Muscular Atrophy, SpinalNCT04674618
Ultrasound-assisted vs Landmark Based Intrathecal Administration of Nusinersen
A study testing US-assisted nusinersen administration in people with Muscular Atrophy, Spinal and Ultrasound, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Intrathecal administration of Nusinersen, an antisense oligonucleotide capable of increasing Survival Motor Neuron protein production, has been tested in Spinal Muscular Atrophy (SMA) to improve motor function and survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscular Atrophy, Spinal, Ultrasound
- What is being tested?
- US-assisted nusinersen administration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteItaly
- Study dates
- 14 Dec 2020to 21 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SMA adult patients
Who cannot join
- coagulation defects;
- medication with anticoagulant;
- infection in puncture site;
- high intracranial pressure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-assisted vs Landmark Based Intrathecal Administration of Nusinersen in Adult Patients With SMA Disease: a Randomized Trial
Intrathecal administration of Nusinersen, an antisense oligonucleotide capable of increasing Survival Motor Neuron protein production, has been tested in Spinal Muscular Atrophy (SMA) to improve motor function and survival. A feature of adult SMA patients is a progressive neuromyopathic scoliosis, so spinal nusinersen administration can be challenging. Landmark identification using a pre-procedure ultrasound (US) facilitates technical performance of spinal anesthesia and allows for the elimination of radiation exposure.
The aim of this randomized prospectic study is to determine if the US assistance for spinal administration of nusinersen is able to increase the proportion at successful 1st needle insertion of the needle. Secondary outcome measures are procedure time, patient satisfaction and prevalence of postdural puncture headache.
Patients will be randomlized to receive a US-assisted nusinersen administration or a landmark based nusinersen administration.
Read the detailed description
Background Nusinersen, an antisense oligonucleotide (ASO) capable of increasing SMN protein production, has been used in clinical trials in infants and children with SMA type 1 or type 2 and has been associated to a significantly better motor development, motor function, and survival compared with placebo groups. Because of the lacking ability of ASOs to cross the blood-brain barrier, nusinersen is administered intrathecally. While most infants with SMA type 1 die in easy childhood without a muscular and nutritional support, SMA type 2 patients often reach adulthood, and patients with SMA type 3 generally have a normal lifespan. A further feature of SMA patients is a progressive neuromyopathic scoliosis, so spinal nusinersen administration can be challenging because of poorly palpable surface landmarks, as in elderly and in obese patients. In patients with anticipated difficult anatomy, the failure rate of neuraxial anesthesia may be as high as 17%. Furthermore, multiple needle punctures are associated with hematoma, post-dural-puncture headache, back pain, and patient dissatisfaction. Current data suggest that landmark identification using a pre-procedure ultrasound (US) is a useful adjunct to neuraxial anesthesia that facilitates technical performance in obstetric and pediatric patients. In adult patients with difficult spinal anatomy a pre-procedure US reduces the number of attempts and the number of needle passes necessary for successful spinal anesthesia and can predict technical difficulty; notably, compared to fluoroscopy, sonography allows for the elimination of radiation exposure for patient and physician and for a cost reduction for institution. Despite these potential advantages, reports of lumbar central neuraxial blocks US guidance in patients with predicted placement difficulties are limited. Most reports to date involve a small number of patients with normal anatomy.
Methods The study will be conducted in Fondazione Policlinico "A.Gemelli" operatory rooms, Rome, Italy. Written informed consent will be obtained from all patients enrolled in the study. SMA adult patients referring to NEMO center of this institution will be enrolled. Exclusion criteria will be: coagulation defects, patients medicated with anticoagulation, any finding of infection in puncture site, high intracranial pressure. A visit will be performed before the procedure.
