Loading clinical trials...

Virtual Reality for the Mitigation of Anxiety During Intrathecal Administration in Participants With Spinal Muscular Atrophy | Clinical Trials | Clareo Health

COMPLETEDNA

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

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.

NCT05354414•Biogen

View on ClinicalTrials.gov

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

Age

7 - No limit years

Sex

ALL

Healthy Volunteers

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

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

Locations (12)

Chu d' Angers

Angers, France

CHRU de Brest

Brest, France

Chu de Clermont Ferrand

Clermont-Ferrand, France

APHP- Raymond Poincaré Paris

Garches, France

Chu de Lille

Lille, France

CHU Montpellier

Montpellier, France

CHU de Nancy

Nancy, France

Chu de Nice

Nice, France

APHP- Necker Paris

Paris, France

APHP- Trousseau Paris

Paris, France

Key Dates

Start Date

May 11, 2022

Primary Completion Date

July 12, 2024

Completion Date

July 12, 2024

Last Updated

April 2, 2025

Enrollment

ACTUAL participants

Conditions

Spinal Muscular Atrophy (SMA)

Interventions

Virtual reality

DEVICE

Standard of Care

PROCEDURE

Long Read Analysis in Spinal Muscular Atrophy - LOREASI

NCT07332702

Spinal Muscular Atrophy (SMA)

View study

RECRUITINGPHASE3

Real World Clinical Effectiveness & Safety of Vesemnogene Lantuparvovec for Spinal Muscular Atrophy (SMA) in Low-middle Income Countries (LMIC).

NCT07265232

Spinal Muscular Atrophy (SMA)

View study

ACTIVE_NOT_RECRUITINGPHASE2/PHASE3

A Study to Investigate the Safety and Efficacy of RO7204239 in Combination With Risdiplam (RO7034067) in Participants With Spinal Muscular Atrophy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Long Read Analysis in Spinal Muscular Atrophy - LOREASI

Real World Clinical Effectiveness & Safety of Vesemnogene Lantuparvovec for Spinal Muscular Atrophy (SMA) in Low-middle Income Countries (LMIC).

A Study to Investigate the Safety and Efficacy of RO7204239 in Combination With Risdiplam (RO7034067) in Participants With Spinal Muscular Atrophy

Psychological Evaluation of the Parental Experience of Newborn Screening for Infantile Spinal Muscular Atrophy in the Grand Est and Nouvelle-Aquitaine Regions