Physiotherapy and Deep Brain Stimulation in Parkinson's Disease

Combined Physiotherapy and Deep Brain Stimulation to Improve Independent Community Mobility in Parkinson's Disease

Deep brain stimulation (DBS) is the most commonly performed surgical treatment for individuals with Parkinson's disease (PD). DBS typically works best to lessen motor symptoms such as stiffness, slowness, and tremor. Despite an overall improvement of these motor symptoms with DBS, past research failed to show an increase in community mobility and have often reported an increase in falling after surgery. The ability to move around on one's own is important for functional independence and improved quality of life. There is growing evidence supporting the positive effects of physiotherapy on individuals with PD. Gait and balance training, in particular, can improve mobility and also prevent falls. So far, no study has shown the effectiveness of rehabilitation in patients receiving DBS.

The purpose of this study is to determine if DBS combined with physiotherapy is effective for improving safe independent mobility in individuals with PD, more so than with patients receiving DBS alone.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Physiotherapy

Detailed Description

This is a single-center, single-blind non-randomized controlled study, whereby individuals receiving DBS will be allocated to receive either physiotherapy or no intervention in keeping with current practice (control group).

Patients will be recruited from a pool of PD patients who have been identified as candidates for DBS in the Movement Disorders Clinics at the Toronto Western Hospital. Approximately 60 individuals will be recruited for the study. Study participation will span 8 months from the time of enrolment to the end of the study assessment.

Participants will be allocated to one of two groups: 1) physiotherapy, or 2) control. Participants living within 50 km of the physiotherapy clinic will be allocated to the physiotherapy group and those living beyond 50 km will be allocated to the control group. Participants assigned to the physiotherapy group will receive physiotherapy treatment at the One Step Ahead Mobility physiotherapy clinic for 1 hour per day, 3 times/week for 8 weeks. Participants assigned to the control group will not receive any additional intervention and will be precluded from starting formal physiotherapy for the duration of the study. However, they will be encouraged to keep an active lifestyle. In order to stay active, they will be recommended to do simple home exercises following a home exercise video that will be presented to them. Participants assigned to the control group will be assessed at the same points in time as participants in the physiotherapy group

All participants enrolled will undergo a similar timetable with assessments completed at five points throughout the study period. At month 0, participants are enrolled in the study, have their baseline assessment completed, and receive DBS surgery. At month 1, participants are started on optimization of DBS settings. At month 3, DBS settings are optimized and participants will have completed 7 days of activity monitoring using a wearable before the pre-intervention assessment. All participants are assessed before the physiotherapy group begins to receive gait and balance focused physiotherapy for 2 months (8 weeks) and the control group receives no intervention for 2 months. At month 5, physiotherapy is completed, and all participants undergo a third assessment immediately after the intervention period. At month 6, all participants are assessed with a Life Space Assessment questionnaire post-intervention and will have completed 7 days of activity monitoring using a wearable before the visit. At month 8, all participants undergo end of study assessment 3 months after completing physiotherapy.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alfonso Fasano, MD, PhD; Phone Number: 5961 (416) 603-5800; Email: alfonso.fasano@uhn.ca
• Study Contact Backup: Name: Sumi Rajalingam, MD, Hon. BSc; Phone Number: 3158 (416) 603-5800; Email: rajasumi.rajalingam@uhnresearch.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Recruiting
      • Movement Disorders Centre - Toronto Western Hospital
      • Contact: Alfonso Fasano, MD, PhD; Phone Number: 5961 (416) 603-5800; Email: alfonso.fasano@uhn.ca
      • Contact: Sumi Rajalingam, MD, Hon. BSc; Phone Number: 3158 (416) 603-5800; Email: rajasumi.rajalingam@uhnresearch.ca
      • Principal Investigator: Alfonso Fasano, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• PD patients who have been identified as candidates for DBS.
• Ability to give informed consent.
• Patients ages 18 years and older.

