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Clinical Trials/NCT04393922
NCT04393922
Unknown
Not Applicable

Spasticity After Spinal Cord Injury

Shirley Ryan AbilityLab1 site in 1 country120 target enrollmentMay 13, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
Shirley Ryan AbilityLab
Enrollment
120
Locations
1
Primary Endpoint
MEP recruitment curves
Last Updated
3 years ago

Overview

Brief Summary

Very often, people who have a SCI have difficulty doing things with their arms or hands as a result of muscle stiffness , or spasticity. Spastacity can cause problems performing even the simplest of everyday tasks. This research will help us understand how the body recovers and changes neurologically after SCI.

Detailed Description

After spinal cord injury (SCI), damage to descending motor pathways has been associated with the development of spasticity (Frigon and Rossignol, 2006; Trompetto et al., 2014). Self-reported questionnaires and clinical exams indicate that individuals with incomplete SCI, who showed residual descending connectivity, have a high prevalence of spasticity compared to individuals with complete SCI (Little et al., 1989; Holtz et al., 2017). In agreement, our recent electrophysiological and spinal cord imaging data in humans with a diagnosis of a clinically motor complete SCI showed the presence of descending motor pathway connectivity in individuals with spasticity compared to those without spasticity (Sangari et al., 2019). However, which descending motor pathways influence spasticity following SCI, and to what extent, remains poorly understood. This proposal has two main goals: 1) to examine the contribution of cortico- and reticulo-spinal pathways to spasticity in upper and lower limb muscles, and 2) to develop strategies to promote functional recovery of upper and lower limb spastic muscles in humans with chronic incomplete SCI. The aims below will test two main hypotheses. In Aim 1, we will use transcranial magnetic stimulation and startle acoustic stimuli to examine the contribution of the cortico- and reticulo-spinal pathway to upper and/or lower limb muscles electromyographic activity. Spinal cord atrophy and morphological characterization of cortico- and reticulo-spinal pathways will be assessed with high-resolution magnetic resonance imaging. Physiological and neuroimaging outcomes will be associated with clinical assessment of spasticity. In Aim 2, we propose to enhance cortico- and reticulo-spinal contribution to upper and/or lower limb function in spastic muscles by using a novel intervention combining startle acoustic stimuli with motor training. This research will provide new knowledge about the contribution of descending motor pathways to the control of spasticity in upper and lower limb muscles following incomplete cervical SCI (Aim1) and might lead to the development of a novel rehabilitation intervention to improve upper and lower limb motor function recovery by enhancing residual descending control over spinal networks (Aim 2).

Registry
clinicaltrials.gov
Start Date
May 13, 2020
End Date
May 18, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Monica Perez

Scientific Chair Arms + Hands Lab

Shirley Ryan AbilityLab

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

MEP recruitment curves

Time Frame: 3-4 hours

Ten stimuli (0.2 Hz) will be delivered at each intensity to plot the mean peak-to-peak amplitude of the MEP from the non-rectified response against the TMS intensity in each subject (MEP recruitment curve).

Modified Ashworth Scale (MAS)

Time Frame: 3-4 hours

This scale measures resistance encountered during manual passive muscle stretching using a six-point ordinal scale.

StartReact

Time Frame: 3-4 hours

Here, participants will be asked to observe a light-emitting diode (LED) located in front of their head. When the LED will illuminate, individuals will be asked to move their arm or leg. In some trials, the LED will be presented with either a quiet acoustic stimulus (80 dB, 500 Hz, 50 ms) or a startling acoustic stimulus (SAS, 120 dB, 500 Hz, 50 ms) delivered through a headphone.

Toronto Rehabilitation Institute-Hand Function Test (TRI-HFT)

Time Frame: 3-4 hours

This exam measures gross motor function frequently used to manipulate objects that participants may encounter in their daily lives.

Participant reported spasticity

Time Frame: 3-4 hours

Spasticity questionnaire

Pendulum Test

Time Frame: 3-4 hours

As part of the physical exam, we will use the pendulum test to measure muscle tone at the knee by using gravity to provoke muscle stretch reflexes during passive swinging of the lower limb.

Portable Spasticity Assessment Device (PSAD)'

Time Frame: 3-4 hours

The PSAD combine biomechanical and electrophysiological measurements for an objective quantification of active and passive component of muscle stiffness

10-meter walk test

Time Frame: 3-4 hours

10-meter walk test will be used to assess walking speed

Ipsilateral MEPs (iMEPs)

Time Frame: 3-4 hours

Ten stimuli will be delivered during head straight and ten stimuli will be delivered during lateral head rotation, randomly alternated (0.2 Hz).

Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP).

Time Frame: 3-4 hours

This exam measures clinical impairment that incorporates three domains vital to upper-limb function: sensation, strength, and prehension.

Study Sites (1)

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