognitive Impairment

Low Intensity Focused Ultrasound for Mild Cognitive Impairment and Mild Alzheimer's Disease

LIFUP-MCIAD
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

The goal of this study is to investigate whether Low Intensity Focused Ultrasound Pulsation (LIFUP) targeting a part of the brain involved in memory will have an affect on brain activity and whether it may improve memory in people with Mild Cognitive Impairment and Mild Alzheimer's Disease. The main questions the study seeks to answer are: 1. Can LIFUP increase brain activity in the targeted area? 2. Can LIFUP improve memory in people with MCI and mild AD? 3. Can LIFUP improve connectivity of memory networks in the brain? Participants in this study will complete MRIs and memory testing, and receive Low Intensity Focused Ultrasound to a part of their brain involved in memory (the entorhinal cortex).

NCT ID: NCT05416905 Recruiting - Clinical trials for Deep Brain Stimulation

Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN

MEIGES
Start date: June 22, 2022
Phase: N/A
Study type: Interventional

MEIGES is a prospective, multicenter, randomized controlled clinical trial with the primary hypothesis that, STN-DBS is non-inferior to GPi-DBS for motor symptoms improvements at 365 days postoperatively in patients with idiopathic craniofacial dystonia.

NCT ID: NCT05337904 Recruiting - Clinical trials for Deep Brain Stimulation

Deep Brain Stimulation Recovery in Treatment-Resistant Schizophrenia

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

The purpose of this project is to improve the clinical response and personal recovery of patients with treatment-resistant schizophrenia (TRS).

NCT ID: NCT05292794 Recruiting - Parkinson Disease Clinical Trials

Use of CereGate Therapy for Freezing of Gait in PD

Start date: April 18, 2022
Phase: N/A
Study type: Interventional

A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed with Parkinson's Disease.

NCT ID: NCT05197439 Not yet recruiting - Clinical trials for Postoperative Delirium

Dexmedetomidine Prevents Postoperative Delirium After Deep Brain Stimulation in Patients With Parkinson's Disease

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Postoperative delirium (POD) is a common complication, and the incidence of POD after deep brain stimulation(DBS) implementation ranges from 10% to 40%. Previous studies suggested that aging and existing non-motor symptom were independent risk factors for POD after supratentorial tumor resections. Therefore, patients undergoing DBS are high-risk populations for POD. A lot of trials show that dexmedetomidine might help to reduce the incidence of delirium in patients undergoing non-cardiac surgery. However, the impact of dexmedetomidine on POD for patients undergoing DBS was seldom reported. The purpose of this study was to investigate the effect of dexmedetomidine on POD in patients with Parkinson' Disease undergoing DBS.

NCT ID: NCT05193825 Recruiting - Parkinson Disease Clinical Trials

Evaluation of Remote DBS Programming.

REMOTE
Start date: March 22, 2022
Phase: N/A
Study type: Interventional

Deep brain stimulation (DBS) represents the treatment of choice for advanced stages of Parkinson's disease (PD). Currently, adaptive closed-loop stimulation systems that apply disease-specific biomarkers, such as local field potentials (LFPs), are being actively examined to facilitate DBS programming. However, the most suitable feedback signal, still remains to be determined. The investigators previously tested the usefulness of the patient's subjective rating on a visual analogue scale (VAS) as a potential feedback signal for DBS adjustment and found that VAS-based programming lead to similar results as our standard approach. One of the practical advantages of using VAS-based programming strategies - in addition to saving time - is the principal applicability of such an approach to a remote programming setting, although a validation of such an approach is required. Within the scope of a prospective, randomized multicenter clinical trial (the REMOTE Trial), the investigators will examine the effectiveness and safety of VAS-based remote DBS programming in PD by using a novel and recently introduced software platform (Abbott NeurosphereTM Virtual Clinic) that allows for the programming through a smartphone-based video connection with the patient. Therefore, n = 50 PD patients undergoing STN-DBS surgery will be randomized and subsequent to surgery will have their IPG settings adjusted either during regular visits at the hospital or alternatively be programmed remotely through a VAS-based approach. Prior to surgery and after a 90 days follow-up period, we will assess specific clinical (MDS-Unified Parkinson's Disease Rating Scale = UPDRS, Parkinson's Disease Questionnaire-39 sum index = PDQ-39 SI, Beck Depression Inventory = BDI, Montreal Cognitive Assessment Scale = MOCA) parameters to determine the effectivity and safety of the two different strategies on the patient outcome and to correlate it with VAS ratings and MRI data. The results will support the examination of remote-based DBS programming and evaluate the patient's subjective judgment as a valid feedback signal.

NCT ID: NCT05103384 Recruiting - Parkinson Disease Clinical Trials

Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming

Start date: July 22, 2022
Phase:
Study type: Observational

The project uses virtual reality technology to recreate situations that cause freezing of gait in individuals with Parkinson's disease. Individuals who underwent deep brain stimulator (DBS) surgery for Parkinson's disease will walk through a virtual reality environment while brain signals are recorded from the DBS device. The goal is to better understand what occurs in the brain during freezing of gait.

NCT ID: NCT05097001 Recruiting - Dystonia Clinical Trials

Dystonia Image-based Programming of Stimulation: A Prospective, Randomized, Double-blind Crossover Trial

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

The primary objective of this exploratory study is to prospectively evaluate the feasibility of image-guided programming of pallidal deep brain stimulation (DBS) for dystonia. The dystonias are a heterogeneous group of movement disorders that share the core clinical feature of abnormal involuntary muscle contractions in common. Pallidal DBS is an established therapy for severe cases with an average improvement in dystonia severity of 50-60%. However, outcomes are variable and difficult to predict, and clinical trials report up to 25% of Nonresponders. Variability in electrode placement and inappropriate stimulation settings may account for much of this variability in outcome. In addition, improvement in dystonia is delayed, often days to weeks after a change in DBS therapy, complicating programming. Our group recently developed a computer model to predict optimal individualized stimulation settings in patients based on the outcome of a large cohort of of chronically treated patients. In-silico testing showed a 16.3% better mean group improvement with computer-assisted programming compared with physician-assisted programming and a dramatic reduction in non-responders (from 25% to 5%). In this prospective study, the computer model will be compared in a randomized, controlled, and double blinded setting against best clinical DBS programming. The primary outcome will be a responder analysis in which dystonia severity will be compared between conventional clinical and model-based programming will be compared.