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Parkinson Disease clinical trials

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NCT ID: NCT03741920 Enrolling by invitation - Parkinson Disease Clinical Trials

Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status

Start date: May 17, 2017
Phase: N/A
Study type: Interventional

The primary objective is to understand the utility of Personal KinetiGraph movement recording system data in the clinical management of Parkinson's disease (PD) in routine clinical care at a movement disorders clinic. Specifically: 1. Measure medication use and clinical management plan changes in a large, multicenter cohort among participants undergoing a clinical assessment with an MDS in which the MDS reviews the participant's PKG during the clinical assessment in half of the enrolled participants (PKG + Group) and in half of the enrolled participants the MDS completes the clinical assessment without the PKG (PKG- Group). 2. Determine the association between frequency of medication changes, the PKG information, and other clinical assessments among participants with and without a PKG report of their PD motor status available to the clinician at the time of evaluation.

NCT ID: NCT03733496 Enrolling by invitation - Parkinson Disease Clinical Trials

Observational, Long-term, Extension Study for Participants of Prior VY-AADC01 or VY-AADC02 Studies

Start date: August 24, 2018
Study type: Observational

An extension study for participants who have completed VY-AADC01 or VY-AADC02 Studies

NCT ID: NCT03702816 Enrolling by invitation - Parkinson Disease Clinical Trials

The Relationship Between Neuropsychological Testing and MRI, PET and COBRE - Project 1: AIM 2 (GE-180)

Start date: December 13, 2018
Phase: Phase 2
Study type: Interventional

The complex pathological cascades leading to both Alzheimer's disease (AD) and Parkinson's disease (PD) involve, at various points, inflammation. Since inflammation is a treatable symptom, understanding how and when it impacts the brain, and where specifically in the brain, would offer important guidance in the development of new treatments, sorely needed in both diseases. Microglia play an important anti-inflammatory role, and produce a substance, mitochondrial translocator protein (TSPO), whose presence can be used as a marker of regional inflammation. GE180 is a newly developed PET ligand which binds to TSPO and hence can be used in imaging studies to analyze regional inflammation in living patients. In prior studies it has shown regional specificity in multiple sclerosis and brain injury. In the current study, the investigators will be using GE180 to analyze regional and global inflammation in the brains of patients with AD and PD at two time points. The results of the current study will provide enriched understanding of inflammation in these conditions, and potentially provide preliminary data to inform design of future interventional trials.

NCT ID: NCT03697434 Enrolling by invitation - Parkinson Disease Clinical Trials

Acceptability of Palliative Care in Parkinson Disease Care

Start date: November 16, 2018
Phase: N/A
Study type: Interventional

This study will assess the feasibility of using specific criteria to standardize the referral of individuals with Parkinson disease to a group of medical providers known as palliative care specialists. Palliative care specialists provide supportive care to individuals living with serious illnesses. The specialty focuses on providing relief from the symptoms and stress of serious illness.

NCT ID: NCT03638531 Enrolling by invitation - Parkinson Disease Clinical Trials

Long- Term Transcranial Direct Current Stimulation in Parkinson's Disease

Start date: July 30, 2018
Phase: Phase 2
Study type: Interventional

The goal of the proposed research is to determine the influence of transcranial direct current stimulation (tDCS) on long-term motor learning, transfer of motor learning, and cortical function in Parkinson's disease (PD). The project comprises a 2 week training study that will involve tDCS applied during two practice motor tasks with behavioral, clinical, and physiological evaluations at baseline as well as 1, 14 and 28 days following the 2 week training and stimulation period. The findings of the proposed studies should have significant clinical significance and applications to comprehensive intervention therapy development in the treatment of PD.

NCT ID: NCT03633513 Enrolling by invitation - Parkinson Disease Clinical Trials

Parkinson's Disease Inflammatory Biomarker Profiling

Start date: July 10, 2018
Study type: Observational

This study compares a comprehensive panel of immunological biomarkers between Parkinson's disease patients and healthy, environmentally matched participants. This unique study design provides the ability to control for differences in environment between study subjects. The goal of this study is to 1) identify a specific set of immunological markers that correlate with a clinical diagnosis of Parkinson's disease and 2) stratify patients by disease severity using these same biomarkers.

NCT ID: NCT03600740 Enrolling by invitation - Parkinson Disease Clinical Trials

Advancing Pre-operative Targeting for Deep Brain Stimulation in the Globus Pallidus Internus

Start date: August 17, 2018
Phase: N/A
Study type: Interventional

In the proposed pilot project, MRI data will be prospectively collected to show the feasibility of the segmentation algorithm and the potential relation to final lead positioning. Patients will be selected from those undergoing GPi DBS placement. This pilot data will serve as a basis for pursuing funding for a larger trial evaluating the prospective ability of the 3T targeting study to improve outcomes and decrease complications in GPi DBS placement. Improved outcomes and patient experience would be expected to further contribute to our facility as a center of excellence for treatment of movement disorders.

NCT ID: NCT03473522 Enrolling by invitation - Parkinson Disease Clinical Trials

Effects of tDCS Combined With Therapeutic Exercises in Patients With Parkinson's Disease.

Start date: February 1, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Parkinson's disease is a progressive, degenerative neurological disease associated with profound changes in the quality of life of its survivors. Therapeutic exercises are widely employed in the attempt to delay or minimize disease progression, characterized by significant motor and sensory deficits. Recent evidence has demonstrated the potential use of transcranial direct current stimulation (TDCs) as a complement to therapeutic exercises. However, few studies have investigated the effects of TDCs combined with therapeutic exercises in patients with Parkinson's disease. This study aims to investigate the effect of TDCs combined with therapeutic exercises in people with Parkinson's disease. Thirty patients will be randomized into two distinct groups to receive either TDCs(anodal) + therapeutic exercises or TDCs (sham) + therapeutic exercises for 24 sessions over a five-week period. The primary clinical outcome (balance) and secondary outcomes (functional capacity, quality of life and perception of overall effect) will be collected before treatment after two and five weeks at month 3 and month 6 after randomization. The data will be collected by a blind examiner to the treatment allocation.

NCT ID: NCT03409120 Enrolling by invitation - Parkinson Disease Clinical Trials

Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

This study occurs during five visits that are already scheduled as part of "Biomarkers to Guide Directional DBS for Parkinson's Disease" ( Identifier: NCT03353688). If participants have dystonia associated with Parkinson's disease, the investigators will consent and administer one additional rating scale (Burke-Fahn-Marsden Dystonia Rating Scale) to assess the severity of dystonia.

NCT ID: NCT03270657 Enrolling by invitation - Parkinson Disease Clinical Trials

Scalar Closed Loop Intraoperative Study

Start date: April 5, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to measure neural activity during deep brain stimulation (DBS). There are two types of neural activity that we will record from DBS electrodes during this study: DBS local evoked potentials (DLEPs) and spontaneous, local field potentials (LFPs). We will measure the effects of varying stimulation parameters on both the neural activity and changes in motor symptoms -- bradykinesia and tremor -- in subjects with Parkinson's disease (PD). Correlating neural activity characteristics with changes in symptoms will improve our understanding of the mechanisms of action of DBS. This intraoperative study will specifically compare our ability to record neural activity using circuitry developed at Duke for this purpose [Kent et al, 2015] to a new, implanted pulse generator (IPG; RC+S) developed by Medtronic. These intraoperative studies will specifically test a preliminary version of the RC+S (that is not designed for implantation), and will lead to a clinical trial assessing the efficacy of the implantable RC+S IPG in PD patients once this device is available and approved for this trial.