- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07647913
Rhythm Psychophysics With Parkinson's Patients (RPPD)
The goal of this interventional study is to understand how the rhythmic abilities of individuals in the early stages of Parkinson's Disease (PD) are impacted by their levels of dopamine. The main questions it aims to answer are:
- Does dopamine shelter the ability to generate and maintain a regular tapping rhythm in the presence of disrupting sensory information?
- Does dopamine allow the adaptation of tapping speed in the presence of changing sensory information?
- Is the engagement of the motor system useful to improve the detection of changes in the tempo of sensory information?
Participants will be asked to perform a battery of simple rhythmic tasks On and Off medication to evaluate the effect of dopamine on their rhythmic skills.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jonathan Cannon, Dr
- Número de teléfono: (905) 531-6902
- Correo electrónico: cannoj9@mcmaster.ca
Copia de seguridad de contactos de estudio
- Nombre: Itzamna Sanchez Moncada, Dr
- Correo electrónico: sanchei@mcmaster.ca
Ubicaciones de estudio
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Ontario
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Hamilton, Ontario, Canadá, L8S 4L8
- Psychology Building
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Contacto:
- Jonathan Cannon, Dr
- Número de teléfono: 9055259140
- Correo electrónico: cannoj9@mcmaster.ca
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Contacto:
- Itzamna Sanchez Moncada, Dr
- Número de teléfono: 3653572844
- Correo electrónico: sanchei@mcmaster.ca
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Parkinson's Disease diagnostic
- Stage 1 or 2 Hoenh-Yahr scale
- Taking immediate-release Levodopa
- MoCA score of 26 or above
Exclusion Criteria:
- Dementia
- Other neurodegenerative disease
- History of substance abuse
- History of hearing disorders
- History of neuropsychiatric disease
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Medication state
Participants will have to attend two sessions scheduled approximately one week apart.
During one session, participants will be tested while On medication (levodopa).
During the other session, participants will be asked to withhold their medication for 12 hours prior to the experimental session.
The order of the sessions will be randomized across participants.
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Participants will have to withhold Levodopa medication 12 h before one of two experimental sessions.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in mean inter-tap intervals following Levodopa withdrawal during rhythmic tapping tasks.
Periodo de tiempo: Between experimental sessions one and two, which will take place approximately one week apart.
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Audio recordings from the tapping tasks will be processed to extract onset times corresponding to participant taps (milliseconds).
These onset times will be used to compute inter-tap intervals (ITI) by subtracting the earlier onset time from the later one (milliseconds).
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Between experimental sessions one and two, which will take place approximately one week apart.
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Changes in constant error following Levodopa withdrawal during rhythmic tapping tasks.
Periodo de tiempo: Between experimental sessions one and two, which will take place approximately one week apart.
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Audio recordings from the tapping tasks will be processed to extract the onset times of participant taps (milliseconds).
These onset times will be used to compute the constant error (milliseconds) by subtracting the base interval (milliseconds) from the mean inter-tap interval (milliseconds).
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Between experimental sessions one and two, which will take place approximately one week apart.
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Changes in asynchronies following Levodopa withdrawal during rhythmic tapping tasks.
Periodo de tiempo: Between experimental sessions one and two, which will take place approximately one week apart.
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Audio recordings from the tapping tasks will be processed to extract onset times corresponding to auditory cues and participant taps (both in milliseconds).
These onset times will be used to compute asynchronies (milliseconds) between the auditory cues and the taps.
The asynchronies will be calculated by subtracting the tap onset from the corresponding auditory cue onset.
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Between experimental sessions one and two, which will take place approximately one week apart.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Impact of Levodopa withdrawal on motor symptoms severity scales.
Periodo de tiempo: Between experimental Sessions one and two, which will take place approximately one week apart.
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Motor symptom severity will be assessed with Part III of the Unified Parkinson's Disease Rating Scale (UPDRS-III).
Scores range from 0 to 132, with higher scores reflecting more severe motor symptoms.
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Between experimental Sessions one and two, which will take place approximately one week apart.
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Impact of Levodopa withdrawal on motor symptoms severity scales.
Periodo de tiempo: Between experimental sessions one and two, which will take place approximately one week apart.
