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Thread: Q&A: Epidural Stimulation and Bladder, Bowel, & Sexual Function

  1. #31
    Senior Member lunasicc42's Avatar
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    Quote Originally Posted by Mize View Post
    Afaik, the first study attempting quantitative evaluation of BBSF (and I'm not sure it includes SF) is the one Frazier/Louisville just received approval to begin recruiting.
    any link
    "That's not smog! It's SMUG!! " - randy marsh, southpark

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  2. #32
    Quote Originally Posted by lunasicc42 View Post
    any link
    Post #1 Paragraph #1 Recovery of Bladder and Sexual Function after Spinal Cord Injury Trial has been recruiting patients for 11 months now.

  3. #33
    Senior Member lunasicc42's Avatar
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    Oh I thought maybe he was talking about something new... I still have plans for my mother to call and inquire about that study but I am waiting a little until after the holidays
    "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
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  4. #34
    Quote Originally Posted by lunasicc42 View Post
    Oh I thought maybe he was talking about something new... I still have plans for my mother to call and inquire about that study but I am waiting a little until after the holidays
    Once the human trial is finished and the data is analyzed, one would expect a paper to be written about it and submitted for publication in a journal.

  5. #35
    Quote Originally Posted by GRAMMY View Post
    Once the human trial is finished and the data is analyzed, one would expect a paper to be written about it and submitted for publication in a journal.

    Grammy can you or anyone else tell me is there a date set when human trials will be finished
    AS I SIT HERE IN MY CHAIR . I LOOK OUT UPON THE GROUND .I WONDER WILL I EVER GET UP AND WALK A ROUND ??


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  6. #36
    Quote Originally Posted by skeaman View Post
    Grammy can you or anyone else tell me is there a date set when human trials will be finished
    https://www.u2fp.org/educate/clinical-trials/

    Recruitment Status ICMJERecruiting
    Estimated Enrollment ICMJE30
    Estimated Completion DateSeptember 2019
    Estimated Primary Completion DateSeptember 2019 (Final data collection date for primary outcome measure)
    Eligibility Criteria ICMJECriteria: Inclusion Criteria:

    • stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate locomotor training, stand, or non-weight bearing training
    • no painful musculoskeletal dysfunction,
    • unhealed fracture, contracture, pressure sore or urinary tract infection that might interfere with training
    • no clinically significant depression or ongoing drug abuse;
    • clear indications that the period of spinal shock is concluded determined by presence of muscle tone, deep tendon reflexes or muscle spasms and discharged from standard inpatient rehabilitation
    • non- progressive suprasacral spinal cord injury
    • bladder and sexual dysfunction as a result of spinal cord injury

    Exclusion criteria:

    • unstable medical condition with cardiopulmonary disease or dysautonomia that would contraindicate locomotor training, stand, or non-weight bearing training;
    • painful musculoskeletal dysfunction, unhealed fractures, contractures, pressure sores or urinary tract infections that might interfere with training
    • clinically significant depression or ongoing drug abuse;
    • clear indications that the period of spinal shock has not concluded and not discharged from standard inpatient rehabilitation
    • progressive spinal cord injury
    • no bladder and sexual dysfunction as a result of spinal cord injury

    Sex/Gender
    Sexes Eligible for Study:All
    Ages18 Years and older (Adult, Senior)
    Accepts Healthy VolunteersYes
    Contacts ICMJE
    Contact: Charles Hubscher, PhD502-852-3058charles.hubscher@louisville.edu
    Contact: Susan Harkema, PhD502-581-8675susanharkema@kentuckyonehealth.org



    https://clinicaltrials.gov/ct2/show/...NA%3AUS&rank=1
    Last edited by GRAMMY; 01-02-2018 at 11:25 AM.

  7. #37
    Here is the 2017 NIH Grant for the PI: Charles H. Hubscher (Awarded July 28, 2017 for $311,250.)



    Project Number:5R01HD080205-04Contact PI / Project Leader:HUBSCHER, CHARLES H.
    Title:EFFECTS OF ACTIVITY DEPENDENT PLASTICITY ON RECOVERY OF BLADDER AND SEXUAL FUNCTION AFTER HUMAN SPINAL CORD INJURYAwardee Organization:UNIVERSITY OF LOUISVILLE




    Abstract Text:
    DESCRIPTION (provided by applicant): Spinal cord injury (SCI) results in impairments of locomotor, sensory and autonomic functions, severely affecting overall health and quality of life. Recent discoveries related to activity-dependent plasticity in humans have led to a widely implemented rehabilitation intervention, Locomotor Training, which includes stepping using body weight support on a treadmill with manual facilitation. Evidence suggests that this particular type of task specific training optimizes the lumbosacral spinal circuitry. We have intriguing evidence from four SCI individuals who are unable to stand or walk showing improved bladder and sexual function after undergoing Locomotor Training. These changes in urogenital function may be due to activity-dependent plasticity of lumbosacral circuitry that mediates micturition and erectile functions. Proper bladder management post-SCI is necessary to decrease the risk of upper urinary tract disease, a major source of morbidity. The life-long urologic care is required for SCI individuals, yet most efforts treat symptoms but do not improve intrinsic function. In addition, paraplegics rank sexual function as the function post-injury that should be given the highest priority in order to enhance quality of life. This proposal focuses on the mechanisms involved in the reorganization of spinal cord circuits for bladder and sexual function in response to activity-dependent plasticity induced by step training after SCI, with and without epidural stimulation. Stand training and/or arm crank exercise serve as controls. Of potential mechanistic importance is that neurotrophins have been implicated in modulating bladder function. It is therefore hypothesized that weight bearing task specific training for locomotion post-SCI induces plasticity of neural networks that mediate not just walking but bladder and sexual function as well and may do so for bladder function by reducing specific neurotrophins that are elevated post-SCI. Our unique approach will utilize the expertise of each investigator to 1) To determine whether the effect of weight-bearing task-specific training for locomotion on voiding frequency and urodynamic parameters is due to an interaction between locomotor and urinary bladder circuitry after traumatic incomplete upper motor neuron SCI in humans (versus standing or general exercise); 2) To assess the effect of LT on urine (biomarkers) and bladder (biopsy tissue) NGF and BDNF levels after severe incomplete SCI; 3) To determine the effect of weight-bearing task-specific training for locomotion on erectile function and sexual satisfaction after traumatic incomplete upper motor neuron SCI in humans; and 4) To assess the effect of epidural stimulation in combination with LT on voiding frequency, urodynamic parameters, erectile function, and bladder/urine NGF and BDNF levels after complete and motor complete/sensory incomplete upper motor neuron SCI in humans. Our innovative multi-disciplinary study may lead to the translation of a combination approach of weight bearing step training, epidural stimulation, and neurotrophic factor manipulation to promote functional recovery for multiple systems following SCI.
    Public Health Relevance Statement:
    PUBLIC HEALTH RELEVANCE: Spinal cord injury (SCI) results in devastating effects on overall health and quality of life. The Christopher and Dana Reeve Foundation has recently estimated that 1,275,000 people are living with paralysis from SCI in the United States alone. This country could save an estimated $400 billion on direct and indirect lifetime costs if we can find ways to treat and prevent SCI. bladder and sexual dysfunction affects daily life, reduces quality of life and results in numerous life-long health complications. Improvements in bladder and sexual function have been reported in some people with incomplete SCI while they are undergoing a new rehabilitation intervention, Locomotor Training. In addition, four individuals with motor complete SCI who have received epidural stimulation in combination with Locomotor Training have also reported significant improvements in bladder and sexual function. We propose unique experimental human studies to understand whether spinal cord circuits responsible for walking are also important for bladder and sexual functions and reorganize in response to Locomotor Training and/or epidural stimulation after SCI to improve these functions and alter important chemicals in the body. The knowledge gained from our innovative multi-disciplinary study may lead to the translation of non-invasive approaches that will improve bladder and sexual function in people with SCI. Because we study humans with SCI directly, what we learn will be immediately applicable to patients and provide immense improvements in quality of life.
    Last edited by GRAMMY; 01-02-2018 at 11:17 AM.

  8. #38
    Here is the 2017 SPARC INITIATIVE AWARD for Functional Mapping with Epidural Stimulation to Restore Bladder Function for PI: Charles H. Hubscher (Award Date: September 20, 2017 for $1,239,591.)

    Project Number:1OT2OD024898-01 Former Number: 1OT2TR002236-01Contact PI / Project Leader:HUBSCHER, CHARLES H.
    Title:FUNCTIONAL MAPPING WITH LUMBOSACRAL EPIDURAL STIMULATION FOR RESTORATION OF BLADDER FUNCTION AFTER SPINAL CORD INJURYAwardee Organization:UNIVERSITY OF LOUISVILLE

