RECRUITING

Facilitating Diagnostics and Prognostics of Parkinsonian Syndromes Using Neuroimaging

Conditions

Parkinson Disease Multiple System Atrophy Progressive Supranuclear Palsy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goals of this study are: 1) to identify biomarkers using neuroimaging that are associated with progression rate using statistical methods, and 2) to identify biomarkers that are associated with the differential diagnosis of Parkinson's disease and atypical parkinsonism.

Official Title

Quantitative Diagnostics of Parkinsonian Syndromes Using Multi-modal Neuroimaging and Deep Learning

Quick Facts

Study Start:2019-03-28

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03872102

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.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Diagnosis of Parkinson disease * Existence of sufﬁcient clinical data from previous UTS Southwestern longitudinal study to determine progression rate (categorized as fast or slow) * Availability of suitable matched participant in the alternate progression group (fast or slow) * Willingness to participate in the imaging studies required for this study and to provide written informed consent * Duration of PD (since diagnosis) is \< 5 years * Willing to participate in imaging and clinical scoring visits, and provide written informed consent * Subject and investigator agree that it is highly likely subject will be able to participate throughout the 2-year study period (no plans to move) * Duration of MSA (since diagnosis) is \< 5 years * Willing to participate in imaging and clinical scoring visits, and provide written informed consent * Subject and investigator agree that it is highly likely subject will be able to participate throughout the 2-year study period (no plans to move away during the study) * Willing to participate in imaging and clinical scoring visits, and provide written informed consent * Subject and investigator agree that it is highly likely subject will be able to participate throughout the 2-year study period (no plans to move away during the study) * Roughly age and sex matched with the subjects in the PD cohort * No history or examination findings suggestive of any neurodegenerative disease * Normal gait, balance, and eye movements for age * No clinical evidence for symptomatic orthostatic hypotension * Willing to participate in imaging and clinical scoring visits, and provide written informed consent * Subject and investigator agree that it is highly likely subject will be able to participate throughout the 2-year study period (no plans to move away during the study)	* Any contraindications to undergoing the multimodal imaging program * All females of child-bearing potential, between the ages of 18-55, will be excluded from the study, unless they are confirmed to be not pregnant with a pregnancy test prior to scanning * This study will require constant clear communication throughout the duration of the study; therefore, non-English speakers will be excluded * Right-handed finger amputees * Cast on right hand or fingers at the time of enrollment * Has clinically significant liver, kidney, lung, metabolic or hormone disturbances which pose safety risk * Has a current clinically significant heart disease that poses a safety risk * Has a current clinically significant infectious disease or a medical comorbidity which poses a safety risk * Has a history of relevant severe drug allergy or hypersensitivity * Have a history of drug, alcohol, or substance dependence or abuse within the last year, or prior prolonged history of dependence or abuse * Currently undergoing chemotherapy or radiation for cancer * Recreational drug use in past six months * Central nervous systems disease or brain injury that would preclude participation in this study * Psychiatric or neurological disorder that would preclude participation in this study * Inability to keep or maintain research appointments * Severe disease progression such that participation in the imaging tests would be impossible or difficult * Non-availability of a suitable matched participant in the alternate progression group (fast or slow) 1. Unequivocal cerebellar abnormalities 2. Downward vertical gaze limitation or slowing of downward saccades 3. Diagnosis of behavioral variant frontotemporal dementia or primary progressive aphasia 4. Parkinsonian features restricted to the lower limbs for \> 3 years 5. Treatment with dopamine blockers or depleters in a time course consistent with drug induced parkinsonism 6. Absence of an observable response to high dose levodopa despite moderate disease severity 7. Expert considers a diagnosis of alternative syndrome more likely than PD 8. Rapid progression of gait impairment requiring wheelchair within 5 years of onset 9. Complete absence of progression of motor symptoms over 5 years unless due to treatment 10. Early bulbar dysfunction within the first 5 years since diagnosis 11. Inspiratory respiratory dysfunction (stridor or frequent sighs) 12. Severe autonomic failure in the first 5 years 13. Recurrent falls (\>1 per year) because of impaired balance in the first 3 years 14. Disproportionate dystonic anterocollis or hand contractures of hands or feet within 10 years 15. Absence of any of the common non-motor features of PD despite 5 years of disease 16. Otherwise unexplained pyramidal tract signs (weakness, hyperreflexia, or extensor toe signs) 17. Bilateral symmetric parkinsonism 1. Clinically significant neuropathy 2. Hallucinations not induced by drugs 3. Onset after age 75 years 4. Family history of ataxia or parkinsonism 5. White matter lesions suggesting multiple sclerosis 1. Predominant, otherwise unexplained impairment of episodic memory, suggestive of AD (Alzheimer's disease) 2. Predominant, otherwise unexplained autonomic failure, e.g., orthostatic hypotension (orthostatic reduction in blood pressure after 3 minutes standing \> 30 mm Hg systolic or \> 15 mm Hg diastolic), suggestive of multiple system atrophy or Lewy body disease 3. Predominant, otherwise unexplained visual hallucinations or fluctuations in alertness, suggestive of dementia with Lewy bodies 4. Predominant, otherwise unexplained multisegmental upper and lower motor neuron signs, suggestive of motor neuron disease (pure upper motor neuron signs are not an exclusion criterion) 5. Sudden onset or step-wise or rapid progression of symptoms, in conjunction with corresponding imaging or laboratory findings, suggestive of vascular etiology, autoimmune encephalitis, metabolic encephalopathies, or prion disease 6. History of encephalitis 7. Prominent appendicular ataxia 8. Identifiable cause of postural instability, e.g., primary sensory deficit, vestibular dysfunction, severe spasticity, or lower motor neuron syndrome