Exclusion Criteria:

• Participants will be excluded if they have ongoing orthopaedic conditions potentially impacting on global mobility.
• Participants with severe cognitive deficits ((Montreal Cognitive Assessment (MoCA) score <17).
• Participants who are already receiving physiotherapy treatment (or that has been receiving it during the three months prior to enrollment) will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physiotherapy group; Participants assigned to the physiotherapy group will receive physiotherapy treatment at One Step Ahead Mobility physiotherapy clinic for 1-hour per day, 3 times/week for 8 weeks. They will begin to receive the physiotherapy treatment at 4 months following their surgery and once their DBS settings are optimized.	Other: Physiotherapy; Participants in the physiotherapy group will receive gait and balance focused physiotherapy at One Step Ahead Mobility physiotherapy clinic for 1-hour per day, 3 times/week for 8 weeks.
No Intervention: Control group; Participants assigned to the control group will not receive any additional intervention and will be precluded from starting formal physiotherapy for the duration of the study. However, they will be encouraged to keep an active lifestyle. In order to stay active, they will be recommended to do simple home exercises following a home exercise video that will be presented to them. They will be asked to do it 3 times/week for 8 weeks and keep an exercise log to help them stay on track.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mobility measures	The primary outcome is the overall amount of independent mobility in the community. This will be measured with the Life Space Assessment (LSA) questionnaire. The LSA is a five-item questionnaire where participants are asked to indicate how often within the previous four weeks they moved within their homes, outside their homes but within their property, within their neighborhoods, within their towns, and outside their towns. LSA is a cross-sectional scale that quantifies the size of one's life space in the past 4 weeks as a score of 0-120 (0 = confined to the bedroom, 120 = daily travel to places outside of one's city/town).	Visit 1: Baseline assessment at month 0, Visit 2: Pre-intervention assessment at month 3, Visit 4: Post-intervention assessment at month 6, and Visit 5: End of study assessment at month 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance	The Mini Balance Evaluation Systems Test (Mini-BESTest) will be used to measure dynamic balance. The Mini-BESTest is a 14-item test that includes four sections: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each item is scored from 0-2 (0 indicates that a person is unable to perform the task while a score of 2 is normal).	Visit 1: Baseline assessment at month 0, Visit 2: Pre-intervention assessment at month 3, Visit 3: Post-intervention assessment at month 5, and Visit 5: End of study assessment at month 8
Gait	Dynamic stability during walking, spatio-temporal gait variability and walking speed will be evaluated using the gait mat Zeno Walkway (ProtoKinetics, Havertown, PA, USA).	Visit 1: Baseline assessment at month 0, Visit 2: Pre-intervention assessment at month 3, Visit 3: Post-intervention assessment at month 5, and Visit 5: End of study assessment at month 8
Balance confidence	Balance confidence will be assessed using the Activity-specific Balance Confidence (ABC) scale. The ABC asks participants to rate, on a scale from 0-100%, how confident they would be performing 16 everyday tasks.	Visit 1: Baseline assessment at month 0, Visit 2: Pre-intervention assessment at month 3, Visit 3: Post-intervention assessment at month 5, and Visit 5: End of study assessment at month 8
Number of falls and near falls	Participants will be provided with a diary on enrolment into the study and will be asked to record any falls and near falls that they experience over the 8 months' duration of the study. A fall is defined as an event that result in a person coming to rest inadvertently on the ground or other lower level not due to a major intrinsic or extrinsic event. If a participant sustains a fall, they will be asked to record the details about the circumstances surrounding the fall with an open-ended questionnaire (setting, activity at the time of fall, physical injury, emergency department visit, hospitalization) in the falls diary. A near fall is defined as stumbling or loss of balance that would result in falling if sufficient recovery mechanisms were not activated. If the participant had a near fall, they will be asked to record the details about the event using the same open-ended questionnaire (setting, activity at the time of near fall, how the fall was avoided) in the diary.	Collected over the 8 months' duration of the study and the diary will be reviewed at visits 2,3,4 and 5.
