Spinal Cord Stimulation for Spinal Cord Injury
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: James J. Peters Veterans Affairs Medical Center
Disqualifiers: Seizures, Diabetes, Heart disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this interventional crossover study is to determine the effects of transcutaneous spinal cord stimulation (TSCS) on the ability to perform moderate exercise and regulate core body temperature in the chronic spinal cord injury community. The main questions it aims to answer are:
* What are the effects of active TSCS targeted for BP control on exercise endurance time and HR recovery during submaximal arm cycle ergometry (ACE) as compared to sham TSCS in participants with chronic, cervical SCI?
* What are the effects of active TSCS on Tcore responses to cool ambient exposure and on subjective reporting of thermal comfort and thermal sensitivity as compared to sham TSCS.
Participants will receive sham and active stimulation while using an arm bicycle or while in a cold room. Participants are free to participate in either the exercise phase, the cold room phase, or both phases of this study.
Please note that there no expected long term benefits of this study.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires that your prescription medications have not changed for at least 30 days before participating.
What data supports the effectiveness of the treatment Transcutaneous Spinal Cord Stimulation (TSCS) for spinal cord injury?
Research indicates that Transcutaneous Spinal Cord Stimulation (TSCS) can enhance motor function and recovery in individuals with spinal cord injury by stimulating spinal circuits and improving the excitability of neural pathways. This non-invasive treatment has shown promise in improving both upper and lower limb function, making it a valuable tool in rehabilitation settings.
12345Is transcutaneous spinal cord stimulation (tSCS) generally safe for humans?
Transcutaneous spinal cord stimulation (tSCS) is considered a non-invasive and generally safe procedure, as it aims to stimulate spinal circuits without surgery. While specific safety data for tSCS in spinal cord injury is limited, spinal cord stimulation in general is regarded as a minor elective procedure with a focus on minimizing potential risks.
14678How does spinal cord stimulation differ from other treatments for spinal cord injury?
Spinal cord stimulation is unique because it is a non-invasive treatment that uses electrodes to stimulate the spinal cord, helping to improve motor function and recovery after a spinal cord injury. Unlike other treatments, it can modulate the spinal cord's circuitry without surgery, potentially enhancing rehabilitation outcomes by activating specific spinal segments.
12459Eligibility Criteria
This trial is for adults over 18 with chronic spinal cord injury (SCI) between C3-T6, who have been injured for more than a year and haven't changed their meds in the last month. They should have previously participated in a related SCI study and not be pregnant or suffering from other neurological conditions, heart diseases, severe head trauma, psychological disorders, recent substance abuse, seizures, diabetes or untreated thyroid disease.Inclusion Criteria
You have taken part in a previous study called 'Targeted Transcutaneous Spinal Cord Stimulation to Restore Autonomic Cardiovascular Health in Individuals with Spinal Cord Injury'.
You have been injured for more than 1 year.
My prescription medications have been the same for the last 30 days.
+3 more
Exclusion Criteria
I rely on a ventilator for breathing or have an open tracheostomy.
I have had a serious head injury or have been diagnosed with cognitive impairment.
You currently have or have had a mental health condition.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Exercise Phase
Participants receive active and sham TSCS during submaximal arm cycle ergometry to assess exercise endurance and heart rate recovery.
2 visits, 3-4 hours each
2 visits (in-person)
Cold Room Phase
Participants receive active and sham TSCS in a cool environment to assess body temperature regulation and thermal comfort.
2 visits, 3-4 hours each
2 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests if transcutaneous spinal cord stimulation (TSCS) can help people with cervical SCI endure moderate exercise longer and regulate body temperature better compared to sham stimulation. Participants will try both real and fake stimulations while exercising or being exposed to cold temperatures.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transcutaneous Spinal Cord StimulationExperimental Treatment1 Intervention
The transcutaneous spinal cord stimulation used in this experiment is specific to each participant as determined in a previous study. Possible parameters include biphasic or monophasic, Russian or Nonrussian, a variety of pulse widths, and location of stimulation (T7-8, T9-10,- T11-12, L1-2). The amplitude of the stimulation also depends on the results of the mapping study. This stimulation will be delivered 30 minutes at a time.
Group II: Sham Transcutaneous Spinal Cord StimulationPlacebo Group1 Intervention
The sham stimulation will follow the above parameters but will only be delivered for a minute rather than the full 30 minutes.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
James J Peters VAMCBronx, NY
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Who Is Running the Clinical Trial?
James J. Peters Veterans Affairs Medical CenterLead Sponsor
References
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).
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.
