Clinical trial NCT05354414: Virtual Reality for the Mitigation of Anxiety During Intrathecal Administration in Participants With Spinal Muscular Atrophy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Muscular Atrophy (SMA)
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2022-04-29
Enrollment: 63
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scale for Anxiety (VAS-A) Score During IT as Evaluated by the Participant Just After IT
timeFrame: Up to 450 days
Secondary outcomes:
measure: Blood Pressure Before and After IT
timeFrame: Up to 450 days
measure: Heart Rate Before and After IT
timeFrame: Up to 450 days
measure: Short State-Trait Anxiety Inventory (Short STAI) Score During IT as Evaluated by the Participant Just After IT
timeFrame: Up to 450 days
measure: Number of Participants With Use of Medication/Intervention for Anxiety and Pain Management Before, During and up to 72 hour (h) After IT
timeFrame: Up to 450 days
measure: Visual Analog Scale for Pain (VAS-P) Score Just After IT
timeFrame: Up to 450 days
measure: Maximal VAS-P Score Within 72h of IT
timeFrame: Up to 450 days
measure: Number of Participants With Satisfactory Experience of Using VR, Desire to Continue IT, Desire to Continue VR
timeFrame: Up to 150 days
measure: Number of Participants With Satisfactory Experience of Using VR, as Assessed by Custom Care Team
timeFrame: Up to 150 days
Other outcomes:
Locations:
city: Angers
country: France
facility: Chu d' Angers
city: Brest
country: France
facility: CHRU de Brest
city: Clermont Ferrand
country: France
facility: Chu de Clermont Ferrand
city: Garches
country: France
facility: APHP- Raymond Poincaré Paris
city: Lille
country: France
facility: Chu de Lille
city: Montpellier
country: France
facility: CHU Montpellier
city: Nancy
country: France
facility: CHU de Nancy
city: Nice
country: France
facility: Chu de Nice
city: Paris
country: France
facility: APHP- Necker Paris
city: Paris
country: France
facility: APHP- Trousseau Paris
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: