TetraplegiaNCT05065437
Virtual Reality and Spinal Stimulation to Improve Arm Function
A study testing Active (Virtual reality and spinal stimulation) in people with Tetraplegia, run by Virginia Commonwealth University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tetraplegia
- What is being tested?
- Active (Virtual reality and spinal stimulation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2022to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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). -
Who cannot join
- Neurologic injury other than spinal cord injury
- severe medical illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Immersive Virtual Reality and Noninvasive Spinal Stimulation to Promote Arm Function in Individuals With Tetraplegia
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.
- Conditions
- Tetraplegia
- Being tested
- Active (Virtual reality and spinal stimulation)
- Keywords
- upper limb function, virtual reality, spinal cord stimulation
- Medical subject headings
- Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active (Virtual reality and spinal stimulation)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality and spinal stimulation | Experimental | Safety and feasibility of a virtual reality and spinal stimulation intervention will be tested. Receives: Other: Active (Virtual reality and spinal stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Post intervention, approximately 4 weeks
Secondary outcomes (4)
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."
Measured: 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").
Measured: 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.
Measured: 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.
Measured: Baseline to post intervention, approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study startJun 2022 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetraplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carrie Peterson, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065437
- Sponsor's protocol ID
- FP00015240
- Status last verified
- Jun 2022
- First submitted
- 22 Sep 2021
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Virtual Reality and Noninvasive Spinal Stimulation to Promote Arm Function in Individuals With Tetraplegia
- ClinicalTrials.gov ID
- NCT05065437
- Acronym / sponsor ID
- FP00015240
- Conditions
- Tetraplegia
- Keywords
- upper limb function, virtual reality, spinal cord stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual reality and spinal stimulation | Experimental | Other: Active (Virtual reality and spinal stimulation)Safety and feasibility of a virtual reality and spinal stimulation intervention will be tested. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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). -
Key exclusion criteria (2 listed)
- Neurologic injury other than spinal cord injury
- severe medical illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Virtual reality and spinal stimulation |
Primary outcome
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.
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.
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.
4 secondary outcomes
Change in affect
Time frame: Baseline to post intervention, approximately 4 weeks
Change in current pain intensity
Time frame: Baseline to post intervention, approximately 4 weeks
Change in clinical muscle strength
Time frame: Baseline to post intervention, approximately 4 weeks
Change in upper limb function
Time frame: Baseline to post intervention, approximately 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Tetraplegia
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A Neuroprosthesis for Seated Posture and Balance
Spinal Cord Injury, Paralysis
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Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Recruiting
Augmenting Upper Limb Function and Functional Neuroplasticity Using Epidural Stimulation of the Cervical Spinal Cord
Spinal Cord Injuries, Cervical Spinal Cord Injury
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie Peterson, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active (Virtual reality and spinal stimulation) in people with Tetraplegia, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in medical status (time frame: Baseline to post intervention, approximately 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.