Benefits of Applying Neuroprosthesis to Improve Grasping and Reaching in Spinal Cord Injury Patients

This study has been completed.
Sponsor:
Collaborators:
Christopher Reeve Paralysis Foundation
The Physicians' Services Incorporated Foundation
Information provided by:
Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT00221117
First received: September 14, 2005
Last updated: September 28, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injuries
Device: Neuroprosthesis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neuroprosthesis for Improving Grasping Function in Spinal Cord Injured Patients

Resource links provided by NLM:


Further study details as provided by Toronto Rehabilitation Institute:

Primary Outcome Measures:
  • Rehabilitation Engineering Laboratory Hand Function Test(REL Test) [ Time Frame: 45 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Klein-Bell ADL (activities of daily living) Scale [ Time Frame: 15 min ] [ Designated as safety issue: No ]
  • Functional Independence Measure (FIM) [ Time Frame: 35 min ] [ Designated as safety issue: No ]
  • Spinal Cord Independence Measure (SCIM) [ Time Frame: 30 min ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2005
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Neuroprosthesis
    The Compex Motion neuroprostesis, developed by Drs. R. Popovic and Thierry Keller,and company Compex SA, ia a flexible device designed to improve grasping function in both SCI and stroke patients.This multi-channel surface stimulation system for grasping provides both palmar and lateral grasp , and holds a number of advantages over the other existing neuroprostheses.
    Other Name: Functional electrical stimulation(FES)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • traumatic spinal cord lesion between C4 and C7(incomplete)
  • participants will be recruited during the first six months post-SCI.

Exclusion Criteria:

  • uncontrolled hypertension
  • susceptibility to autonomic dysreflexia
  • pressure ulcer
  • cardiac pacemakers
  • skin rush
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221117

Sponsors and Collaborators
Toronto Rehabilitation Institute
Christopher Reeve Paralysis Foundation
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Milos Popovic, Ph.D University of Toronto
  More Information

Additional Information:
Publications:
Responsible Party: Milos R. Popovic, Toronto Rehab Institute
ClinicalTrials.gov Identifier: NCT00221117     History of Changes
Other Study ID Numbers: TRI REB #02-032
Study First Received: September 14, 2005
Last Updated: September 28, 2010
Health Authority: Canada: Health Canada

Keywords provided by Toronto Rehabilitation Institute:
Spinal Cord Injuries

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 29, 2014