Ultrasound-assisted vs Landmark Based Intrathecal Administration of Nusinersen

NCT04674618 | Completed

• 1 other identifier: 3352
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Muscular Atrophy, Spinal; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  During the procedure (spinal injection of nusinersen)

Secondary Outcomes (3)

• Successful administration

  During the procedure (spinal injection of nusinersen)

• Procedure time

  During the procedure (spinal injection of nusinersen)

• Patients satisfaction

  5 minutes after the end of the procedure (spinal injection of nusinersen)

Study Arms (2)

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.

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.

Interventions

US-assisted nusinersen administration DEVICE

Ultrasound identification of intervertebral space (L2-L3 or L3-L4)

US-assisted nusinersen administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SMA adult patients

You may not qualify if:

• coagulation defects;
• medication with anticoagulant;
• infection in puncture site;
• high intracranial pressure

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

IRCCS Policlinico Agostino Gemelli

Rome, 00168, Italy

Location

Related Publications (25)

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MeSH Terms

Conditions

Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Neuromuscular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 19, 2020
• Study Start: December 14, 2020
• Primary Completion: December 14, 2021
• Study Completion: December 21, 2023
• Last Updated: February 21, 2024

Record last verified: 2021-07

Locations

IT (1)