H-reflex in Spastic Lower Limb Cryoneurotomy

NCT04907201 | Active Not Recruiting

• 1 other identifier: H20-02294
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Spasticity is a common complication after many upper motor neurone disorders. Many surgical techniques have been introduced for patients with refractory spasticity though they are not without peri-operative risks. Cryoneurotomy is another procedure which is cheaper, faster and less invasive in comparison to other surgical interventions. While many studies support the use of cryoneurotomy for pain relief, there are not much studies on use of cryoneurotomy to manage spasticity. The purpose of this study to measure the effect of tibial nerve cryoneurotomy on electrophysiological and clinical spasticity measures in adult patients with spastic equinovarus or equinus foot, who will receive this procedure as a part of their treatment based on spasticity treatment available guidelines. The results will provide us valuable information like how long cryoneurotomy is effective, before regeneration happens.

Conditions

Muscle Spasticity

Keywords

spasticity; Lower limb; H reflex; Cryoneurotomy; Range of motion

Outcome Measures

Primary Outcomes (2)

• Any changes in H max to M max amplitude ratio (H/ M ratio)

  The ratio of maximum H reflex amplitude to maximum M wave amplitude as another electrophysiological analog for spasticity will be measured by a commercially available clinical electrodiagnosis machine before the procedure and at 1, 3 and 12 months after it. The results will be presented as a ratio and percentage.

  up to 12 months

• Changes in maximum H reflex amplitude

  The maximum H reflex amplitude as an analog of spasticity as it measure excitability of the monosynaptic reflex arc will be assessed by a commercially available clinical electrodiagnosis machine. The assessment will be done before the procedure and at 1, 3 and 12 months after it and at both sides. The measurement unit will be millivolt (mV).

  up to 12 months after procedure

Secondary Outcomes (2)

• Degree of changes in ankle dorsi-flexion spasticity as measured by Modified Ashworth Scale (MAS)

  up to 12 months after procedure

• Degree of changes in ankle dorsiflexion range of motion

  Up to 12 months

Study Arms (2)

Patients

A group pf 30 patients with lower limb spasticity who are already candidate for cryoneurotomy will be invited to have an extra electrophysiological test for participation in this study. The test will be done for both limbs for a better comparison.

Procedure: Cryoneurotomy

Healthy participants

A group of 30 healthy participants will be invited as a control group, and they will have a single session of electrodiagnostic test for their lower limb in dominant side.

Interventions

Cryoneurotomy PROCEDURE

Cryoneurotomy or application of a low temperature probe with guidance of ultrasound which is offered to the patients with lower limbs refractory spasticity as a part of their medical cares.

Also known as: nerve cryoablation

Patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any adult patient with lower limb spasticity who is already candidate for cryoneurotmy as a part of their medical care will be asked to be enrolled in the study.

You may qualify if:

• Patients who will have cryoneurotomy as part of their standard treatment for spastic equinovarus foot in VGH spasticity multidisciplinary clinic
• Adults 18-70 years of age (male and female)
• Ability to attend testing sessions, comply with testing protocols and provide written informed consent.
• Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).
• Any healthy participants with the age between 18 to 70. Over 70 will be excluded due to the expected natural alterations in electrophysiological parameters
• Able to attend and comply with the testing protocols
• Able to provide informed written consent
• Able to understand and speak English or have access to an appropriate interpreter

You may not qualify if:

• History of previous nerve procedures such as chemical neurolysis with alcohol, cryoneurotomy, any surgery of the tibial nerve.
• Any other neurological pathology different from that responsible for the spasticity.

Sponsors & Collaborators

• Vancouver Island Health Authority: lead

Study Sites (1)

Victoria General Hospital

Victoria, British Columbia, V8Z 6R5, Canada

Location

Related Publications (4)

• Bollens B, Deltombe T, Detrembleur C, Gustin T, Stoquart G, Lejeune TM. Effects of selective tibial nerve neurotomy as a treatment for adults presenting with spastic equinovarus foot: a systematic review. J Rehabil Med. 2011 Mar;43(4):277-82. doi: 10.2340/16501977-0786.

  PMID: 21305231 BACKGROUND

• Deltombe T, Bleyenheuft C, Gustin T. Comparison between tibial nerve block with anaesthetics and neurotomy in hemiplegic adults with spastic equinovarus foot. Ann Phys Rehabil Med. 2015 Apr;58(2):54-9. doi: 10.1016/j.rehab.2014.12.003. Epub 2015 Jan 9.

  PMID: 25614022 BACKGROUND

• Friedman T, Richman D, Adler R. Sonographically guided cryoneurolysis: preliminary experience and clinical outcomes. J Ultrasound Med. 2012 Dec;31(12):2025-34. doi: 10.7863/jum.2012.31.12.2025.

  PMID: 23197557 BACKGROUND

• Ilfeld BM, Gabriel RA, Trescot AM. Ultrasound-guided percutaneous cryoneurolysis for treatment of acute pain: could cryoanalgesia replace continuous peripheral nerve blocks? Br J Anaesth. 2017 Oct 1;119(4):703-706. doi: 10.1093/bja/aex142. No abstract available.

  PMID: 29121277 BACKGROUND

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: December 15, 2020
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

CA (1)