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Virtual Reality for Chronic Neuropathic Pain

Primary Purpose

Spinal Cord Injuries, Neuropathic Pain

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Immersive Virtual Reality (Gear VR)
Sponsored by
Kathleen Friel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Burke Medical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Somatic IVR (s-IVR)

Distractive IVR (d-IVR)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Upper Extremity Motor Score (UEMS)
Clinical measure of motor strength
Modified Ashworth Scale
Measure of spasticity scored from 1 (no increase in tone) to 4 (rigid limb)
Spinal Cord Independence Measure (SCIM III)
Measures patient's ability to complete activities of daily living
Beck Depression Inventory
Self-report measuring characteristic attitudes and symptoms of depression
Immersive Tendencies Questionnaire (ITQ)
Measures an individual's sense of engagement and involvement in an activity
The Presence Questionnaire
Measure of presence (ex: selective attention, involvement, immersive response, etc)
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).
Transcranial Magnetic Stimulation
Assess brain reorganization, output and responsiveness as determined by motor threshold, motor evoked potential and amplitude of response.

Full Information

First Posted
May 17, 2018
Last Updated
July 8, 2019
Sponsor
Kathleen Friel
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1. Study Identification

Unique Protocol Identification Number
NCT03592394
Brief Title
Virtual Reality for Chronic Neuropathic Pain
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
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kathleen Friel

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Neuropathic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Somatic IVR (s-IVR)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Distractive IVR (d-IVR)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Immersive Virtual Reality (Gear VR)
Intervention Description
Immersing the user in a total visual environment.
Primary Outcome Measure Information:
Title
Change in Neuropathic Pain Scale
Description
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.
Time Frame
Baseline compared with immediately after intervention, and 1 month follow up
Secondary Outcome Measure Information:
Title
Upper Extremity Motor Score (UEMS)
Description
Clinical measure of motor strength
Time Frame
Baseline, immediately after intervention, and 1 month follow up
Title
Modified Ashworth Scale
Description
Measure of spasticity scored from 1 (no increase in tone) to 4 (rigid limb)
Time Frame
Baseline, immediately after intervention, and 1 month follow up
Title
Spinal Cord Independence Measure (SCIM III)
Description
Measures patient's ability to complete activities of daily living
Time Frame
Baseline, immediately after intervention, and 1 month follow up
Title
Beck Depression Inventory
Description
Self-report measuring characteristic attitudes and symptoms of depression
Time Frame
Baseline, immediately after intervention, and 1 month follow up
Title
Immersive Tendencies Questionnaire (ITQ)
Description
Measures an individual's sense of engagement and involvement in an activity
Time Frame
Baseline, immediately after intervention, and 1 month follow up
Title
The Presence Questionnaire
Description
Measure of presence (ex: selective attention, involvement, immersive response, etc)
Time Frame
Baseline, post-intervention, and 1 month follow up
Title
Patient's Global Impression of Change
Description
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).
Time Frame
Baseline, immediately after intervention, and 1 month follow up
Title
Transcranial Magnetic Stimulation
Description
Assess brain reorganization, output and responsiveness as determined by motor threshold, motor evoked potential and amplitude of response.
Time Frame
Baseline, immediately after intervention, and 1 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Friel, PhD
Organizational Affiliation
Burke Medical Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
Burke Medical Research Institute
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers at this time.

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Virtual Reality for Chronic Neuropathic Pain

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