Home-Based Spinal Cord Stimulation for Quadriplegia

Overseen By Jenny Kiratli, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Palo Alto Health Care System

Disqualifiers: Cardiopulmonary disease, Autonomic dysreflexia, Implanted device, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist individuals with quadriplegia (paralysis of all four limbs) through spinal cord stimulation at home. The goal is to determine if this home-based treatment, called Home Based Transcutaneous Spinal Cord Stimulation, combined with video call support, can enhance upper body movement in those with chronic spinal cord injuries. It specifically targets veterans who have had a cervical spinal cord injury for over a year and retain some hand function. Participants must also have a helper at home to set up the equipment and a reliable internet connection for video calls. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for improving quality of life.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but you cannot participate if you are involved in another drug or device trial.

What prior data suggests that this home-based transcutaneous spinal cord stimulation is safe for quadriplegia?

Research has shown that using transcutaneous spinal cord stimulation (tSCS) at home is generally safe for people with spinal cord injuries. In one study, participants who used tSCS at home improved their arm and hand movements, and no serious side effects occurred. Another study examined tSCS for issues like low blood pressure and found it safe for home use.

These studies suggest that tSCS is easy to tolerate and can be safely used outside of a hospital. This makes it a promising option for those seeking to improve mobility and daily function. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Home-Based Transcutaneous Spinal Cord Stimulation (tSCS) for quadriplegia because it offers a unique, non-invasive approach to spinal cord stimulation, which traditionally requires surgical implantation. This method involves applying electrical currents to the skin over the spinal cord, potentially improving motor function without the risks of surgery. Additionally, the integration of home tele-video support allows for remote monitoring and personalized adjustments, making the treatment more accessible and convenient for patients. Unlike existing treatments that often require hospital visits, this home-based approach could greatly enhance patient comfort and autonomy.

What evidence suggests that home-based transcutaneous spinal cord stimulation is effective for quadriplegia?

Research has shown that transcutaneous spinal cord stimulation (tSCS) can improve arm and hand movement in people with spinal cord injuries. In one study, all participants experienced better movement in their upper limbs, and some even saw improvements in their overall injury status. Another study found that combining tSCS with activity-based exercises restored function in people with long-term spinal cord injuries, with improvements observed after 60 or more sessions. This trial will evaluate tSCS plus home tele-video support, a promising method to help those with spinal cord injuries regain some movement. ^{1 2 3 4 6}

Who Is on the Research Team?

Jenny Kiratli, PhD

Principal Investigator

VA Palo Alto Health Care System

Are You a Good Fit for This Trial?

This trial is for veterans aged 18-65 with chronic quadriplegia (C2-C8 spinal injury) who are at least one year post-injury and have some arm function. Participants need internet for video calls, can travel to VA Palo Alto Medical Center, and must have a helper for device setup. Excluded are those with implanted devices, skin issues where electrodes go, involved in other trials, pregnant or breastfeeding women, or if they have severe heart/lung problems or uncontrolled spasms.

Inclusion Criteria

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Willingness to travel to the VA Palo Alto Medical Center

Your GRASSP-Prehension score is higher than 10, or your GRASSP Strength score is higher than 30.

Exclusion Criteria

Pregnant, are planning to become pregnant, or breastfeeding

I have severe or uncontrolled autonomic dysreflexia.

I have heart or lung disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants and their companions are trained to operate the neurostimulation unit and perform upper extremity home program

2 months

Regular video telehealth support

Follow-up

Participants are monitored for changes in upper extremity performance and feasibility of the telehealth model

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Home Based Transcutaneous Spinal Cord Stimulation

Trial Overview

The study tests the use of transcutaneous Spinal Cord Stimulation (tSCS) as a home-based therapy to improve upper limb function in people with spinal cord injuries. It's delivered through telehealth support and aims to see how practical and effective it is when participants do it from home.

How Is the Trial Designed?

Group I: tSCS plus home tele-video support Experimental Treatment 1 Intervention

Cervical transcutaneous spinal stimulation during home tele-video visits

Who Is Running the Clinical Trial?

VA Palo Alto Health Care System

Lead Sponsor

Trials

97

Recruited

58,500+

ONWARD Medical, Inc.

Industry Sponsor

Trials

5

Recruited

110+

Published Research Related to This Trial

Transcutaneous spinal cord stimulation (tSCS) shows potential for generating motor activity in individuals with spinal cord injury, but the overall quality of the studies reviewed was poor-to-fair, indicating a need for more rigorous research.

The review identified significant variability in stimulation parameters and outcome measurements across the 25 studies analyzed, highlighting the necessity for standardized methods to improve the reliability and comparability of tSCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. Taylor, C., McHugh, C., Mockler, D., et al.[2022]

In a study of 68 patients who had spinal cord stimulation paddle electrodes removed, the most common reason for removal was loss of coverage or effect (75%), indicating that while SCS is effective, it may not always provide lasting relief.

