Use of Implanted Microstimulators for Decreasing Spasticity and Improving Motion Following Spinal Cord Injury - Full Text View

Sponsors and Collaborators:	The Alfred E. Mann Foundation for Scientific Research Walter Reed Army Medical Center
Information provided by:	The Alfred E. Mann Foundation for Scientific Research
ClinicalTrials.gov Identifier:	NCT00781833

Purpose

The primary aims of this study are to determine the safety of the RFM System (Alfred Mann Foundation, Santa Clarita, CA) in a patient with incomplete SCI and the effect of the RFM system on lower limb strength and spasticity. The secondary aim is to analyze any improvement in the participant's mobility.

Condition	Intervention
Incomplete Spinal Cord Injury	Device: Radio Frequency Microstimulator

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Case Study Testing the Use of Implanted Microstimulators for Decreasing Spasticity and Improving Motion Following Spinal Cord Injury

Further study details as provided by The Alfred E. Mann Foundation for Scientific Research:

Primary Outcome Measures:

Adverse Events [ Time Frame: Throughout ] [ Designated as safety issue: Yes ]
Lower Limb Strength [ Time Frame: 6, 12, 24 weeks, 12, 24 months ] [ Designated as safety issue: No ]
Lower Limb Spasticity [ Time Frame: 6, 12, 24 weeks, 12, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mobility [ Time Frame: 6, 12, 24 weeks, 12, 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment: Experimental Intramuscular Electrical Stimulation	Device: Radio Frequency Microstimulator Implantable peripheral muscle microstimulator, delivering controlled pulsatile stimulation to femoral nerves for knee extension and peroneal nerves for dorsiflexion.

Detailed Description:

Restoring mobility after spinal cord injury (SCI) is one of the most important goals of rehabilitation. Even for patients with partial lower limb motor function after SCI, many have limited mobility because of significant spasticity. Therapeutic electrical neuromuscular stimulation (TNS) has been used to improve muscle tone and strength and to enable walking and standing in patients with SCI. We propose to use the Radio Frequency Microstimulator (RFM) System, a new and novel implantable TNS system developed by the Alfred E. Mann Foundation, to improve muscle strength and reduce spasticity in a patient with incomplete SCI. The RFM System has several advantages over current TNS systems. The RFM implant devices are small enough (diameter 2.4 mm, length 16.7 mm) to be inserted using an incision approximately 5 mm long and have no lead wires passing through the skin since the microstimulator contains both the anode and cathode. Implanted RFM devices can be placed near multiple motor points and/or nerves and are controlled individually using radio frequency technology. Up to six (6) RFM devices will be inserted, two to three in each lower limb to provide stimulation to a patient's bilateral knee extensors (femoral nerve stimulation) and ankle dorsiflexors (peroneal nerve stimulation) to assess the effects on muscle strength, limb spasticity and patient mobility.

Eligibility

Ages Eligible for Study:	55 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

an incomplete C6 ASIA C (Central Cord) spinal cord injury
lower motor function impaired and suffers from significant spasticity (Ashworth scale 4)
able to ambulate approximately 10-20 feet with a rolling walker and minimal assistance
has sufficient endurance to complete at least two 20-minute therapy sessions per day
cognitive abilities are intact

Exclusion Criteria:

psychiatric diagnosis
medical contraindications
history of bleeding disorders
allergy to anesthesia
acute or progressive disease
active implantable device

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781833

Locations

United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307

Sponsors and Collaborators

The Alfred E. Mann Foundation for Scientific Research

Walter Reed Army Medical Center

Investigators

Principal Investigator:

Paul F Pasquina, M.D.

Walter Reed Army Medical Center

More Information

Responsible Party:	Walter Reed Army Medical Center ( Paul F. Pasquina, M.D., Chief Integrated Department of Orthopedics and Rehabilitation )
Study ID Numbers:	AMF CP-0005
Study First Received:	October 27, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00781833
Health Authority:	United States: Food and Drug Administration

Keywords provided by The Alfred E. Mann Foundation for Scientific Research:

Therapeutic Electric Stimulation
Functional Electric Stimulation
Implantable Stimulator
Muscle Strength
Muscle Spasticity

Study placed in the following topic categories:

Spinal Cord Injuries
Muscle Spasticity
Spinal Cord Diseases
Wounds and Injuries

Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009