Ultrasound-assisted or Landmark-based Intrathecal Administration of Nusinersen in Adult Patients With Spinal Muscular Atrophy (The EchoSpin Study)

CompletedOBSERVATIONAL
Enrollment

51

Participants

Timeline

Start Date

December 16, 2022

Primary Completion Date

January 10, 2023

Study Completion Date

January 10, 2023

Conditions
Anesthesia, SpinalSpinal Puncture ComplicationsSpinal Muscular AtrophyUltrasonography
Interventions
PROCEDURE

Interlaminar ultrasound-assisted intrathecal administration of nusinersen

All procedures were performed with patients either seated or placed in a lateral decubitus. After skin disinfection with 2% chlorhexidine in 70% alcohol, using a convex array, the L3-4 or L4-5 intervertebral space was identified and a left paramedian sagittal oblique view was obtained; the probe was rotated 90° into a transverse orientation, centered on the neuraxial midline, and moved in either the cephalad or caudal direction to obtain a transverse interlaminar view; the intersection between the two markings of the spinal midline and interspinous space was identified as the spinal entry point of the needle. After local anesthesia (LA) with lidocaine 2%, a 25-gauge non-traumatic 90 mm Whitacre spinal needle or a traumatic 90 mm Quincke spinal needle was used to access the subarachnoid space. After confirmation of cerebrospinal fluid (CSF) flow, 5 mL of CSF were removed. Subsequently, nusinersen was administered intrathecally over 1-3 min.

PROCEDURE

Landmark-based intrathecal administration of nusinersen

All procedures were performed with patients placed in their most comfortable position (either seated or placed in a lateral decubitus). After skin disinfection with 2% chlorhexidine in 70% alcohol, conventional palpation of the superior aspect of iliac crest was performed and the palpated intercristal line was assumed to cross the spine at L4 vertebral body or L4-L5 interspace. The skin was marked with horizontal and vertical lines at the L3-L4 or L2-L3 interspaces and was referred as entry point of the needle. The procedure was then completed in the same fashion as for US-assisted technique.

Trial Locations (1)

Unknown

Fondazione Policlinico Gemelli, Roma

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER