DBS Virtual Learning Experience

NCT ID: NCT06436313

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-02-01

Brief Summary

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Educational Group

Patients will receive two extra virtual educational sessions.

Group Type: EXPERIMENTAL

Educational Sessions

Intervention Type: OTHER

Two online educational sessions will be organized before DBS surgery. These will be scheduled between consultation with the neurologist and the consultation with the neurosurgeon. Each virtual session will last about 1 hour. Patients can login from home, together with their caregivers. The virtual sessions will be held on MS Teams virtual platform.

One of the sessions will include a DBS patient where patients will have the opportunity to ask peer-to-peer questions. The session includes testimonials from patient before and after their surgery.

The second session (about two weeks later) is a summary presentation, a quiz and time for Q&A. During one of the sessions (first or second), a DBS patient (who has been implanted) can be invited to participate togive the attendees the opportunity to ask peer-to-peer questions. The quiz contains questions to assess the patients' knowledge of DBS.

Standard-of-Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Educational Sessions

Two online educational sessions will be organized before DBS surgery. These will be scheduled between consultation with the neurologist and the consultation with the neurosurgeon. Each virtual session will last about 1 hour. Patients can login from home, together with their caregivers. The virtual sessions will be held on MS Teams virtual platform.

One of the sessions will include a DBS patient where patients will have the opportunity to ask peer-to-peer questions. The session includes testimonials from patient before and after their surgery.

The second session (about two weeks later) is a summary presentation, a quiz and time for Q&A. During one of the sessions (first or second), a DBS patient (who has been implanted) can be invited to participate togive the attendees the opportunity to ask peer-to-peer questions. The quiz contains questions to assess the patients' knowledge of DBS.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients of any age over 18 who are capable of understanding and granting informed consent.

2. Consecutive enrollment of Parkinson's disease patients, eligible for DBS surgery who will be operated in Toronto Western Hospital.

3. Targets of surgery (STN or GPi) equally in each study arm.

4. Patients must be able to follow the assessment procedure.

Exclusion Criteria

1. people with limited digital skills (to the discretion of the PI).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Alfonso Fasano

Professor, Department of Medicine, Division of Neurology at University of Toronto, Toronto Western Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Movement Disorders Centre - Toronto Western Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

23-5018

Identifier Type: -

Identifier Source: org_study_id