DBS Virtual Learning Experience

Not Applicable

Active, not recruiting

• Conditions: Parkinson Disease
• Interventions: Other: Educational Sessions

• Registration Number: NCT06436313
• Lead Sponsor: University of Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Study First Submitted: 2024-05-24
• Study First Submitted QC: 2024-05-24
• Study First Posted: 2024-05-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04
• Primary Completion: 2025-03-30
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational Group	Educational Sessions	Patients will receive two extra virtual educational sessions.

Primary Outcome Measures

Name	Time	Method
Parkinson Anxiety Scale (PAS)	Baseline, 3 months post op	is a 12-item observer or patient-rated scale with three subscales, for persistent and episodic anxiety, and avoidance behaviour. The total score on the PAS can range from 0 to 48.; Higher scores indicate greater experiences of anxiety
The Beck Depression Inventory (BDI)	Baseline, 3 months post op	Is a 21-items questionnaire that is filled out by the patient to self-rate mood-related statements. The total score can range from 0 to 63.; Higher scores indicate greater severity of depressive symptoms.
The Parkinson's Disease Questionnaire (PDQ-39)	Baseline, 3 months post op	This questionnaire assesses how often people with Parkinson's experience difficulties. across 8 dimensions of daily living. The total score for each dimension ranges from 0 (never have difficulty) to 100 (always have difficulty). Lower scores indicate better quality of life.
Structured survey	Baseline, one day before surgery, 3 months post op	Assesses the level of knowledge (score range: 0-110), anxiety (score range: 0-100), expectation (score range: 0-100), satisfaction (score range: 0-80).
MDS-UPDRS (Movement Disorders Society Unified Parkinson's Disease Rating Scale)	Baseline, 3 months post op	Is composed of 4 parts4. Part 1 in on the non-motor aspects of experiences of daily living, with the first half begin rated by the health care professional, based on input from the patient and the caregiver; and the second half a patient questionnaire. Part 2 is on the motor aspects of experiences of daily living, which is a questionnaire filled out by the patient and the caregiver. In the 3rd part the motor condition of the patient evaluated by the physician or nurse practitioner, in meds-ON and DBS-ON condition. The fourth and final part evaluates the motor complications and is rated by the health care professional, based on input from the patient and the caregiver.; The total score on the MDS-UPDRS ranges from 0 to 260. The score indicates: 0: No disability 260: Total disability.

Trial Locations

Locations (1)

Movement Disorders Centre - Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada