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Virtual Reality and Spinal Stimulation to Improve Arm Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05065437
Recruitment Status : Withdrawn (No IRB application has been prepared for this study and other studies have taken priority. The study team will not be working on this study for the foreseeable future.)
First Posted : October 4, 2021
Last Update Posted : July 1, 2022
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tetraplegia Other: Active (Virtual reality and spinal stimulation) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immersive Virtual Reality and Noninvasive Spinal Stimulation to Promote Arm Function in Individuals With Tetraplegia
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Virtual reality and spinal stimulation
Safety and feasibility of a virtual reality and spinal stimulation intervention will be tested.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in medical status [ Time Frame: Baseline to post intervention, approximately 4 weeks ]
    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.

  2. Acceptability of the treatment [ Time Frame: Post intervention, approximately 4 weeks ]
    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.

  3. Usability of the treatment [ Time Frame: Post intervention, approximately 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in affect [ Time Frame: Baseline to post intervention, approximately 4 weeks ]
    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."

  2. Change in current pain intensity [ Time Frame: Baseline to post intervention, approximately 4 weeks ]
    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").

  3. Change in clinical muscle strength [ Time Frame: Baseline to post intervention, approximately 4 weeks ]
    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.

  4. Change in upper limb function [ Time Frame: Baseline to post intervention, approximately 4 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05065437


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Carrie Peterson, PhD Virginia Commonwealth University
More Information
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT05065437    
Other Study ID Numbers: FP00015240
First Posted: October 4, 2021    Key Record Dates
Last Update Posted: July 1, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Virginia Commonwealth University:
upper limb function
virtual reality
spinal cord stimulation
Additional relevant MeSH terms:
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Quadriplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases