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

NCT05354414 | Completed

• 1 other identifier: FR-NMD-12094
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 12

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.

Conditions

Spinal Muscular Atrophy (SMA)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Blood Pressure Before and After IT

  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

  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

  Up to 450 days

Study Arms (2)

VR followed by SOC

EXPERIMENTAL

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; Procedure: Standard of Care

SOC followed by VR

EXPERIMENTAL

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; Procedure: Standard of Care

Interventions

Virtual reality DEVICE

Administered as specified in the treatment arm.

SOC followed by VR; VR followed by SOC

Standard of Care PROCEDURE

Administered as specified in the treatment arm.

SOC followed by VR; VR followed by SOC

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

Study Sites (12)

Chu d' Angers

Angers, 49933, France

Location

CHRU de Brest

Brest, 29609, France

Location

Chu de Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

APHP- Raymond Poincaré Paris

Garches, 92380, France

Location

Chu de Lille

Lille, 59000, France

Location

CHU Montpellier

Montpellier, 34295, France

Location

CHU de Nancy

Nancy, 54511, France

Location

Chu de Nice

Nice, 06000, France

Location

APHP- Necker Paris

Paris, 75015, France

Location

APHP- Trousseau Paris

Paris, 75571, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67200, France

Location

CHU de Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Muscular Atrophy, Spinal

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: April 29, 2022
• Study Start: May 11, 2022
• Primary Completion: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (12)