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

NCT00781833 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2012-01-23

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injury at C5-C7 Level With Incomplete Lesion

Interventions

DEVICE

Radio Frequency Microstimulator

Implantable peripheral muscle microstimulator, delivering controlled pulsatile stimulation to femoral nerves for knee extension and peroneal nerves for dorsiflexion.

Sponsors & Collaborators

  • Walter Reed Army Medical Center

    collaborator FED

  • The Alfred E. Mann Foundation for Scientific Research

    lead OTHER

Principal Investigators

  • KEVIN F FITZPATRICK, M.D. · Walter Reed Army Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00781833 on ClinicalTrials.gov