Patients will be randomly assigned in ratio 1:1 to one of two groups using a sealed envelope: Group 1 (US-assisted nusinersen administration) and Group 2 (landmark based nusinersen administration). Nusinersen administration will be performed with a single-operator technique by one of two anesthesiologists trained on US-guided or -assisted central neuraxial blocks. With patient in sitting position, or in lateral position if forced posture will be needed, after skin disinfection with 2% chlorhexidine in 70% alcohol, the spinal administration will be performed as follows: Group 1 (US- guided nusinersen administration). The paramedian sagittal oblique view will be used to identify specific lumbar interspaces and perform the procedure. Starting at the sacrum and moving cephalad, the L2-3 or L3-4 intervertebral interspace will be identified. After local anesthesia with lidocaine 2% (3-5 mL), a 25-gauge Withacre spinal needle will be used to identify subarachnoid space. After confirmation of the flow of cerebrospinal fluid and after removing 5 ml of CSF, nusinersen will be administered intrathecally over 1-3 min. Group 2 (landmark based nusinersen administration).
The desired intervertebral space (L2-3 or L3-4) was first identified by manual palpation of surface landmarks and marked on the skin. After local anesthesia with lidocaine 2% (3-5 mL) a 25-gauge Withacre spinal needle will be used. After confirmation of the flow of cerebrospinal fluid and after removing 5 ml of CSF, nusinersen will be administered as previously described. After successful administration, patients will be positioned in the supine position for 2-3 h. Within 72 hours of administration a phone survey will be conducted to evaluate the development of postdural puncture headache. Another outpatient visit will be performed at 30 days after the procedure.
- Conditions
- Muscular Atrophy, Spinal, Ultrasound
- Being tested
- US-assisted nusinersen administration
- 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.
US-assisted nusinersen administrationDevice
Ultrasound identification of intervertebral space (L2-L3 or L3-L4)
| Study group | Role | What they receive |
|---|---|---|
| US-assisted nusinersen administration | Experimental | A paramedian sagittal oblique view will be used to identify with ultrasound specific lumbar interspaces. After local anesthesia the spinal needle will be used to identify subarachnoid space. After confirmation of the flow of cerebrospinal fluid and after removing 5 ml of CSF, nusinersen will be administered intrathecally over 1-3 min. Receives: Device: US-assisted nusinersen administration |
| landmark based nusinersen administration | No intervention | The desired intervertebral space will be first identified by manual palpation of surface landmarks and marked on the skin. After local anesthesia the spinal needle will be usedto identify subarachnoid space. After confirmation of the flow of cerebrospinal fluid and after removing 5 ml of CSF, nusinersen will be administered intrathecally over 1-3 min. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of attempts
The number of needle insertions through the skin surface. If complete withdrawal of the needle from the patient's skin surface will be needed, followed by reinsertion in a different skin location or a different spinal level, this will be counted as a second attempt.
Measured: During the procedure (spinal injection of nusinersen)
Secondary outcomes (3)
Successful administration
confirmation of the flow of cerebrospinal fluid through the spinal needle and subsequent nusinersen administration
Measured: During the procedure (spinal injection of nusinersen)
Procedure time
the time in seconds from the start of US imaging to visualization of cerebrospinal fluid flow in intervention group and from the first hand contact to the skin to visualization of cerebrospinal fluid flow in control group.
Measured: During the procedure (spinal injection of nusinersen)
Patients satisfaction
will be evaluated with a five-point Likert Scale (from a value of 1- extremely unsatisfied to a value of 5-extremely satisfied)
Measured: 5 minutes after the end of the procedure (spinal injection of nusinersen)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start14 Dec 2020
- Primary completion14 Dec 2021
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Muscular Atrophy, SpinalStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674618
- Sponsor's protocol ID
- 3352
- Status last verified
- Jul 2021
- First submitted
- 10 Dec 2020
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Finkel RS, Mercuri E, Darras BT, Connolly AM, Kuntz NL, Kirschner J, Chiriboga CA, Saito K, Servais L, Tizzano E, Topaloglu H, Tulinius M, Montes J, Glanzman AM, Bishop K, Zhong ZJ, Gheuens S, Bennett CF, Schneider E, Farwell W, De Vivo DC; ENDEAR Study Group. Nusinersen versus Sham Control in Infantile-Onset Spinal Muscular Atrophy. N Engl J Med. 2017 Nov 2;377(18):1723-1732. doi: 10.1056/NEJMoa1702752.
