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

Spinal Muscular Atrophy (SMA) Clinical Trial

— REALITY  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05354414
• Other study ID #: FR-NMD-12094
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: April 2023
• Source: Biogen
• Contact: US Biogen Clinical Trial Center
• Phone: 866-633-4636
• Email: clinicaltrials[@]biogen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Spinal Muscular Atrophy (SMA)

Intervention

Device:
• Virtual reality
Administered as specified in the treatment arm.

Procedure:
• Standard of Care
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
France	Research SIte	Angers
France	Research Site	Brest
France	Research Site	Clermont Ferrand
France	Research Site	Garches
France	Research Site	Lille
France	Research Site	Nancy
France	Research Site	Nice
France	Research Site	Paris
France	Research Site	Paris
France	Research Site	Strasbourg
France	Research Site	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood Pressure Before and After IT	Systolic and diastolic blood pressures will be assessed.	Up to 450 days
Secondary	Heart Rate Before and After IT		Up to 450 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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