Transcutaneous Spinal Stimulation for Spinal Cord Injury
Recruiting in Palo Alto (17 mi)
Overseen byAndrea L Behrman, PT, PhD
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Louisville
Must not be taking: Botox, Baclofen
Disqualifiers: Unhealed fracture, Congenital SCI, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests a new therapy using mild electrical stimulation and exercises to help children with neck spinal cord injuries improve their arm and hand movements. The goal is to make it easier for these children to play and do everyday tasks. This approach has been shown to increase independence and reduce the need for help and special equipment in children and adolescents with spinal cord injuries.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop using baclofen and not have used botox in the past 3 months.
What data supports the idea that Transcutaneous Spinal Stimulation for Spinal Cord Injury is an effective treatment?
The available research shows that Transcutaneous Spinal Stimulation (tSCS) can help people with spinal cord injuries improve their ability to move. Studies have found that tSCS can activate muscles in both the upper and lower parts of the body, leading to better voluntary movement, muscle strength, and function. For example, one review found that all studies included showed increased muscle activity and strength in participants with spinal cord injuries. This suggests that tSCS is a promising treatment for improving motor function in these individuals.
12345What safety data is available for transcutaneous spinal stimulation for spinal cord injury?
The safety data for transcutaneous spinal stimulation (tSCS) is not explicitly detailed in the provided research abstracts. However, the studies reviewed indicate that tSCS is a non-invasive method used to facilitate motor responses and improve motor function in individuals with spinal cord injury. The systematic review of tSCS studies included 55 participants and reported induced muscle activation and improvements in voluntary movement, muscle strength, and function. While these studies suggest tSCS is a feasible therapeutic strategy, they emphasize the need for more statistically powered and controlled clinical trials to fully understand its safety and efficacy. The abstracts do not report specific adverse events or safety concerns, indicating a need for further research to establish comprehensive safety data.
23467Is the treatment Biostim-5 transcutaneous spinal stimulator a promising treatment for spinal cord injury?
Yes, the Biostim-5 transcutaneous spinal stimulator is a promising treatment for spinal cord injury. It is a non-invasive method that uses electrodes to stimulate the spinal cord, helping to improve movement and muscle strength in people with spinal cord injuries. Studies have shown that it can enhance voluntary movement and function in both the upper and lower limbs.
12345Eligibility Criteria
This trial is for children with chronic spinal cord injuries in the neck or high thoracic area, who have been injured for over a year and struggle to use their arms and hands. They should be past in-patient rehab but not using certain muscle relaxants or have unhealed fractures.Inclusion Criteria
I have difficulty using my arms for tasks like reaching overhead or grasping.
I have had a spinal cord injury for over a year.
My spinal cord injury is in the neck or upper back area.
+1 more
Exclusion Criteria
You rely completely on a ventilator for breathing.
You were born with a spinal cord injury.
I have no health issues preventing me from joining in physical assessments or arm exercises.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo transcutaneous spinal stimulation combined with activity-based upper extremity training for 40 sessions
8 weeks
40 sessions (in-person), 5 days/week
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial tests a new therapy using the Biostim-5 device to stimulate the spinal cord while kids practice movements like grasping and reaching. The aim is to see if it's safe, comfortable, and practical for improving arm function.
1Treatment groups
Experimental Treatment
Group I: Transcutaneous spinal stimulation - Acute and TrainingExperimental Treatment1 Intervention
Safety and feasibility outcome measures are collected during application of transcutaneous spinal stimulation while upper extremity function is assessed at 3 time points (acute) and/or in combination with activity-based upper extremity training (40 sessions, 1.5 hours/day, 5 days/week); stimulation will be applied intermittently for no more than 10 minutes at a time. Upper extremity training is based on usual care activities to challenge use of the hands and arms, e.g. reaching, grasping, manipulating objects.
Biostim-5 transcutaneous spinal stimulator is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Biostim-5 transcutaneous spinal stimulator for:
- Spinal cord injury rehabilitation
- Upper limb function improvement
🇪🇺 Approved in European Union as Transcutaneous Spinal Cord Stimulation (tSCS) for:
- Spinal cord injury rehabilitation
- Pain relief
- Motor function improvement
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Department of NeurosurgeryLouisville, KY
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Who Is Running the Clinical Trial?
University of LouisvilleLead Sponsor
The Jewish Heritage Foundation for ExcellenceCollaborator
References
The effect of transcutaneous spinal direct current stimulation on corticospinal excitability in chronic incomplete spinal cord injury. [2018]This study investigated the feasibility of modulating bilateral corticospinal excitability with different polarities of transcutaneous spinal direct current stimulation (tsDCS) in chronic, incomplete spinal cord injury (SCI).
Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]Transcutaneous spinal cord stimulation (tSCS) is a non-invasive modality in which electrodes can stimulate spinal circuitries and facilitate a motor response. This review aimed to evaluate the methodology of studies using tSCS to generate motor activity in persons with spinal cord injury (SCI) and to appraise the quality of included trials.
Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. [2022]Cervical transcutaneous spinal cord stimulation (tSCS) is a rehabilitation tool which has been used to promote upper-limb motor recovery after spinal cord injury. Importantly, optimizing sensory fiber activation at specific spinal segments could enable activity-dependent neuromodulation during rehabilitation.
Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. [2021]Background. Epidural spinal electrical stimulation at the lumbar spinal level evokes rhythmic muscle activation of lower-limb antagonists, attributed to the central pattern generator. However, the efficacy of noninvasive spinal stimulation for the activation of lower-limb muscles is not yet clear. This review aimed to analyze the feasibility and efficacy of noninvasive transcutaneous spinal cord stimulation (tSCS) on motor function in individuals with spinal cord injury. Methods. A search for tSCS studies was made of the following databases: PubMed; Cochrane Registry; and Physiotherapy Evidence Database (PEDro). In addition, an inverse manual search of the references cited by the identified articles was carried out. The keywords transcutaneous, non-invasive, electrical stimulation, spinal cord stimulation [Mesh term], and spinal cord injury were used. Results. A total of 352 articles were initially screened, of which 13 studies met the inclusion criteria for systematic review. The total participant sample comprised 55 persons with spinal cord injury. All studies with tSCS provided evidence of induced muscle activation in the lower and upper limbs, and applied stimulation at the level of the T11-T12 and C4-C7 interspinous space, respectively. All studies reported an increase in motor response measured by recording surface electromyography, voluntary movement, muscle strength, or function. Conclusions. Although this review highlights tSCS as a feasible therapeutic neuromodulatory strategy to enhance voluntary movement, muscle strength, and function in patients with chronic spinal cord injury, the clinical impact and efficacy of electrode location and current intensity need to be characterized in statistically powered and controlled clinical trials.
Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. [2022]To evaluate the impact of using transcutaneous electrical spinal cord stimulation (TSCS) on upper and lower extremity function in individuals with chronic spinal cord injury (SCI).
The effect of spinal cord stimulation, overall, and the effect of differing spinal cord stimulation technologies on pain, reduction in pain medication, sleep, and function. [2022]Background. Spinal cord stimulation (SCS) is effective in reducing pain from a number of differing medical conditions that are refractory to other, more conservative treatments. Much is written in the literature regarding efficacy and safety of SCS; however, no one to our knowledge has compared and reported safety and efficacy of SCS when using differing manufactured SCS devices. We undertook such a preliminary evaluation. Methods. Charts from the years 2001-2005 of our clinic's patients who had undergone trials and placement of permanent SCS systems were selected for review. All patients who had received either an Advanced Bionics SCS system (Advanced Bionics, Valencia, CA, USA), an Advanced Neuromodulation Systems (ANS) SCS system (ANS, Plano, TX, USA), or a Medtronic SCS system (Medtronic, Inc., Minneapolis, MN, USA) were given a survey to complete for data analysis. Patients were categorized into three groups: those patients having received a Medtronic (Mdt) SCS system, those patients having received an Advance Bionics (ABi) SCS system, and those patients having received an Advance Neuromodulation Systems (ANS) SCS system. Data, limited to volunteers, who gave their written consent, were analyzed for efficacy and complications. Differences in outcomes and safety were analyzed overall and according to manufacturer. Results. Eighty surveys were mailed out to 80 patients and 30 surveys were completed and returned, a return and completion rate of 37.5%. All patients showed improvement in all aspects including pain relief, sleep, functional activities, and medication use for pain control. When comparing outcomes of SCS from the three different companies, there was no significant statistical difference in average percentage pain relief, sleep improvement, and medication needed for pain control. However, there was a statistically different less change in functional improvement in the ABi group when compared to patients in the Mdt and ANS groups. Conclusions. Spinal cord stimulation improves pain, sleep, and function in patients with intractable pain. Because of the low number of patients evaluable in this study, we believe that conclusions should not be made regarding the effect of technology on outcomes or safety. We believe that an analysis of this type in larger populations is warranted to understand the role, if any, that present-day technology has on outcomes of SCS.
A Pilot Study of the Effect of Transcutaneous Spinal Cord Stimulation on Micturition-Related Brain Activity and Lower Urinary Tract Symptoms After Stroke. [2023]Transcutaneous spinal cord stimulation (TSCS) is a novel neuromodulation modality developed to promote functional restoration in patients with neurological injury or disease. Previous pilot data suggest that lower urinary tract dysfunction (LUTD) due to stroke may be partially alleviated by TSCS. In this study, we examine the mechanism of this effect by evaluating bladder-related brain activity in patients before and after TSCS therapy and comparing it to healthy volunteers.