SudoScan as a Biomarker of Parkinson's Disease
Palabras clave
Abstracto
fechas
Verificado por última vez: | 09/30/2018 |
Primero enviado: | 01/21/2016 |
Inscripción estimada enviada: | 05/05/2016 |
Publicado por primera vez: | 05/09/2016 |
Última actualización enviada: | 10/28/2018 |
Última actualización publicada: | 10/29/2018 |
Fecha de inicio real del estudio: | 05/31/2016 |
Fecha estimada de finalización primaria: | 11/30/2017 |
Fecha estimada de finalización del estudio: | 05/31/2018 |
Condición o enfermedad
Intervención / tratamiento
Device: Sudoscan and clinical assessment
Genetic: Skin biopsy
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
Active Comparator: Parkinson's disease (PD) patients 40 patients will be recruited. All will meet criteria for probable PD, according to the new MDS Clinical Diagnostic criteria. All participants will be 40 or older (young-onset PD includes many genetic causes, which often have normal autonomic function). | |
Active Comparator: parkinsonsism (non-PD) patients 20 patients will also be recruited. These will include patients with progressive supranuclear palsy, multiple system atrophy, 'vascular parkinsonism' or corticobasal syndrome. All patients will have parkinsonism according to UK brain bank criteria, with a diagnosis of one of the above conditions made according to gold-standard expert evaluation. No patient will meet MDS Criteria for probable PD. | |
Active Comparator: idiopathic REM sleep behavior disorder patient 40 patients will be recruited. All patients will have polysomnogram-confirmed RBD according to American Academy of Sleep Medicine Criteria. Patients will be free of parkinsonism and dementia according to neurological examination and will have no untreated sleep apnea, epilepsy, or other abnormalities that could cause dream enactment behavior. | |
Placebo Comparator: Controls 40 controls will be age matched (within 5 years) and sex-matched (with >90% concordance). All controls will have an examination confirming the absence of parkinsonism, and will have no symptoms of REM sleep behavior disorder, as assessed with the RBD1Q and expert interview. |
Criterio de elegibilidad
Edades elegibles para estudiar | 40 Years A 40 Years |
Sexos elegibles para estudiar | All |
Acepta voluntarios saludables | si |
Criterios | Inclusion Criteria: 1. PD patients: All will meet criteria for probable PD, according to the new MDS Clinical Diagnostic criteria 2. Non-PD parkinsonism patients: They will have with progressive supranuclear palsy, multiple system atrophy, 'vascular parkinsonism' or corticobasal syndrome. All patients will have parkinsonism according to UK brain bank criteria, with a diagnosis of one of the above conditions made according to gold-standard expert evaluation. No patient will meet MDS Criteria for probable PD. 3. iRBD patients: All patients will have polysomnogram-confirmed RBD according to American Academy of Sleep Medicine Criteria. Patients will be free of parkinsonism and dementia according to neurological examination and will have no untreated sleep apnea, epilepsy, or other abnormalities that could cause dream enactment behavior. 4. Controls: These will be age matched (within 5 years) and sex-matched (with >90% concordance). All controls will have an examination confirming the absence of parkinsonism, and will have no symptoms of REM sleep behavior disorder, as assessed with the RBD1Q and expert interview. Exclusion Criteria: 1. Diabetes Mellitus - In addition to causing autonomic neuropathy, hyperglycemia itself is known to interfere with results of the sudomotor scan 2. Any preceding diagnosis of autonomic neuropathy (of a cause other than PD) 3. Dementia of severity sufficient to preclude informed consent, MoCA <23. 4. Prescription of medications that directly alter peripheral autonomic function, including beta-blockers, sympatholytics (i.e. clonidine) and non-specific alpha-blockers. |
Salir
Medidas de resultado primarias
1. Electrochemical skin conductance [up to 6 months]
Medidas de resultado secundarias
1. PD severity-Hoehn and Yahr stage [up to 6 months]
2. PD severity-MDS-UPDRS [up to 6 months]
3. Autonomic symptoms and signs [up to 6 months]
4. EKG [up to 6 months]
5. Neuropathy [up to 6 months]
6. Non-motor symptoms associated with PD [up to 6 months]
7. Skin biopsy [up to 12 months]