At a glance
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Ultrasound-assisted vs Landmark Based Intrathecal Administration of Nusinersen in Adult Patients With SMA Disease: a Randomized Trial
In Brief
A clinical study evaluating US-assisted nusinersen administration for Muscular Atrophy, Spinal and Ultrasound. Completed, enrolled 58 participants across 1 site.
Detailed 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. 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.
Study Details
Timeline
Interventions
Ultrasound identification of intervertebral space (L2-L3 or L3-L4)