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NeuralgiaNCT04700033

Immersive Virtual Reality for Chronic Neuropathic Pain After Spinal Cord Injury: A Feasibility Trial

A study testing Somatic IVR (sIVR) and Distractive IVR (dIVR) in people with Neuralgia and Spinal Cord Injuries, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to provide critical information about the efficacy of Immersive Virtual Reality (IVR) to decrease the experience of neuropathic pain in the upper and lower extremities of people with a spinal cord injury. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuralgia, Spinal Cord Injuries, Chronic Pain
What is being tested?
Somatic IVR (sIVR) and Distractive IVR (dIVR)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
1 siteUnited States
Study dates
17 Jul 2019to 5 May 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Spinal cord injury survivors (chronic only)
  • Presence of 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 2 out of 10 in the numerical pain rating scale (NPRS) test at baseline
  • Stable pharmacological treatment for at least 4 weeks prior to the study and throughout the trial

Who cannot join

  • Psychiatric or other neurological disorders (Participants will not be excluded for having a SCI, if they score 0-30 points on the BDI, or if they report having anxiety)
  • Head injuries causing cognitive or visual impairment
  • Severe vertigo

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

The aim of this study is to provide critical information about the efficacy of Immersive Virtual Reality (IVR) to decrease the experience of neuropathic pain in the upper and lower extremities of people with a spinal cord injury.

Read the detailed description

When a spinal cord injury occurs, the spinal somatosensory circuit is thought to generate aberrant nociceptive impulses that the brain interprets as pain. Neuropathic pain (NP) affects 40 to 70% of people with SCI and is a very disabling clinical condition. Many treatment options have been offered, but provide limited effects, leaving people with SCI with a reduced quality of life. The study team believes that Immersive Virtual Reality (IVR) neurorehabilitation has the potential to be an effective treatment for chronic neuropathic pain. For this reason, the objective of this study is to evaluate the feasibility of using a virtual reality device to decrease chronic neuropathic pain in individuals with spinal cord injury.

Being tested
Somatic IVR (sIVR), Distractive IVR (dIVR), Control IVR (cIVR)
Keywords
Virtual Reality, Neuronal Plasticity, Neurological Rehabilitation, Immersive Virtual Reality
Medical subject headings
Neuralgia, Spinal Cord Injuries, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Somatic IVR (sIVR)Device

    This intervention will consist of an IVR protocol that is focused on somatic interaction that encourages 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 (dIVR)Device

    This intervention will consist of an IVR that is focused 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.

  • Control IVR (cIVR)Device

    This intervention will consist of an IVR exposure to a black screen for 20 minutes. No light, images or scenery will be present in the IVR and it will serve as a control condition for the trial.

Study groups in NCT04700033
Study groupRoleWhat they receive
Somatic IVRExperimentalParticipants with participate in Somatic IVR protocol three times per week for four weeks.
Receives: Device: Somatic IVR (sIVR)
Distractive IVRActive comparatorParticipants with participate in Distractive IVR protocol three times per week for four weeks.
Receives: Device: Distractive IVR (dIVR)
Control IVRPlacebo comparatorParticipants with participate in Control IVR protocol three times per week for four weeks.
Receives: Device: Control IVR (cIVR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neuropathic Pain Symptom Inventory (NPSI)

    Neuropathic Pain Symptom Inventory (NPSI): This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). It includes 12 items, assessing spontaneous pain, brief attacks of pain, provoked pain and abnormal sensations in the painful area. This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Total score range for NPSI is 0-100, higher scores indicate more severity.

    Measured: Up to 10 Weeks

Secondary outcomes (8)
  1. User Experience Score (UES)

    Participants rate their experience using the technology on a scale with a total score range of 0 to 10, where 0 means no enjoyment and 10 means very high levels of enjoyment.

    Measured: 14 Days

  2. Spinal Cord Independence Measure (SCIM III)

    Spinal cord independence measure (SCIM III) measures the ability of patients with SCI to perform everyday tasks. SCIM is used for quantitative functional outcome assessment following interventions designed to promote recovery from spinal cord injury and to increase functional achievement; it covers 19 tasks in 16 categories, with a score range 0-100; all activities of daily living, grouped into four areas of function (subscales): Self-Care (scored 0-20), Respiration and Sphincter Management (0-40), Mobility in Room and Toilet (0-10), and Mobility Indoors and Outdoors (0-30). VR neurorehabilitation has shown to improve motor function as well as to reduce neuropathic pain in incomplete SCI patients. The study team is planning to monitor the effects that this IVR protocol has in motor recovery. Total score range for SCIM II is 0 - 100, where a score of 0 defines total dependence and a score of 100 is indicative of complete independence.

    Measured: Up to 10 Weeks

  3. Numerical Pain Rating Scale (NPRS)

    Users report the score of both neuropathic and other pain. The total score range is from 0 to 10, lowest score indicating 0, "No pain" and highest score indicating 10, "Pain as bad as it could be". The type of "other" pain will also be recorded (musculoskeletal, etc).

    Measured: 16 Days

  4. Beck Depression Inventory (BDI)

    Beck Depression Inventory (BDI): Depression symptoms are estimated to be highly prevalent in SCI population and are associated with a myriad of negative outcomes including lower functional independence, and greater incidence of pain. This questionnaire is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Depression may be a major contributor to a lack of reduction of pain, the study team expects subjects with high BDI score may have worse results after the IVR. Total score range for BDI is 0 - 63; scores from 0 through 9 indicate no or minimal depression; from 10 through 18 indicate mild to moderate depression; from 19 through 29 indicate moderate to severe depression; and from 30 through 63 indicate severe depression.

    Measured: Up to 10 Weeks

  5. Patient's Global Impression of Change (PGIC)

    Self-reported relieving effect: At the end of the treatment (post-intervention), the Patient's Global Impression of Change (PGIC) will evaluate both motor function and pain. The total score range includes no change (score 0-1), minimally improved (score 2-3), much improved (score 4-5), and very much improved (score 6-7) as the highest score. The patients will answer the following question: "Since beginning treatment at this program, how would you describe the change (if any) in activity limitations, symptoms, emotions, and overall quality of life related to your condition?".

    Measured: Up to 10 Weeks

  6. Immersive Tendencies Questionnaire (ITQ)

    Immersive tendencies questionnaire (ITQ): In the field of virtual reality, presence and immersion are standard measures of an individual's sense of engagement and involvement in an activity. The study team expects that high levels of immersion might indicate greater engagement and therefore reduction of the pain. Total score range for ITQ: 18 - 126.

    Measured: Up to 10 Weeks

  7. UQO- Presence Questionnaire (UPO-PQ)

    The UQO Presence questionnaire (UQO-PQ): Presence can be a major factor that determines the quality and success of a virtual environment implementation. Several factors such as impression of being present, realness, and discomfort are measured in this questionnaire. The questionnaire has users rank the extent the agree with each question with the total score range of 0 - 100; the lowest score indicating 0 - "Not at all" and the highest score indicating 100- "Totally".

    Measured: 16 Days

  8. Neuropathic Pain Scale (NPS)

    Neuropathic Pain Scale (NPS): This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). 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. Total score range for NPS is 0 - 100, higher scores indicate more severity.

    Measured: Up to 10 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2021
  2. Study start17 Jul 2019
  3. Primary completion5 May 2022
  4. Study completion5 May 2022

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study is a single center, prospective randomized controlled clinical trial. The purpose of the study is to provide critical information about the efficacy of Immersive Virtual Reality (IVR) to decrease the experience of neuropathic pain in the upper and lower extremities of people with a spinal cord injury.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04700033
Sponsor's protocol ID
GCO 18-0891
Status last verified
Jun 2022
First submitted
5 Jan 2021
Last updated
23 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Somatic IVR (sIVR) and Distractive IVR (dIVR) in people with Neuralgia and Spinal Cord Injuries, run by Icahn School of Medicine at Mount Sinai 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 23 Jun 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Neuropathic Pain Symptom Inventory (NPSI) (time frame: Up to 10 Weeks). 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 23 Jun 2022.

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