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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05960331
Other study ID # 202304047RINC
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date December 31, 2025

Study information

Verified date May 2023
Source National Taiwan University Hospital
Contact YA-YUN LEE, PhD
Phone +886-2-33668155
Email yayunlee@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to explore the benefits of autonomy supported learning in patients with Parkinson's disease. The main questions to answer are: - Whether autonomy supported learning can benefit motor learning in PD patients - Whether autonomy supported learning can enhance intrinsic motivation and/ or information processing of PD patients in learning a new task. - Whether autonomy supported learning can facilitate cortical excitability change after practicing a new task. Participants will be recruited into two groups (Self-control group, SC; and yoked group, YK) to learn a finger-pressing trajectory matching task - Participants in SC group will have choice over feedback schedule during trial practice - Participants in YK group will receive feedback with no-choice during trial practice Researchers will compare the retention test performance to see if autonomy supported learning will lead to better learning effect.


Description:

Autonomy is the sense of learner to actively participate in determining their own behaviour. The present study aims to investigate whether an autonomy supported practice (with self-controlled feedback) would benefit adults with Parkinson's disease (PD), along with increased intrinsic motivation, information processing and cortical excitability. Two groups of healthy adults and two groups of PD patients will be recruited to learn a finger-pressing trajectory matching task. Participants will be allocated in either a self-control group (choice over feedback schedule), or a yoked group (receive feedback with no-choice). Learning will be assessed on the second day and one week later, along with an error estimation of learners' own performance to represent their information processing ability. Cortical excitability and inhibition will be assessed via transcranial magnetic stimulation as indicators of cortical plasticity. Questionnaire regarding motivation will be assessed before and after practice trials. Study hypothesized that individual with PD would benefit from autonomy supported learning, with better performance, enhanced motivation and information processing, associates with change of cortical excitability


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 72
Est. completion date December 31, 2025
Est. primary completion date July 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - age above 20-years-old - able to follow instructions to perform the tasks (Montreal Cognitive Assessment = 24) - no surgery and injury in upper extremities in recent 6 months Exclusion Criteria: - other neurological disorders in addition to Parkinson's disease - Parkinson's disease dementia - symptom of severe tremor in upper extremities (score = 3 in Question 15 to 18 of UPDRS-III) - deep brain stimulation or pacemaker implanted - medical history of seizure - a blood-relative with history of epilepsy - unstable medical conditions - pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Autonomy supported learning
The ability of learners to participate in determining their own behaviour, which is the feedback schedule regarding their practice performance in this study.
Practice with predetermined feedback
Learners practice the motor task, while the feedback is provided according to their counterpartner

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

References & Publications (2)

Carter MJ, Ste-Marie DM. Not all choices are created equal: Task-relevant choices enhance motor learning compared to task-irrelevant choices. Psychon Bull Rev. 2017 Dec;24(6):1879-1888. doi: 10.3758/s13423-017-1250-7. — View Citation

Chiviacowsky S, Wulf G, Lewthwaite R, Campos T. Motor learning benefits of self-controlled practice in persons with Parkinson's disease. Gait Posture. 2012 Apr;35(4):601-5. doi: 10.1016/j.gaitpost.2011.12.003. Epub 2011 Dec 30. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Performance accuracy Overall performance accuracy relative to the target waveform was assessed using root mean square error (RMSE), which is the mean difference between the target waveform and the participant's movement trajectory calculated over their actual movement time. up to day 7
Secondary Intrinsic Motivation Inventory A questionnaire with subscales of perceived competence and autonomy. Questions were either taken directly or modified from the IMI, regarding to the participants subjective motivation after completing their practice trials. day 1, day 2, day 7
Secondary Error Estimation Participants will be instructed to estimate their error in RMSE after completing each trial in retention and transfer test. Error estimation is used to assess the cognitive processing of participants during the trials. day 2, day 7
Secondary Cortical excitability changes Transcranial magnetic stimulation (TMS) device (The Magstim Company Ltd, Whitland, UK) will be used to determine the neurophysiological changes of corticomotor excitability before and after the acquisition phase. Baseline, day 2, day 7
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