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

NCT01488981 | Terminated Phase 1

• 1 other identifier: CP-0014
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Brain Injury

Keywords

Radio Frequency Microstimulator; Traumatic Brain Injury; TBI; Arm Rehabilitation; electrical stimulation; FES

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

  Number of Device-Related Serious Adverse Events during the course of the study.

  2.25 years

• Action Research Arm Test (ARAT) Score

  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.

  12 weeks

Secondary Outcomes (4)

• Fugl-Meyer Upper Extremity (FM-UE) Test Score

  12 weeks

• Wolf Motor Function Test (WMFT) Score

  12 weeks

• Box and Block Test (BBT)Score

  12 weeks

• Motor Activity Log (MAL) Score

  12 weeks

Interventions

Upper Extremity Therapy without stimulation OTHER

Two 12 week phases of occupational therapy without electrical stimulation.

Also known as: Arm Rehabilitation, Upper Extremity Rehabilitation, Occupational Therapy, OT

Upper Extremity Therapy with stimulation from the Radiofrequency Microstimulator (RFM) System (Alfred Mann Foundation, Santa Clarita, CA) DEVICE

Two 12 week phases of occupational therapy that incorporates electrical stimulation from the RFM System.

Also known as: FES, functional electrical stimulation, electrical stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject sustained a Traumatic Brain Injury at least 6 and no more than 48 months prior to time of consenting.
• As a result of Traumatic Brain Injury, subject has impaired hand function associated with poor control and weakness of wrist and elbow extensors on at least one side.
• Subject has some preserved control of the arm to be treated as demonstrated by any voluntary movement of fingers and shoulder.
• Subject has functional, passive Range of Motion at the shoulder, elbow, wrist and finger joints of the arm to be treated.
• Subject's spasticity has been maximally medically controlled and documented stable without change in medication or therapies for a minimum of one month.
• Peripheral neuromuscular system is intact as demonstrated by electrophysiologic response to routine clinical nerve conduction studies and electromyography on the arm to be treated.
• Subject is assigned a level no less than VII on the Rancho Los Amigos Levels of Cognitive Functioning Scale.
• Subject is fluent in English.
• Subject or their legally authorized representative has signed an informed consent form.
• Subject (either male or female) is at least 18 years of age at time of consent.
• Subject is willing and capable of traveling to the investigational site for study visits outlined in this protocol.
• In the opinion of the Principal Investigator (PI), subject will be able to apply per protocol therapy at home, with the aid of a caregiver if necessary.

You may not qualify if:

• Subject is unwilling to perform all of the therapies and assessments required for the study.
• Subject has an active implant device (e.g. pacemaker, implanted cardiac defibrillator, neurostimulator, or drug infusion device).
• Subject has a metal implant (e.g. orthopedic hardware, stent, etc.) that is located within 12 cm of where the RF Coil surface will be placed for the RFM E-Stim therapy.
• Subject has metal fragments, metal implants, bullet fragments, metal chips or clips in or around the orbits or cranium or any other metal inside the body that would contraindicate an MRI or make it unreadable for the purpose of analysis.
• Subject with a congenital defect, contracture, upper extremity trauma, or other non-TBI condition that limits range of motion or neuromuscular function of the involved arm.
• Subject has a documented diagnosis of HIV or other life limiting infection or disease.
• A female subject who is pregnant, nursing, or planning to become pregnant during the course of the study. Women of childbearing potential must maintain effective contraception during the study period, as judged by the Investigator.
• Subject has a major psychological disorder, such as poorly controlled schizophrenia or paranoia, such that cooperative status is inconsistent.
• Subject has severe claustrophobia, movement that cannot be medically controlled or other condition that would limit their ability to undergo an MRI scan or remain still throughout an MRI scan.
• Subject has non-controlled epilepsy.
• In the opinion of the PI, subject has a high level of residual spasticity despite maximal medical therapy.
• Subject has peripheral neuropathy or myopathy in either upper extremity that would preclude implementation of proposed stimulation techniques (i.e. involvement of peripheral nerves or muscles involved in extension of the elbow, wrist, or fingers). An exception is made for carpel tunnel syndrome.
• Subject has a muscle power grade of more than 3 on the elbow, wrist and finger extensors of the arm to be treated, according to the Medical Research Council (MRC) scale.
• Subject has a history of endocarditis, a prosthetic valve or murmur.
• Subject has a history of adverse reactions to anesthetic agents.

Sponsors & Collaborators

• The Alfred E. Mann Foundation for Scientific Research: lead

Study Sites (1)

James A. Haley VA Medical Center

Tampa, Florida, 33612, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Occupational Therapy; Drug Delivery Systems; Electric Stimulation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Drug Therapy; Physical Stimulation; Investigative Techniques

Study Officials

• Subhra Jit Mookerjee, DO

  James A. Haley VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 9, 2011
• Study Start: February 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

US (1)