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Thread: ESTIM Clinical Trial (Epidural Stimulation in Minnesota)

  1. #1

    ESTIM Clinical Trial (Epidural Stimulation in Minnesota)

    The epidural stimulation clinical trial in Minneapolis, Minnesota began enrolling today! You can find out more at this website.

    https://www.estand.org/

    Here is the inclusion and exclusion criteria:
    Inclusion Criteria:
    1. 22 years of age or older
    2. Able to undergo the informed consent process
    3. Stable, motor-complete paraplegia
    4. Discrete spinal cord injury between C6 and T10
    5. ASIA A or B Spinal Cord Injury Classification
    6. Medically stable
    7. Intact segmental reflexes below the lesion of injury
    8. Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation
    9. Willing to attend all scheduled appointments

    Exclusion Criteria:
    1. Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery (e.g. cardiopulmonary issues)
    2. Inability to withhold antiplatelet/anticoagulation agents perioperatively
    3. Significant dysautonomia
    4. Botulinum toxin injections in the previous 6 months
    5. Volitional movements present during EMG testing in bilateral lower extremities
    6. Unhealed spinal fracture
    7. Presence of significant contracture
    8. Presence of pressure ulcers
    9. Recurrent urinary tract infection refractory to antibiotics
    10. Current Pregnancy

  2. #2
    Senior Member lunasicc42's Avatar
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    so is anyone inquiring? As usual, I don't fit the criteria
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


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  3. #3
    Quote Originally Posted by lunasicc42 View Post
    so is anyone inquiring? As usual, I don't fit the criteria
    I filled out their pre-screen survey so will see what happens.

  4. #4
    Quote Originally Posted by lunasicc42 View Post
    so is anyone inquiring? As usual, I don't fit the criteria
    I think I'll have a hard time making it to appointments.


  5. #5
    Quote Originally Posted by Barrington314mx View Post
    I think I'll have a hard time making it to appointments.

    Yeah, me too. I'm to the NW of you. Boy, would I like too though!

  6. #6
    Senior Member Wills77's Avatar
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    Quote Originally Posted by Barrington314mx View Post
    I think I'll have a hard time making it to appointments.
    The trial I'm participating in pays my mileage and hotel stay. They fly a several people from California to Ohio. This one may be the same... but I don't know
    c6 inc since 2-19-11
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  7. #7
    Senior Member lunasicc42's Avatar
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    Wills, does the trial that you're in have a website with info?
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


    2010 SCINet Clinical Trial Support Squad Member
    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

  8. #8
    Senior Member Wills77's Avatar
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    Quote Originally Posted by lunasicc42 View Post
    Wills, does the trial that you're in have a website with info?
    http://www.aptcenter.research.va.gov/

    The human studies tab shows the different studies they are doing for spinal cord injuries.
    c6 inc since 2-19-11
    ex pro-am motocross racer
    tilite aero z s2

  9. #9
    Here is a talk from W2W from Dr. Darrow, who is the PI, about this study.

    https://vimeo.com/album/4252235/video/191041172

  10. #10
    Well I've been consider for this trail. Here is the email that I got

    "Dear Potential E-STAND Candidate,Our team is excited to consider you for our epidural stimulation trial. You are receiving this email because you submitted a prescreened survey and have been selected as a potential candidate in our clinical trial. Congratulations!
    The next step in our participant selection process is your visit to Hennepin County Medical Center in Minneapolis, Minnesota for formal screening and evaluation. The goal of the screening visit is to identify appropriate participants through a physical exam performed by the trial physician and considering the trial inclusion and exclusion criteria. Our first screening interval will be during the week of April 10th – 14th. Don’t worry if you can’t make this first session. There will be more. Your visit will be approximately 2-3 hours. Please note: This study is a five year study, where each participant will complete 13 months, and passing the screening process is just the first step. In order to ensure your safety and ensure the feasibility of study procedures, you may be found ineligible to participate in this trial. This decision is made purely on objective medical factors and does not impact your ability to participate in other clinical trials.
    We will provide a fact sheet explaining the details and logistics of your visit to Minneapolis. You will need to cover travel, lodging, and food costs. In addition to the physical evaluation, we will need the materials listed below to determine your eligibility. Please obtain as many of the following materials as possible and send to our office or bring with you.
    Please collect:

    1. Medical Records: (These may all come from the primary physician or may have to be obtained from the records of different specialists for different aspects of SCI)

    Most recent history and physical
    Any medical report of the event causing the spinal cord injury (could be in history and physical)
    The medical report of your most recent ASIA classification
    Medications:
    Current and inactive medication list with dosing details for the past year
    Medical History:
    Detailed family history of medical diagnoses
    Surgical history: especially spine surgeries
    History of bladder infections
    Discharge summary from hospitalizations within last year

    1. Rehabilitation records: (From PT/OT)

    A schedule of what types of rehabilitation you have received and when it was received

    1. Lab tests:

    Most recent laboratory tests
    Most recent lipid panel

    1. Imaging:

    CT/MRI spinal imaging, most recent and from the time of the injury

    1. Primary Care Physician:

    Name and contact information
    If you are able to gather the material in time, you can mail your records to:
    E-STAND Trial
    Brain Injury Research Lab
    701 Park Ave S, PL.610,
    Minneapolis MN 55414


    or you can bring your records with you to your appointment. You will receive a separate email about scheduling. My team and I look forward to meeting you, if you have questions about the required materials or screening process please contact us at estand@umn.edu.


    Sincerely,
    Dr. Darrow and the E-STAND team"

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