PubMed 29091570Mercuri E, Darras BT, Chiriboga CA, Day JW, Campbell C, Connolly AM, Iannaccone ST, Kirschner J, Kuntz NL, Saito K, Shieh PB, Tulinius M, Mazzone ES, Montes J, Bishop KM, Yang Q, Foster R, Gheuens S, Bennett CF, Farwell W, Schneider E, De Vivo DC, Finkel RS; CHERISH Study Group. Nusinersen versus Sham Control in Later-Onset Spinal Muscular Atrophy. N Engl J Med. 2018 Feb 15;378(7):625-635. doi: 10.1056/NEJMoa1710504.
PubMed 29443664Geary RS, Yu RZ, Levin AA. Pharmacokinetics of phosphorothioate antisense oligodeoxynucleotides. Curr Opin Investig Drugs. 2001 Apr;2(4):562-73.
PubMed 11566019Zerres K, Rudnik-Schoneborn S, Forrest E, Lusakowska A, Borkowska J, Hausmanowa-Petrusewicz I. A collaborative study on the natural history of childhood and juvenile onset proximal spinal muscular atrophy (type II and III SMA): 569 patients. J Neurol Sci. 1997 Feb 27;146(1):67-72. doi: 10.1016/s0022-510x(96)00284-5.
PubMed 9077498Oskoui M, Levy G, Garland CJ, Gray JM, O'Hagen J, De Vivo DC, Kaufmann P. The changing natural history of spinal muscular atrophy type 1. Neurology. 2007 Nov 13;69(20):1931-6. doi: 10.1212/01.wnl.0000290830.40544.b9.
PubMed 17998484Kim JH, Song SY, Kim BJ. Predicting the difficulty in performing a neuraxial blockade. Korean J Anesthesiol. 2011 Nov;61(5):377-81. doi: 10.4097/kjae.2011.61.5.377. Epub 2011 Nov 23.
PubMed 22148085Fettes PD, Jansson JR, Wildsmith JA. Failed spinal anaesthesia: mechanisms, management, and prevention. Br J Anaesth. 2009 Jun;102(6):739-48. doi: 10.1093/bja/aep096. Epub 2009 May 6.
PubMed 19420004Sahin T, Balaban O, Sahin L, Solak M, Toker K. A randomized controlled trial of preinsertion ultrasound guidance for spinal anaesthesia in pregnancy: outcomes among obese and lean parturients: ultrasound for spinal anesthesia in pregnancy. J Anesth. 2014 Jun;28(3):413-9. doi: 10.1007/s00540-013-1726-1. Epub 2013 Oct 20.
PubMed 24141882Scapinelli R. Morphological and functional changes of the lumbar spinous processes in the elderly. Surg Radiol Anat. 1989;11(2):129-33. doi: 10.1007/BF02096469.
PubMed 2763004Angle P, Tang SL, Thompson D, Szalai JP. Expectant management of postdural puncture headache increases hospital length of stay and emergency room visits. Can J Anaesth. 2005 Apr;52(4):397-402. doi: 10.1007/BF03016283.
PubMed 15814755Sng BL, Lim Y, Sia AT. An observational prospective cohort study of incidence and characteristics of failed spinal anaesthesia for caesarean section. Int J Obstet Anesth. 2009 Jul;18(3):237-41. doi: 10.1016/j.ijoa.2009.01.010. Epub 2009 May 17.
PubMed 19450971Horlocker TT, McGregor DG, Matsushige DK, Schroeder DR, Besse JA. A retrospective review of 4767 consecutive spinal anesthetics: central nervous system complications. Perioperative Outcomes Group. Anesth Analg. 1997 Mar;84(3):578-84. doi: 10.1097/00000539-199703000-00021.
PubMed 9052305Vallejo MC, Phelps AL, Singh S, Orebaugh SL, Sah N. Ultrasound decreases the failed labor epidural rate in resident trainees. Int J Obstet Anesth. 2010 Oct;19(4):373-8. doi: 10.1016/j.ijoa.2010.04.002. Epub 2010 Aug 8.
PubMed 20696564Grau T, Leipold RW, Conradi R, Martin E, Motsch J. Efficacy of ultrasound imaging in obstetric epidural anesthesia. J Clin Anesth. 2002 May;14(3):169-75. doi: 10.1016/s0952-8180(01)00378-6.
PubMed 12031746Grau T, Leipold RW, Fatehi S, Martin E, Motsch J. Real-time ultrasonic observation of combined spinal-epidural anaesthesia. Eur J Anaesthesiol. 2004 Jan;21(1):25-31. doi: 10.1017/s026502150400105x.
PubMed 14768920
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-assisted vs Landmark Based Intrathecal Administration of Nusinersen in Adult Patients With SMA Disease: a Randomized Trial
- ClinicalTrials.gov ID
- NCT04674618
- Acronym / sponsor ID
- 3352
- Conditions
- Muscular Atrophy, Spinal, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 19 Dec 2020 (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.
Intrathecal administration of Nusinersen, an antisense oligonucleotide capable of increasing Survival Motor Neuron protein production, has been tested in Spinal Muscular Atrophy (SMA) to improve motor function and survival. A feature of adult SMA patients is a progressive neuromyopathic scoliosis, so spinal nusinersen administration can be challenging. Landmark identification using a pre-procedure ultrasound (US) facilitates technical performance of spinal anesthesia and allows for the elimination of radiation exposure.
The aim of this randomized prospectic study is to determine if the US assistance for spinal administration of nusinersen is able to increase the proportion at successful 1st needle insertion of the needle. Secondary outcome measures are procedure time, patient satisfaction and prevalence of postdural puncture headache.
Patients will be randomlized to receive a US-assisted nusinersen administration or a landmark based nusinersen administration.
Detailed description
Background Nusinersen, an antisense oligonucleotide (ASO) capable of increasing SMN protein production, has been used in clinical trials in infants and children with SMA type 1 or type 2 and has been associated to a significantly better motor development, motor function, and survival compared with placebo groups. Because of the lacking ability of ASOs to cross the blood-brain barrier, nusinersen is administered intrathecally. While most infants with SMA type 1 die in easy childhood without a muscular and nutritional support, SMA type 2 patients often reach adulthood, and patients with SMA type 3 generally have a normal lifespan. A further feature of SMA patients is a progressive neuromyopathic scoliosis, so spinal nusinersen administration can be challenging because of poorly palpable surface landmarks, as in elderly and in obese patients. In patients with anticipated difficult anatomy, the failure rate of neuraxial anesthesia may be as high as 17%. Furthermore, multiple needle punctures are associated with hematoma, post-dural-puncture headache, back pain, and patient dissatisfaction. Current data suggest that landmark identification using a pre-procedure ultrasound (US) is a useful adjunct to neuraxial anesthesia that facilitates technical performance in obstetric and pediatric patients. In adult patients with difficult spinal anatomy a pre-procedure US reduces the number of attempts and the number of needle passes necessary for successful spinal anesthesia and can predict technical difficulty; notably, compared to fluoroscopy, sonography allows for the elimination of radiation exposure for patient and physician and for a cost reduction for institution. Despite these potential advantages, reports of lumbar central neuraxial blocks US guidance in patients with predicted placement difficulties are limited. Most reports to date involve a small number of patients with normal anatomy.
Methods The study will be conducted in Fondazione Policlinico "A.Gemelli" operatory rooms, Rome, Italy. Written informed consent will be obtained from all patients enrolled in the study. SMA adult patients referring to NEMO center of this institution will be enrolled. Exclusion criteria will be: coagulation defects, patients medicated with anticoagulation, any finding of infection in puncture site, high intracranial pressure. A visit will be performed before the procedure.
