Physiotherapy and Deep Brain Stimulation for Parkinson's Disease

Overseen By Alfonso Fasano, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Orthopaedic conditions, Severe cognitive deficits, Physiotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 29

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Alfonso Fasano, MD, PhD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Parkinson's Disease who are candidates for Deep Brain Stimulation (DBS) surgery and can consent to participate. It excludes those already in physiotherapy, with orthopedic issues affecting mobility, or severe cognitive deficits (MoCA score <17).

Inclusion Criteria

PD patients who have been identified as candidates for DBS.

Ability to give informed consent.

Exclusion Criteria

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.

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).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

DBS Surgery and Optimization

Participants undergo DBS surgery and optimization of DBS settings

3 months

3 visits (in-person)

Treatment

Participants in the physiotherapy group receive gait and balance focused physiotherapy for 8 weeks, while the control group receives no intervention

8 weeks

24 visits (in-person) for physiotherapy group

Post-intervention Assessment

All participants undergo assessments to evaluate the effects of the intervention

1 month

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Deep Brain Stimulation
• Physiotherapy

Trial Overview The study tests if combining DBS with physiotherapy improves independent mobility and reduces falls better than DBS alone in Parkinson's patients. The effectiveness of gait and balance training post-DBS will be evaluated.

How Is the Trial Designed?

Group I: Physiotherapy group Experimental Treatment 1 Intervention

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.

Group II: Control group Active Control 1 Intervention

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.

Deep Brain Stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Deep Brain Stimulation for:

• Essential tremor
• Parkinson's disease
• Dystonia
• Obsessive-compulsive disorder
• Epilepsy
• Chronic pain
• Stroke-related motor deficits (under investigation)

Approved in European Union as Deep Brain Stimulation for:

• Essential tremor
• Parkinson's disease
• Dystonia
• Obsessive-compulsive disorder
• Epilepsy
• Chronic pain

Approved in Canada as Deep Brain Stimulation for:

• Essential tremor
• Parkinson's disease
• Dystonia
• Obsessive-compulsive disorder
• Epilepsy
• Chronic pain

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+