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Use of Implanted Microstimulators for Decreasing Spasticity and Improving Motion Following Spinal Cord Injury

This study has been terminated.
(Participation of single subject enrolled was terminated.)
Sponsor:
Collaborator:
Walter Reed Army Medical Center
Information provided by (Responsible Party):
The Alfred E. Mann Foundation for Scientific Research
ClinicalTrials.gov Identifier:
NCT00781833
First received: October 27, 2008
Last updated: January 19, 2012
Last verified: January 2012
History of Changes
  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
Spinal Cord Injury at C5-C7 Level With Incomplete Lesion
 Device: Radio Frequency Microstimulator

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Case Study Testing the Use of Implanted Microstimulators for Decreasing Spasticity and Improving Motion Following Spinal Cord Injury

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 1
Study Start Date: October 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
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: KEVIN F FITZPATRICK, M.D. Walter Reed Army Medical Center
  More Information

No publications provided

Responsible Party: The Alfred E. Mann Foundation for Scientific Research
ClinicalTrials.gov Identifier: NCT00781833     History of Changes
Other Study ID Numbers: AMF CP-005
Study First Received: October 27, 2008
Last Updated: January 19, 2012
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

Additional relevant MeSH terms:
Muscle Spasticity
Spinal Cord Injuries
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
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 16, 2013