TSCS for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Overseen by Jill Wecht, EdD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Implanted stimulators, Coronary disease, Cancer, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This project will focus on a novel approach to stabilizing blood pressure (BP) during inpatient rehabilitation after acute SCI. After SCI, people have unstable blood pressure, ranging from too low (orthostatic hypotension) to too high (autonomic dysreflexia). Unstable BP often interferes with performing effective physical rehabilitation after SCI. A critical need exists for the identification of safe, practical and effective treatment options that stabilize BP after traumatic SCI. Transcutaneous Spinal Cord Stimulation (TSCS) has several advantages over pharmacological approaches: (1) does not exacerbate polypharmacy, (2) can be activated/deactivated rapidly, and (3) can be applied in synergy with physical exercise. The study team is asking the key question: "What if applying TSCS earlier after injury could prevent the development of BP instability?" To facilitate adoption of TSCS for widespread clinical use, the study team plans to map and develop a parameter configuration that will result in an easy to follow algorithm to maximize individual benefits, while minimizing the burden on healthcare professionals. This project will provide the foundational evidence to support the feasible and safe application of TSCS in the newly injured population, thereby overcoming barriers to engagement in prescribed inpatient rehabilitation regimens that are imposed by BP instability.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study focuses on a non-drug approach to stabilize blood pressure, it might not require changes to your medication regimen. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Transcutaneous Spinal Cord Stimulation (tSCS) for spinal cord injury?

Research shows that Transcutaneous Spinal Cord Stimulation (tSCS) can help improve movement and function in people with spinal cord injuries by stimulating the spinal cord non-invasively. Studies have found that tSCS can promote recovery in both upper and lower limbs and enhance sensorimotor rehabilitation by modulating spinal cord activity. ^{1 2 3 4 5}

Is transcutaneous spinal cord stimulation (tSCS) safe for humans?

Transcutaneous spinal cord stimulation (tSCS) is generally considered safe for humans, as it is a non-invasive method that has been used in studies to stimulate spinal circuits without significant adverse effects reported. While specific safety data for tSCS in spinal cord injury is limited, related procedures like cervical spinal cord stimulation have shown low complication rates, suggesting a favorable safety profile. ^{1 6 7 8 9}

How is transcutaneous spinal cord stimulation (tSCS) different from other treatments for spinal cord injury?

Transcutaneous spinal cord stimulation (tSCS) is unique because it is a non-invasive treatment that uses electrodes placed on the skin to stimulate the spinal cord, helping to improve movement and sensation in people with spinal cord injuries. Unlike other treatments that may require surgery or medication, tSCS can modulate spinal cord activity without the need for invasive procedures. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults over 18 who've had a spinal cord injury (SCI) within the last year and are in acute inpatient rehab. They should have unstable blood pressure due to their SCI, but can't join if they're pregnant, lack mental capacity for consent, have certain implants or heart issues, open skin lesions where electrodes go, or recent heart attacks.

Inclusion Criteria

You have low blood pressure when resting or when standing up, or your blood pressure changes a lot during the day.

I am over 18, had a spinal cord injury within the last year, and am in a special rehab program.

All patients who are admitted with a new spinal cord injury during the 42-month recruitment period.

Exclusion Criteria

I am unable to understand and consent to the trial on my own.

Pregnancy

Deemed unsuitable by study physician

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Transcutaneous Spinal Cord Stimulation (TSCS) to stabilize blood pressure during inpatient rehabilitation

3 weeks

Weekly visits until discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Transcutaneous spinal cord stimulation (Other)

Trial Overview The study tests Transcutaneous Spinal Cord Stimulation (TSCS) as a way to stabilize blood pressure during early rehab after an SCI. It aims to find the best settings for TSCS that work well with physical exercises without adding more drugs into patients' routines.

Participant Groups

Group I: Acute Inpatients With Spinal Cord Injury Experimental Treatment 2 Interventions

Inpatient participants undergoing rehabilitation after acute traumatic SCI.

