Study of an Implantable Functional Neuromuscular Stimulation System for Patients With Spinal Cord Injuries

• Sponsor: Case Western Reserve University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00004445
• Collaborator: (none)
• Enrollment: 18
• Locations: 2
• Arm: 1
• Duration (Months): 244
• Patients Per Site: 9
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

OBJECTIVES:

1. Establish the procedures for implementing and assessing the clinical utility of functional neuromuscular stimulation using an implanted eight-channel standing and transfer system in patients with incomplete tetraplegia or paraplegia.

2. Develop and apply quantitative functional evaluations of system performance in these patients.

3. Perform long term follow up and monitor system use outside of the laboratory.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury	Procedure: Surgery; Device: IRS-8	N/A

Detailed Description

PROTOCOL OUTLINE: Patients undergo surgery in which electrodes are sutured into areas of the pelvis and legs. Electrode leads are inserted into a receiver/stimulator implanted in a subcutaneous pocket in the abdomen. Following implantation, patients undergo training in standing, transfers, and other advanced mobility skills using the functional neuromuscular stimulation system. Restricted activity continues for 2 weeks after surgery, followed by 8 weeks of exercise. Standing training then begins, and continues for up to 6 weeks. Home-based training follows prior to discharge with the system for spontaneous use.

Patients are followed at 3, 6, and 12 months, then annually thereafter.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Eight Channel Implanted Neuroprosthesis for Exercise, Standing and Transfers
• Study Start Date: Sep 1, 1996
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Dec 31, 2016

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Implanted 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. Interventions include: Procedure/Surgery Rehabilitation/Exercise Device includes: IRS-8 Stimulating Electrodes External Controller

Procedure: Surgery; Device: IRS-8

Outcome Measures

Primary Outcome Measures

1. Standing Performance [Discharge, 1 follow-up between 6-12 months follow-up]

   A measure of how long an individual can maintain a standing position.

Secondary Outcome Measures

1. Distribution of Body Weight Through the Legs and Arms While Standing [Discharge, 1 follow-up between 6-12 months]

   Measure of how much weight is placed on the legs and arms while standing

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Low cervical or thoracic spinal cord injuries (C6-T12) Must be skeletally mature ASIA impairment scale A (complete motor and sensory deficits), B (sensory sparing), or C (motor and sensory sparing) Intact lower motor neurons Greater than 6 months since injury Range of motion within normal limits No renal compromise No cardiac abnormalities No circulatory compromise No pulmonary compromise No acute or chronic psychological problems or chemical dependency No acute orthopedic complications (scoliosis, history of spontaneous fractures, dislocations, etc.) No acute medical complications (no skin breakdowns, uncontrolled seizures, immunological compromise, etc.)

Exclusion Criteria:

Failure to meet inclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Case Western Reserve University	Cleveland	Ohio	United States	44106
2	MetroHealth System	Cleveland	Ohio	United States	44109

Sponsors and Collaborators

• Case Western Reserve University

Investigators

• Study Chair: Ronald J. Triolo, Case Western Reserve University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ronald J. Triolo, Biomedical Enginer, Case Western Reserve University
• ClinicalTrials.gov Identifier: NCT00004445
• Other Study ID Numbers: 199/13455; CWRU-FDR001244
• First Posted: Oct 19, 1999
• Last Update Posted: Aug 20, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Ronald J. Triolo, Biomedical Enginer, Case Western Reserve University: environmental/toxic disorders; neurologic and psychiatric disorders; rare disease; spinal cord injury
• Additional relevant MeSH terms: Spinal Cord Injuries

Study Results

Participant Flow

Recruitment Details	Recruitment of participants is based on evaluation of past medical history and in person evaluation including strength, ROM, and response to stimulation to determine eligibility.
Pre-assignment Detail	Participants will go through a screening process that will determine eligibility for the study. If they don't meet the inclusion or exclusion criteria they will not be invited to continue to the second phase of the study.

Arm/Group Title	Implanted Neuroprosthesis
Arm/Group Description	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 [ost-operative training and follow-up procedures. Surgery IRS-8
Period Title: Overall Study
STARTED	18
COMPLETED	15
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Implanted Neuroprosthesis
Arm/Group Description	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 [ost-operative training and follow-up procedures. Surgery IRS-8
Overall Participants	15
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	15 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.7 (7.3)
Sex: Female, Male (Count of Participants)
Female	1 6.7%
Male	14 93.3%
Region of Enrollment (participants) [Number]
United States	15 100%

Outcome Measures

1. Primary Outcome

Title	Standing Performance
Description	A measure of how long an individual can maintain a standing position.
Time Frame	Discharge, 1 follow-up between 6-12 months follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Implanted Neuroprosthesis
Arm/Group Description	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. Interventions include: Procedure/Surgery Rehabilitation/Exercise Device includes: IRS-8 Stimulating Electrodes External Controller Surgery IRS-8
Measure Participants	15
Discharge standing time	27.4 (38.6)
6-12 month follow-up standing time	15.6 (21.8)

2. Secondary Outcome

Title	Distribution of Body Weight Through the Legs and Arms While Standing
Description	Measure of how much weight is placed on the legs and arms while standing
Time Frame	Discharge, 1 follow-up between 6-12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Implanted Neuroprosthesis
Arm/Group Description	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. Interventions include: Procedure/Surgery Rehabilitation/Exercise Device includes: IRS-8 Stimulating Electrodes External Controller Surgery IRS-8
Measure Participants	15
Discharge body weight distribution	90.0 (13.1)
6-12 month follow-up body weight distribution	76.7 (22.2)

Adverse Events

Arm/Group Title	Implanted Neuroprosthesis
Arm/Group Description	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 [ost-operative training and follow-up procedures. Surgery IRS-8
All Cause Mortality
	Implanted Neuroprosthesis
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Implanted Neuroprosthesis
	Affected / at Risk (%)	# Events
Total	1/15 (6.7%)
Infections and infestations
Infection	1/15 (6.7%)	1
Other (Not Including Serious) Adverse Events
	Implanted Neuroprosthesis
	Affected / at Risk (%)	# Events
Total	0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.