Feasibility of the Radio-Frequency Microstimulator System to Improve Arm Function Following Traumatic Brain Injury
This study will evaluate the feasibility of using fully implanted microstimulators to rehabilitate arm function in patients who have suffered a traumatic brain injury.
Traumatic Brain Injury
Other: Upper Extremity Therapy without stimulation
Device: Upper Extremity Therapy with stimulation from the Radiofrequency Microstimulator (RFM) System (Alfred Mann Foundation, Santa Clarita, CA)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Primary Safety Endpoint [ Time Frame: 2.25 years ] [ Designated as safety issue: Yes ]Number of Device-Related Serious Adverse Events during the course of the study.
- Action Research Arm Test (ARAT) Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The ARAT is an observational test used to determine upper extremity function. The test measures a subject's ability to perform arm and hand activities of a general nature used in ordinary daily living. These activities are designed to test grasp, pinch, placing, arm extension, elevation, supination and pronation, and, to a lesser extent, strength.
ARAT score after therapy with RFM stimulation will be compared to ARAT score after therapy without RFM stimulation.
- Fugl-Meyer Upper Extremity (FM-UE) Test Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The FM-UE test is an impairment-based Likert scale to assess motor deficits of the upper extremity in neurological patients.
FM-UE test score after therapy with RFM stimulation will be compared to FM-UE test score after therapy without RFM stimulation.
- Wolf Motor Function Test (WMFT) Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The WMFT is a lab-based test focusing on arm function that involves 15 functional tasks and 2 force-based measures which progress in complexity from engaging individual joints to use of the total arm.
WMFT score after therapy with RFM stimulation will be compared to WMFT score after therapy without RFM stimulation.
- Box and Block Test (BBT)Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The BBT measures unilateral gross manual dexterity. The BBT is composed of a wooden box divided in two compartments and 150 blocks. The subject is asked to move as many blocks as possible from one compartment of a box to another, within 60 seconds.
The number of blocks moved after therapy with RFM stimulation will be compared to the number of blocks moved after therapy without RFM stimulation.
- Motor Activity Log (MAL) Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The MAL is a semi-structured interview in which subjects are asked to rate how often they use their impaired arm to complete Activities of Daily Living and how well they are able to complete each Activity.
MAL score after therapy with RFM stimulation will be compared to MAL score after therapy without RFM stimulation.
|Study Start Date:||February 2012|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Other: Upper Extremity Therapy without stimulation
- Arm Rehabilitation
- Upper Extremity Rehabilitation
- Occupational Therapy
- functional electrical stimulation
- electrical stimulation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488981
|United States, Florida|
|James A. Haley VA Medical Center|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Subhra Jit Mookerjee, DO||James A. Haley VA Medical Center|