Inclusion Criteria

Exclusion Criteria

* Diagnosis of Parkinson disease
* Existence of sufﬁcient clinical data from previous UTS Southwestern longitudinal study to determine progression rate (categorized as fast or slow)
* Availability of suitable matched participant in the alternate progression group (fast or slow)
* Willingness to participate in the imaging studies required for this study and to provide written informed consent
* Duration of PD (since diagnosis) is \< 5 years
* Willing to participate in imaging and clinical scoring visits, and provide written informed consent
* Subject and investigator agree that it is highly likely subject will be able to participate throughout the 2-year study period (no plans to move)
* Duration of MSA (since diagnosis) is \< 5 years
* Willing to participate in imaging and clinical scoring visits, and provide written informed consent
* Subject and investigator agree that it is highly likely subject will be able to participate throughout the 2-year study period (no plans to move away during the study)
* Willing to participate in imaging and clinical scoring visits, and provide written informed consent
* Subject and investigator agree that it is highly likely subject will be able to participate throughout the 2-year study period (no plans to move away during the study)
* Roughly age and sex matched with the subjects in the PD cohort
* No history or examination findings suggestive of any neurodegenerative disease
* Normal gait, balance, and eye movements for age
* No clinical evidence for symptomatic orthostatic hypotension
* Willing to participate in imaging and clinical scoring visits, and provide written informed consent
* Subject and investigator agree that it is highly likely subject will be able to participate throughout the 2-year study period (no plans to move away during the study)

