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

Case Study Testing the Use of Implanted Microstimulators for Decreasing Spasticity and Improving Motion Following Spinal Cord Injury

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.

Study Overview

• Status: Terminated
• Conditions: Spinal Cord Injury at C5-C7 Level With Incomplete Lesion
• Intervention / Treatment: Device: Radio Frequency Microstimulator

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse Events	Throughout
Lower Limb Strength	6, 12, 24 weeks, 12, 24 months
Lower Limb Spasticity	6, 12, 24 weeks, 12, 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Mobility	6, 12, 24 weeks, 12, 24 months

Collaborators and Investigators

• Sponsor: The Alfred E. Mann Foundation for Scientific Research
• Collaborators: Walter Reed Army Medical Center
• Investigators: Principal Investigator: KEVIN F FITZPATRICK, M.D., Walter Reed Army Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ACTUAL): June 1, 2010

Study Registration Dates

• First Submitted: October 27, 2008
• First Submitted That Met QC Criteria: October 27, 2008
• First Posted (ESTIMATE): October 29, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): January 23, 2012
• Last Update Submitted That Met QC Criteria: January 19, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Muscle Strength; Muscle Spasticity; Therapeutic Electric Stimulation; Functional Electric Stimulation; Implantable Stimulator
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Muscle Hypertonia; Wounds and Injuries; Spinal Cord Injuries; Muscle Spasticity
• Other Study ID Numbers: AMF CP-005