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Cognitive assessment will be performed using the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG).
Scores range from 0 to 43, with higher scores reflecting better cognitive function.
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Between experimental sessions one and two, which will take place approximately one week apart.
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Colverson A, Barsoum S, Cohen R, Williamson J. Rhythmic musical activities may strengthen connectivity between brain networks associated with aging-related deficits in timing and executive functions. Exp Gerontol. 2024 Feb;186:112354. doi: 10.1016/j.exger.2023.112354. Epub 2024 Jan 3.
- Allen NE, Schwarzel AK, Canning CG. Recurrent falls in Parkinson's disease: a systematic review. Parkinsons Dis. 2013;2013:906274. doi: 10.1155/2013/906274. Epub 2013 Mar 5.
- Gratton I, Brandimonte MA, Bruno N. Absolute Memory for Tempo in Musicians and Non-Musicians. PLoS One. 2016 Oct 19;11(10):e0163558. doi: 10.1371/journal.pone.0163558. eCollection 2016.
- Zhou ZD, Yi LX, Wang DQ, Lim TM, Tan EK. Role of dopamine in the pathophysiology of Parkinson's disease. Transl Neurodegener. 2023 Sep 18;12(1):44. doi: 10.1186/s40035-023-00378-6.
- Yc K, Prado L, Merchant H. The scalar property during isochronous tapping is disrupted by a D2-like agonist in the nonhuman primate. J Neurophysiol. 2019 Mar 1;121(3):940-949. doi: 10.1152/jn.00804.2018. Epub 2018 Dec 21.
- Witt ST, Laird AR, Meyerand ME. Functional neuroimaging correlates of finger-tapping task variations: an ALE meta-analysis. Neuroimage. 2008 Aug 1;42(1):343-56. doi: 10.1016/j.neuroimage.2008.04.025. Epub 2008 Apr 16.
- Vishne G, Jacoby N, Malinovitch T, Epstein T, Frenkel O, Ahissar M. Slow update of internal representations impedes synchronization in autism. Nat Commun. 2021 Sep 14;12(1):5439. doi: 10.1038/s41467-021-25740-y.
- van der Steen MC, Keller PE. The ADaptation and Anticipation Model (ADAM) of sensorimotor synchronization. Front Hum Neurosci. 2013 Jun 10;7:253. doi: 10.3389/fnhum.2013.00253. eCollection 2013.
- Schwartze M, Keller PE, Patel AD, Kotz SA. The impact of basal ganglia lesions on sensorimotor synchronization, spontaneous motor tempo, and the detection of tempo changes. Behav Brain Res. 2011 Jan 20;216(2):685-91. doi: 10.1016/j.bbr.2010.09.015. Epub 2010 Sep 29.
- Rose D, Delevoye-Turrell Y, Ott L, Annett LE, Lovatt PJ. Music and Metronomes Differentially Impact Motor Timing in People with and without Parkinson's Disease: Effects of Slow, Medium, and Fast Tempi on Entrainment and Synchronization Performances in Finger Tapping, Toe Tapping, and Stepping on the Spot Tasks. Parkinsons Dis. 2019 Aug 18;2019:6530838. doi: 10.1155/2019/6530838. eCollection 2019.
- Repp BH, Su YH. Sensorimotor synchronization: a review of recent research (2006-2012). Psychon Bull Rev. 2013 Jun;20(3):403-52. doi: 10.3758/s13423-012-0371-2.
- Repp BH, Keller PE. Adaptation to tempo changes in sensorimotor synchronization: effects of intention, attention, and awareness. Q J Exp Psychol A. 2004 Apr;57(3):499-521. doi: 10.1080/02724980343000369.
- Repp BH. Sensorimotor synchronization: a review of the tapping literature. Psychon Bull Rev. 2005 Dec;12(6):969-92. doi: 10.3758/bf03206433.
- Spencer RM, Ivry RB. Comparison of patients with Parkinson's disease or cerebellar lesions in the production of periodic movements involving event-based or emergent timing. Brain Cogn. 2005 Jun;58(1):84-93. doi: 10.1016/j.bandc.2004.09.010. Epub 2004 Nov 18.
