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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality | Device | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure Before and After IT | Systolic and diastolic blood pressures will be assessed. | Up to 450 days |
| Heart Rate Before and After IT | Up to 450 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu d' Angers | Angers | 49933 | France | |||
| CHRU de Brest |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| Standard of Care | Procedure | Administered as specified in the treatment arm. |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Brest |
| 29609 |
| France |
| Chu de Clermont Ferrand | Clermont-Ferrand | 63003 | France |
| APHP- Raymond Poincaré Paris | Garches | 92380 | France |
| Chu de Lille | Lille | 59000 | France |
| CHU Montpellier | Montpellier | 34295 | France |
| CHU de Nancy | Nancy | 54511 | France |
| Chu de Nice | Nice | 06000 | France |
| APHP- Necker Paris | Paris | 75015 | France |
| APHP- Trousseau Paris | Paris | 75571 | France |
| Hôpitaux Universitaires de Strasbourg | Strasbourg | 67200 | France |
| CHU de Toulouse | Toulouse | 31059 | France |
| ID | Term |
|---|---|
| D009134 | Muscular Atrophy, Spinal |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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