Utility and Feasibility of Transcutaneous Spinal Cord Stimulation for Patients With Incomplete SCI in Therapeutic Settings: A Review of Topic. [2022]Transcutaneous Spinal Cord Stimulation (TSCS) has been shown to enhance the excitability of spinal neural circuits. This excitation is associated with enhanced voluntary performance in patients with incomplete SCI (iSCI). Though there is much we do not know, combining this altered state of exciability with therapy has the potential to enhance the outcomes associated with activity-based interventions. It is a promising tool to augment the work being done in therapeutic settings with the potential to expedite recovery. There is, however, a lag in assimilating the science for clinical practice. This article will examine current literature related to the application of TSCS in combination with therapeutic interventions for motor recovery and aims to elucidate trends in waveform selection, duration and frequency, and combinatorial therapies that may inform clinical practice. With specific consideration for therapeutic settings, potential benefits, applications, and pitfalls for clinical use are considered. Finally, the next steps in research to move toward wider clinical utility are discussed.
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.
Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. [2022]Transcutaneous spinal cord stimulation (tSCS) has the potential to promote improved sensorimotor rehabilitation by modulating the circuitry of the spinal cord non-invasively. Little is currently known about how cervical or lumbar tSCS influences the excitability of spinal and corticospinal networks, or whether the synergistic effects of multi-segmental tSCS occur between remote segments of the spinal cord. The aim of this review is to describe the emergence and development of tSCS as a novel method to modulate the spinal cord, while highlighting the effectiveness of tSCS in improving sensorimotor recovery after spinal cord injury. This review underscores the ability of single-site tSCS to alter excitability across multiple segments of the spinal cord, while multiple sites of tSCS converge to facilitate spinal reflex and corticospinal networks. Finally, the potential and current limitations for engaging cervical and lumbar spinal cord networks through tSCS to enhance the effectiveness of rehabilitation interventions are discussed. Further mechanistic work is needed in order to optimize targeted rehabilitation strategies and improve clinical outcomes.
Anticipating and preventing complications in spinal cord stimulator implantation. [2023]Spinal cord stimulation is considered a minor elective procedure. The inherent goal is to provide safe, reliable, effective treatment with mitigation of known potential risk of adverse events.
Spinal direct current stimulation with locomotor training in chronic spinal cord injury. [2021]Transcutaneous spinal direct current stimulation (tsDCS) is a non-invasive method of stimulating spinal circuits that can modulate and induce changes in corticospinal excitability (CE) in incomplete spinal cord injury (SCI). A double-blinded sham controlled study of 2 male patients (A and B) with SCI was carried out. Patient A received sham and cathodal tsDCS, while Patient B received sham and anodal tsDCS. Four baselines were recorded prior to each arm of stimulation. Outcomes were then measured post each arm of stimulation; 10-meter walk test, modified ashworth scale, berg balance scale, manual muscle testing, and spinal cord independence measure-III. Transcranial magnetic stimulation, assessed motor evoked potentials. Cathodal tsDCS increased the scores in few of the outcome measures and decreased others. Anodal stimulation increased scores in all measures. Motor evoked potentials increased in post-cathode and deteriorated in post-anode. In conclusion, tsDCS modulated gait parameters, spasticity, and CE in incomplete SCI.
Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]Spinal cord stimulation (SCS) is a safe, reversible surgical treatment for complex regional pain syndrome and failed back surgery syndrome refractory to conventional medical management. Paddle electrodes are routinely used for the permanent implant because of the reduced risk of migration, lower energy requirements, and expanded coverage options. The risks associated with paddle lead removal are not well defined in the literature.
Adapting Human-Based Transcutaneous Spinal Cord Stimulation to Develop a Clinically Relevant Animal Model. [2023]Transcutaneous spinal cord stimulation (tSCS) as a neuromodulatory strategy has received great attention as a method to promote functional recovery after spinal cord injury (SCI). However, due to the noninvasive nature of tSCS, investigations have primarily focused on human applications. This leaves a critical need for the development of a suitable animal model to further our understanding of this therapeutic intervention in terms of functional and neuroanatomical plasticity and to optimize stimulation protocols. The objective of this study is to establish a new animal model of thoracolumbar tSCS that (1) can accurately recapitulate studies in healthy humans and (2) can receive a repeated and stable tSCS treatment after SCI with minimal restraint, while the electrode remains consistently positioned. We show that our model displays bilateral evoked potentials in multisegmental leg muscles characteristically comparable to humans. Our data also suggest that tSCS mainly activates dorsal root structures like in humans, thereby accounting for the different electrode-to-body-size ratio between the two species. Finally, a repeated tSCS treatment protocol in the awake rat after a complete spinal cord transection is feasible, tolerable, and safe, even with minimal body restraint. Additionally, repeated tSCS was capable of modulating motor output after SCI, providing an avenue to further investigate stimulation-based neuroplasticity and optimize treatment.