Spinal Cord Injuries Clinical Trial
Official title:
Neuroprosthesis for Improving Grasping Function in Spinal Cord Injured Patients
Functional electrical stimulation is a process that uses low intensity electrical pulses generated by an electric stimulator to create muscle contractions. By contracting muscles in a specific sequence, one can generate various body functions such as grasping, walking, and standing.The study is designed to evaluate the effectiveness and long term benefits of applying functional electrical simulation during early rehabilitation to improve grasping function in persons who have suffered a spinal cord injury. By using functional electrical stimulation,these patients could potentially improve their grasping function.
The main objective of this study is to determine the effectiveness of a new treatment regime
that uses a neuroprosthesis for the improvement and recovery of grasping functions in persons
with spinal cord injuries (SCI). This treatment has been shown to be useful for stroke
patients with hemiplegic arm in the recovery of reaching and grasping 1, and our preliminary
work indicates that this may also be the case with SCI patients 3. Further, aside from the
potential of promoting voluntary grasp in SCI patients, this novel therapeutic approach may
also impact the way service is currently delivered in SCI rehabilitation settings.
A neuroprosthesis for grasping is a device that can improve or restore the grasping, holding,
and releasing functions in persons with SCI 2, 3. The neuroprosthesis applies functional
electrical stimulation (FES) to artificially generate a muscle contraction by applying short
current pulses to motor nerves innervating muscles. FES can be applied to individuals with
incomplete SCI to help them restore functions such as walking and grasping by contracting
groups of paralyzed muscles in an orchestrated manner 4. FES was originally envisioned as an
intervention that was 'permanent' in nature. In other words, an individual had to wear/use an
FES orthotic device at all times if s/he wanted to generate the function that was impaired by
SCI 4. Our application of the neuroprosthesis for grasping in this proposal presents a
departure from this standard and established approach of FES application. Rather than having
people be dependent on the neuroprosthesis to perform their activities of daily living (ADL),
we plan to use the neuroprosthesis for grasping as a short-term intervention that will help
SCI individuals recover voluntary grasping function. Hence, we believe that those
participants who undergo our FES therapy with the neuroprosthesis should be able to perform
grasping functions without its use once the treatment program is completed.
Recent innovative advances in FES applications, spearheaded by our team, clearly indicate
that the short-term, therapeutic intervention of the neuroprosthesis for grasping can enhance
voluntary function in individuals with SCI 3, 5, 6. These studies also suggest that this
novel method of applying FES to augment functional improvement has the potential to improve
overall physical and psychological well being of persons with incomplete SCI. Since 1999, the
Co-PI of this application, Dr. Milos Popovic and Dejan Popovic's team from the University of
Belgrade have reported anecdotal evidence that some C5 to C7 SCI individuals who were unable
to voluntarily grasp, were later able to do so after intensive training with a
neuroprosthesis for grasping 2, 7, 8, 9. They observed that approximately 20 to 25% of the
individuals who trained with the FES systems were able to grasp without the assistance of the
neuroprosthesis once the systems were removed. Although this evidence has been presented in
several peer-reviewed publications, there have been no comprehensive studies to date that
have investigated the long-term effects of FES treatment on recovery of the voluntary
grasping function in persons with SCI. Consequently, this study seeks to 1) investigate
whether a series of orchestrated FES therapies can be applied to re-train/improve voluntary
grasping function in acute SCI individuals, and; 2) to determine whether this therapy will
yield better results than conventional occupational therapy. Specifically, we will recruit
participants who have C5 to C7 incomplete SCI. These individuals typically can generate weak
wrist extension but can neither flex, extend, abduct or adduct the fingers, nor flex, extend,
abduct or adduct the thumb. Our therapy will be used to help these individuals recover some
or all of these functions.
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