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

10 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Home Based Transcutaneous 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 with complete tetraplegia. In one study, participants experienced significant improvements in hand strength and function after receiving tSCS combined with hand training, suggesting potential benefits for quadriplegia. ^{1 2 3 4 5}

Is home-based spinal cord stimulation generally safe for humans?

Transcutaneous spinal cord stimulation (tSCS) is considered a non-invasive and generally safe method for stimulating spinal circuits, as it has been used in studies with individuals who have spinal cord injuries without significant safety concerns reported. ^{1 2 6 7 8}

How does home-based spinal cord stimulation treatment for quadriplegia differ from other treatments?

Home-based spinal cord stimulation for quadriplegia is unique because it allows patients to receive therapy in their own homes, using non-invasive electrical stimulation to enhance the excitability of the spinal network. This approach can improve motor and sensory functions by modulating the spinal cord's neural circuits, offering a novel rehabilitation method compared to traditional therapies that often require hospital visits. ^{1 2 4 9 10}

What is the purpose of this trial?

The proposed study will focus on the feasibility of and effectiveness to a home-based program for persons with chronic SCI focused on upper limb training augmented with a transcutaneous neurostimulator supported via a video telehealth platform.

Research Team

Jenny Kiratli, PhD

Principal Investigator

VA Palo Alto Health Care System

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. [2022]

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

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]

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]

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

Cervical Spinal Cord Transcutaneous Stimulation Improves Upper Extremity and Hand Function in People With Complete Tetraplegia: A Case Study. [2021]

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

The Effects of Adding Transcutaneous Spinal Cord Stimulation (tSCS) to Sit-To-Stand Training in People with Spinal Cord Injury: A Pilot Study. [2020]

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

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]

7. 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]

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

Spinal direct current stimulation with locomotor training in chronic spinal cord injury. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation and Augmentative Control Strategies for Leg Movement after Spinal Paralysis in Humans. [2020]

10. Switzerland 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. [2023]