Patients will be randomly assigned in ratio 1:1 to one of two groups using a sealed envelope: Group 1 (US-assisted nusinersen administration) and Group 2 (landmark based nusinersen administration). Nusinersen administration will be performed with a single-operator technique by one of two anesthesiologists trained on US-guided or -assisted central neuraxial blocks. With patient in sitting position, or in lateral position if forced posture will be needed, after skin disinfection with 2% chlorhexidine in 70% alcohol, the spinal administration will be performed as follows: Group 1 (US- guided nusinersen administration). The paramedian sagittal oblique view will be used to identify specific lumbar interspaces and perform the procedure. Starting at the sacrum and moving cephalad, the L2-3 or L3-4 intervertebral interspace will be identified. After local anesthesia with lidocaine 2% (3-5 mL), a 25-gauge Withacre spinal needle will be used to identify subarachnoid space. After confirmation of the flow of cerebrospinal fluid and after removing 5 ml of CSF, nusinersen will be administered intrathecally over 1-3 min. Group 2 (landmark based nusinersen administration).
The desired intervertebral space (L2-3 or L3-4) was first identified by manual palpation of surface landmarks and marked on the skin. After local anesthesia with lidocaine 2% (3-5 mL) a 25-gauge Withacre spinal needle will be used. After confirmation of the flow of cerebrospinal fluid and after removing 5 ml of CSF, nusinersen will be administered as previously described. After successful administration, patients will be positioned in the supine position for 2-3 h. Within 72 hours of administration a phone survey will be conducted to evaluate the development of postdural puncture headache. Another outpatient visit will be performed at 30 days after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US-assisted nusinersen administration | Experimental | Device: US-assisted nusinersen administrationA paramedian sagittal oblique view will be used to identify with ultrasound specific lumbar interspaces. After local anesthesia the spinal needle will be used to identify subarachnoid space. After confirmation of the flow of cerebrospinal fluid and after removing 5 ml of CSF, nusinersen will be administered intrathecally over 1-3 min. |
| landmark based nusinersen administration | No intervention | –The desired intervertebral space will be first identified by manual palpation of surface landmarks and marked on the skin. After local anesthesia the spinal needle will be usedto identify subarachnoid space. After confirmation of the flow of cerebrospinal fluid and after removing 5 ml of CSF, nusinersen will be administered intrathecally over 1-3 min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- SMA adult patients
Key exclusion criteria (4 listed)
- coagulation defects;
- medication with anticoagulant;
- infection in puncture site;
- high intracranial pressure
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 |
|---|---|---|
| US-assisted nusinersen administrationUltrasound identification of intervertebral space (L2-L3 or L3-L4) | Device | US-assisted nusinersen administration |
Primary outcome
Number of attempts
Time frame: During the procedure (spinal injection of nusinersen)
The number of needle insertions through the skin surface. If complete withdrawal of the needle from the patient's skin surface will be needed, followed by reinsertion in a different skin location or a different spinal level, this will be counted as a second attempt.
3 secondary outcomes
Successful administration
Time frame: During the procedure (spinal injection of nusinersen)
Procedure time
Time frame: During the procedure (spinal injection of nusinersen)
Patients satisfaction
Time frame: 5 minutes after the end of the procedure (spinal injection of nusinersen)
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 21 Feb 2024.
- Background: PubMed 29091570Finkel RS, Mercuri E, Darras BT, Connolly AM, Kuntz NL, Kirschner J, Chiriboga CA, Saito K, Servais L, Tizzano E, Topaloglu H, Tulinius M, Montes J, Glanzman AM, Bishop K, Zhong ZJ, Gheuens S, Bennett CF, Schneider E, Farwell W, De Vivo DC; ENDEAR Study Group. Nusinersen versus Sham Control in Infantile-Onset Spinal Muscular Atrophy. N Engl J Med. 2017 Nov 2;377(18):1723-1732. doi: 10.1056/NEJMoa1702752.
