Virtual Reality and Spinal Stimulation to Improve Arm Function

Tetraplegia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05065437
• Other study ID #: FP00015240
• Status: Withdrawn
• Phase: N/A
• Start date: June 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: June 2022
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. incomplete low tetraplegia (C5-8; [ASIA] classification B-D),

2. free of contraindications to transspinal stimulation,

3. more than one-year post-injury,

4. stable medication regimen for the past month,

5. utilization of wheelchair as a primary mode of mobility (>75% of the time). -

Exclusion Criteria:

1. Neurologic injury other than spinal cord injury

2. severe medical illness.

Related Conditions & MeSH terms

• Quadriplegia
• Tetraplegia

Intervention

Other:
• Active (Virtual reality and spinal stimulation)
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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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