Back to resultsVirtual Reality for the Mitigation of Anxiety During Intrathecal Administration in Participants With Spinal Muscular Atrophy (REALITY)
Primary Purpose
Spinal Muscular Atrophy (SMA)
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual reality
Standard of Care
Sponsored by
About this trial
This is an interventional supportive care trial for Spinal Muscular Atrophy (SMA)
Eligibility Criteria
Key Inclusion Criteria:
- Participants aged 7 years and greater
- Genetically documented spinal muscular atrophy linked to chromosome 5q (5q-SMA)
- Loading nusinersen dose period is completed, and ongoing treatment with nusinersen
- Ability of the candidate and/or their legally authorized representatives (e.g., parent, spouse, or legal guardian), as appropriate and applicable, to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations
- Signed written informed consent from adult participants, or from legal authorized representatives for minors
Key Exclusion Criteria:
- History of any clinically significant abnormalities that would render the candidate unsuitable for VR (e.g., visual or hearing impairment, presence of eye, face or sclap injuries) or for inclusion (e.g. cognitive impairment), as determined by the Investigator
- Conditions that could be exacerbated by the VR environment, such as: (i) current symptomatic nausea, vomiting, dizziness, migraine; (ii) history of psychosis, hallucinations, epilepsy
- Ongoing medical conditions or treatments that according to the Investigator would interfere with the conduct and assessments of the study (e.g. general anesthesia)
- Participants wearing a pacemaker and pregnant woman
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
VR followed by SOC
SOC followed by VR
Arm Description
Participants will receive a 20-minute (min) VR session at the first nusinersen IT (IT1), followed by SOC (local anesthesia - lidocaine or intravenous sedation) at the subsequent nusinersen IT (IT2) during the main study, later followed by 20-min VR sessions at two subsequent nusinersen ITs (IT3 and IT4) during the extension period, for up to 450 days.
Participants will receive SOC (local anesthesia - lidocaine or intravenous sedation) at nusinersen IT1, followed by a 20-min VR session at the subsequent nusinersen IT (IT2) during the main study, later followed by 20-min VR sessions at two subsequent nusinersen ITs (IT3 and IT4) during the extension period, for up to 450 days.
Outcomes
Primary Outcome Measures
Visual Analog Scale for Anxiety (VAS-A) Score During IT as Evaluated by the Participant Just After IT
The VAS-A scale is used in the assessment of anxiety. The 101-point scale (0 to 100) is a horizontal 100 millimeter (mm) line that starts with no anxiety on the left and ends with maximum anxiety on the right. The VAS score is determined by measuring in mm from the left-hand end of the line to the point that the participant marks. High scores on the scale indicate that anxiety is high.
Secondary Outcome Measures
Blood Pressure Before and After IT
Systolic and diastolic blood pressures will be assessed.
Heart Rate Before and After IT
Short State-Trait Anxiety Inventory (Short STAI) Score During IT as Evaluated by the Participant Just After IT
The 6-item short form of the Spielberger STAI is used to measure self-reported symptoms of state anxiety. It consists of 6 questions each having scale 1 (Almost Never) to 4 (Almost Always). The score range for the short STAI is 6 to 24 points, with 6 points signifying no anxiety and 24 points signifying the highest level of anxiety.
Number of Participants With Use of Medication/Intervention for Anxiety and Pain Management Before, During and up to 72 hour (h) After IT
Visual Analog Scale for Pain (VAS-P) Score Just After IT
The VAS-P scale is used in the assessment of pain. The 101 point scale (0 to 100) is a horizontal 100 mm line that starts with no pain on the left and ends with maximum pain on the right. The VAS score is determined by measuring in mm from the left hand end of the line to the point that the participant marks. High scores indicate worse pain.
Maximal VAS-P Score Within 72h of IT
The VAS-P scale is used in the assessment of pain. The 101 point scale (0 to 100) is a horizontal 100 mm line that starts with no pain on the left and ends with maximum pain on the right. The VAS score is determined by measuring in mm from the left hand end of the line to the point that the participant marks. High scores indicate worse pain.
Number of Participants With Satisfactory Experience of Using VR, Desire to Continue IT, Desire to Continue VR
Participants will be asked to complete a satisfaction survey to evaluate his/her experience. It is a questionnaire consisting of 6 (for age >12 years) to 7 (for age <12 years) questions.
Number of Participants With Satisfactory Experience of Using VR, as Assessed by Custom Care Team
The custom care team will be asked to complete a satisfaction survey to evaluate participant's experience. It is a questionnaire consisting of 5 questions.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05354414
Brief Title
Virtual Reality for the Mitigation of Anxiety During Intrathecal Administration in Participants With Spinal Muscular Atrophy
Acronym
REALITY
Official Title
A Randomized Crossover Pragmatic Study to Evaluate Virtual Reality for the Mitigation of Anxiety During Intrathecal Administration in Patients With Spinal Muscular Atrophy. REALITY Study.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
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 primary objective of the study is to evaluate anxiety level during intrathecal administration (IT) under standard of care (SOC) and virtual reality (VR) conditions using a reliable self-rating scale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Muscular Atrophy (SMA)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VR followed by SOC
Arm Type
Experimental
Arm Description
Participants will receive a 20-minute (min) VR session at the first nusinersen IT (IT1), followed by SOC (local anesthesia - lidocaine or intravenous sedation) at the subsequent nusinersen IT (IT2) during the main study, later followed by 20-min VR sessions at two subsequent nusinersen ITs (IT3 and IT4) during the extension period, for up to 450 days.
