Feasibility of the Radio-Frequency Microstimulator System to Improve Arm

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01488981
Study type	Interventional
Source	The Alfred E. Mann Foundation for Scientific Research
Contact
Status	Terminated
Phase	Phase 1
Start date	February 2012
Completion date	July 2013

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms