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

[Wise Young]

http://clinicaltrials.gov/ct/gui/c/a1b/show/NCT00004445?order=1&JServSessionId zone_ct=ytqjceg4j1 (http://clinicaltrials.gov/ct/gui/c/a1b/show/NCT00004445?order=1&JServSessionIdzone_ct=ytqjceg4j1)

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

This study is currently recruiting patients.

Sponsored by

FDA Office of Orphan Products Development Case Western Reserve University

Purpose


OBJECTIVES: I. 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.

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

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


Condition
spinal cord injury


MEDLINEplusrelated topics:SpinalCordInjuries

Study Type:Treatment


Further Study Details:


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.


PROJECTED ACCRUAL: A total of 17 patients will be accrued for this study within 2 years.

Eligibility

Ages Eligible for Study: 18 Years and above

Criteria


PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

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

--Prior/Concurrent Therapy--

Not specified

-Patient Characteristics--

Age: 18 and over

Performance status: Not specified

Hematopoietic: Not specified

Hepatic: Not specified

Renal: No renal compromise

Cardiovascular: No cardiac abnormalities No circulatory compromise

Pulmonary: No pulmonary compromise

Other: 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.)

Location and Contact Information

Ohio
Case Western Reserve University,Cleveland, Ohio, 44106, United States;Recruiting

Ronald J. Triolo 216-778-7877

Ohio
MetroHealth System,Cleveland, Ohio, 44109, United States;Recruiting

John A. Davis 216-778-3456

Study chairs or principal investigators

Ronald J. Triolo, Study Chair
Case Western Reserve University


More Information

More information is available for this study.

Study ID Numbers 199/13455; CWRU-FDR001244 NLM Identifier NCT00004445

Date study startedSeptember 29, 1996

Last Updated May 1, 1999

[This message was edited by Wise Young on August 06, 2001 at 12:45 PM.]

[Wise Young]

From Max:

Topic: Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries in Clinical Trials Edit Message
by Max on Jun 03, 2002 at 07:01 PM from IP 216.209.61.246
Moderation reason: Forum moderation settings.

Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries
This study is currently recruiting patients.
Sponsored by
FDA Office of Orphan Products Development
Case Western Reserve University
Purpose
OBJECTIVES: I. 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. II. Develop and apply quantitative functional evaluations of system performance in these patients. III. Perform long term follow up and monitor system use outside of the laboratory.
Condition Treatment or Intervention
Spinal Cord Injury Procedure: Surgery
MEDLINEplus related topics: Spinal Cord Injuries
Study Type: Interventional
Study Design: Treatment, Non-Randomized
Further Study Details:
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.
Eligibility
Ages Eligible for Study: 18 Years and above , Genders Eligible for Study: Both
Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- 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 --Patient Characteristics-- Renal: No renal compromise Cardiovascular: No cardiac abnormalities No circulatory compromise Pulmonary: No pulmonary compromise Other: 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.)
Expected Total Enrollment: 17
Location and Contact Information
Ohio
Case Western Reserve University, Cleveland, Ohio, 44106, United States; Recruiting
Ronald J. Triolo 216-778-7877
Ohio
MetroHealth System, Cleveland, Ohio, 44109, United States; Recruiting
John A. Davis 216-778-3456
Study chairs or principal investigators
Ronald J. Triolo, Study Chair
Case Western Reserve University
More Information
Study ID Numbers 199/13455; CWRU-FDR001244
Date study started September 1996
Record last reviewed May 1999
NLM Identifier NCT00004445
ClinicalTrials.gov processed this record on 2002-05-24

[giambjj]

These studies have been gone on over the past year at the Schriners Hospital in Philly. Saw some nice results first hand. It is a good start, however, the kids movements are very robotic and ackward!

JJG