Trial record 10 of 28 for:
Open Studies | "Quadriplegia"
A Neuroprosthesis for Seated Posture and Balance (Trunk Protocol)
This study is currently recruiting participants.
Verified March 2013 by Case Western Reserve University
Sponsor:
Case Western Reserve University
Collaborator:
Information provided by (Responsible Party):
Ronald J. Triolo, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01474148
First received: November 8, 2011
Last updated: March 20, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Cord Injury Paralysis Tetraplegia Paraplegia |
Device: IRS-8 (8-Channel implanted stimulator-telemeter) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Neuroprosthesis for Seated Posture and Balance |
Resource links provided by NLM:
Further study details as provided by Case Western Reserve University:
Primary Outcome Measures:
- Effect of Trunk stimulation on control seated posture, respiration, seated interface pressures, reach ability, seated stability & personal mobility. [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]Experiments involving the effects of trunk stimulation on postural alignment; trunk stability and posture on respiration, postural variation on seated interface pressures; effects of trunk stimulation on reaching ability; effects of trunk stimulation on seated stability, and personal mobility.
Secondary Outcome Measures:
- Design a simple position controller [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]The position controller will be developed to keep the trunk posture at a neutral seated position while allowing movement to lean forward, backward, or side-to-side. Testing will be carried out with an automated pull system applied to the trunk which pulls the body in various ways (side-to-side, forward, backward)
| Estimated Enrollment: | 10 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Neuroprosthesis
Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures.
|
Device: IRS-8 (8-Channel implanted stimulator-telemeter)
Surgical implantation of the 8-channel neuroprosthesis
Other Names:
|
Detailed Description:
In a single surgical procedure electrodes will be inserted into muscles of the trunk and hip musculature. The electrode leads are connected to a stimulator/telemeter located in the abdomen. After a typical post-operative period of two to five days, neuroprosthesis recipients will be discharged to home for two to six weeks of restricted activity to promote healing of all surgical incisions. After a period of exercise and training, functional use of the neuroprosthesis will begin. Laboratory assessments of strength, balance, and functional abilities with and without the system, as well as the technical performance of the implanted components will be evaluated.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age greater than 21
- C4-T12
- ASIA Scale A through C
- Time post injury greater than 6 months
- Innervated and excitable trunk and pelvis musculature
- Absence of acute or chronic psychological problems or chemical dependency
- Range of motion within normal limits
- Controlled spasticity and absence of hip flexion and adduction spasm
- Height and weight within normal limits
- No history of balance problems or spontaneous falls
- No history of spontaneous fracture or evidence low bone density
- No acute orthopaedic problems
- No acute medical complications
- Adequate social support and stability
- Able to speak and read English
Exclusion Criteria:
- Pregnancy
- Non-English speaking
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474148
Contacts
| Contact: Lisa M Lombardo, MPT | 216-791-3800 ext 4909 | llombardo@fescenter.org |
| Contact: Jeanne F Marlow, RN | 216-791-3800 ext 4236 | jmarlow@fescenter.org |
Locations
| United States, Ohio | |
| Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Lisa M Lombardo, MPT 216-791-3800 ext 4909 llombardo@fescenter.org | |
| Contact: Jeanne F Marlow, RN 216-791-3800 ext 4236 jmarlow@fescenter.org | |
| Principal Investigator: Ronald J Triolo, Ph.D | |
Sponsors and Collaborators
Case Western Reserve University
Investigators
| Principal Investigator: | Ronald J Triolo, Ph.D. | Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Ronald J. Triolo, Director Advanced Platform Technology Center, Case Western Reserve University |
| ClinicalTrials.gov Identifier: | NCT01474148 History of Changes |
| Other Study ID Numbers: | IRB#07101-H36 |
| Study First Received: | November 8, 2011 |
| Last Updated: | March 20, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Case Western Reserve University:
|
paraplegia tetraplegia Spinal cord injured FES |
Additional relevant MeSH terms:
|
Quadriplegia Paraplegia Spinal Cord Injuries Paralysis Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Spinal Cord Diseases Central Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013