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Active, Not Recruiting

NCT Number: NCT06436313

DBS Virtual Learning Experience

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Movement Disorders Centre - Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of any age over 18 who are capable of understanding and granting informed consent.
  • Consecutive enrollment of Parkinson's disease patients, eligible for DBS surgery who will be operated in Toronto Western Hospital.
  • Targets of surgery (STN or GPi) equally in each study arm.
  • Patients must be able to follow the assessment procedure.

Exclusion criteria

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

Treatment and study plan

Educational sessions

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.

Primary outcomes

  1. The Parkinson's Disease Questionnaire (PDQ-39)

    Time frame: 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.

  2. MDS-UPDRS (Movement Disorders Society Unified Parkinson's Disease Rating Scale)

    Time frame: 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.

  3. Parkinson Anxiety Scale (PAS)

    Time frame: 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

  4. The Beck Depression Inventory (BDI)

    Time frame: 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.

  5. Structured survey

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Official study title

The Value of Virtual Education on Deep Brain Stimulation for Surgical Candidates

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 31, 2024
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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