Falls risk and functional mobility	The Timed Up and Go test (TUG) will be used to assess the falls risk and functional mobility. The TUG test is a physical performance measure in which the ability to rise up from a seated chair position, walk 3m, turn, walk back, and sit down is timed. The TUG test is highly correlated with functional mobility, gait speed, and falls in older adults.	Visit 1: Baseline assessment at month 0, Visit 2: Pre-intervention assessment at month 3, Visit 3: Post-intervention assessment at month 5, and Visit 5: End of study assessment at month 8
Mood	Mood will be assessed using the Beck Depression Inventory (BDI-I).The BDI-I is a 21-item questionnaire to assess depressive symptoms with a score of 0-3 for each item.	Visit 1: Baseline assessment at month 0, Visit 2: Pre-intervention assessment at month 3, Visit 3: Post-intervention assessment at month 5, and Visit 5: End of study assessment at month 8
Anxiety	The Hamilton Anxiety Rate Scale (HAM-A) will be used to measure the anxiety symptoms. The scale consists of 14 items with a score of 0-4 for each item.	Visit 1: Baseline assessment at month 0, Visit 2: Pre-intervention assessment at month 3, Visit 3: Post-intervention assessment at month 5, and Visit 5: End of study assessment at month 8
Exercise and activity levels	Exercise and activity levels will be monitored through a set of questions about how much exercise or physical activity they do on a regularly. For the intensity of the activity, they will be asked to separate how much time they spend doing vigorous, moderate, and light activity.	Visit 1: Baseline assessment at month 0, Visit 2: Pre-intervention assessment at month 3, Visit 3: Post-intervention assessment at month 5, and Visit 5: End of study assessment at month 8
Health-related quality of life	Health-related quality of life will be assessed using the 39-item Parkinson's Disease Questionnaire (PDQ-39). The PDQ-39 asks participants to rate how often they encounter difficulty on items within eight subscales: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort.	Visit 1: Baseline assessment at month 0, Visit 2: Pre-intervention assessment at month 3, Visit 3: Post-intervention assessment at month 5, and Visit 5: End of study assessment at month 8
Parkinson's disease symptoms	Parkinson's disease symptoms will be evaluated with the Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) part 3 scores. The maximum total MDS-UPDRS score for part 3 ranges from 0 to 132. Higher scores indicate a worse outcome of Parkinson's disease.	Visit 1: Baseline assessment at month 0, Visit 2: Pre-intervention assessment at month 3, Visit 3: Post-intervention assessment at month 5, and Visit 5: End of study assessment at month 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory outcome - average number of steps	A wearable activity monitor Fitbit Inspire 2 (Fitbit Inc., San Francisco, CA, USA) will be used to measure the average number of steps (the total number of steps per day averaged over the number of days worn). The participants will be provided with a Fitbit Inspire 2 activity monitor before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months. They will be instructed to wear the activity monitor on their wrist for 7 days including during sleep before the assessment visits.	7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months
Exploratory outcome - distance	A wearable activity monitor Fitbit Inspire 2 (Fitbit Inc., San Francisco, CA, USA) will be used to measure the distance (kilometers). The participants will be provided with a Fitbit Inspire 2 activity monitor before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months. They will be instructed to wear the activity monitor on their wrist for 7 days including during sleep before the assessment visits.	7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months
Exploratory outcome - physically active time	A wearable activity monitor Fitbit Inspire 2 (Fitbit Inc., San Francisco, CA, USA) will be used to measure the time being physically active. The participants will be provided with a Fitbit Inspire 2 activity monitor before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months. They will be instructed to wear the activity monitor on their wrist for 7 days including during sleep before the assessment visits.	7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months
Exploratory outcome - heart rate	A wearable activity monitor Fitbit Inspire 2 (Fitbit Inc., San Francisco, CA, USA) will be used to measure the heart rate (rates per minute). The participants will be provided with a Fitbit Inspire 2 activity monitor before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months. They will be instructed to wear the activity monitor on their wrist for 7 days including during sleep before the assessment visits.	7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months
Exploratory outcome - sleep quality	A wearable activity monitor Fitbit Inspire 2 (Fitbit Inc., San Francisco, CA, USA) will be used to measure sleep quality (minutes). The participants will be provided with a Fitbit Inspire 2 activity monitor before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months. They will be instructed to wear the activity monitor on their wrist for 7 days including during sleep before the assessment visits.	7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months

Collaborators and Investigators

• Sponsor: University of Toronto
• Investigators: Principal Investigator: Alfonso Fasano, MD, PhD, University of Toronto

Publications and helpful links

General Publications

• BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
• HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.
• Peto V, Jenkinson C, Fitzpatrick R, Greenhall R. The development and validation of a short measure of functioning and well being for individuals with Parkinson's disease. Qual Life Res. 1995 Jun;4(3):241-8. doi: 10.1007/BF02260863.
• Franchignoni F, Horak F, Godi M, Nardone A, Giordano A. Using psychometric techniques to improve the Balance Evaluation Systems Test: the mini-BESTest. J Rehabil Med. 2010 Apr;42(4):323-31. doi: 10.2340/16501977-0537.
• Tudor-Locke C, Craig CL, Aoyagi Y, Bell RC, Croteau KA, De Bourdeaudhuij I, Ewald B, Gardner AW, Hatano Y, Lutes LD, Matsudo SM, Ramirez-Marrero FA, Rogers LQ, Rowe DA, Schmidt MD, Tully MA, Blair SN. How many steps/day are enough? For older adults and special populations. Int J Behav Nutr Phys Act. 2011 Jul 28;8:80. doi: 10.1186/1479-5868-8-80.
• Leddy AL, Crowner BE, Earhart GM. Utility of the Mini-BESTest, BESTest, and BESTest sections for balance assessments in individuals with Parkinson disease. J Neurol Phys Ther. 2011 Jun;35(2):90-7. doi: 10.1097/NPT.0b013e31821a620c.
• Baker PS, Bodner EV, Allman RM. Measuring life-space mobility in community-dwelling older adults. J Am Geriatr Soc. 2003 Nov;51(11):1610-4. doi: 10.1046/j.1532-5415.2003.51512.x.
• Tinetti ME, Speechley M, Ginter SF. Risk factors for falls among elderly persons living in the community. N Engl J Med. 1988 Dec 29;319(26):1701-7. doi: 10.1056/NEJM198812293192604.
• Tomlinson CL, Patel S, Meek C, Herd CP, Clarke CE, Stowe R, Shah L, Sackley CM, Deane KH, Wheatley K, Ives N. Physiotherapy versus placebo or no intervention in Parkinson's disease. Cochrane Database Syst Rev. 2013 Sep 10;2013(9):CD002817. doi: 10.1002/14651858.CD002817.pub4.
• Rochester L, Chastin SF, Lord S, Baker K, Burn DJ. Understanding the impact of deep brain stimulation on ambulatory activity in advanced Parkinson's disease. J Neurol. 2012 Jun;259(6):1081-6. doi: 10.1007/s00415-011-6301-9. Epub 2011 Nov 16.
• Lozano AM, Dostrovsky J, Chen R, Ashby P. Deep brain stimulation for Parkinson's disease: disrupting the disruption. Lancet Neurol. 2002 Aug;1(4):225-31. doi: 10.1016/s1474-4422(02)00101-1.
• Kelly VE, Israel SM, Samii A, Slimp JC, Goodkin R, Shumway-Cook A. Assessing the effects of subthalamic nucleus stimulation on gait and mobility in people with Parkinson disease. Disabil Rehabil. 2010;32(11):929-36. doi: 10.3109/09638280903374139.
• Yamada K, Goto S, Hamasaki T, Kuratsu JI. Effect of bilateral subthalamic nucleus stimulation on levodopa-unresponsive axial symptoms in Parkinson's disease. Acta Neurochir (Wien). 2008 Jan;150(1):15-22; discussion 22. doi: 10.1007/s00701-007-1451-3. Epub 2008 Jan 10.
• Fasano A, Aquino CC, Krauss JK, Honey CR, Bloem BR. Axial disability and deep brain stimulation in patients with Parkinson disease. Nat Rev Neurol. 2015 Feb;11(2):98-110. doi: 10.1038/nrneurol.2014.252. Epub 2015 Jan 13.
• Daneault JF, Duval C, Barbat-Artigas S, Aubertin-Leheudre M, Jodoin N, Panisset M, Sadikot AF. Subthalamic stimulation improves motor function but not home and neighborhood mobility. Mov Disord. 2014 Dec;29(14):1816-9. doi: 10.1002/mds.25911. Epub 2014 May 22.
• Allert N, Cheeran B, Deuschl G, Barbe MT, Csoti I, Ebke M, Glaser M, Kang JS, Kelm S, Krack P, Kroth J, Jobst U, Leisse M, Oliviero A, Nolte PN, Quick-Weller J, Strothjohann M, Tamas G, Werner M, Muthuraman M, Volkmann J, Fasano A, Groppa S. Postoperative rehabilitation after deep brain stimulation surgery for movement disorders. Clin Neurophysiol. 2018 Mar;129(3):592-601. doi: 10.1016/j.clinph.2017.12.035. Epub 2018 Jan 10.
• Tomlinson CL, Patel S, Meek C, Herd CP, Clarke CE, Stowe R, Shah L, Sackley C, Deane KH, Wheatley K, Ives N. Physiotherapy intervention in Parkinson's disease: systematic review and meta-analysis. BMJ. 2012 Aug 6;345:e5004. doi: 10.1136/bmj.e5004.
