Virtual Reality and Spinal Stimulation to Improve Arm Function

Study Overview
=================
Brief Summary
-----------------
The main objective of our work is to develop and test the safety and feasibility of a home-based upper limb rehabilitation program for individuals with tetraplegia. The program will consist of simultaneous non-invasive spinal cord stimulation and immersive virtual exercises of the upper limbs, with a focus on shoulder and elbow function.

Official Title
-----------------
Immersive Virtual Reality and Noninvasive Spinal Stimulation to Promote Arm Function in Individuals With Tetraplegia

Conditions
-----------------
Tetraplegia

Intervention / Treatment
-----------------
* Other: Active (Virtual reality and spinal stimulation)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: incomplete low tetraplegia (C5-8; [ASIA] classification B-D), free of contraindications to transspinal stimulation, more than one-year post-injury, stable medication regimen for the past month, utilization of wheelchair as a primary mode of mobility (>75% of the time). - Exclusion Criteria: Neurologic injury other than spinal cord injury severe medical illness.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality and spinal stimulation<br>Safety and feasibility of a virtual reality and spinal stimulation intervention will be tested. | Other: Active (Virtual reality and spinal stimulation)<br>* Each session is 25 minutes; 5 minutes of setup, and 20 minutes of simultaneous spinal stimulation at the cervical level and immersive virtual experience/gameplay.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in medical status | Safety of the intervention will be assessed as the number of participants who experience a reduction in medical stability and/or functionality from before to after the intervention. | Baseline to post intervention, approximately 4 weeks | 
| Acceptability of the treatment | Acceptability of the treatment will be assessed using the Treatment Evaluation Inventory-Short Form. Items are scored using a 5-point scale, with 1 equaling strongly disagree and 5 equaling strongly agree. TEI-SF scores can range from 9 to 45, with higher scores representing greater acceptance of the treatment. | Post intervention, approximately 4 weeks | 
| Usability of the treatment | Usability of the treatment will be assessed using the Usefulness, Satisfaction, and Ease of Use (USE) Questionnaire. Items are rated on a seven-point scale ranging from strongly disagree to strongly agree. A higher scale score indicates higher usability. | Post intervention, approximately 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in affect | Affect will be assessed using the Positive and Negative Affect Schedule (PANAS). The PANAS is a 20-item measure that measures the intensity of 20 emotions on a 0-5 scale ranging from not at all to extremely. | Baseline to post intervention, approximately 4 weeks | 
| Change in current pain intensity | Current pain intensity will be assessed using a Numeric Rating Scale (NRS). Participants will rate their current pain (multiple types of pain) on a 0-10 scale (0 = no pain and 10 = worst possible pain). | Baseline to post intervention, approximately 4 weeks | 
| Change in clinical muscle strength | Clinical muscle strength will be assessed using the American Spinal Cord Injury Association (ASIA) Upper Extremity Motor Score. Motor strength is rated on a 6 point scale with higher ratings indicating greater strength. | Baseline to post intervention, approximately 4 weeks | 
| Change in upper limb function | Upper limb function will be assessed using the Spinal Cord Independence Measure (SCIM). The SCIM is composed of 19 items that assess function. SCIM scores range from 0 to 100. | Baseline to post intervention, approximately 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
upper limb function, virtual reality, spinal cord stimulation