Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05638191 |
| Other study ID # |
H20-03350 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 3, 2021 |
| Est. completion date |
January 2026 |
Study information
| Verified date |
December 2022 |
| Source |
University of British Columbia |
| Contact |
Michael Berger, MD, PhD |
| Phone |
778-990-7615 |
| Email |
michael.berger[@]vch.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The goal of this prospective, open label cohort study is to assess functional and motor
outcomes in individuals with cervical spinal cord injury who have undergone nerve transfer
surgery, with the goal of increasing upper limb function. We will also compare these outcomes
to a cohort of similarly matched individuals who have not undergone nerve transfer surgery,
using robust outcome measures, rigorous pre-operative clinical and neurophysiological
assessments, and standardized rehabilitation. At the end of this project we aim to develop a
model for predicting nerve transfer outcomes using pre-operative clinical and
neurophysiological characteristics.
Description:
The purposes of this study are:
1. To quantify functional and motor outcomes of NT in patients with SCI, using robust
outcome measures, rigorous pre-operative clinical and neurophysiological assessments,
and standardized rehabilitation, and to compare these outcomes against individuals who
did not undergo nerve transfer surgery.
2. To develop a model for predicting NT outcomes using pre-operative clinical and
neurophysiological characteristics.
Outcome measures:
Purpose 1: The primary study outcome is the Graded Redefined Assessment of Strength,
Sensibility and Prehension (GRASSP Ver. 1). Secondary outcomes are the Spinal Cord
Independence Measure (SCIM) and motor outcomes in recipient muscles following NT, including
muscle strength and neurophysiological assessments at 3 months intervals post-operatively, to
final outcome measurement at 24 months.
Purpose 2: Relevant demographic, clinical variables and neurophysiological variables
(including joint range of motion, muscle spasticity, pain, depression motor unit number
estimation in recipient muscles and ultrasound evaluation of recipient muscle quality), are a
priori variables that will be collected at baseline, in order to develop a clinical
prediction tool to inform prognosis.
Research Design:
All SCI individuals referred to an interdisciplinary clinic for potential nerve transfer will
undergo a standardized clinical examination, according to the International Standards for
Neurological Classification of Spinal Cord Injury (ISNCSCI), to classify neurological level
of injury. As well, electrodiagnostic test which will be performed by one of our highly
qualified physicians. Individuals who are deemed candidates for nerve transfer surgery will
be screened and invited to participate in the study. Participation in the study will not, in
any way, influence clinical care.
After receiving written consent, outcome measurement will take place pre-operatively, then at
3-month intervals post operatively; final analysis will occur at 24 months after surgery. As
well, a control group consisting of those SCI individuals who chose to not undergo or are not
candidates for surgery will be recruited. This "control group" will undergo assessments at 24
months following their injuries, in line with the anticipated functional plateau in
spontaneous recovery expected . Outcome measurement will be performed at GF Strong
Rehabilitation Hospital (Primary site), the International Collaboration on Repair Discoveries
(ICORD), Sunnybrook Hospital in Toronto, and Kingston Health Science Centre. Rehabilitation
will be administered by highly qualified hand therapists with standardized frequency, and
duration for all individuals. All study data will be stored in a REDCap database which will
be shared between all participating institutions.
Outcome measurement & information collected include:
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP), which is a
validated upper limb functional measure, specifically designed for use in SCI (Kalsi-Ryan et
al. 2012). It incorporates three domains vital to upper limb function: sensation, strength,
and prehension. It is a multimodal test comprising 5 subtests for each upper limb: dorsal
sensation, palmar sensation, strength, prehension ability and prehension performance. The
GRASSP results in 5 numerical scores that provide a comprehensive profile of upper-limb
function and will be administered by GRASSP certified research personnel. As well,
individuals will be asked to complete the Spinal Cord Independence Measure (SCIM)
questionnaire (Catz A, et al. 1997) on the same day of their visit.
At Baseline, a validated technique called motor unit number estimation (MUNE) counts the
number of MN's and can be essential in evaluating MN health. We aim to carry out this
technique towards measuring the health of MN's in functionally relevant muscles in patients
with SCI and comparing this with healthy controls. The purpose of this study is to provide a
quantitative measure of the size of MN pool in clinically relevant muscles below the level of
SCI using MPS and MScan MUNE. We will also supplement information about MNs with
ultrasound-derived measures of muscle quality.
Ultrasound sonography recording will be taken to analyze the structural health of recipient
muscles and to quantify muscle fibrosis and atrophy. The muscles of interest will be
anatomically identified and marked, and ultrasound gel will be applied to skin surface of the
upper limb prior to placing the ultrasound probe. Individuals will be asked to lie in a dimly
lit room for this portion of the study.
Demographic information will be collected for each participant, including
- age;
- sex;
- medical comorbidities; and
- medications
Clinical factors influencing functional and motor recovery in SCI will be measured:
- spasticity with modified Ashworth scores;
- depression with Beck's depression inventory (Beck, A. T., et al. 1996);
- passive ranges of motion in joints targeted by NT; and
- brief pain inventory (Ullrich PM, et al. 2008).
