Multiple SclerosisNCT03606668
Virtual Reality (VR) to Improve Quality of Life in Patients Diagnosed With Neurological Disorders
A study testing HTC Vive Virtual Reality (VR) system in people with Multiple Sclerosis and Chronic Pain, run by NYU Langone Health at 1 site in United States.
Trial summary
Participants with neurological disorders will be recruited to complete sessions of virtual reality (VR) immersion. VR has been shown to have therapeutic benefit in certain patient populations and requires further clinical study to determine the extent to which VR can be used to rehabilitate and reduce symptom burden. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Multiple Sclerosis, Chronic Pain, Neurological Disorder
- What is being tested?
- HTC Vive Virtual Reality (VR) system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2018to 2 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-79 years of age
- Has been diagnosed by a clinician as having MS
- Able to commit to the designated period of testing
- Able to understand the informed consent process and provide consent to participate in the study
- Capacity to complete study procedures as determined by screening personnel
- A Brief Pain Inventory interference score of at least 3 or more.
- SDMT Z-Score > -3.0
- WRAT4 Standard Score > or = 85
Who cannot join
- Visual, auditory, and motor deficits that would prevent full ability to understand study
- Visual, auditory, and motor deficits that would prevent full ability to operate VR equipment
- Uncontrolled epilepsy
- Current diagnosis of vertigo
- Uncontrolled mood disorders
- History of Psychosis or Schizophrenia
- Expanded Disability Status Scale (EDSS) Score greater than 6.5
- Unable to tolerate or manipulate VR treatment procedures (as evidenced by VR capability assessment)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Participants with neurological disorders will be recruited to complete sessions of virtual reality (VR) immersion. VR has been shown to have therapeutic benefit in certain patient populations and requires further clinical study to determine the extent to which VR can be used to rehabilitate and reduce symptom burden. This study seeks to pilot newly developed VR methods and collect preliminary data in order to support research grants and inform larger clinical trials. Additionally, this proposed study will explore the tolerability and preliminary efficacy of Virtual Reality (VR), specifically to determine whether VR can acutely reduce the severity of symptom burden caused by neurological disorders.
- Conditions
- Multiple Sclerosis, Chronic Pain, Neurological Disorder
- Being tested
- HTC Vive Virtual Reality (VR) system
- Medical subject headings
- Multiple Sclerosis, Chronic Pain, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTC Vive Virtual Reality (VR) systemDevice
VR treatment will entail use of computer software designed to immerse participants and engage them in exercises. Software includes virtual painting, walking through vivid and calming settings, solving puzzles, among others.
| Study group | Role | What they receive |
|---|---|---|
| People with Multiple Sclerosis (PwMS) and Chronic Pain | Experimental | Participants with MS will only be able to receive eight treatment sessions in this study group and will complete their treatment over four weeks. Two treatments sessions must be completed each week (of the four weeks) and separated by at least one day.
Participants will attend a baseline visit with assessment and training procedures and receive their first treatment immediately after all baseline assessments. Participants will then complete the remaining seven treatment sessions over four weeks. At the final treatment session, participants will repeat assessments. One week following the final treatment session, participants will be asked to return to clinic to complete assessments once more to test cumulative benefits one week following treatment end. Receives: Device: HTC Vive Virtual Reality (VR) system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score
PROMIS - Pain Intensity - Short Form 3a consists of 3 questions -- participants report on the intensity of pain experienced in the past 7 days. Each question is scored between 1 (had no pain) to 5 (very severe). The total score range is 3-15; the higher the score, the more intense the pain.
Measured: Baseline (Week 1), Treatment End (Week 4)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score
PROMIS - Pain Intensity - Short Form 3a consists of 3 questions -- participants report on the intensity of pain experienced in the past 7 days. Each question is scored between 1 (had no pain) to 5 (very severe). The total score range is 3-15; the higher the score, the more intense the pain.
Measured: Baseline (Week 1), Study End (Week 5)
Secondary outcomes (4)
Change in Neuro-Quality of Life (Neuro-QOL) - Fatigue - Short Form Score
Neuro-QOL - Fatigue - Short Form consists of 8 statements -- participants report on fatigue symptoms experienced in the past 7 days. Each statement is scored 1 (never) to 5 (always). The total score range is 8-40; the higher the score, the more severe the fatigue.
Measured: Baseline (Week 1), Treatment End (Week 4)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Score
PROMIS - Sleep Related Impairment consists of 16 items. Participants report on sleep related impairment experienced in the past 7 days. Each statement is scored between 1 (not at all) and 5 (very much). The total score range is 16-80; the higher the score, the higher the level of sleep related impairment.
