Epidural Stimulation + Training for Spinal Cord Injury (MC-PP-3 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Susan Harkema PhD
No Placebo Group
Trial Summary
What is the purpose of this trial?The loss of movement and walking ability significantly affects quality of life after spinal cord injury. In addition, bladder dysfunction consistently ranks as one of the top disorders affecting quality of life after spinal cord injury. The overall objective of this study is to demonstrate that epidural stimulation may be a method for improving stepping, standing and bladder function in individuals with spinal cord injury. With the use of epidural stimulation, the investigators propose to investigate how well the participant can stand and walk and how well the participant's bladder can store or hold urine as well as void or empty urine. The results of this study may aid in the development of treatments to help individuals with spinal cord injuries that are unable to stand or walk and have impaired bladder function.
Is Epidural Stimulation + Training a promising treatment for spinal cord injury?Yes, Epidural Stimulation + Training is a promising treatment for spinal cord injury. It has shown potential to improve physical functions like standing and walking, enhance bladder function, and positively impact body composition. This treatment can help people with spinal cord injuries regain some motor functions and improve their quality of life.29101112
What data supports the idea that Epidural Stimulation + Training for Spinal Cord Injury is an effective treatment?The available research shows that Epidural Stimulation + Training can improve certain functions in people with spinal cord injuries. For example, one study found that this treatment helped improve bladder control, allowing for better reflexive bladder emptying. Another study noted improvements in body composition, such as increased muscle mass, although it also mentioned potential negative effects on bladder function. Overall, these findings suggest that Epidural Stimulation + Training can enhance some physical functions, but it may have mixed effects on bladder health.127912
Do I have to stop taking my current medications for this trial?The trial requires that you are not on any anti-spasticity medications and have not received botox injections in the past six months. Other medications are not specified, so check with the trial coordinators.
What safety data is available for Epidural Stimulation treatments for spinal cord injury?The provided research does not directly address the safety data for Epidural Stimulation treatments for spinal cord injury. The articles focus on adverse events related to antiepileptic drugs, catheter use, traumatic spinal cord injury care, and general adverse event reporting in clinical trials. For specific safety data on Epidural Stimulation, it would be necessary to consult studies or clinical trials specifically evaluating this treatment.34568
Eligibility Criteria
This trial is for adults over 18 with a stable, non-progressive spinal cord injury (SCI) between T1 and T10. They must be within one year post-injury, unable to stand or walk independently, have bladder dysfunction due to SCI, and not on anti-spasticity meds or received botox in the last six months. Excluded are those ventilator-dependent, with untreated major health issues or psychiatric disorders/drug abuse.Inclusion Criteria
I cannot move all the joints in my legs on my own.
I have bladder problems due to a spinal cord injury.
I am not taking any medication for muscle stiffness.
I cannot move all the joints in my legs on my own.
My spinal cord injury is between the T1 and T10 vertebrae.
I cannot stand or walk on my own.
I am not currently taking any medication for muscle stiffness.
My spinal cord injury is not getting worse.
I am 18 years old or older.
Exclusion Criteria
I have heart, lung, bladder, or kidney conditions not caused by my spinal cord injury.
I rely on a machine to help me breathe.
I have untreated painful bone or muscle issues, fractures, or pressure sores.
Participant Groups
The study tests if epidural stimulation can improve standing, walking, and bladder functions in people with acute SCI. Participants will undergo different training protocols: Bladder Capacity Training, Bladder Voiding Efficiency Training, Step Training or Stand Training alongside the epidural stimulation.
2Treatment groups
Experimental Treatment
Group I: LocomotionExperimental Treatment2 Interventions
Participants will receive 160 locomotor training sessions with epidural stimulation. These sessions may occur once a day (stand and step will alternate days) or twice a day (stand and step on the same day) as recommended by the study physician. Participants will train 5 days per week and each session will last between 1 to 1.5 hours.
Group II: Bladder+LocomotionExperimental Treatment4 Interventions
Participants will receive 80 sessions of bladder training alone followed by 80 sessions of locomotor training sessions with epidural stimulation. They will be asked to continue with your bladder training once you start locomotor training. Locomotor Training sessions may occur once a day (stand and step will alternate days) or twice a day (stand and step on the same day) as recommended by the study physician. Participants will train 5 days per week and each session will last between 1 to 1.5 hours.
Epidural stimulation + Bladder Capacity Training is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as Epidural Stimulation for:
- Spinal cord injury rehabilitation
- Bladder dysfunction management
- Motor function improvement
🇨🇦 Approved in Canada as Spinal Cord Epidural Stimulation for:
- Spinal cord injury rehabilitation
- Chronic pain management
🇪🇺 Approved in European Union as Epidural Electrical Stimulation for:
- Spinal cord injury rehabilitation
- Motor function improvement
- Autonomic function management
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Kentucky Spinal Cord Injury Center - University of LouisvilleLouisville, KY
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Who is running the clinical trial?
Susan Harkema PhDLead Sponsor
University of LouisvilleLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
References
Surface stimulation techniques for bladder management in the spinal dog. [2019]Electrical stimulation of the bladder wall or sacral nerves may be effective for bladder management in the spinal cord injured patient. However, extensive surgery has been required for electrode implantation. We compared urodynamic responses using surface and minimally invasive epidural stimulating techniques in the chronic spinal male dog. Various surface stimulating techniques were effective: 1) sacral monopolar electrical stimulation with negative electrodes over S2 sacral foramina and positive electrodes on the legs, 2) sacral bipolar electrical stimulation with electrodes only over sacral foramina, 3) perineal monopolar electrical stimulation, and 4) perineal tactile stimulation. Urodynamic responses were similar to those for sacral epidural electrodes implanted adjacent to sacral nerves. Voiding was obtained both during stimulation and poststimulation. Stimulating parameters that were effective for daily voiding with sacral surface electrodes were 10 pps, 30 to 45 ma, 0.6 ms pulse duration, and 2 to 5 sec stimulation train duration.
[Epidural spinal electrostimulation (ESES) in patients with chronic pain and central motor disturbances (author's transl)]. [2006]Epidural spinal electrostimulation (ESES), as method in the treatment of patients with chronic pain or severe central motor disturbances, especially spastic paresis of spinal origin and bladder dysfunction, is indicated when conservative measures prove ineffectual and before surgical intervention is considered. The biochemical and innervation processes which are brought about by ESES are discussed, as well as the literature on the efficacy and possible complications of the method. Twenty cases were subjected to a test stimulation and in twelve of these the stimulation system was implanted. Spinal spasticity and the range of mobility were improved by 20 to 30% in 8 patients with multiple sclerosis and 3 other patients with myelopathy of varied aetiology. In addition, spastic cramps of abrupt onset, with or without pain, disappeared almost completely following ESES in all cases. Three cases with chronic pain, two after a caudal lesion and one with cervical radicular damage, were markedly improved.
Incidence of acute care adverse events and long-term health-related quality of life in patients with TSCI. [2015]Adverse events (AEs) with significant resultant morbidity are common during the acute hospital care of patients with traumatic spinal cord injury (TSCI). The Rick Hansen SCI Registry (RHSCIR) collects Canada-wide data on patients with TSCI, such as sociodemographic, injury, diagnosis, intervention, and health outcome details. These data contribute to an evidence base for informing best practice and improving SCI care. As the RHSCIR captures data on patients from prehospital to community phases of care, it is an invaluable resource for providing information on health outcomes resulting from TSCI, including outcomes related to AEs.
Frequency of Adverse Events Before, During, and After Hospital Admission. [2018]Adverse events (AEs) are unintended physical injuries resulting from or contributed to by medical or surgical care. We determined the frequency and type of AEs before, during, and after hospital admission.
Liverpool Adverse Events Profile: Italian validation and predictive value for dropout from antiepileptic treatment in people with epilepsy. [2019]Adverse events (AEs) of antiepileptic drugs (AEDs) affect patient compliance and dropout. No questionnaire measuring AEs of AEDs is available for Italian-speaking people with epilepsy. Moreover, no questionnaire has been shown to predict patient dropout.
[Analysis of Adverse Events in Clinical Use of Catheter]. [2018]In recent years, with the extensive use of various clinical catheter, Adverse events in the clinical catheter products also showed an upward trend. Here we wil review the common adverse event performance, risk point and reasons of AEs adverse events about the catheter during the clinical use, through a large number of clinical research, visit and literature review, in order to provide evidence to support in reducing the incidence of catheter clinical adverse events, and prevent recurrence and spread of the serious adverse events during the using of process.
Lumbosacral spinal cord epidural stimulation improves voiding function after human spinal cord injury. [2019]Deficits in urologic function after spinal cord injury (SCI) manifest both as a failure to store and empty, greatly impacting daily life. While current management strategies are necessary for urological maintenance, they oftentimes are associated with life-long side effects. Our objective was to investigate the efficacy of spinal cord epidural stimulation (scES) as a promising therapy to improve bladder control after SCI. A bladder mapping study was undertaken for sixteen sessions over the course of four months in an individual with chronic, motor complete SCI. Varying combinations of stimulating cathode electrodes were initially tested during filling cystometry resulting in the identification of an effective configuration for reflexive bladder emptying at the caudal end of the electrode array. Subsequent systematic testing of different frequencies at a fixed stimulus intensity and pulse width yielded lowest post-void residual volumes at 30 Hz. These stimulation parameters were then tested in four additional research participants and found to also improve reflexive voiding efficiency. Taken together with SCI studies on step, stand, voluntary motor control and cardiovascular regulation, these findings further corroborate that scES has an all-encompassing potential to increase the central state of excitability, allowing for the control of multiple body functions, including the urological system.
Opportunities for selective reporting of harms in randomized clinical trials: Selection criteria for non-systematic adverse events. [2020]Adverse events (AEs) in clinical trials may be reported in multiple sources. Different methods for reporting adverse events across trials or across sources for a single trial may produce inconsistent information about the adverse events associated with interventions.
Impact of long-term epidural electrical stimulation enabled task-specific training on secondary conditions of chronic paraplegia in two humans. [2021]Introduction: Spinal cord injury (SCI) often results in chronic secondary health conditions related to autonomic and metabolic dysfunction. Epidural electrical stimulation (EES) combined with task-specific training has been shown to enable motor function in individuals with chronic paralysis. The reported effects of EES on secondary health conditions, such as bladder function and body composition, are limited. We report the impact of EES on SCI-related secondary health changes in bladder function and body composition.Methods: Two participants with motor and sensory complete SCI performed 6 months of rehabilitation without EES followed by 12 months of task-specific training with EES after implantation of a 16-electrode array on the surface of the lumbosacral spinal cord. Participants performed three days of training per week in the laboratory, and additionally performed task-specific activities with EES at home during this time frame. Changes in bladder and body composition were recorded via clinically-available testing of neurogenic bladder functionality and dual-energy X-ray absorptiometry, respectively.Results: In one participant, we observed an increase in episodes of urinary incontinence with worsening bladder compliance and pressures at the end of the study. Bone mineral density changes were insignificant in both participants; however, one participant showed a substantial increase in lean mass (+9.1 kg; 6 months of training) via redistribution of body fat through an android/gynoid ratio reduction (-0.15; 6 months of training).Conclusion: EES optimized for standing and stepping may negatively impact neurogenic bladder functionality. Close monitoring of bladder health is imperative to prevent undesirable bladder compliance, which can lead to upper urinary tract deteriorations. Conversely, EES may serve as an adjunct tool with regular exercise modalities to improve body composition through activation of musculature innervated by spinal segments that are below the SCI.
Epidural electrical stimulation to facilitate locomotor recovery after spinal cord injury. [2022]Tonic or phasic electrical epidural stimulation of the lumbosacral region of the spinal cord facilitates locomotion and standing in a variety of preclinical models with severe spinal cord injury. However, the mechanisms of epidural electrical stimulation that facilitate sensorimotor functions remain largely unknown. This review aims to address how epidural electrical stimulation interacts with spinal sensorimotor circuits and discusses the limitations that currently restrict the clinical implementation of this promising therapeutic approach.
High-density spinal cord stimulation selectively activates lower urinary tract nerves. [2023]Objective.Epidural spinal cord stimulation (SCS) is a potential intervention to improve limb and autonomic functions, with lumbar stimulation improving locomotion and thoracic stimulation regulating blood pressure. Here, we asked whether sacral SCS could be used to target the lower urinary tract (LUT) and used a high-density epidural electrode array to test whether individual electrodes could selectively recruit LUT nerves.Approach. We placed a high-density epidural SCS array on the dorsal surface of the sacral spinal cord and cauda equina of anesthetized cats and recorded the stimulation-evoked activity from nerve cuffs on the pelvic, pudendal and sciatic nerves.Main results. Here we show that sacral SCS evokes responses in nerves innervating the bladder and urethra and that these nerves can be activated selectively. Sacral SCS always recruited the pelvic and pudendal nerves and selectively recruited both of these nerves in all but one animal. Individual branches of the pudendal nerve were always recruited as well. Electrodes that selectively recruited specific peripheral nerves were spatially clustered on the arrays, suggesting anatomically organized sensory pathways.Significance.This selective recruitment demonstrates a mechanism to directly modulate bladder and urethral function through known reflex pathways, which could be used to restore bladder and urethral function after injury or disease.
Effects of percutaneously-implanted epidural stimulation on cardiovascular autonomic function and spasticity after complete spinal cord injury: A case report. [2023]There is a revived interest to explore spinal cord epidural stimulation (SCES) to improve physical function after spinal cord injury (SCI). This case report highlights the potential of eliciting multiple functional improvements with a single SCES configuration, a strategy which could improve clinical translation.