- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Jonathan Cannon, Dr
- Номер телефона: (905) 531-6902
- Электронная почта: cannoj9@mcmaster.ca
Учебное резервное копирование контактов
- Имя: Itzamna Sanchez Moncada, Dr
- Электронная почта: sanchei@mcmaster.ca
Места учебы
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Ontario
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Hamilton, Ontario, Канада, L8S 4L8
- Psychology Building
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Контакт:
- Jonathan Cannon, Dr
- Номер телефона: 9055259140
- Электронная почта: cannoj9@mcmaster.ca
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Контакт:
- Itzamna Sanchez Moncada, Dr
- Номер телефона: 3653572844
- Электронная почта: sanchei@mcmaster.ca
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Changes in mean inter-tap intervals following Levodopa withdrawal during rhythmic tapping tasks.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Impact of Levodopa withdrawal on motor symptoms severity scales.
Временное ограничение: 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.
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 19513
- RGEC27/2025 (Другой номер гранта/финансирования: Human Frontiers Science Program)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .