Virtual Reality for the Mitigation of Anxiety During Intrathecal Administration in Participants With Spinal Muscular Atrophy (REALITY)

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.

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 Overview

• Status: Completed
• Conditions: Spinal Muscular Atrophy (SMA)
• Intervention / Treatment: Device: Virtual reality; Procedure: Standard of Care

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Chu D' Angers
  • Brest, France, 29609
    • CHRU de Brest
  • Clermont Ferrand, France, 63003
    • CHU de Clermont Ferrand
  • Garches, France, 92380
    • APHP- Raymond Poincaré Paris
  • Lille, France, 59000
    • CHU de Lille
  • Montpellier, France, 34295
    • CHU Montpellier
  • Nancy, France, 54511
    • CHU de Nancy
  • Nice, France, 06000
    • Chu de Nice
  • Paris, France, 75015
    • APHP- Necker Paris
  • Paris, France, 75571
    • APHP- Trousseau Paris
  • Strasbourg, France, 67200
    • Hopitaux universitaires de Strasbourg
  • Toulouse, France, 31059
    • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR followed by SOC; 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.	Device: Virtual reality; Administered as specified in the treatment arm.; Procedure: Standard of Care; Administered as specified in the treatment arm.
Experimental: SOC followed by VR; 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.	Device: Virtual reality; Administered as specified in the treatment arm.; Procedure: Standard of Care; Administered as specified in the treatment arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 450 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure Before and After IT	Systolic and diastolic blood pressures will be assessed.	Up to 450 days
Heart Rate 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	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.	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
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.	Up to 450 days
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.	Up to 450 days
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.	Up to 150 days
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.	Up to 150 days

Collaborators and Investigators

• Sponsor: Biogen
• Investigators: Study Director: Medical Director, Biogen

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2022
• Primary Completion (Actual): July 12, 2024
• Study Completion (Actual): July 12, 2024

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; Motor Neuron Disease; Atrophy; Muscular Atrophy; Muscular Atrophy, Spinal
• Other Study ID Numbers: FR-NMD-12094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No