Arm Title
SOC followed by VR
Arm Type
Experimental
Arm Description
Participants will receive SOC (local anesthesia - lidocaine or intravenous sedation) at nusinersen IT1, followed by a 20-min VR session at the subsequent nusinersen IT (IT2) during the main study, later followed by 20-min VR sessions at two subsequent nusinersen ITs (IT3 and IT4) during the extension period, for up to 450 days.
Intervention Type
Device
Intervention Name(s)
Virtual reality
Intervention Description
Administered as specified in the treatment arm.
Intervention Type
Procedure
Intervention Name(s)
Standard of Care
Intervention Description
Administered as specified in the treatment arm.
Primary Outcome Measure Information:
Title
Visual Analog Scale for Anxiety (VAS-A) Score During IT as Evaluated by the Participant Just After IT
Description
The VAS-A scale is used in the assessment of anxiety. The 101-point scale (0 to 100) is a horizontal 100 millimeter (mm) line that starts with no anxiety on the left and ends with maximum anxiety on the right. The VAS score is determined by measuring in mm from the left-hand end of the line to the point that the participant marks. High scores on the scale indicate that anxiety is high.
Time Frame
Up to 450 days
Secondary Outcome Measure Information:
Title
Blood Pressure Before and After IT
Description
Systolic and diastolic blood pressures will be assessed.
Time Frame
Up to 450 days
Title
Heart Rate Before and After IT
Time Frame
Up to 450 days
Title
Short State-Trait Anxiety Inventory (Short STAI) Score During IT as Evaluated by the Participant Just After IT
Description
The 6-item short form of the Spielberger STAI is used to measure self-reported symptoms of state anxiety. It consists of 6 questions each having scale 1 (Almost Never) to 4 (Almost Always). The score range for the short STAI is 6 to 24 points, with 6 points signifying no anxiety and 24 points signifying the highest level of anxiety.
Time Frame
Up to 450 days
Title
Number of Participants With Use of Medication/Intervention for Anxiety and Pain Management Before, During and up to 72 hour (h) After IT
Time Frame
Up to 450 days
Title
Visual Analog Scale for Pain (VAS-P) Score Just After IT
Description
The VAS-P scale is used in the assessment of pain. The 101 point scale (0 to 100) is a horizontal 100 mm line that starts with no pain on the left and ends with maximum pain on the right. The VAS score is determined by measuring in mm from the left hand end of the line to the point that the participant marks. High scores indicate worse pain.
Time Frame
Up to 450 days
Title
Maximal VAS-P Score Within 72h of IT
Description
The VAS-P scale is used in the assessment of pain. The 101 point scale (0 to 100) is a horizontal 100 mm line that starts with no pain on the left and ends with maximum pain on the right. The VAS score is determined by measuring in mm from the left hand end of the line to the point that the participant marks. High scores indicate worse pain.
Time Frame
Up to 450 days
Title
Number of Participants With Satisfactory Experience of Using VR, Desire to Continue IT, Desire to Continue VR
Description
Participants will be asked to complete a satisfaction survey to evaluate his/her experience. It is a questionnaire consisting of 6 (for age >12 years) to 7 (for age <12 years) questions.
Time Frame
Up to 150 days
Title
Number of Participants With Satisfactory Experience of Using VR, as Assessed by Custom Care Team
Description
The custom care team will be asked to complete a satisfaction survey to evaluate participant's experience. It is a questionnaire consisting of 5 questions.
Time Frame
Up to 150 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Participants aged 7 years and greater
Genetically documented spinal muscular atrophy linked to chromosome 5q (5q-SMA)
Loading nusinersen dose period is completed, and ongoing treatment with nusinersen
Ability of the candidate and/or their legally authorized representatives (e.g., parent, spouse, or legal guardian), as appropriate and applicable, to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations
Signed written informed consent from adult participants, or from legal authorized representatives for minors
Key Exclusion Criteria:
History of any clinically significant abnormalities that would render the candidate unsuitable for VR (e.g., visual or hearing impairment, presence of eye, face or sclap injuries) or for inclusion (e.g. cognitive impairment), as determined by the Investigator
Conditions that could be exacerbated by the VR environment, such as: (i) current symptomatic nausea, vomiting, dizziness, migraine; (ii) history of psychosis, hallucinations, epilepsy
Ongoing medical conditions or treatments that according to the Investigator would interfere with the conduct and assessments of the study (e.g. general anesthesia)
Participants wearing a pacemaker and pregnant woman
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US Biogen Clinical Trial Center
Phone
866-633-4636
Email
clinicaltrials@biogen.com
First Name & Middle Initial & Last Name or Official Title & Degree
Global Biogen Clinical Trial Center
Email
clinicaltrials@biogen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research SIte
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Garches
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75571
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
IPD Sharing URL
https://vivli.org/
Learn more about this trial
Virtual Reality for the Mitigation of Anxiety During Intrathecal Administration in Participants With Spinal Muscular Atrophy
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