Transcutaneous spinal cord stimulation is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Transcutaneous Spinal Cord Stimulation for:

• Motor rehabilitation in individuals with spinal cord injury
• Pain management in chronic neuropathic or ischemic pain

🇪🇺 Approved in European Union as Transcutaneous Spinal Cord Stimulation for:

• Motor rehabilitation in individuals with spinal cord injury
• Pain management in chronic neuropathic or ischemic pain

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mount Sinai Spinal Cord Injury Model System New York, NY

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai Lead Sponsor

James J. Peters Veterans Affairs Medical Center Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

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.

2. Switzerland pubmed.ncbi.nlm.nih.gov

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).

3. United States pubmed.ncbi.nlm.nih.gov

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.

4. United States pubmed.ncbi.nlm.nih.gov

Enhanced selectivity of transcutaneous spinal cord stimulation by multielectrode configuration. [2023] Transcutaneous spinal cord stimulation (tSCS) has been gaining momentum as a non-invasive rehabilitation approach to restore movement to paralyzed muscles after spinal cord injury (SCI). However, its low selectivity limits the types of movements that can be enabled and, thus, its potential applications in rehabilitation.

5. Switzerland pubmed.ncbi.nlm.nih.gov

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.

6. New Zealand pubmed.ncbi.nlm.nih.gov

Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. [2022] Advances in spinal cord stimulator (SCS) technology and increasing prevalence of magnetic resonance imaging (MRI) diagnostic testing require empirical evidence describing the presence of MRI-related SCS adverse events related to off-label use of imaging. MRI safety recommendations vary based on the type of stimulator used with scant availability regarding adverse events associated with off-label MRI use. The aim of this case series is to describe the type and frequency of adverse events associated with off-label MRI use in patients with implanted SCSs.

7. United States pubmed.ncbi.nlm.nih.gov

The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. [2022] Spinal cord stimulation (SCS) has been proven effective for multiple chronic pain syndromes. Over the past 40 years of use, the complication rates of SCS have been well defined in the literature; however, the incidence of one of the most devastating complications, spinal cord injury (SCI), remains largely unknown. The goal of the study was to quantify the incidence of SCI in both percutaneous and paddle electrode implantation.

8. Saudi Arabia pubmed.ncbi.nlm.nih.gov

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.

9. United States pubmed.ncbi.nlm.nih.gov

Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation. [2017] OBJECTIVE Cervical spinal cord stimulation (cSCS) is used to treat pain of the cervical region and upper extremities. Case reports and small series have shown a relatively low risk of complication after cSCS, with only a single reported case of perioperative spinal cord injury in the literature. Catastrophic cSCS-associated spinal cord injury remains a concern as a result of underreporting. To aid in preoperative counseling, it is necessary to establish a minimum rate of spinal cord injury and surgical complication following cSCS. METHODS The Nationwide Inpatient Sample (NIS) is a stratified sample of 20% of all patient discharges from nonfederal hospitals in the United States. The authors identified discharges with a primary procedure code for spinal cord stimulation (ICD-9 03.93) associated with a primary diagnosis of cervical pathology from 2002 to 2011. They then analyzed short-term safety outcomes including the presence of spinal cord injury and neurological, medical, and general perioperative complications and compared outcomes using univariate analysis. RESULTS Between 2002 and 2011, there were 2053 discharges for cSCS. The spinal cord injury rate was 0.5%. The rates of any neurological, medical, and general perioperative complications were 1.1%, 1.4%, and 11.7%, respectively. There were no deaths. CONCLUSIONS In the largest series of cSCS, the risk of spinal cord injury was higher than previously reported (0.5%). Nonetheless, this procedure remains relatively safe, and physicians may use these data to corroborate the safety of cSCS in an appropriately selected patient population. This may become a key treatment option in an increasingly opioid-dependent, aging population.