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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the DBS Virtual Learning Experience treatment for Parkinson's Disease?

Research shows that educational sessions for patients undergoing deep brain stimulation (DBS) surgery help them feel more prepared and improve their satisfaction with the treatment. This suggests that the DBS Virtual Learning Experience could be effective in enhancing patient readiness and satisfaction. ^{1 2 3 4 5}

Is the DBS Virtual Learning Experience safe for humans?

Deep brain stimulation (DBS) has been used for Parkinson's disease, but it can have complications like infections, device issues, and sometimes requires additional surgery. Older patients may experience more serious mental health side effects. ^{6 7 8 9 10}

How does the educational sessions treatment for Parkinson's disease differ from other treatments?

The educational sessions for Parkinson's disease focus on providing patients and caregivers with comprehensive information and support, which is different from traditional medical treatments that primarily address symptoms. This approach aims to improve understanding and management of the condition through tailored education, potentially enhancing the overall quality of life for patients and their families. ^{1 11 12 13 14}

What is the purpose of this trial?

The success of Deep Brain Stimulation (DBS) is more correlated to fulfillment of patients' expectations, than merely improvement of motor status1. Therefore, it is of utmost importance to inform the DBS candidates as good as possible to set realistic expectations. Currently, the patient - most of the time accompanied by a family member - is informed about the surgery and its benefits and risks during the outpatient consultation of the neurologist, and later on during the consultation of the neurosurgeon. Written information is provided in the form of a booklet that the patients take home. Due to the large amount of information, not all of it can be captured by the patient. Therefore, we would like to investigate whether an additional online immersive educational session on DBS would better educate the patient. The online session is a 1-hour video call with a small group of DBS candidates and their caregivers, lead by DBS experts, where testimonials of other patients are shown, together with multiple infographics. Two weeks later their will be a second online session summarizing the information and providing the opportunity for Q\&A.

Eligibility Criteria

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

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

My surgery targets are balanced in the study.

Patients must be able to follow the assessment procedure

Exclusion Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient and Caregiver Perspectives of Preoperative Teaching for Deep Brain Stimulation Surgery. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Bridging the Gaps in Patient Education for DBS Surgery in Parkinson's Disease. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Selecting candidates for Deep Brain Stimulation in Parkinson's disease: the role of patients' expectations. [2020]

4. England pubmed.ncbi.nlm.nih.gov

A controlled trial of an educational programme for people with Parkinson's disease. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

A U.S. survey of patients with Parkinson's disease: satisfaction with medical care and support groups. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. Austria pubmed.ncbi.nlm.nih.gov

Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Relationship between higher rates of adverse events in deep brain stimulation using standardized prospective recording and patient outcomes. [2019]

9. United States 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. [2023]

10. Switzerland 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. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Online multimedia teaching tool for Parkinson's disease. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Computer-Based Visualization System for the Study of Deep Brain Structures Involved in Parkinson's Disease. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Home visiting by nursing students to patients with Parkinson's disease. [2019]

14. Ireland pubmed.ncbi.nlm.nih.gov

Patient education in Parkinson's disease: Formative evaluation of a standardized programme in seven European countries. [2022]