- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07647913
Rhythm Psychophysics With Parkinson's Patients (RPPD)
2026년 6월 9일 업데이트: McMaster University
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.
연구 개요
연구 유형
중재적
등록 (추정된)
34
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Jonathan Cannon, Dr
- 전화번호: (905) 531-6902
- 이메일: cannoj9@mcmaster.ca
연구 연락처 백업
- 이름: Itzamna Sanchez Moncada, Dr
- 이메일: sanchei@mcmaster.ca
연구 장소
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Ontario
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Hamilton, Ontario, 캐나다, L8S 4L8
- Psychology Building
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연락하다:
- Jonathan Cannon, Dr
- 전화번호: 9055259140
- 이메일: cannoj9@mcmaster.ca
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연락하다:
- Itzamna Sanchez Moncada, Dr
- 전화번호: 3653572844
- 이메일: sanchei@mcmaster.ca
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in mean inter-tap intervals following Levodopa withdrawal during rhythmic tapping tasks.
기간: 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.
기간: 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.
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Impact of Levodopa withdrawal on motor symptoms severity scales.
기간: 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.
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2027년 9월 30일
연구 완료 (추정된)
2027년 10월 31일
연구 등록 날짜
최초 제출
2026년 6월 1일
QC 기준을 충족하는 최초 제출
2026년 6월 9일
처음 게시됨 (실제)
2026년 6월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 9일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 19513
- RGEC27/2025 (기타 보조금/기금 번호: Human Frontiers Science Program)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
파킨슨병(PD)에 대한 임상 시험
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Nandakumar NarayananNational Institute of Neurological Disorders and Stroke (NINDS)초대로 등록
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Oxford Biodynamics Inc.Community Clinical Oncology Research Network, LLC모병암 | 면역 요법 | PD-L1 | PD-1 | 면역관문치료미국
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Dr. Mehak NaeemUniversity of Health Sciences Lahore모병
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Tianjin Medical UniversityTianjin Medical University General Hospital모병PD-L1 유전자 돌연변이 | 양전자 방출 단층 촬영 | PD-L1 유전자 증폭 | PD-L1-related Disease중국
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Agenus Inc.완전한고급 고형암 | PD-1 및 PD-L1 요법에 대한 고급 고체 암미국
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Aida Frías GonzálezSpanish Society of Nephrology; SOMANE (MADRID SOCIETY OF NEPHROLOGY); Foundation for Biomedical...모병
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EicOsis Human Health Inc.University of California, Davis; Michael J. Fox Foundation for Parkinson's Research모병
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University of HailHealth Education Research Foundation (HERF)모병
Withholding Levodopa에 대한 임상 시험
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Nanjing University알려지지 않은
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AbbVie (prior sponsor, Abbott)Quintiles, Inc.완전한
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University Hospital TuebingenGerman Research Foundation; Uppsala University모병
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Yousheng XiaoJiangbin Hospital of Guangxi Zhuang Autonomous Region; Guangxi Hospital Division of The... 그리고 다른 협력자들모병
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University Hospital Tuebingen모병