Status:
COMPLETED
Virtual Reality for the Mitigation of Anxiety During Intrathecal Administration in Participants With Spinal Muscular Atrophy
Lead Sponsor:
Biogen
Conditions:
Spinal Muscular Atrophy (SMA)
Eligibility:
All Genders
7+ years
Phase:
NA
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 sca...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2024
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT05354414
Start Date
May 11 2022
End Date
July 12 2024
Last Update
April 2 2025
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Chu d' Angers
Angers, France, 49933
2
CHRU de Brest
Brest, France, 29609
3
Chu de Clermont Ferrand
Clermont-Ferrand, France, 63003
4
APHP- Raymond Poincaré Paris
Garches, France, 92380