Parkinson DiseaseNCT06436313
DBS Virtual Learning Experience
A study testing Educational Sessions in people with Parkinson Disease, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Educational Sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2023to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. people with limited digital skills (to the discretion of the PI).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Movement Disorders Centre - Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
Official title: The Value of Virtual Education on Deep Brain Stimulation for Surgical Candidates
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
- Being tested
- Educational Sessions
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational SessionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Educational Group | Experimental | Patients will receive two extra virtual educational sessions. Receives: Other: Educational Sessions |
| Standard-of-Care | No intervention | Patients will not receive any extra educational sessions. Their education will be provided as per standard-of-care by the clinical team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Parkinson's Disease Questionnaire (PDQ-39)
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.
Measured: Baseline, 3 months post op
MDS-UPDRS (Movement Disorders Society Unified Parkinson's Disease Rating Scale)
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.
Measured: Baseline, 3 months post op
Parkinson Anxiety Scale (PAS)
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
Measured: Baseline, 3 months post op
The Beck Depression Inventory (BDI)
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.
Measured: Baseline, 3 months post op
Structured survey
Assesses the level of knowledge (score range: 0-110), anxiety (score range: 0-100), expectation (score range: 0-100), satisfaction (score range: 0-80).
Measured: Baseline, one day before surgery, 3 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Sep 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Fasano, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436313
- Sponsor's protocol ID
- 23-5018
- Status last verified
- Sep 2025
- First submitted
- 24 May 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Virtual Education on Deep Brain Stimulation for Surgical Candidates
- ClinicalTrials.gov ID
- NCT06436313
- Acronym / sponsor ID
- 23-5018
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Group | Experimental | Other: Educational SessionsPatients will receive two extra virtual educational sessions. |
| Standard-of-Care | No intervention | –Patients will not receive any extra educational sessions. Their education will be provided as per standard-of-care by the clinical team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. people with limited digital skills (to the discretion of the PI).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational SessionsTwo 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. | Other | Educational Group |
Primary outcome
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.
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.
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
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Sessions in people with Parkinson Disease, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Parkinson's Disease Questionnaire (PDQ-39) (time frame: Baseline, 3 months post op). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.