    Abstract Text:
    PROJECT SUMMARY/ABSTRACT The overall objective of this functional bladder mapping study is to identify the spinal cord epidural stimulation (scES) configurations (anode/cathode selection, amplitude, frequency and pulse width) at the lumbosacral level that can promote neural control of bladder storage (capacity) and voiding efficiency after spinal cord injury (SCI). This comprehensive functional mapping study in both humans and animals in parallel involves a novel clinical application of a marketed Medtronic device for bladder dysfunction after SCI. The mapping (human and animal) and training (human) experiments address several specific objectives of the SPARC Program initiative per RFA-RM-15-018 including neural circuit maps regarding functional connectivity (Aim 1), neural plasticity related to stimulation (bladder training experiments – Aim 2), variability (animal-to- animal and patient-to-patient), and research on what organ functions results from different types of stimulation (storage vs voiding and identifying any additional effects on bowel and/or sexual function). The long-term reduction in the cost to the health care system, care givers and society would be dramatic. SCI results in impairments of locomotor, sensory and autonomic functions, severely affecting overall health and quality of life. Proper bladder management post-SCI is necessary to decrease the risk of upper urinary tract disease, a major source of morbidity. Life-long urologic care is required for SCI individuals, yet most efforts treat symptoms but do not improve intrinsic function. Current therapies for bladder management after SCI include catheterization, pharmacologic and surgical interventions, functional electrical stimulation (peripheral), and urethral stents, but all have deleterious effects. We have exciting data from multiple individuals with severe injuries (AIS A and B) indicating improved bladderfunction after undergoing a widely implemented activity-based rehabilitation, locomotor training (LT), which includes stepping using body weight support on a treadmill with manual facilitation. In addition, we have intriguing preliminary data from several completely paralyzed individuals receiving scES in combination with task specific training that recovered standing and voluntary movement and showed improvements in both bladder capacity and voiding efficiency. Our most recent pilot data also indicate an immediate benefit of scES alone on bladder function. Thus, we propose to determine the functional gains that can be achieved in the storage and voiding phases of lower urinary tract function as a result of activation of spinal circuits with scES in humans with SCI and in a clinically- relevant rodent SCI model. We will test the general hypothesis that bladdercapacity and voiding efficiency increases with scES post-SCI and to an even greater extent with scES bladder training over time. This proposal involves the collaboration of clinicians and scientists with extensive experience in animal and human SCI models. Our unique approach will utilize the expertise of a multi-disciplinary team (expertise in bladder function, neuromodulation, rehabilitation, engineering, and statistics) to 1) determine the optimal stimulation parameters for storage and voiding in SCI research participants already implanted with the scES Medtronic device (16-electrode array from L1-S1); 2) quantify the long-term effects of daily bladder training using optimal stimulation parameters (all the same research participants); 3) measurement of secondary benefits (bladder medication usage, susceptibility to urinary tract infections, indirect cardiovascular, bowel and sexual function benefits) of long-term bladder training; and 4) address with a small animal model the impact of location, lesion severity, chronicity and gender. Our innovative approach and novel application of this Medtronic Specify 5-6-5 device will allow us to determine specific types of scES needed for bladder function which will lay the groundwork for expedient translation of this promising technique to larger numbers of individuals with SCI in the next phase of the SPARC initiative, with additional refinement in parallel using a large animal SCI model (pig) that is currently under development within the Kentucky Spinal Cord Research Center.
    Public Health Relevance Statement:
    PROJECT NARRATIVE Spinal cord injury (SCI) results in devastating effects on overall health and quality of life. The Christopher and Dana Reeve Foundation have recently estimated that 1,275,000 people are living with paralysis from SCI in the United States alone. This country could save an estimated $400 billion on direct and indirect lifetime costs if we can find ways to treat and prevent SCI. Bladder dysfunction affects daily life, reduces quality of life and results in numerous life-long health complications. Improvements in bladder function have been recently discovered in SCI subjects while they are undergoing an efficacious rehabilitation intervention, activity-based locomotor training (LT). In addition, multiple individuals with motor complete SCI who have received epidural stimulation in combination with LT also have significant improvements in bladder function. This proposal is an early feasibility study in a small number of subjects for a novel clinical application (bladder dysfunction after SCI) of a marketed Medtronic device (initial clinical safety and device functionality study). A parallel animal study will also be done. The overall objective of this study is to demonstrate that lumbosacral epidural stimulation may be a viable therapeutic strategy for improving storage (continence) and urination (voiding) after SCI. The knowledge gained from our innovative application of an existing stimulation device may lead to the translation and immediate application to a larger cohort of SCI individuals and provide immense improvements in quality of life.
    Last edited by GRAMMY; 01-02-2018 at 11:28 AM.

  9. #39
    Granny
    Thanks for the update it says 2019 the trials will be finish .
    Do you know are the trials running on schedule . If I only had by
    BBS back that would do me sorry I may have posted this twice
    AS I SIT HERE IN MY CHAIR . I LOOK OUT UPON THE GROUND .I WONDER WILL I EVER GET UP AND WALK A ROUND ??


    http://justadollarplease.org

  10. #40
    Quote Originally Posted by skeaman View Post
    Granny
    Thanks for the update it says 2019 the trials will be finish .
    Do you know are the trials running on schedule . If I only had by
    BBS back that would do me sorry I may have posted this twice
    Sorry Skeaman, I don't know anything about the patient facility scheduling. Their total is 30 but I don't know how many they can work with at any given time or when they started... You'd have to call or email the Contact Information.
    Last edited by GRAMMY; 12-30-2017 at 05:43 PM.

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