Measured: Baseline (Week 1), Study End (Week 5)
Change in PROMIS - Fatigue Score
PROMIS-fatigue short form consists of 8 questions -- participants report on the intensity of fatigue experienced in the past 7 days. Each question is scored between 1 (had no fatigue) to 5 (always). The total score range is 8-40; the higher the score, the more intense the fatigue.
Measured: Baseline (Week 1), Treatment End (Week 4)
Change in PROMIS - Fatigue Score
PROMIS-fatigue short form consists of 8 questions -- participants report on the intensity of fatigue experienced in the past 7 days. Each question is scored between 1 (had no fatigue) to 5 (always). The total score range is 8-40; the higher the score, the more intense the fatigue.
Measured: Baseline (Week 1), Study End (Week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start20 Jun 2018
- Primary completion2 Mar 2020
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leigh Charvet, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606668
- Sponsor's protocol ID
- 18-00151
- Status last verified
- Jan 2022
- First submitted
- 23 Jul 2018
- Last updated
- 11 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality (VR) to Improve Quality of Life in Patients Diagnosed With Neurological Disorders
- ClinicalTrials.gov ID
- NCT03606668
- Acronym / sponsor ID
- 18-00151
- Conditions
- Multiple Sclerosis, Chronic Pain, Neurological Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Posted 11 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants with neurological disorders will be recruited to complete sessions of virtual reality (VR) immersion. VR has been shown to have therapeutic benefit in certain patient populations and requires further clinical study to determine the extent to which VR can be used to rehabilitate and reduce symptom burden. This study seeks to pilot newly developed VR methods and collect preliminary data in order to support research grants and inform larger clinical trials. Additionally, this proposed study will explore the tolerability and preliminary efficacy of Virtual Reality (VR), specifically to determine whether VR can acutely reduce the severity of symptom burden caused by neurological disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with Multiple Sclerosis (PwMS) and Chronic Pain | Experimental | Device: HTC Vive Virtual Reality (VR) systemParticipants with MS will only be able to receive eight treatment sessions in this study group and will complete their treatment over four weeks. Two treatments sessions must be completed each week (of the four weeks) and separated by at least one day. Participants will attend a baseline visit with assessment and training procedures and receive their first treatment immediately after all baseline assessments. Participants will then complete the remaining seven treatment sessions over four weeks. At the final treatment session, participants will repeat assessments. One week following the final treatment session, participants will be asked to return to clinic to complete assessments once more to test cumulative benefits one week following treatment end. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-79 years of age
- Has been diagnosed by a clinician as having MS
- Able to commit to the designated period of testing
- Able to understand the informed consent process and provide consent to participate in the study
- Capacity to complete study procedures as determined by screening personnel
Key exclusion criteria (8 listed)
- Visual, auditory, and motor deficits that would prevent full ability to understand study
- Visual, auditory, and motor deficits that would prevent full ability to operate VR equipment
- Uncontrolled epilepsy
- Current diagnosis of vertigo
- Uncontrolled mood disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HTC Vive Virtual Reality (VR) systemVR treatment will entail use of computer software designed to immerse participants and engage them in exercises. Software includes virtual painting, walking through vivid and calming settings, solving puzzles, among others. | Device | People with Multiple Sclerosis (PwMS) and Chronic Pain |
Primary outcome
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score
Time frame: Baseline (Week 1), Treatment End (Week 4)
PROMIS - Pain Intensity - Short Form 3a consists of 3 questions -- participants report on the intensity of pain experienced in the past 7 days. Each question is scored between 1 (had no pain) to 5 (very severe). The total score range is 3-15; the higher the score, the more intense the pain.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score
Time frame: Baseline (Week 1), Study End (Week 5)
PROMIS - Pain Intensity - Short Form 3a consists of 3 questions -- participants report on the intensity of pain experienced in the past 7 days. Each question is scored between 1 (had no pain) to 5 (very severe). The total score range is 3-15; the higher the score, the more intense the pain.
4 secondary outcomes
Change in Neuro-Quality of Life (Neuro-QOL) - Fatigue - Short Form Score
Time frame: Baseline (Week 1), Treatment End (Week 4)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Score
Time frame: Baseline (Week 1), Study End (Week 5)
Change in PROMIS - Fatigue Score
Time frame: Baseline (Week 1), Treatment End (Week 4)
Change in PROMIS - Fatigue Score
Time frame: Baseline (Week 1), Study End (Week 5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leigh Charvet, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HTC Vive Virtual Reality (VR) system in people with Multiple Sclerosis and Chronic Pain, run by NYU Langone Health 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 8 inclusion and 8 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 11 Feb 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. 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?
Yes. Results are posted in the registry (first posted 11 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score (time frame: Baseline (Week 1), Treatment End (Week 4)). The study lists 2 primary outcomes in all. 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 11 Feb 2022.