Spinal Cord InjuriesPhase 3NCT03592394
Virtual Reality for Chronic Neuropathic Pain
A Phase 3 study testing Immersive Virtual Reality (Gear VR) in people with Spinal Cord Injuries and Neuropathic Pain, run by Kathleen Friel at 1 site in United States.
Trial summary
The investigators hypothesize that SCI patients using immersive IVR training will show improved reduction of neuropathic pain that will outlast the training sessions and transfers into daily life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Neuropathic Pain
- What is being tested?
- Immersive Virtual Reality (Gear VR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Dec 2019
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of chronic neuropathic pain at or below SCI level for at least 6 months following trauma or disease of the spinal cord;
- A pain intensity of at least 4 out of 10 in the numerical rating scale (NRS) in the Neuropathic Pain Scale (NPS) test at both screening (baseline) and randomization (pre-evaluation);
- Stable pharmacological treatment for at least 2 weeks prior to the study and throughout the trial;
- Incomplete lesion (American Spinal Injury Association Impairment Scale, AIS B, C or D; B= motor complete, sensory incomplete; C= sensorimotor incomplete with an average strength of the muscles below the level of the lesion <3, D= sensorimotor incomplete with average muscle strength >3);
- Cervical level of lesion (C2 to T1) with presence of pain in the upper extremities
Who cannot join
- Presence of severe pain of other origin, such as musculoskeletal pain
- Psychiatric or other neurological disorders
- Head injuries causing cognitive or visual impairment
- Severe vertigo
- Presence of potential risk factors for brain stimulation (TMS): history of seizures, presence of surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull;
- Medically unstable
Trial locations and contacts
1 site in 1 country.
United States1 site
Burke Medical Research Institute
White Plains, New York, 10605
About this study
Official title: Immersive Virtual Reality for Chronic Neuropathic Pain After Spinal Cord Injury: A Feasibility Trial
The investigators hypothesize that SCI patients using immersive IVR training will show improved reduction of neuropathic pain that will outlast the training sessions and transfers into daily life.
Read the detailed description
Neuropathic pain (NP) affects 40 to 70% of people with SCI and is a very disabling clinical condition. The definitions of NP as well as its neurophysiology are widely discussed in the literature. Many treatment options have been offered, but provide limited effects, leaving people with SCI with a reduced quality of life.
Pain is a very complex experience that depends strongly on cognitive, emotional, and educational influences. Despite intensive investigations, the cause of neuropathic pain often remains unknown. A careful assessment of the pain including the use of tools to objectively measure pain will help with the diagnosis and the quantification of the damage. These tools include: 1) Laboratory testing that uses quantitative tests and measures objective responses in neurophysiology, sensory evoked potentials...etc.; 2) Quantitative sensory testing, that tests the perception of pain in response to external stimuli; 3) Bedside examination: physicians assessment on location, quality and intensity of pain; 4) Pain questionnaires, depending entirely on the subject's self-reported experience.
When spinal cord injury occurs, the spinal somatosensory circuit is thought to generate aberrant nociceptive impulses that the brain interprets as pain. Thalamic circuits may also serve as amplifiers of nociceptive signals. Sensory deafferentation after injury to the spinal cord produces extensive and long-lasting reorganization of the cortical and subcortical sensory maps. It has been suggested that pain and phantom limb sensations are the consequence of those cortical plasticity change. Therefore, strategies aimed at reversing or modulating the somatosensory neural reorganization may be valuable alternative approaches to neuropathic pain. Immersive virtual reality (IVR) is an emerging approach to the treatment of neuropathic pain conditions in SCI. Despite promising initial studies, IVR therapy has not yet been made widely available to individuals with SCI, because equipment is expensive and can be difficult for clinicians to use, especially those with limited experience with technology. However, with the development of 'plug and play', low-cost IVR devices such as the Oculus Rift, Gear VR and Google Cardboard, IVR no longer requires such specific technical knowledge. As a result, IVR is now a feasible and affordable treatment option for neuropathic pain.
The investigators believe that IVR neurorehabilitation exploits the idea of inducing activation in action observation, motor imagery, and processing systems, which in turn, should activate downstream cortical areas involved in movement and motor imagery. Also, perturbations of the somatosensory system associated with central pain can be reversed or modulated by employing motor imagery and related task execution combined with visual illusions. The investigators hypothesize that SCI patients using immersive IVR training will show improved reduction of neuropathic pain that will outlast the training sessions and transfers into daily life.
- Conditions
- Spinal Cord Injuries, Neuropathic Pain
- Being tested
- Immersive Virtual Reality (Gear VR)
- Medical subject headings
- Spinal Cord Injuries, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality (Gear VR)Device
Immersing the user in a total visual environment.
| Study group | Role | What they receive |
|---|---|---|
| Somatic IVR (s-IVR) | Active comparator | This group will use an Immersive Virtual Reality (Gear VR) device to focus on encouraging disassociation between pain and visualization and movement of the affected limbs. Subjects in this group will be exposed to an IVR environment that cycles them through a series of stretching and mobility exercises for the affected limbs bilaterally. Receives: Device: Immersive Virtual Reality (Gear VR) |
| Distractive IVR (d-IVR) | Active comparator | This group will use an Immersive Virtual Reality (Gear VR) device to focus on distracting the subject from the pain. Subjects in this group will be exposed to a variety of engaging landscape IVR environments, without the ability to visualize their own body. Receives: Device: Immersive Virtual Reality (Gear VR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neuropathic Pain Scale
It includes 11 items, assessing global pain intensity, unpleasantness, and one item which allows the patient to describe the temporal aspects of their pain and its qualities in their own words. The remaining 8 items assess specific NP qualities: "Sharp," "Hot," "Dull," "Cold," "Sensitive," "Itchy," "Deep," and "Surface." This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention.
Measured: Baseline compared with immediately after intervention, and 1 month follow up
Secondary outcomes (8)
Upper Extremity Motor Score (UEMS)
Clinical measure of motor strength
Measured: Baseline, immediately after intervention, and 1 month follow up
Modified Ashworth Scale
Measure of spasticity scored from 1 (no increase in tone) to 4 (rigid limb)
Measured: Baseline, immediately after intervention, and 1 month follow up
Spinal Cord Independence Measure (SCIM III)
Measures patient's ability to complete activities of daily living
Measured: Baseline, immediately after intervention, and 1 month follow up
Beck Depression Inventory
Self-report measuring characteristic attitudes and symptoms of depression
Measured: Baseline, immediately after intervention, and 1 month follow up
Immersive Tendencies Questionnaire (ITQ)
Measures an individual's sense of engagement and involvement in an activity
Measured: Baseline, immediately after intervention, and 1 month follow up
The Presence Questionnaire
Measure of presence (ex: selective attention, involvement, immersive response, etc)
Measured: Baseline, post-intervention, and 1 month follow up
Patient's Global Impression of Change
Evaluates both motor function and pain with no change (score 0-1), minimally improved (score 2-3), much improved (score 4-5), and very much improved (score 6-7).
Measured: Baseline, immediately after intervention, and 1 month follow up
Transcranial Magnetic Stimulation
Assess brain reorganization, output and responsiveness as determined by motor threshold, motor evoked potential and amplitude of response.
Measured: Baseline, immediately after intervention, and 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study startJul 2016
- Primary completionDec 2017
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kathleen Friel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kathleen Friel, Burke Medical Research Institute
- Investigators
- Kathleen Friel, PhD, Study director, Burke Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592394
- Sponsor's protocol ID
- BRC527
- Status last verified
- Jul 2019
- First submitted
- 17 May 2018
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers at this time.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Virtual Reality for Chronic Neuropathic Pain After Spinal Cord Injury: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT03592394
- Acronym / sponsor ID
- BRC527
- Conditions
- Spinal Cord Injuries, Neuropathic Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kathleen FrielUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 19 Jul 2018 (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 investigators hypothesize that SCI patients using immersive IVR training will show improved reduction of neuropathic pain that will outlast the training sessions and transfers into daily life.
Detailed description
Neuropathic pain (NP) affects 40 to 70% of people with SCI and is a very disabling clinical condition. The definitions of NP as well as its neurophysiology are widely discussed in the literature. Many treatment options have been offered, but provide limited effects, leaving people with SCI with a reduced quality of life.
Pain is a very complex experience that depends strongly on cognitive, emotional, and educational influences. Despite intensive investigations, the cause of neuropathic pain often remains unknown. A careful assessment of the pain including the use of tools to objectively measure pain will help with the diagnosis and the quantification of the damage. These tools include: 1) Laboratory testing that uses quantitative tests and measures objective responses in neurophysiology, sensory evoked potentials...etc.; 2) Quantitative sensory testing, that tests the perception of pain in response to external stimuli; 3) Bedside examination: physicians assessment on location, quality and intensity of pain; 4) Pain questionnaires, depending entirely on the subject's self-reported experience.
