Clinical trial NCT00781833: Use of Implanted Microstimulators for Decreasing Spasticity and Improving Motion Following Spinal Cord Injury
Official title: Case Study Testing the Use of Implanted Microstimulators for Decreasing Spasticity and Improving Motion Following Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injury at C5-C7 Level With Incomplete Lesion
Keywords: Therapeutic Electric Stimulation
Functional Electric Stimulation
Implantable Stimulator
Muscle Strength
Muscle Spasticity
Lead sponsor: The Alfred E. Mann Foundation for Scientific Research
Sponsor class: OTHER
Collaborators: name: Walter Reed Army Medical Center
First posted: 2008-10-29
Enrollment: 1
Sex: MALE
Minimum age (years): 55
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Adverse Events
timeFrame: Throughout
measure: Lower Limb Strength
timeFrame: 6, 12, 24 weeks, 12, 24 months
measure: Lower Limb Spasticity
timeFrame: 6, 12, 24 weeks, 12, 24 months
Secondary outcomes:
measure: Mobility
timeFrame: 6, 12, 24 weeks, 12, 24 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
Study officials:
affiliation: Walter Reed Army Medical Center
name: KEVIN F FITZPATRICK, M.D.
role: PRINCIPAL_INVESTIGATOR
References: