## Protocol Section
### Identification Module
**NCT ID:** NCT06436287

**Brief Title:** Handwriting Analysis in Movement Disorders.

**Official Title:** Handwriting Analysis in Movement Disorders.

#### Organization Study ID Info
**ID:** 123953
#### Organization
**Class:** OTHER
**Full Name:** Western University
### Status Module
#### Completion Date
**Date:** 2030-07

**Type:** ESTIMATED

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

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-26

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2029-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Western University

#### Responsible Party

**Investigator Affiliation:** Western University

**Investigator Full Name:** Aditya Murgai

**Investigator Title:** Assistant Professor in Neurology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Movement disorders are a group of neurological conditions that cause problems with movement, either in the form of excessive, reduced, or slow movements. Some commonly known movement disorders include Parkinson disease, dystonia, ataxia, and Tourette syndrome. Multiple movement disorders have unique handwriting characteristics that can be measured using an inkless pen and a digitalized tablet. Handwriting is a complex skill that requires a combination of cognition, motor planning, and visuomotor integration. Handwriting deteriorates in patients with neurodegenerative diseases.

This study aims to discern variations in the kinematics (movement patterns) involved in handwriting between individuals with movement disorders and healthy controls. Participants will be invited to carry out a series of handwriting tasks. The pen motions will be captured using an inkless pen and a digitizing tablet linked to a laptop. The entire set of tasks is designed to be completed within 30 minutes. The data will then be collected, processed, and analyzed utilizing a handwriting analysis software.

**Detailed Description:** Background: Handwriting is a complex skill that requires a combination of cognition, motor planning, and visuomotor integration. Various brain structures including the cerebral cortex, basal ganglia, and cerebellum are involved in learning and performing handwriting. Many neurological disorders impact these brain structures in unique ways, leading to distinct effects on handwriting. Changes in handwriting performance are a prominent feature of Parkinson disease (PD), ataxias, and other movement disorders. Handwriting analysis can serve as a tool to distinguish and monitor the progression of movement disorders. Patients suffering from PD exhibit impairments of previously learned motor skills, including handwriting. It has been demonstrated that patients in the early stages of Parkinson disease exhibit variations in handwriting when compared to healthy individuals. The current research will investigate kinematics, visuospatial adaptation, and learning in different movement disorders through handwriting analysis.

Data collection and Measurement techniques: The subject will be seated comfortably at a table with the digitalized tablet positioned to allow a natural writing position for the subject. Pen movements will be recorded using a non-inking pen and Wacom Cintiq 16-inch digitizing tablet connected to a laptop. A practice session will be provided to each participant to familiarize them with the inkless writing pen and tablet. Before each task, participants will be given instructions on how to perform the task. Participants will be instructed to complete several writing exercises aimed at evaluating various aspects of their handwriting skills. Each task will be repeated multiple times and the entire set of handwriting exercises will be completed within 30 minutes.

### Conditions Module

**Conditions:**

- Movement Disorders

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 1 Day

### Arms Interventions Module

#### Arm Group 1

**Description:** Diagnosed with a movement disorder

**Label:** Cases

#### Arm Group 2

**Description:** Healthy controls

**Label:** Control

### Outcomes Module

#### Primary Outcomes

**Description:** Average absolute vertical velocity (cm/s)

**Measure:** Primary handwriting kinematic parameter (velocity)

**Time Frame:** Day 1

#### Secondary Outcomes

**Description:** Average absolute vertical acceleration (cm/s²)

**Measure:** Secondary handwriting kinematic parameter (acceleration)

**Time Frame:** Day 1

**Description:** Average stroke duration (msec)

**Measure:** Secondary handwriting kinematic parameter (duration)

**Time Frame:** Day 1

**Description:** Average pen pressure (levels)

**Measure:** Pen pressure

**Time Frame:** Day 1

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

(1) Diagnosed with a movement disorder.

Exclusion Criteria:

1. Action tremor or weakness in the dominant hand interfering with writing task.
2. Unable to write or understand English

**Healthy Volunteers:** True

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Movement disorder patients will be recruited from the London Movement Disorder Clinic.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** aditya.murgai@lhsc.on.ca

**Name:** Aditya Murgai

**Phone:** 519-685-8500

**Phone Ext:** 33121

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** London

**Contacts:**

***Contact 1:***

- **Email:** amurgai@uwo.ca

- **Name:** Aditya Murgai, MBBS, MD, DM

- **Phone:** 5196633121

- **Role:** CONTACT

**Country:** Canada

**Facility:** Aditya Murgai

**State:** Ontario

**Zip:** N6A5A5

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12029

- Name: Movement Disorders

- Relevance: HIGH

- As Found: Movement Disorders

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009069

- Term: Movement Disorders

### Misc Info Module

- Version Holder: 2024-05-31
