Biomarkers in Neural Disorders

Status Completed

Clinical Trial Summary

This study seeks to establish the sensitivity and specificity of what appears to be a unique brainstem biomarker of Parkinson's Disease (PD) - an electrically induced olygosynaptic nasotrigeminal reflex response - in differentiating early stage PD from normal controls and from patients with various other neurodegenerative diseases. This study will additionally compare the biomarker to olfactory testing.

Clinical Trial Description

Parkinson's disease (PD), a devastating age-related disease that is clinically defined by its effects on the motor system, afflicts more than six million people worldwide, imposing enormous burdens on patients, relatives, caretakers, and society in general. Diagnostic errors are common, particularly as symptoms first arise. The most common misdiagnoses are Alzheimer's disease (AD), essential tremor, and vascular pseudo-Parkinson's Disease. An accurate diagnosis is typically made at a later stage of the disease when marked and irreversible damage has occurred within the motor control system of the brain. Sensitive and specific biomarkers of the early stages of PD are urgently needed. Identification of such markers is critical for the development and assessment of medications and other interventions designed to eliminate or reduce the gradual and irreversible decline of neurons involved in the disorder. This study seeks to establish the sensitivity and specificity of what appears to be a unique brainstem biomarker of PD - an electrically induced trigeminal nerve blink reflex response - in differentiation of early stage PD from normal controls and such neurodegenerative diseases as early stage AD, progressive supranuclear palsy (PSP), and diffuse Lewy Body disease (DLBD). This study will additionally compare the biomarker to olfactory test results. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02761707
Study type	Observational
Source	University of Pennsylvania
Contact
Status	Completed
Phase
Start date	June 2016
Completion date	July 16, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02915848` - Long-term Stability of LFP Recorded From the STN and the Effects of DBS
Recruiting	`NCT03648905` - Clinical Laboratory Evaluation of Chronic Autonomic Failure
Terminated	`NCT02688465` - Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).	Phase 4
Completed	`NCT05040048` - Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
Active, not recruiting	`NCT04006210` - Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations	Phase 3
Completed	`NCT02562768` - A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease	Phase 1
Completed	`NCT00105521` - Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia	Phase 3
Completed	`NCT00105508` - Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia	Phase 3
Recruiting	`NCT06002581` - Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease	N/A
Completed	`NCT02236260` - Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation	N/A
Completed	`NCT00529724` - Body Weight Gain, Parkinson, Subthalamic Stimulation	Phase 2
Active, not recruiting	`NCT05699460` - Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
Completed	`NCT03703570` - A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations	Phase 2
Completed	`NCT03462680` - GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures	N/A
Completed	`NCT02837172` - Diagnosis of PD and PD Progression Using DWI
Not yet recruiting	`NCT04046276` - Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease	N/A
Recruiting	`NCT02952391` - Assessing Cholinergic Innervation in Parkinson's Disease Using the PET Imaging Marker [18F]Fluoroethoxybenzovesamicol	N/A
Active, not recruiting	`NCT02937324` - The CloudUPDRS Smartphone Software in Parkinson's Study.	N/A
Completed	`NCT02939391` - A Study of KW-6356 in Subjects With Early Parkinson's Disease	Phase 2
Completed	`NCT02874274` - Vaccination Uptake (VAX) in PD	N/A