• Smania N, Corato E, Tinazzi M, Stanzani C, Fiaschi A, Girardi P, Gandolfi M. Effect of balance training on postural instability in patients with idiopathic Parkinson's disease. Neurorehabil Neural Repair. 2010 Nov-Dec;24(9):826-34. doi: 10.1177/1545968310376057.
• Shen X, Mak MK. Repetitive step training with preparatory signals improves stability limits in patients with Parkinson's disease. J Rehabil Med. 2012 Nov;44(11):944-9. doi: 10.2340/16501977-1056.
• Shen X, Mak MK. Technology-assisted balance and gait training reduces falls in patients with Parkinson's disease: a randomized controlled trial with 12-month follow-up. Neurorehabil Neural Repair. 2015 Feb;29(2):103-11. doi: 10.1177/1545968314537559. Epub 2014 Jun 24.
• Ferrazzoli D, Ortelli P, Madeo G, Giladi N, Petzinger GM, Frazzitta G. Basal ganglia and beyond: The interplay between motor and cognitive aspects in Parkinson's disease rehabilitation. Neurosci Biobehav Rev. 2018 Jul;90:294-308. doi: 10.1016/j.neubiorev.2018.05.007. Epub 2018 May 4.
• Grobbelaar R, Venter R, Welman KE. Backward compared to forward over ground gait retraining have additional benefits for gait in individuals with mild to moderate Parkinson's disease: A randomized controlled trial. Gait Posture. 2017 Oct;58:294-299. doi: 10.1016/j.gaitpost.2017.08.019. Epub 2017 Aug 18.
• Zhu L, Duval C, Boissy P, Montero-Odasso M, Zou G, Jog M, Speechley M. Comparing GPS-Based Community Mobility Measures with Self-report Assessments in Older Adults with Parkinson's Disease. J Gerontol A Biol Sci Med Sci. 2020 Nov 13;75(12):2361-2370. doi: 10.1093/gerona/glaa012.
• Steffen T, Seney M. Test-retest reliability and minimal detectable change on balance and ambulation tests, the 36-item short-form health survey, and the unified Parkinson disease rating scale in people with parkinsonism. Phys Ther. 2008 Jun;88(6):733-46. doi: 10.2522/ptj.20070214. Epub 2008 Mar 20. Erratum In: Phys Ther. 2010 Mar;90(3):462.
• The prevention of falls in later life. A report of the Kellogg International Work Group on the Prevention of Falls by the Elderly. Dan Med Bull. 1987 Apr;34 Suppl 4:1-24.
• Pohl P, Nordin E, Lundquist A, Bergstrom U, Lundin-Olsson L. Community-dwelling older people with an injurious fall are likely to sustain new injurious falls within 5 years--a prospective long-term follow-up study. BMC Geriatr. 2014 Nov 18;14:120. doi: 10.1186/1471-2318-14-120.
• Stack E, Ashburn A. Fall events described by people with Parkinson's disease: implications for clinical interviewing and the research agenda. Physiother Res Int. 1999;4(3):190-200. doi: 10.1002/pri.165.
• Gazibara T, Kisic Tepavcevic D, Svetel M, Tomic A, Stankovic I, Kostic VS, Pekmezovic T. Near-falls in people with Parkinson's disease: Circumstances, contributing factors and association with falling. Clin Neurol Neurosurg. 2017 Oct;161:51-55. doi: 10.1016/j.clineuro.2017.08.008. Epub 2017 Aug 24.
• Lindholm B, Hagell P, Hansson O, Nilsson MH. Prediction of falls and/or near falls in people with mild Parkinson's disease. PLoS One. 2015 Jan 30;10(1):e0117018. doi: 10.1371/journal.pone.0117018. eCollection 2015.
• Nocera JR, Stegemoller EL, Malaty IA, Okun MS, Marsiske M, Hass CJ; National Parkinson Foundation Quality Improvement Initiative Investigators. Using the Timed Up & Go test in a clinical setting to predict falling in Parkinson's disease. Arch Phys Med Rehabil. 2013 Jul;94(7):1300-5. doi: 10.1016/j.apmr.2013.02.020. Epub 2013 Mar 6.
• Pradhan S, Kelly VE. Quantifying physical activity in early Parkinson disease using a commercial activity monitor. Parkinsonism Relat Disord. 2019 Sep;66:171-175. doi: 10.1016/j.parkreldis.2019.08.001. Epub 2019 Aug 3.
• Lamont RM, Daniel HL, Payne CL, Brauer SG. Accuracy of wearable physical activity trackers in people with Parkinson's disease. Gait Posture. 2018 Jun;63:104-108. doi: 10.1016/j.gaitpost.2018.04.034. Epub 2018 Apr 24.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: June 26, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: deep brain stimulation; physiotherapy; Parkinson disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 20-6338

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No