AzTrials
AzTrials

Traumatic Brain InjuryPhase 1NCT01488981

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

A Phase 1 study testing Upper Extremity Therapy without stimulation and Upper Extremity Therapy with stimulation from the Radiofrequency Microstimulator (RFM) System (Alfred Mann Foundation, Santa Clarita, CA) in people with Traumatic Brain Injury, run by The Alfred E. Mann Foundation for Scientific Research at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Traumatic Brain Injury
What is being tested?
Upper Extremity Therapy without stimulation and Upper Extremity Therapy with stimulation from the Radiofrequency Microstimulator (RFM) System (Alfred Mann Foundation, Santa Clarita, CA)
Type of treatment
Medical device
How many people
1 participants
Where
1 siteUnited States
Study dates
Feb 2012to Jul 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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.
  • Recent or current participation in research that may influence response to either study intervention, or be harmful to the subject in any way.
  • Subject's life expectancy is less than 1.5 years.
  • Subject has any bleeding or clotting disorder.
  • Subject has pain that in the opinion of the PI would impair participation.
  • Subject is unwilling to refrain from use of transcutaneous electrical stimulation on the arm to be treated for the duration of their study participation.
  • The PI does not feel the subject is a suitable candidate for the study, for any reason.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • James A. Haley VA Medical Center

    Tampa, Florida, 33612

Other trials in United States

About this study

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

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

Read the 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.

Being tested
Upper Extremity Therapy without stimulation, Upper Extremity Therapy with stimulation from the Radiofrequency Microstimulator (RFM) System (Alfred Mann Foundation, Santa Clarita, CA)
Keywords
Radio Frequency Microstimulator, Traumatic Brain Injury, TBI, Arm Rehabilitation, electrical stimulation, FES
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Upper Extremity Therapy without stimulationOther

    Also called Arm Rehabilitation, Upper Extremity Rehabilitation, Occupational Therapy, OT

    Two 12 week phases of occupational therapy without electrical stimulation.

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

    Also called FES, functional electrical stimulation, electrical stimulation

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Safety Endpoint

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

    Measured: 2.25 years

  2. 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.

    Measured: 12 weeks

Secondary outcomes (4)

  1. Fugl-Meyer Upper Extremity (FM-UE) Test Score

    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.

    Measured: 12 weeks

  2. Wolf Motor Function Test (WMFT) Score

    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.

    Measured: 12 weeks

  3. Box and Block Test (BBT)Score

    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.

    Measured: 12 weeks

  4. Motor Activity Log (MAL) Score

    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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2011 (estimated)
  2. Study startFeb 2012
  3. Primary completionJul 2013
  4. Study completionJul 2013

Why it stopped: low enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01488981
Sponsor's protocol ID
CP-0014
Status last verified
Dec 2013
First submitted
5 Dec 2011
Last updated
19 Dec 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Upper Extremity Therapy without stimulation and Upper Extremity Therapy with stimulation from the Radiofrequency Microstimulator (RFM) System (Alfred Mann Foundation, Santa Clarita, CA) in people with Traumatic Brain Injury, run by The Alfred E. Mann Foundation for Scientific Research at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: low enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Endpoint (time frame: 2.25 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01488981.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in