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NCT03872102Toboroz

Facilitating Diagnostics and Prognostics of Parkinsonian Syndromes Using Neuroimaging

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jan. 27.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Toboroz
Vizsgálattípus
Megfigyeléses
Résztvevők száma
90 (tervezett)
Első benyújtás
2019. márc. 7.
Kezdés
2019. márc. 28.
Elsődleges befejezés
2026. dec. 31.
Fő szponzor
University of Texas Southwestern Medical Center
Betegségek
Parkinson-kór
NCT-szám
NCT03872102

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Tervezett résztvevők: 90
  • 2019. márc. 28. és az elsődleges befejezés (2026. dec. 31.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • 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
  • Have a history of drug, alcohol, or substance dependence or abuse within the last year, or prior prolonged history of dependence or abuse
  • Recreational drug use in past six months
  • Treatment with dopamine blockers or depleters in a time course consistent with drug induced parkinsonism
  • Hallucinations not induced by drugs

Más betegség

  • 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
  • Currently undergoing chemotherapy or radiation for cancer
  • 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
  • Severe disease progression such that participation in the imaging tests would be impossible or difficult
  • Diagnosis of behavioral variant frontotemporal dementia or primary progressive aphasia
  • Absence of an observable response to high dose levodopa despite moderate disease severity
  • Expert considers a diagnosis of alternative syndrome more likely than PD
  • Rapid progression of gait impairment requiring wheelchair within 5 years of onset
  • Severe autonomic failure in the first 5 years
  • Absence of any of the common non-motor features of PD despite 5 years of disease
  • Family history of ataxia or parkinsonism
  • Predominant, otherwise unexplained impairment of episodic memory, suggestive of AD (Alzheimer's disease)
  • 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
  • Predominant, otherwise unexplained visual hallucinations or fluctuations in alertness, suggestive of dementia with Lewy bodies
  • 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)
  • History of encephalitis
  • Identifiable cause of postural instability, e.g., primary sensory deficit, vestibular dysfunction, severe spasticity, or lower motor neuron syndrome
    • Control subjects

Laborértékek

  • 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

Életkor

  • Parkinsonian features restricted to the lower limbs for > 3 years
  • Onset after age 75 years

Egyéb

  • For Aims 1 and 2:
  • Any contraindications to undergoing the multimodal imaging program
  • 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
  • Inability to keep or maintain research appointments
    • For Aim 1:
  • Non-availability of a suitable matched participant in the alternate progression group (fast or slow)
    • For Aim 2:
    • PD subjects
  • Unequivocal cerebellar abnormalities
  • Downward vertical gaze limitation or slowing of downward saccades
  • Complete absence of progression of motor symptoms over 5 years unless due to treatment
  • Early bulbar dysfunction within the first 5 years since diagnosis
  • Inspiratory respiratory dysfunction (stridor or frequent sighs)
  • Recurrent falls (>1 per year) because of impaired balance in the first 3 years
  • Disproportionate dystonic anterocollis or hand contractures of hands or feet within 10 years
  • Otherwise unexplained pyramidal tract signs (weakness, hyperreflexia, or extensor toe signs)
  • Bilateral symmetric parkinsonism
    • MSA subjects
  • Clinically significant neuropathy
  • White matter lesions suggesting multiple sclerosis
    • PSP subjects
  • Prominent appendicular ataxia
  • In the investigator's opinion, an unsuitable candidate to serve as a control

Kiket keres a vizsgálat

  • For Aim 1:
  • 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
    • For Aim 2:
    • PD subjects will be recruited in accordance with the MDS Clinical Diagnostic Criteria for PD.
  • 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)
    • MSA subjects will be recruited in accordance with the Second Consensus Statement on Diagnosis of Multiple System Atrophy.
  • 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)
    • PSP subjects will be recruited in accordance with the MDS Criteria for Diagnosis of Progressive Supranuclear Palsy and must meet the designation of "probable PSP" for inclusion.
  • 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)
    • Control subjects will be recruited who meet the following criteria:
  • 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)

Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
UT Southwestern Medical CenterDallasEgyesült ÁllamokToboroz

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