- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02761707
Biomarkers in Neural Disorders
July 16, 2019 updated by: University of Pennsylvania
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.
Study Overview
Status
Completed
Conditions
Detailed 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 Type
Observational
Enrollment (Actual)
54
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Normal controls and patients with such neural disorders as Parkinson's Disease(PD), Alzheimer's disease (AD), progressive supranuclear palsy (PSP), essential tremor (ET), dementia with Parkinson's disease (D-PD), myasthenia gravis (MG), multiple system atrophy (MSA), diffuse Lewy body disease (DLBD), and Spinal Cord Injury (SCI).
None will be cigarette smokers.
The patients will be diagnosed accord to current consensus criteria.
The healthy controls will be matched to the PD patients on such variables as sex, age, education level, and ethnicity.
The Healthy Controls will be asked to answer questions regarding the disease state of their first degree family members to ensure that these first degree family members do not have a neurodegenerative diseases.
Every effort will be made to include women and minority subjects.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Parkinson's Disease
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.
|
Eye blink responses will be induced using standard stimulating electrodes employed in surface electromyography (EMG).
The subjects will recline with their eyes gently closed.
Sticky electrodes will be placed to the left and below the left eye.
6 different facial regions will be stimulated.
The electrical stimulation will be kept constant during the test sessions.
To prevent habituation, the stimuli will be delivered randomly at intervals of 45-60 sec.
Four 0.2 msec pulses will be presented.
In some cases, paired pulse stimulation will be performed, and a conditioning stimulus will be applied to the target facial regions at the following intervals: 10, 200, 400, 600 and 800 msec.
4 pulses will be presented at each stimulus interval with randomized interval and pulse sequences.
Other Names:
Olfactory testing will be performed using standard tests.
The University of Pennsylvania Smell Identification Test (UPSIT) assesses a subjects ability to identify odors in a forced choice format.
The Snap and Sniff Threshold Test provides a threshold measure of phenyl ethyl alcohol.
Short-term odor memory will be assessed using a standardized 12-item four-alternative forced-choice Odor Memory Test.
This non-lexical test employs 10-, 30-, and 60-second delay intervals between the presentation of the target odorant and the first of four successively presented odors from which the target is to be selected.
During a 2-hour visual deprivation period, subjects will wear comfortable light-tight goggles with lenses that have been blackened by flat black paint.
Subjects will be given the opportunity to recline comfortable in a padded reclining chair during this time.
Electrical stimulation will be applied to a nerve of your arm.
Sticky electrode pads will also be placed on a hand muscle.
You will receive electrical stimulations that lasts less than a second.
The stimulations will make your muscle twitch.
Other Names:
|
Alzheimer's Disease
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.
|
Eye blink responses will be induced using standard stimulating electrodes employed in surface electromyography (EMG).
The subjects will recline with their eyes gently closed.
Sticky electrodes will be placed to the left and below the left eye.
6 different facial regions will be stimulated.
The electrical stimulation will be kept constant during the test sessions.
To prevent habituation, the stimuli will be delivered randomly at intervals of 45-60 sec.
Four 0.2 msec pulses will be presented.
In some cases, paired pulse stimulation will be performed, and a conditioning stimulus will be applied to the target facial regions at the following intervals: 10, 200, 400, 600 and 800 msec.
4 pulses will be presented at each stimulus interval with randomized interval and pulse sequences.
Other Names:
Olfactory testing will be performed using standard tests.
The University of Pennsylvania Smell Identification Test (UPSIT) assesses a subjects ability to identify odors in a forced choice format.
The Snap and Sniff Threshold Test provides a threshold measure of phenyl ethyl alcohol.
Short-term odor memory will be assessed using a standardized 12-item four-alternative forced-choice Odor Memory Test.
This non-lexical test employs 10-, 30-, and 60-second delay intervals between the presentation of the target odorant and the first of four successively presented odors from which the target is to be selected.
Electrical stimulation will be applied to a nerve of your arm.
Sticky electrode pads will also be placed on a hand muscle.
You will receive electrical stimulations that lasts less than a second.
The stimulations will make your muscle twitch.
Other Names:
|
Progressive Supranuclear Palsy
Non-smokers, ages 18-80, diagnosed with Progressive Supranuclear Palsy.
Must meet 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.
|
Eye blink responses will be induced using standard stimulating electrodes employed in surface electromyography (EMG).
The subjects will recline with their eyes gently closed.
Sticky electrodes will be placed to the left and below the left eye.
6 different facial regions will be stimulated.
The electrical stimulation will be kept constant during the test sessions.
To prevent habituation, the stimuli will be delivered randomly at intervals of 45-60 sec.
Four 0.2 msec pulses will be presented.
In some cases, paired pulse stimulation will be performed, and a conditioning stimulus will be applied to the target facial regions at the following intervals: 10, 200, 400, 600 and 800 msec.
4 pulses will be presented at each stimulus interval with randomized interval and pulse sequences.
Other Names:
Olfactory testing will be performed using standard tests.
The University of Pennsylvania Smell Identification Test (UPSIT) assesses a subjects ability to identify odors in a forced choice format.
The Snap and Sniff Threshold Test provides a threshold measure of phenyl ethyl alcohol.
Short-term odor memory will be assessed using a standardized 12-item four-alternative forced-choice Odor Memory Test.
This non-lexical test employs 10-, 30-, and 60-second delay intervals between the presentation of the target odorant and the first of four successively presented odors from which the target is to be selected.
Electrical stimulation will be applied to a nerve of your arm.
Sticky electrode pads will also be placed on a hand muscle.
You will receive electrical stimulations that lasts less than a second.
The stimulations will make your muscle twitch.
Other Names:
|
Essential Tremor
Non-smokers, ages 18-80, diagnosed with Essential Tremor.
|
Eye blink responses will be induced using standard stimulating electrodes employed in surface electromyography (EMG).
The subjects will recline with their eyes gently closed.
Sticky electrodes will be placed to the left and below the left eye.
6 different facial regions will be stimulated.
The electrical stimulation will be kept constant during the test sessions.
To prevent habituation, the stimuli will be delivered randomly at intervals of 45-60 sec.
Four 0.2 msec pulses will be presented.
In some cases, paired pulse stimulation will be performed, and a conditioning stimulus will be applied to the target facial regions at the following intervals: 10, 200, 400, 600 and 800 msec.
4 pulses will be presented at each stimulus interval with randomized interval and pulse sequences.
Other Names:
Olfactory testing will be performed using standard tests.
The University of Pennsylvania Smell Identification Test (UPSIT) assesses a subjects ability to identify odors in a forced choice format.
The Snap and Sniff Threshold Test provides a threshold measure of phenyl ethyl alcohol.
Short-term odor memory will be assessed using a standardized 12-item four-alternative forced-choice Odor Memory Test.
This non-lexical test employs 10-, 30-, and 60-second delay intervals between the presentation of the target odorant and the first of four successively presented odors from which the target is to be selected.
Electrical stimulation will be applied to a nerve of your arm.
Sticky electrode pads will also be placed on a hand muscle.
You will receive electrical stimulations that lasts less than a second.
The stimulations will make your muscle twitch.
Other Names:
|
Drug-Induced Parkinson's Disease
Non-smokers, ages 18-80, diagnosed with Drug-Induced Parkinson's Disease.
|
Eye blink responses will be induced using standard stimulating electrodes employed in surface electromyography (EMG).
The subjects will recline with their eyes gently closed.
Sticky electrodes will be placed to the left and below the left eye.
6 different facial regions will be stimulated.
The electrical stimulation will be kept constant during the test sessions.
To prevent habituation, the stimuli will be delivered randomly at intervals of 45-60 sec.
Four 0.2 msec pulses will be presented.
In some cases, paired pulse stimulation will be performed, and a conditioning stimulus will be applied to the target facial regions at the following intervals: 10, 200, 400, 600 and 800 msec.
4 pulses will be presented at each stimulus interval with randomized interval and pulse sequences.
Other Names:
Olfactory testing will be performed using standard tests.
The University of Pennsylvania Smell Identification Test (UPSIT) assesses a subjects ability to identify odors in a forced choice format.
The Snap and Sniff Threshold Test provides a threshold measure of phenyl ethyl alcohol.
Short-term odor memory will be assessed using a standardized 12-item four-alternative forced-choice Odor Memory Test.
This non-lexical test employs 10-, 30-, and 60-second delay intervals between the presentation of the target odorant and the first of four successively presented odors from which the target is to be selected.
Electrical stimulation will be applied to a nerve of your arm.
Sticky electrode pads will also be placed on a hand muscle.
You will receive electrical stimulations that lasts less than a second.
The stimulations will make your muscle twitch.
Other Names:
|
Myasthenia Gravis
Non-smokers, ages 18-80, diagnosed with Myasthenia Gravis.
|
Eye blink responses will be induced using standard stimulating electrodes employed in surface electromyography (EMG).
The subjects will recline with their eyes gently closed.
Sticky electrodes will be placed to the left and below the left eye.
6 different facial regions will be stimulated.
The electrical stimulation will be kept constant during the test sessions.
To prevent habituation, the stimuli will be delivered randomly at intervals of 45-60 sec.
Four 0.2 msec pulses will be presented.
In some cases, paired pulse stimulation will be performed, and a conditioning stimulus will be applied to the target facial regions at the following intervals: 10, 200, 400, 600 and 800 msec.
4 pulses will be presented at each stimulus interval with randomized interval and pulse sequences.
Other Names:
Olfactory testing will be performed using standard tests.
The University of Pennsylvania Smell Identification Test (UPSIT) assesses a subjects ability to identify odors in a forced choice format.
The Snap and Sniff Threshold Test provides a threshold measure of phenyl ethyl alcohol.
Short-term odor memory will be assessed using a standardized 12-item four-alternative forced-choice Odor Memory Test.
This non-lexical test employs 10-, 30-, and 60-second delay intervals between the presentation of the target odorant and the first of four successively presented odors from which the target is to be selected.
Electrical stimulation will be applied to a nerve of your arm.
Sticky electrode pads will also be placed on a hand muscle.
You will receive electrical stimulations that lasts less than a second.
The stimulations will make your muscle twitch.
Other Names:
|
Multiple System Atrophy
Non-smokers, ages 18-80, who have been diagnosed with Multiple System Atrophy.
|
Eye blink responses will be induced using standard stimulating electrodes employed in surface electromyography (EMG).
The subjects will recline with their eyes gently closed.
Sticky electrodes will be placed to the left and below the left eye.
6 different facial regions will be stimulated.
The electrical stimulation will be kept constant during the test sessions.
To prevent habituation, the stimuli will be delivered randomly at intervals of 45-60 sec.
Four 0.2 msec pulses will be presented.
In some cases, paired pulse stimulation will be performed, and a conditioning stimulus will be applied to the target facial regions at the following intervals: 10, 200, 400, 600 and 800 msec.
4 pulses will be presented at each stimulus interval with randomized interval and pulse sequences.
Other Names:
Olfactory testing will be performed using standard tests.
The University of Pennsylvania Smell Identification Test (UPSIT) assesses a subjects ability to identify odors in a forced choice format.
The Snap and Sniff Threshold Test provides a threshold measure of phenyl ethyl alcohol.
Short-term odor memory will be assessed using a standardized 12-item four-alternative forced-choice Odor Memory Test.
This non-lexical test employs 10-, 30-, and 60-second delay intervals between the presentation of the target odorant and the first of four successively presented odors from which the target is to be selected.
Electrical stimulation will be applied to a nerve of your arm.
Sticky electrode pads will also be placed on a hand muscle.
You will receive electrical stimulations that lasts less than a second.
The stimulations will make your muscle twitch.
Other Names:
|
Diffuse Lewy Body Disease
Non-smokers, ages 18-80, diagnosed with Diffuse Lewy Body Disease.
Must meet the Consensus Criteria for the clinical diagnosis of DLBD.
|
Eye blink responses will be induced using standard stimulating electrodes employed in surface electromyography (EMG).
The subjects will recline with their eyes gently closed.
Sticky electrodes will be placed to the left and below the left eye.
6 different facial regions will be stimulated.
The electrical stimulation will be kept constant during the test sessions.