Postoperative complications occurred in 11.75% of patients, with two major complications requiring reoperation, highlighting that while SCS removal is generally safe, it does carry some risks that patients should be aware of.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. Maldonado-Naranjo, AL., Frizon, LA., Sabharwal, NC., et al.[2022]

Epidural spinal cord stimulation can activate spared neural circuitry below severe spinal cord injuries, enabling paralyzed individuals to achieve motor outputs like standing and stepping during assisted treadmill exercises.

This stimulation not only generates immediate motor responses but also supports rehabilitation by promoting long-term neural plasticity, potentially leading to lasting improvements in motor function for patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation and Augmentative Control Strategies for Leg Movement after Spinal Paralysis in Humans. Minassian, K., Hofstoetter, US.[2020]

In a study of 69 patients with implanted spinal cord stimulators (SCSs) who underwent 78 MRI scans, the overall adverse event rate for off-label MRI use was low at 9.72%, with no serious adverse events reported.

All reported clinical adverse events were minor and resolved, suggesting that the benefits of MRI for pain management in patients with older SCS models may outweigh the associated risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. Ragukonis, T.[2022]

In a double-blinded study involving 2 male patients with incomplete spinal cord injury, anodal transcutaneous spinal direct current stimulation (tsDCS) improved all measured outcomes, including gait and balance, while cathodal tsDCS showed mixed results.

Both types of tsDCS were able to modulate corticospinal excitability, indicating that this non-invasive method could be a promising approach for enhancing rehabilitation in patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal direct current stimulation with locomotor training in chronic spinal cord injury. Abualait, TS., Ibrahim, AI.[2021]

Targeted transcutaneous spinal cord stimulation (tSCS) in two individuals with motor-complete spinal cord injury led to a remarkable increase in exerted force by up to 1,136% when combined with weekly activity-based training.

This study is the first to report a significant improvement in tactile sensation, with a 2-point increase in clinical assessments, and the benefits persisted for at least one month after stimulation, indicating potential for lasting recovery of motor and sensory functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted transcutaneous spinal cord stimulation promotes persistent recovery of upper limb strength and tactile sensation in spinal cord injury: a pilot study. Chandrasekaran, S., Bhagat, NA., Ramdeo, R., et al.[2023]

Cervical transcutaneous spinal cord stimulation (tSCS) can effectively activate sensory fibers at lower stimulation intensities when the cathode electrode is positioned at the C7 or T1 vertebra, compared to C6, which may enhance rehabilitation outcomes for upper-limb motor recovery after spinal cord injury.

Using smaller electrode sizes not only lowers the activation threshold for sensory fibers but also optimizes the recruitment of these fibers before α-motor fibers, suggesting a strategic approach to improve hand muscle activation during tSCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. de Freitas, RM., Capogrosso, M., Nomura, T., et al.[2022]

In a pilot study involving 7 individuals with chronic spinal cord injury, the use of transcutaneous electrical spinal cord stimulation (TSCS) combined with functional training led to improvements in upper and lower extremity function, with all participants showing progress on the Capabilities of Upper Extremity Test (CUE-T).

Notably, two participants improved their ASIA impairment scale classification, and five individuals experienced enhanced sensation, demonstrating that TSCS can facilitate recovery even after a plateau in rehabilitation progress, without any serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. Tefertiller, C., Rozwod, M., VandeGriend, E., et al.[2022]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S1094715925000078

Safety and Effectiveness of Multisite Transcutaneous ...

Combined tSCS + ABT facilitated functional recovery after chronic SCI. Improvements required ≥60 tSCS-ABT sessions, with further exposure to tSCS facilitating ...

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neurology.org

neurology.org/doi/10.1212/CPJ.0000000000200537

Home-Based Noninvasive Spinal Cord Stimulation Safely ...

All 7 individuals experienced improved upper extremity function, with 2 improving their American Spinal Injury Association Impairment Scale (AIS) ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12548825/

Protocol for a Systematic Review and Meta-Analysis - PMC

Transcutaneous spinal cord stimulation (tSCS) has emerged as a promising neuromodulation technique for enhancing motor recovery and walking ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06838637

Transcutaneous Spinal Cord Stimulation Home Study

To test the safety and feasibility of home-based transcutaneous spinal cord stimulation therapy on orthostatic hypotension and bowel dysfunction.

5.

withpower.com

withpower.com/trial/phase-quadriplegia-2024-48176

Home-Based Spinal Cord Stimulation for Quadriplegia

Research shows that transcutaneous spinal cord stimulation (tSCS) can improve upper limb and hand function in people with spinal cord injuries, including those ...

6.

clinicaltrials.ucsf.edu

clinicaltrials.ucsf.edu/trial/NCT07090473

UCSF Spinal Cord Injury Trial → Transcutaneous Electrical ...

The goal of this study is to test whether electrical stimulation from the skin surface starting 3 days after spinal cord injury (SCI) is ...