* Any contraindications to undergoing the multimodal imaging program
* All females of child-bearing potential, between the ages of 18-55, will be excluded from the study, unless they are confirmed to be not pregnant with a pregnancy test prior to scanning
* This study will require constant clear communication throughout the duration of the study; therefore, non-English speakers will be excluded
* Right-handed finger amputees
* Cast on right hand or fingers at the time of enrollment
* Has clinically significant liver, kidney, lung, metabolic or hormone disturbances which pose safety risk
* Has a current clinically significant heart disease that poses a safety risk
* Has a current clinically significant infectious disease or a medical comorbidity which poses a safety risk
* Has a history of relevant severe drug allergy or hypersensitivity
* Have a history of drug, alcohol, or substance dependence or abuse within the last year, or prior prolonged history of dependence or abuse
* Currently undergoing chemotherapy or radiation for cancer
* Recreational drug use in past six months
* Central nervous systems disease or brain injury that would preclude participation in this study
* Psychiatric or neurological disorder that would preclude participation in this study
* Inability to keep or maintain research appointments
* Severe disease progression such that participation in the imaging tests would be impossible or difficult
* Non-availability of a suitable matched participant in the alternate progression group (fast or slow)
1. Unequivocal cerebellar abnormalities
2. Downward vertical gaze limitation or slowing of downward saccades
3. Diagnosis of behavioral variant frontotemporal dementia or primary progressive aphasia
4. Parkinsonian features restricted to the lower limbs for \> 3 years
5. Treatment with dopamine blockers or depleters in a time course consistent with drug induced parkinsonism
6. Absence of an observable response to high dose levodopa despite moderate disease severity
7. Expert considers a diagnosis of alternative syndrome more likely than PD
8. Rapid progression of gait impairment requiring wheelchair within 5 years of onset
9. Complete absence of progression of motor symptoms over 5 years unless due to treatment
10. Early bulbar dysfunction within the first 5 years since diagnosis
11. Inspiratory respiratory dysfunction (stridor or frequent sighs)
12. Severe autonomic failure in the first 5 years
13. Recurrent falls (\>1 per year) because of impaired balance in the first 3 years
14. Disproportionate dystonic anterocollis or hand contractures of hands or feet within 10 years
15. Absence of any of the common non-motor features of PD despite 5 years of disease
16. Otherwise unexplained pyramidal tract signs (weakness, hyperreflexia, or extensor toe signs)
17. Bilateral symmetric parkinsonism
1. Clinically significant neuropathy
2. Hallucinations not induced by drugs
3. Onset after age 75 years
4. Family history of ataxia or parkinsonism
5. White matter lesions suggesting multiple sclerosis
1. Predominant, otherwise unexplained impairment of episodic memory, suggestive of AD (Alzheimer's disease)
2. Predominant, otherwise unexplained autonomic failure, e.g., orthostatic hypotension (orthostatic reduction in blood pressure after 3 minutes standing \> 30 mm Hg systolic or \> 15 mm Hg diastolic), suggestive of multiple system atrophy or Lewy body disease
3. Predominant, otherwise unexplained visual hallucinations or fluctuations in alertness, suggestive of dementia with Lewy bodies
4. Predominant, otherwise unexplained multisegmental upper and lower motor neuron signs, suggestive of motor neuron disease (pure upper motor neuron signs are not an exclusion criterion)
5. Sudden onset or step-wise or rapid progression of symptoms, in conjunction with corresponding imaging or laboratory findings, suggestive of vascular etiology, autoimmune encephalitis, metabolic encephalopathies, or prion disease
6. History of encephalitis
7. Prominent appendicular ataxia
8. Identifiable cause of postural instability, e.g., primary sensory deficit, vestibular dysfunction, severe spasticity, or lower motor neuron syndrome

Contacts and Locations

Study Contact

Pheba Sunny

CONTACT

214-648-7578

phebaelizabath.sunny@utsouthwestern.edu

Principal Investigator

Richard B Dewey, MD

PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Albert Montillo, PhD

PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Study Locations (Sites)

UT Southwestern Medical Center

Dallas, Texas, 75390

United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

Richard B Dewey, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center
Albert Montillo, PhD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

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 Registration Dates

Study Start Date2019-03-28

Study Completion Date2024-12

Study Record Updates

Study Start Date2019-03-28

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

Parkinson Disease
Multiple System Atrophy
Progressive Supranuclear Palsy