To prevent habituation, the stimuli will be delivered randomly at intervals of 45-60 sec.
Four 0.2 msec pulses will be presented.
In some cases, paired pulse stimulation will be performed, and a conditioning stimulus will be applied to the target facial regions at the following intervals: 10, 200, 400, 600 and 800 msec.
4 pulses will be presented at each stimulus interval with randomized interval and pulse sequences.
Other Names:
Olfactory testing will be performed using standard tests.
The University of Pennsylvania Smell Identification Test (UPSIT) assesses a subjects ability to identify odors in a forced choice format.
The Snap and Sniff Threshold Test provides a threshold measure of phenyl ethyl alcohol.
Short-term odor memory will be assessed using a standardized 12-item four-alternative forced-choice Odor Memory Test.
This non-lexical test employs 10-, 30-, and 60-second delay intervals between the presentation of the target odorant and the first of four successively presented odors from which the target is to be selected.
Electrical stimulation will be applied to a nerve of your arm.
Sticky electrode pads will also be placed on a hand muscle.
You will receive electrical stimulations that lasts less than a second.
The stimulations will make your muscle twitch.
Other Names:
|
Healthy Controls
Non-smokers, ages 18-80, with no neurodegenerative disease, and no first-degree relatives with a neurodegenerative disease.
|
Eye blink responses will be induced using standard stimulating electrodes employed in surface electromyography (EMG).
The subjects will recline with their eyes gently closed.
Sticky electrodes will be placed to the left and below the left eye.
6 different facial regions will be stimulated.
The electrical stimulation will be kept constant during the test sessions.
To prevent habituation, the stimuli will be delivered randomly at intervals of 45-60 sec.
Four 0.2 msec pulses will be presented.
In some cases, paired pulse stimulation will be performed, and a conditioning stimulus will be applied to the target facial regions at the following intervals: 10, 200, 400, 600 and 800 msec.
4 pulses will be presented at each stimulus interval with randomized interval and pulse sequences.
Other Names:
Olfactory testing will be performed using standard tests.
The University of Pennsylvania Smell Identification Test (UPSIT) assesses a subjects ability to identify odors in a forced choice format.
The Snap and Sniff Threshold Test provides a threshold measure of phenyl ethyl alcohol.
Short-term odor memory will be assessed using a standardized 12-item four-alternative forced-choice Odor Memory Test.
This non-lexical test employs 10-, 30-, and 60-second delay intervals between the presentation of the target odorant and the first of four successively presented odors from which the target is to be selected.
During a 2-hour visual deprivation period, subjects will wear comfortable light-tight goggles with lenses that have been blackened by flat black paint.
Subjects will be given the opportunity to recline comfortable in a padded reclining chair during this time.
Electrical stimulation will be applied to a nerve of your arm.
Sticky electrode pads will also be placed on a hand muscle.
You will receive electrical stimulations that lasts less than a second.
The stimulations will make your muscle twitch.
Other Names:
|
Spinal Cord Injury
|
Eye blink responses will be induced using standard stimulating electrodes employed in surface electromyography (EMG).
The subjects will recline with their eyes gently closed.
Sticky electrodes will be placed to the left and below the left eye.
6 different facial regions will be stimulated.
The electrical stimulation will be kept constant during the test sessions.
To prevent habituation, the stimuli will be delivered randomly at intervals of 45-60 sec.
Four 0.2 msec pulses will be presented.
In some cases, paired pulse stimulation will be performed, and a conditioning stimulus will be applied to the target facial regions at the following intervals: 10, 200, 400, 600 and 800 msec.
4 pulses will be presented at each stimulus interval with randomized interval and pulse sequences.
Other Names:
Olfactory testing will be performed using standard tests.
The University of Pennsylvania Smell Identification Test (UPSIT) assesses a subjects ability to identify odors in a forced choice format.
The Snap and Sniff Threshold Test provides a threshold measure of phenyl ethyl alcohol.
Short-term odor memory will be assessed using a standardized 12-item four-alternative forced-choice Odor Memory Test.
This non-lexical test employs 10-, 30-, and 60-second delay intervals between the presentation of the target odorant and the first of four successively presented odors from which the target is to be selected.
