Spinal Muscular Atrophy (SMA)REALITYNCT05354414
Virtual Reality for the Mitigation of Anxiety During Intrathecal Administration in Participants With Spinal Muscular Atrophy
A study testing Virtual reality in people with Spinal Muscular Atrophy (SMA), run by Biogen at 12 sites in France.
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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Spinal Muscular Atrophy (SMA)
- What is being tested?
- Virtual reality
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 12 sitesFrance
- Study dates
- 11 May 2022to 12 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Chu d' Angers
Angers, 49933
CHRU de Brest
Brest, 29609
Chu de Clermont Ferrand
Clermont-Ferrand, 63003
APHP- Raymond Poincaré Paris
Garches, 92380
Chu de Lille
Lille, 59000
CHU Montpellier
Montpellier, 34295
CHU de Nancy
Nancy, 54511
Chu de Nice
Nice, 06000
APHP- Necker Paris
Paris, 75015
APHP- Trousseau Paris
Paris, 75571
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67200
CHU de Toulouse
Toulouse, 31059
About this study
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.
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.
- Conditions
- Spinal Muscular Atrophy (SMA)
- Being tested
- Virtual reality, Standard of Care
- Medical subject headings
- Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
Administered as specified in the treatment arm.
Standard of CareProcedure or surgery
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| VR followed by SOC | Experimental | Participants will receive a 20-minute (min) VR session at the first nusinersen IT (IT1), followed by SOC (local anesthesia - lidocaine or intravenous sedation) at the subsequent nusinersen IT (IT2) during the main study, later followed by 20-min VR sessions at two subsequent nusinersen ITs (IT3 and IT4) during the extension period, for up to 450 days. Receives: Device: Virtual reality; Procedure: Standard of Care |
| SOC followed by VR | Experimental | Participants will receive SOC (local anesthesia - lidocaine or intravenous sedation) at nusinersen IT1, followed by a 20-min VR session at the subsequent nusinersen IT (IT2) during the main study, later followed by 20-min VR sessions at two subsequent nusinersen ITs (IT3 and IT4) during the extension period, for up to 450 days. Receives: Device: Virtual reality; Procedure: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 450 days
Secondary outcomes (8)
Blood Pressure Before and After IT
Systolic and diastolic blood pressures will be assessed.
Measured: Up to 450 days
Heart Rate Before and After IT
Measured: Up to 450 days
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.
Measured: Up to 450 days
Number of Participants With Use of Medication/Intervention for Anxiety and Pain Management Before, During and up to 72 hour (h) After IT
Measured: Up to 450 days
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.
Measured: Up to 450 days
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.
Measured: Up to 450 days
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.
Measured: Up to 150 days
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.
Measured: Up to 150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start11 May 2022
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Muscular Atrophy (SMA)Studies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354414
- Sponsor's protocol ID
- FR-NMD-12094
- Acronym
- REALITY
- Status last verified
- Apr 2025
- First submitted
- 26 Apr 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05354414
- Acronym / sponsor ID
- REALITY / FR-NMD-12094
- Conditions
- Spinal Muscular Atrophy (SMA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 11 May 2022 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR followed by SOC | Experimental | Device: Virtual reality, Procedure: Standard of CareParticipants will receive a 20-minute (min) VR session at the first nusinersen IT (IT1), followed by SOC (local anesthesia - lidocaine or intravenous sedation) at the subsequent nusinersen IT (IT2) during the main study, later followed by 20-min VR sessions at two subsequent nusinersen ITs (IT3 and IT4) during the extension period, for up to 450 days. |
| SOC followed by VR | Experimental | Device: Virtual reality, Procedure: Standard of CareParticipants will receive SOC (local anesthesia - lidocaine or intravenous sedation) at nusinersen IT1, followed by a 20-min VR session at the subsequent nusinersen IT (IT2) during the main study, later followed by 20-min VR sessions at two subsequent nusinersen ITs (IT3 and IT4) during the extension period, for up to 450 days. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityAdministered as specified in the treatment arm. | Device | SOC followed by VR, VR followed by SOC |
| Standard of CareAdministered as specified in the treatment arm. | Procedure or surgery | SOC followed by VR, VR followed by SOC |
Primary outcome
Visual Analog Scale for Anxiety (VAS-A) Score During IT as Evaluated by the Participant Just After IT
Time frame: Up to 450 days
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.
8 secondary outcomes
Blood Pressure Before and After IT
Time frame: Up to 450 days
Heart Rate Before and After IT
Time frame: Up to 450 days
Short State-Trait Anxiety Inventory (Short STAI) Score During IT as Evaluated by the Participant Just After IT
Time frame: Up to 450 days
Number of Participants With Use of Medication/Intervention for Anxiety and Pain Management Before, During and up to 72 hour (h) After IT
Time frame: Up to 450 days
Visual Analog Scale for Pain (VAS-P) Score Just After IT
Time frame: Up to 450 days
Maximal VAS-P Score Within 72h of IT
Time frame: Up to 450 days
Number of Participants With Satisfactory Experience of Using VR, Desire to Continue IT, Desire to Continue VR
Time frame: Up to 150 days
Number of Participants With Satisfactory Experience of Using VR, as Assessed by Custom Care Team
Time frame: Up to 150 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Spinal Muscular Atrophy (SMA), run by Biogen at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale for Anxiety (VAS-A) Score During IT as Evaluated by the Participant Just After IT (time frame: Up to 450 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.