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

• ClinicalTrials.gov Identifier: NCT04700033
• Recruitment Status: Recruiting
• First Posted: January 7, 2021
• Last Update Posted: June 18, 2021
• Sponsor: Icahn School of Medicine at Mount Sinai
• Information provided by (Responsible Party): David.Putrino, Icahn School of Medicine at Mount Sinai

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Neuralgia; Spinal Cord Injuries; Chronic Pain	Device: Somatic IVR (sIVR); Device: Distractive IVR (dIVR); Device: Control IVR (cIVR)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Participant, Investigator, Outcomes Assessor)
• Masking Description: Participant, PI and Outcome Assessor remain blinded for the entirety of the study.
• Primary Purpose: Treatment
• Official Title: Immersive Virtual Reality for Chronic Neuropathic Pain After Spinal Cord Injury: A Feasibility Trial
• Actual Study Start Date: July 17, 2019
• Estimated Primary Completion Date: April 2022
• Estimated Study Completion Date: April 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Somatic IVR; Participants with participate in Somatic IVR protocol three times per week for four weeks.	Device: Somatic IVR (sIVR); 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.
Active Comparator: Distractive IVR; Participants with participate in Distractive IVR protocol three times per week for four weeks.	Device: Distractive IVR (dIVR); 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.
Placebo Comparator: Control IVR; Participants with participate in Control IVR protocol three times per week for four weeks.	Device: Control IVR (cIVR); 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.

Outcome Measures

Primary Outcome Measures :

1. Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Up to 10 Weeks ]
   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.

Secondary Outcome Measures :

1. User Experience Score (UES) [ Time Frame: 14 Days ]
   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.
2. Spinal Cord Independence Measure (SCIM III) [ Time Frame: Up to 10 Weeks ]
   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.
3. Numerical Pain Rating Scale (NPRS) [ Time Frame: 16 Days ]
   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).
4. Beck Depression Inventory (BDI) [ Time Frame: Up to 10 Weeks ]
   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.
5. Patient's Global Impression of Change (PGIC) [ Time Frame: Up to 10 Weeks ]
   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?".
6. Immersive Tendencies Questionnaire (ITQ) [ Time Frame: Up to 10 Weeks ]
   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.
7. UQO- Presence Questionnaire (UPO-PQ) [ Time Frame: 16 Days ]
   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".
8. Neuropathic Pain Scale (NPS) [ Time Frame: Up to 10 Weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Contacts

Contact: Laura Tabacof, MD; 212-241-9922; laura.tabacof@mountsinai.org

Contact: David Putrino, PT, PhD; 212-824-8369; david.putrino@mountsinai.org

Locations

United States, New York

Icahn School of Medicine at Mount Sinai; Recruiting

New York, New York, United States, 10029

Contact: Laura Tabacof, MD 212-241-9922 laura.tabacof@mountsinai.org

Principal Investigator: David Putrino, PT, PhD

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: David Putrino, PT, PhD; Icahn School of Medicine at Mount Sinai

More Information

• Responsible Party: David.Putrino, Director of Rehabilitation Innovation, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT04700033
• Other Study ID Numbers: GCO 18-0891
• First Posted: January 7, 2021
• Last Update Posted: June 18, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David.Putrino, Icahn School of Medicine at Mount Sinai:

Virtual Reality; Neuronal Plasticity; Neurological Rehabilitation; Immersive Virtual Reality

Additional relevant MeSH terms:

Spinal Cord Injuries; Neuralgia; Chronic Pain; Wounds and Injuries; Pain; Neurologic Manifestations; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Peripheral Nervous System Diseases; Neuromuscular Diseases