Electrical stimulation will be applied to a nerve of your arm.
Sticky electrode pads will also be placed on a hand muscle.
You will receive electrical stimulations that lasts less than a second.
The stimulations will make your muscle twitch.
Other Names:
|
Asymptomatic Relatives
|
Eye blink responses will be induced using standard stimulating electrodes employed in surface electromyography (EMG).
The subjects will recline with their eyes gently closed.
Sticky electrodes will be placed to the left and below the left eye.
6 different facial regions will be stimulated.
The electrical stimulation will be kept constant during the test sessions.
To prevent habituation, the stimuli will be delivered randomly at intervals of 45-60 sec.
Four 0.2 msec pulses will be presented.
In some cases, paired pulse stimulation will be performed, and a conditioning stimulus will be applied to the target facial regions at the following intervals: 10, 200, 400, 600 and 800 msec.
4 pulses will be presented at each stimulus interval with randomized interval and pulse sequences.
Other Names:
Olfactory testing will be performed using standard tests.
The University of Pennsylvania Smell Identification Test (UPSIT) assesses a subjects ability to identify odors in a forced choice format.
The Snap and Sniff Threshold Test provides a threshold measure of phenyl ethyl alcohol.
Short-term odor memory will be assessed using a standardized 12-item four-alternative forced-choice Odor Memory Test.
This non-lexical test employs 10-, 30-, and 60-second delay intervals between the presentation of the target odorant and the first of four successively presented odors from which the target is to be selected.
Electrical stimulation will be applied to a nerve of your arm.
Sticky electrode pads will also be placed on a hand muscle.
You will receive electrical stimulations that lasts less than a second.
The stimulations will make your muscle twitch.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Latency, amplitude, and area under the curve of brainstem reflex response
Time Frame: 1 Hour
|
Latency, amplitude, and area under the curve of electrical brainstem reflex response of trigeminal nerve branches measured on the face musculature (before and after short-term visual deprivation).
|
1 Hour
|
Score on the University of Pennsylvania Smell Identification Test
Time Frame: 20 Minutes
|
The number of correct odor identification responses out of 40 from the standardized University of Pennsylvania Smell Identification Test (before and after short-term visual deprivation).
|
20 Minutes
|
Score on the Odor Discrimination/Memory Test
Time Frame: 30 Minutes
|
The number of correct responses in picking out an odor previously presented from three foils 10, 30, and 60 sec later using the standardized Odor Detection/Discrimination Test (before and after short-term visual deprivation).
|
30 Minutes
|
Score on an Odor Detection Threshold Test
Time Frame: 20 Minutes
|
The average of 7 reversals in a staircase odor detection threshold test that employs phenyl ethyl alcohol (rose oil) concentrations ranging from -7 to -2 log dilutions in light mineral oil.
|
20 Minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2016
Primary Completion (ACTUAL)
June 1, 2018
Study Completion (ACTUAL)
July 16, 2019
Study Registration Dates
First Submitted
April 18, 2016
First Submitted That Met QC Criteria
May 3, 2016
First Posted (ESTIMATE)
May 4, 2016
Study Record Updates
Last Update Posted (ACTUAL)
July 18, 2019
Last Update Submitted That Met QC Criteria
July 16, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Neoplasms
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Neoplasms by Site
- Eye Diseases
- Neurologic Manifestations
- Wounds and Injuries
- Neurocognitive Disorders
- Neuromuscular Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Trauma, Nervous System
- Spinal Cord Diseases
- Nervous System Neoplasms
- Dementia
- Tauopathies
- Cranial Nerve Diseases
- Autonomic Nervous System Diseases
- Ocular Motility Disorders
- Paraneoplastic Syndromes, Nervous System
- Paraneoplastic Syndromes
- Neuromuscular Junction Diseases
- Paralysis
- Primary Dysautonomias
- Hypotension
- Ophthalmoplegia
- Parkinson Disease
- Alzheimer Disease
- Myasthenia Gravis
- Spinal Cord Injuries
- Lewy Body Disease
- Multiple System Atrophy
- Shy-Drager Syndrome
- Supranuclear Palsy, Progressive
- Essential Tremor
Other Study ID Numbers
- 827731
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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