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

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 thepurpose and risks of the study, to provide informed consent, and to authorize theuse of confidential health information in accordance with national and local privacyregulations

• Signed written informed consent from adult participants, or from legal authorizedrepresentatives for minors

Key Exclusion Criteria:

• History of any clinically significant abnormalities that would render the candidateunsuitable for VR (e.g., visual or hearing impairment, presence of eye, face orsclap injuries) or for inclusion (e.g. cognitive impairment), as determined by theInvestigator

• Conditions that could be exacerbated by the VR environment, such as: (i) currentsymptomatic nausea, vomiting, dizziness, migraine; (ii) history of psychosis,hallucinations, epilepsy

• Ongoing medical conditions or treatments that according to the Investigator wouldinterfere 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.