Educational Sessions for Parkinson's Disease

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Limited digital skills

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if additional online educational sessions enhance patients' understanding of Deep Brain Stimulation (DBS) for Parkinson's disease. Patients will either attend two virtual sessions featuring expert talks and patient stories or receive standard educational materials from their doctors. The trial seeks Parkinson's patients eligible for DBS surgery at Toronto Western Hospital who are comfortable using digital tools. By exploring whether these sessions improve understanding, the goal is to help patients set realistic expectations about their surgery. As an unphased trial, this study offers patients a unique opportunity to enhance their knowledge and make informed decisions about their treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this educational session is safe for patients with Parkinson's Disease?

Research has shown that the DBS Virtual Learning Experience is safe for patients. One study found that managing DBS therapy through an online platform was both safe and effective, offering benefits more quickly than traditional methods. Another study demonstrated that dual-task training is safe for individuals with Parkinson’s disease who have undergone DBS. This suggests that participating in virtual educational sessions should be well-tolerated.

These educational sessions are informative video calls, not medical treatments, so they involve minimal risk. The main goal is to help patients better understand their DBS treatment, and similar approaches have been shown to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Educational Sessions for Parkinson's Disease trial because it explores a new way to support patients through virtual learning. Unlike standard care, which typically involves in-person education from the medical team, this trial offers two additional virtual educational sessions focused specifically on deep brain stimulation (DBS). These sessions aim to empower patients by providing them with more accessible and flexible learning opportunities about their condition and treatment options. By leveraging virtual technology, this approach could enhance patient understanding and engagement, potentially leading to better management of Parkinson's symptoms.

What evidence suggests that the DBS Virtual Learning Experience is effective for educating Parkinson's Disease patients?

Research has shown that Deep Brain Stimulation (DBS) can greatly improve movement and quality of life for people with Parkinson’s disease. Studies have found that adjusting DBS settings remotely is safe and effective, potentially enhancing treatment outcomes. Real-world data from many patients confirm improvements in symptoms and overall well-being. In this trial, participants in the Educational Group will receive two additional virtual educational sessions to better prepare for DBS, helping them set realistic expectations and understand the potential benefits. While these educational sessions are new, the positive effects of DBS on Parkinson’s disease are well-documented. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease who are candidates for Deep Brain Stimulation (DBS) surgery. They should be able to attend two online educational sessions about DBS, including a Q&A. The specific inclusion and exclusion criteria are not provided in the details given.

Inclusion Criteria

My surgery targets are balanced in the study.

I am a Parkinson's patient eligible for DBS surgery at Toronto Western Hospital.

Patients must be able to follow the assessment procedure

Exclusion Criteria

People with limited digital skills (to the discretion of the PI)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Intervention

Participants receive two virtual educational sessions on Deep Brain Stimulation (DBS) led by DBS experts, including testimonials and infographics.

2 weeks

2 virtual sessions

Standard-of-Care Education

Participants receive standard education about DBS during outpatient consultations with a neurologist and neurosurgeon, and take home written information.

Follow-up

Participants are monitored for safety and effectiveness after the educational intervention and surgery, with assessments at baseline, one day before surgery, and 3 months post-op.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• DBS Virtual Learning Experience

Trial Overview The study is testing whether virtual learning experiences can help patients set realistic expectations about DBS surgery. It involves two online sessions: an immersive educational video call and a follow-up session for summarizing information and answering questions.

How Is the Trial Designed?

Group I: Educational Group Experimental Treatment 1 Intervention

Patients will receive two extra virtual educational sessions.

Group II: Standard-of-Care Active Control 1 Intervention

Patients will not receive any extra educational sessions. Their education will be provided as per standard-of-care by the clinical team.

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Published Research Related to This Trial

Deep brain stimulation (DBS) is an important treatment option for Parkinson's disease, but estimating the prevalence and categorizing adverse events (AEs) associated with it is challenging due to inconsistent reporting.

The authors advocate for a standardized scheme for reporting AEs related to DBS, which would help in conducting meaningful risk/benefit analyses and assist both physicians and patients in making informed decisions about surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for Parkinson's disease: prevalence of adverse events and need for standardized reporting. Videnovic, A., Metman, LV.[2008]

A review of 221 unique adverse events related to deep brain stimulation (DBS) devices for Parkinson's disease revealed that the most common complications were infections (16.2%) and lead migrations (8.6%).

Over 40% of the reported adverse events required patients to return to the operating room for device explantation or revision, highlighting the need for further research to improve the safety and reliability of DBS systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. Bennett, J., MacGuire, J., Novakovic, E., et al.[2023]

Deep brain stimulation (DBS) for Parkinson's disease is generally safe, with a low mortality rate of 0.2% and permanent morbidity at 0.6%, but complications such as intracerebral hemorrhage (ICH) and seizures can occur in a small percentage of cases.

The study found that the type of lead used in DBS can influence complications, with Medtronic's leads associated with higher rates of perielectrode brain edema compared to Boston Scientific's, highlighting the need for further research on hardware design to improve safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. Servello, D., Galbiati, TF., Iess, G., et al.[2023]

In a study of 26 elderly patients with Parkinson's disease undergoing subthalamic deep brain stimulation (STN-DBS), there was a higher incidence of serious adverse events, particularly psychosis and hallucinations, compared to younger patients from the EARLYSTIM study.

Despite these psychiatric complications being transient, the overall benefits of STN-DBS in improving Parkinson's symptoms were found to outweigh the risks, highlighting the importance of thorough psychiatric evaluations before and after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Candidates for Subthalamic Deep Brain Stimulation in Parkinson's Disease Have a Higher Incidence of Psychiatric Serious Adverse Events. Cozac, VV., Ehrensperger, MM., Gschwandtner, U., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11785990/

Accelerated symptom improvement in Parkinson's disease ... These results suggest that remotely adjusting DBS settings could benefit patients and improve treatment outcomes. Gharabaghi et al assess the ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1353802022000256

Necessity and feasibility of remote tele-programming ... The survey was conducted to assess the need for telemedicine among PD patients with DBS and the usability of the telehealth interface for DBS teleprogramming.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9111520/

Remote Programming in Patients With Parkinson's Disease ... Remote programming is safe and effective after DBS in patients with Parkinson's disease. Moreover, it reduces expenditure and time costs for patients and ...

4. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2839117

Long-Term Personalized Adaptive Deep Brain Stimulation ... This nonrandomized clinical trial evaluates the use of adaptive deep brain stimulation in Parkinson disease.

5. neurology.org neurology.org/doi/10.1212/WNL.0000000000204562

Real-world Outcomes Using DBS Systems with ... Real-world outcomes from this large, prospective, multicenter outcomes registry demonstrated improvement in motor function, quality-of-life, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11780920/

Development and application of a clinical core data set for ... Development and application of a clinical core data set for deep brain stimulation in Parkinson's disease, dystonia or tremor: from data collection to data ...

7. nature.com nature.com/articles/s41598-025-14519-6

Travel distance may have a negative impact on the ... Potential beneficial effects of teleprogramming on the efficacy of deep brain stimulation (DBS) have not been studied.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1353802025006613

Including individuals with Parkinson's disease and deep ... Initial data suggest dual-task training is safe and feasible for PwPD with DBS. Having DBS presents unique challenges including advanced motor symptoms ...