Clinical trial · Observational
Biomarkers in Neural Disorders
NCT02761707CI-TRIAL-00039568completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alzheimer's Disease | — | UNRESOLVED | — |
| Diffuse Lewy Body Disease | — | UNRESOLVED | — |
| Drug Induced Parkinson's Disease | — | UNRESOLVED | — |
| Essential Tremor | — | UNRESOLVED | — |
| Multiple System Atrophy | — | UNRESOLVED | — |
| Myasthenia Gravis | — | UNRESOLVED | — |
| Parkinson's Disease | — | UNRESOLVED | — |
| Progressive Supranuclear Palsy | — | UNRESOLVED | — |
| Spinal Cord Injuries | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electrical Brainstem Responses | Other | — | UNRESOLVED |
| Olfactory Tests | Other | — | UNRESOLVED |
| Peripheral Nerve Stimulation | Other | — | UNRESOLVED |
| Visual Deprivation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (11)
- label
- Parkinson's Disease
- description
- Non-smokers, ages 18-80, diagnosed with Parkinson's Disease. Must be Hoehn and Yahr stage 2 or less with a history of motor symptoms less than two years.
- interventionNames
- Other: Electrical Brainstem Responses
- Other: Olfactory Tests
- Other: Visual Deprivation
- Other: Peripheral Nerve Stimulation
- label
- Alzheimer's Disease
- description
- Non-smokers, ages 18-80, diagnosed with Alzheimer's Disease. Must meet the 2011 National Institute on Aging-Alzheimer's Association and the 1984 National Institute for Neurological and Communicative Disorders and Stroke-Alzheimer's disease and Related Disorders Association criteria for probable AD.
- interventionNames
- Other: Electrical Brainstem Responses
- Other: Olfactory Tests
- Other: Peripheral Nerve Stimulation
- label
- Progressive Supranuclear Palsy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * The Parkinson's disease (PD) patients will be Hoehn and Yahr stage 2 or less with a history of motor symptoms less than two years. * The Alzheimer's disease (AD) patients will meet the 2011 National Institute on Aging-Alzheimer's Association and the 1984 National Institute for Neurological and Communicative Disorders and Stroke-Alzheimer's disease and Related Disorders Association criteria for probable AD. * The progressive supranuclear palsy (PSP) patients will have met the NINDS-SPSP criteria for probable PSP, which requires vertical supranuclear gaze palsy, prominent postural instability, and falls in the first year of onset, as well as a number of other clinical features. * The DLBD patients will meet the Consensus Criteria for the clinical diagnosis of DLBD. * The healthy controls will be matched to the PD patients on such variables as sex, age, education level, and ethnicity. * The essential tremor (ET), multiple system atrophy (MSA), myasthenia gravis (MG), multiple system atrophy (MSA), Parkinson's disease dementia (D-PD), and Spinal Cord Injury (SCI) patients will meet the generally-accepted diagnostic criteria for these disorders. Exclusion Criteria: * Drug abuse. * Any other known and potentially confounding condition that could reasonably be expected to interfere with the study assessments. * Under age 18. * Over age 80. * Smoker. * Pregnant or nursing. * Healthy control with a first degree relative who has a neurodegenerative disease.
References
Publications (0)
Data not yet available
No reference posted for this study.