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

Primary Purpose

Neuralgia, Spinal Cord Injuries, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Somatic IVR (sIVR)
Distractive IVR (dIVR)
Control IVR (cIVR)
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuralgia focused on measuring Virtual Reality, Neuronal Plasticity, Neurological Rehabilitation, Immersive Virtual Reality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Somatic IVR

Distractive IVR

Control IVR

Arm Description

Participants with participate in Somatic IVR protocol three times per week for four weeks.

Participants with participate in Distractive IVR protocol three times per week for four weeks.

Participants with participate in Control IVR protocol three times per week for four weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
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.
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?".
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.
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".
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.

Full Information

First Posted
January 5, 2021
Last Updated
June 17, 2022
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT04700033
Brief Title
Immersive Virtual Reality for Chronic Neuropathic Pain After Spinal Cord Injury: A Feasibility Trial
Official Title
Immersive Virtual Reality for Chronic Neuropathic Pain After Spinal Cord Injury: A Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 17, 2019 (Actual)
Primary Completion Date
May 5, 2022 (Actual)
Study Completion Date
May 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia, Spinal Cord Injuries, Chronic Pain
Keywords
Virtual Reality, Neuronal Plasticity, Neurological Rehabilitation, Immersive Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participant, PI and Outcome Assessor remain blinded for the entirety of the study.
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Somatic IVR
Arm Type
Experimental
Arm Description
Participants with participate in Somatic IVR protocol three times per week for four weeks.
Arm Title
Distractive IVR
Arm Type
Active Comparator
Arm Description
Participants with participate in Distractive IVR protocol three times per week for four weeks.
Arm Title
Control IVR
Arm Type
Placebo Comparator
Arm Description
Participants with participate in Control IVR protocol three times per week for four weeks.
Intervention Type
Device
Intervention Name(s)
Somatic IVR (sIVR)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Distractive IVR (dIVR)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Control IVR (cIVR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neuropathic Pain Symptom Inventory (NPSI)
Description
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.
Time Frame
Up to 10 Weeks
Secondary Outcome Measure Information:
Title
User Experience Score (UES)
Description
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.
Time Frame
14 Days
Title
Spinal Cord Independence Measure (SCIM III)
Description
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.
Time Frame
Up to 10 Weeks
Title
Numerical Pain Rating Scale (NPRS)
Description
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).
Time Frame
16 Days
Title
Beck Depression Inventory (BDI)
Description
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.
Time Frame
Up to 10 Weeks
Title
Patient's Global Impression of Change (PGIC)
Description
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?".
Time Frame
Up to 10 Weeks
Title
Immersive Tendencies Questionnaire (ITQ)
Description
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.
Time Frame
Up to 10 Weeks
Title
UQO- Presence Questionnaire (UPO-PQ)
Description
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".
Time Frame
16 Days
Title
Neuropathic Pain Scale (NPS)
Description
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.
Time Frame
Up to 10 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Putrino, PT, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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