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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in United States

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.

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 groups in NCT03592394
Study groupRoleWhat they receive
Somatic IVR (s-IVR)Active comparatorThis 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 comparatorThis 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.

  1. 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)
  1. Upper Extremity Motor Score (UEMS)

    Clinical measure of motor strength

    Measured: Baseline, immediately after intervention, and 1 month follow up

  2. 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

  3. 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

  4. Beck Depression Inventory

    Self-report measuring characteristic attitudes and symptoms of depression

    Measured: Baseline, immediately after intervention, and 1 month follow up

  5. 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

  6. The Presence Questionnaire

    Measure of presence (ex: selective attention, involvement, immersive response, etc)

    Measured: Baseline, post-intervention, and 1 month follow up

  7. 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

  8. 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.

  1. First posted19 Jul 2018
  2. Study startJul 2016
  3. Primary completionDec 2017
  4. Study completionDec 2019 (estimated)

Resources

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)
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.

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.

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