- Pinto SR, Uchida N. Tonic dopamine and biases in value learning linked through a biologically inspired reinforcement learning model. bioRxiv [Preprint]. 2023 Nov 29:2023.11.10.566580. doi: 10.1101/2023.11.10.566580.
- O'Boyle DJ, Freeman JS, Cody FW. The accuracy and precision of timing of self-paced, repetitive movements in subjects with Parkinson's disease. Brain. 1996 Feb;119 ( Pt 1):51-70. doi: 10.1093/brain/119.1.51.
- Merchant H, Luciana M, Hooper C, Majestic S, Tuite P. Interval timing and Parkinson's disease: heterogeneity in temporal performance. Exp Brain Res. 2008 Jan;184(2):233-48. doi: 10.1007/s00221-007-1097-7. Epub 2007 Sep 9.
- Mazzoni P, Shabbott B, Cortes JC. Motor control abnormalities in Parkinson's disease. Cold Spring Harb Perspect Med. 2012 Jun;2(6):a009282. doi: 10.1101/cshperspect.a009282.
- Lenc T, Merchant H, Keller PE, Honing H, Varlet M, Nozaradan S. Mapping between sound, brain and behaviour: four-level framework for understanding rhythm processing in humans and non-human primates. Philos Trans R Soc Lond B Biol Sci. 2021 Oct 11;376(1835):20200325. doi: 10.1098/rstb.2020.0325. Epub 2021 Aug 23.
- Lee DH, Woo BS, Park YH, Lee JH. General Treatments Promoting Independent Living in Parkinson's Patients and Physical Therapy Approaches for Improving Gait-A Comprehensive Review. Medicina (Kaunas). 2024 Apr 25;60(5):711. doi: 10.3390/medicina60050711.
- Kirkham E. How does the brain process rhythm? Elife. 2014 Mar 25;3:e02658. doi: 10.7554/eLife.02658.
- Jones CR, Jahanshahi M. Motor and perceptual timing in Parkinson's disease. Adv Exp Med Biol. 2014;829:265-90. doi: 10.1007/978-1-4939-1782-2_14.
- Jones CR, Claassen DO, Yu M, Spies JR, Malone T, Dirnberger G, Jahanshahi M, Kubovy M. Modeling accuracy and variability of motor timing in treated and untreated Parkinson's disease and healthy controls. Front Integr Neurosci. 2011 Dec 23;5:81. doi: 10.3389/fnint.2011.00081. eCollection 2011.
- Guthrie M, Myers CE, Gluck MA. A neurocomputational model of tonic and phasic dopamine in action selection: a comparison with cognitive deficits in Parkinson's disease. Behav Brain Res. 2009 Jun 8;200(1):48-59. doi: 10.1016/j.bbr.2008.12.036. Epub 2009 Jan 8.
- Grahn JA, Brett M. Impairment of beat-based rhythm discrimination in Parkinson's disease. Cortex. 2009 Jan;45(1):54-61. doi: 10.1016/j.cortex.2008.01.005. Epub 2008 Oct 30.
- Gandhi KR, Saadabadi A. Levodopa (L-Dopa). 2023 Apr 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482140/
- Collier GL, Ogden RT. Adding drift to the decomposition of simple isochronous tapping: an extension of the Wing-Kristofferson model. J Exp Psychol Hum Percept Perform. 2004 Oct;30(5):853-72. doi: 10.1037/0096-1523.30.5.853.
- Bienkiewicz MM, Craig CM. Parkinson's Is Time on Your Side? Evidence for Difficulties with Sensorimotor Synchronization. Front Neurol. 2015 Nov 27;6:249. doi: 10.3389/fneur.2015.00249. eCollection 2015.
- Benoit CE, Dalla Bella S, Farrugia N, Obrig H, Mainka S, Kotz SA. Musically cued gait-training improves both perceptual and motor timing in Parkinson's disease. Front Hum Neurosci. 2014 Jul 7;8:494. doi: 10.3389/fnhum.2014.00494. eCollection 2014.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 19513
- RGEC27/2025 (Otro número de subvención/financiamiento: Human Frontiers Science Program)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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