## Protocol Section
### Identification Module
**NCT ID:** NCT06436313

**Brief Title:** DBS Virtual Learning Experience

**Official Title:** The Value of Virtual Education on Deep Brain Stimulation for Surgical Candidates

#### Organization Study ID Info
**ID:** 23-5018
#### Organization
**Class:** OTHER
**Full Name:** University of Toronto
### Status Module
#### Completion Date
**Date:** 2025-02-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-09-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Toronto

#### Responsible Party

**Investigator Affiliation:** University of Toronto

**Investigator Full Name:** Alfonso Fasano

**Investigator Title:** Professor, Department of Medicine, Division of Neurology at University of Toronto, Toronto Western Hospital

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Parkinson Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients will receive two extra virtual educational sessions.

**Intervention Names:**

- Other: Educational Sessions

**Label:** Educational Group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** Standard-of-Care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Educational Group

**Description:** 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.

**Name:** Educational Sessions

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** his questionnaire assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living.

**Measure:** The Parkinson's Disease Questionnaire (PDQ-39)

**Time Frame:** Baseline, 3 months post op

**Description:** 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.

**Measure:** MDS-UPDR (Movement Disorders Society Unified Parkinson's Disease Rating Scale)

**Time Frame:** Baseline, 3 months post op

**Description:** is a 12-item observer or patient-rated scale with three subscales, for persistent and episodic anxiety, and avoidance behaviour.

**Measure:** Parkinson Anxiety Scale

**Time Frame:** Baseline, 3 months post op

**Description:** Is a 21-items questionnaire that is filled out by the patient to self-rate mood-related statements.

**Measure:** The Beck Depression Inventory

**Time Frame:** Baseline, 3 months post op

**Description:** Assesses the level of knowledge, expectation, and anxiety

**Measure:** Structured survey

**Time Frame:** Baseline, one day before surgery, 3 months post op

### Eligibility Module

**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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Toronto

**Contacts:**

***Contact 1:***

- **Email:** alfonso.fasano@uhn.ca

- **Name:** Alfonso Fasano, MD, PhD

- **Phone:** (416) 603-5800

- **Phone Ext:** 5961

- **Role:** CONTACT

**Country:** Canada

**Facility:** Movement Disorders Centre - Toronto Western Hospital

**State:** Ontario

**Status:** RECRUITING

**Zip:** M5T 2S8

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020734

- Term: Parkinsonian Disorders

- ID: D000001480

- Term: Basal Ganglia Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009069

- Term: Movement Disorders

- ID: D000080874

- Term: Synucleinopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M13213

- Name: Parkinson Disease

- Relevance: HIGH

- As Found: Parkinson's Disease

- ID: M22494

- Name: Parkinsonian Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M25603

- Name: Ganglion Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M16358

- Name: Synovial Cyst

- Relevance: LOW

- As Found: Unknown

- ID: M4774

- Name: Basal Ganglia Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12029

- Name: Movement Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M2217

- Name: Synucleinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010300

- Term: Parkinson Disease

### Misc Info Module

- Version Holder: 2024-05-31