- Background: PubMed 29443664Mercuri E, Darras BT, Chiriboga CA, Day JW, Campbell C, Connolly AM, Iannaccone ST, Kirschner J, Kuntz NL, Saito K, Shieh PB, Tulinius M, Mazzone ES, Montes J, Bishop KM, Yang Q, Foster R, Gheuens S, Bennett CF, Farwell W, Schneider E, De Vivo DC, Finkel RS; CHERISH Study Group. Nusinersen versus Sham Control in Later-Onset Spinal Muscular Atrophy. N Engl J Med. 2018 Feb 15;378(7):625-635. doi: 10.1056/NEJMoa1710504.
- Background: PubMed 11566019Geary RS, Yu RZ, Levin AA. Pharmacokinetics of phosphorothioate antisense oligodeoxynucleotides. Curr Opin Investig Drugs. 2001 Apr;2(4):562-73.
- Background: PubMed 9077498Zerres K, Rudnik-Schoneborn S, Forrest E, Lusakowska A, Borkowska J, Hausmanowa-Petrusewicz I. A collaborative study on the natural history of childhood and juvenile onset proximal spinal muscular atrophy (type II and III SMA): 569 patients. J Neurol Sci. 1997 Feb 27;146(1):67-72. doi: 10.1016/s0022-510x(96)00284-5.
- Background: PubMed 17998484Oskoui M, Levy G, Garland CJ, Gray JM, O'Hagen J, De Vivo DC, Kaufmann P. The changing natural history of spinal muscular atrophy type 1. Neurology. 2007 Nov 13;69(20):1931-6. doi: 10.1212/01.wnl.0000290830.40544.b9.
- Background: PubMed 22148085Kim JH, Song SY, Kim BJ. Predicting the difficulty in performing a neuraxial blockade. Korean J Anesthesiol. 2011 Nov;61(5):377-81. doi: 10.4097/kjae.2011.61.5.377. Epub 2011 Nov 23.
- Background: PubMed 19420004Fettes PD, Jansson JR, Wildsmith JA. Failed spinal anaesthesia: mechanisms, management, and prevention. Br J Anaesth. 2009 Jun;102(6):739-48. doi: 10.1093/bja/aep096. Epub 2009 May 6.
- Background: PubMed 24141882Sahin T, Balaban O, Sahin L, Solak M, Toker K. A randomized controlled trial of preinsertion ultrasound guidance for spinal anaesthesia in pregnancy: outcomes among obese and lean parturients: ultrasound for spinal anesthesia in pregnancy. J Anesth. 2014 Jun;28(3):413-9. doi: 10.1007/s00540-013-1726-1. Epub 2013 Oct 20.
- Background: PubMed 2763004Scapinelli R. Morphological and functional changes of the lumbar spinous processes in the elderly. Surg Radiol Anat. 1989;11(2):129-33. doi: 10.1007/BF02096469.
- Background: PubMed 15814755Angle P, Tang SL, Thompson D, Szalai JP. Expectant management of postdural puncture headache increases hospital length of stay and emergency room visits. Can J Anaesth. 2005 Apr;52(4):397-402. doi: 10.1007/BF03016283.
- Background: PubMed 19450971Sng BL, Lim Y, Sia AT. An observational prospective cohort study of incidence and characteristics of failed spinal anaesthesia for caesarean section. Int J Obstet Anesth. 2009 Jul;18(3):237-41. doi: 10.1016/j.ijoa.2009.01.010. Epub 2009 May 17.
- Background: PubMed 9052305Horlocker TT, McGregor DG, Matsushige DK, Schroeder DR, Besse JA. A retrospective review of 4767 consecutive spinal anesthetics: central nervous system complications. Perioperative Outcomes Group. Anesth Analg. 1997 Mar;84(3):578-84. doi: 10.1097/00000539-199703000-00021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US-assisted nusinersen administration in people with Muscular Atrophy, Spinal and Ultrasound, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 1 inclusion and 4 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 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Number of attempts (time frame: During the procedure (spinal injection of nusinersen)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04674618, which also lists 25 linked publications.
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 21 Feb 2024.