NCT05354414CompletedNot Applicable
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.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Biogen
- Enrollment
- 63
- Locations
- 24
- Primary Endpoint
- Visual Analog Scale for Anxiety (VAS-A) Score During IT as Evaluated by the Participant Just After IT
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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.
Outcomes
Primary Outcomes
Visual Analog Scale for Anxiety (VAS-A) Score During IT as Evaluated by the Participant Just After IT
Time Frame: Up to 450 days
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 Outcomes
- Maximal VAS-P Score Within 72h of IT(Up to 450 days)
- Number of Participants With Satisfactory Experience of Using VR, as Assessed by Custom Care Team(Up to 150 days)
- Visual Analog Scale for Pain (VAS-P) Score Just After IT(Up to 450 days)
- Heart Rate Before and After IT(Up to 450 days)
- Number of Participants With Use of Medication/Intervention for Anxiety and Pain Management Before, During and up to 72 hour (h) After IT(Up to 450 days)
- Number of Participants With Satisfactory Experience of Using VR, Desire to Continue IT, Desire to Continue VR(Up to 150 days)
- Blood Pressure Before and After IT(Up to 450 days)
- Short State-Trait Anxiety Inventory (Short STAI) Score During IT as Evaluated by the Participant Just After IT(Up to 450 days)
Investigators
Study Sites (24)
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