NCT01488981

Feasibility of the Radio-Frequency Microstimulator System to Improve Arm Function Following Traumatic Brain Injury

A Feasibility Study to Assess the Safety and Efficacy of the Radio-Frequency Microstimulator System to Improve Function of the Arm Following Traumatic Brain Injury

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: The Alfred E. Mann Foundation for Scientific Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the feasibility of using fully implanted microstimulators to rehabilitate arm function in patients who have suffered a traumatic brain injury.

Detailed description

Traumatic brain injury (TBI) could involve damage to motor pathways within the central nervous system, resulting in loss of arm function from symptoms including general weakness, loss of power, motor control abnormalities and spasticity. The Radiofrequency Microstimulator (RFM) System consists of fully implanted, leadless stimulators that are injected in a minimally invasive procedure. RFMs measure 16.7mm long, 2.4mm dia. and can be placed directly at target nerves in the arm to drive specific muscle contractions. This system has demonstrated efficacy in arm rehabilitation for stroke patients who suffer from loss of arm function similar to that experienced by some TBI patients. This feasibility study will evaluate if the RFM system can be used to assist patients in the rehabilitation of arm function following TBI. TBI patients that pass screening will have up to 7 RFM devices implanted in their disabled arm. After implantation, patients will participate in four phases of therapy, each lasting 12 weeks and consisting of standard occupational therapy occurring at regular intervals at home and in the clinic. In the first phase, therapy will not involve use of the RFM System. In the second phase, occupational therapy will be assisted by electrical stimulation using the RFM System. The third and fourth phases will repeat the therapies of the first and second phases, respectively. Arm function following therapy with RFM stimulation will be compared to arm function after therapy without RFM stimulation.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
OTHER	Upper Extremity Therapy without stimulation	Two 12 week phases of occupational therapy without electrical stimulation.
DEVICE	Upper Extremity Therapy with stimulation from the Radiofrequency Microstimulator (RFM) System (Alfred Mann Foundation, Santa Clarita, CA)	Two 12 week phases of occupational therapy that incorporates electrical stimulation from the RFM System.

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2011-12-09
• Last updated: 2013-12-19

Locations

1 site across 1 country: United States