When spinal cord injury occurs, the spinal somatosensory circuit is thought to generate aberrant nociceptive impulses that the brain interprets as pain. Thalamic circuits may also serve as amplifiers of nociceptive signals. Sensory deafferentation after injury to the spinal cord produces extensive and long-lasting reorganization of the cortical and subcortical sensory maps. It has been suggested that pain and phantom limb sensations are the consequence of those cortical plasticity change. Therefore, strategies aimed at reversing or modulating the somatosensory neural reorganization may be valuable alternative approaches to neuropathic pain. Immersive virtual reality (IVR) is an emerging approach to the treatment of neuropathic pain conditions in SCI. Despite promising initial studies, IVR therapy has not yet been made widely available to individuals with SCI, because equipment is expensive and can be difficult for clinicians to use, especially those with limited experience with technology. However, with the development of 'plug and play', low-cost IVR devices such as the Oculus Rift, Gear VR and Google Cardboard, IVR no longer requires such specific technical knowledge. As a result, IVR is now a feasible and affordable treatment option for neuropathic pain.
The investigators believe that IVR neurorehabilitation exploits the idea of inducing activation in action observation, motor imagery, and processing systems, which in turn, should activate downstream cortical areas involved in movement and motor imagery. Also, perturbations of the somatosensory system associated with central pain can be reversed or modulated by employing motor imagery and related task execution combined with visual illusions. The investigators hypothesize that SCI patients using immersive IVR training will show improved reduction of neuropathic pain that will outlast the training sessions and transfers into daily life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Somatic IVR (s-IVR) | Active comparator | Device: Immersive Virtual Reality (Gear VR)This group will use an Immersive Virtual Reality (Gear VR) device to focus on encouraging disassociation between pain and visualization and movement of the affected limbs. Subjects in this group will be exposed to an IVR environment that cycles them through a series of stretching and mobility exercises for the affected limbs bilaterally. |
| Distractive IVR (d-IVR) | Active comparator | Device: Immersive Virtual Reality (Gear VR)This group will use an Immersive Virtual Reality (Gear VR) device to focus on distracting the subject from the pain. Subjects in this group will be exposed to a variety of engaging landscape IVR environments, without the ability to visualize their own body. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Presence of chronic neuropathic pain at or below SCI level for at least 6 months following trauma or disease of the spinal cord;
- A pain intensity of at least 4 out of 10 in the numerical rating scale (NRS) in the Neuropathic Pain Scale (NPS) test at both screening (baseline) and randomization (pre-evaluation);
- Stable pharmacological treatment for at least 2 weeks prior to the study and throughout the trial;
- Incomplete lesion (American Spinal Injury Association Impairment Scale, AIS B, C or D; B= motor complete, sensory incomplete; C= sensorimotor incomplete with an average strength of the muscles below the level of the lesion <3, D= sensorimotor incomplete with average muscle strength >3);
- Cervical level of lesion (C2 to T1) with presence of pain in the upper extremities
Key exclusion criteria (6 listed)
- Presence of severe pain of other origin, such as musculoskeletal pain
- Psychiatric or other neurological disorders
- Head injuries causing cognitive or visual impairment
- Severe vertigo
- Presence of potential risk factors for brain stimulation (TMS): history of seizures, presence of surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull;
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 |
|---|---|---|
| Immersive Virtual Reality (Gear VR)Immersing the user in a total visual environment. | Device | Distractive IVR (d-IVR), Somatic IVR (s-IVR) |
Primary outcome
Change in Neuropathic Pain Scale
Time frame: Baseline compared with immediately after intervention, and 1 month follow up
It includes 11 items, assessing global pain intensity, unpleasantness, and one item which allows the patient to describe the temporal aspects of their pain and its qualities in their own words. The remaining 8 items assess specific NP qualities: "Sharp," "Hot," "Dull," "Cold," "Sensitive," "Itchy," "Deep," and "Surface." This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention.
8 secondary outcomes
Upper Extremity Motor Score (UEMS)
Time frame: Baseline, immediately after intervention, and 1 month follow up
Modified Ashworth Scale
Time frame: Baseline, immediately after intervention, and 1 month follow up
Spinal Cord Independence Measure (SCIM III)
Time frame: Baseline, immediately after intervention, and 1 month follow up
Beck Depression Inventory
Time frame: Baseline, immediately after intervention, and 1 month follow up
Immersive Tendencies Questionnaire (ITQ)
Time frame: Baseline, immediately after intervention, and 1 month follow up
The Presence Questionnaire
Time frame: Baseline, post-intervention, and 1 month follow up
Patient's Global Impression of Change
Time frame: Baseline, immediately after intervention, and 1 month follow up
Transcranial Magnetic Stimulation
Time frame: Baseline, immediately after intervention, and 1 month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers at this time.
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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.
Kathleen Friel, PhD study director
Burke Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immersive Virtual Reality (Gear VR) in people with Spinal Cord Injuries and Neuropathic Pain, run by Kathleen Friel 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 6 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: status not confirmed, as of the sponsor's last update on 10 Jul 2019. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 Neuropathic Pain Scale (time frame: Baseline compared with immediately after intervention, and 1 month follow up). 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 10 Jul 2019.