10 Participants Needed

Home-Based Spinal Cord Stimulation for Quadriplegia

JJ
JK
Overseen ByJenny Kiratli, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Palo Alto Health Care System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12678

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.124910

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

JK

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.
See 6 more

Exclusion Criteria

Pregnant, are planning to become pregnant, or breastfeeding
I have severe or uncontrolled autonomic dysreflexia.
I have heart or lung disease.
See 5 more

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
1Treatment groups
Experimental Treatment
Group I: tSCS plus home tele-video supportExperimental Treatment1 Intervention
Cervical transcutaneous spinal stimulation during home tele-video visits

Find a Clinic Near You

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.
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.
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.
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]

References

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. [2022]
Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]
Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. [2022]
Cervical Spinal Cord Transcutaneous Stimulation Improves Upper Extremity and Hand Function in People With Complete Tetraplegia: A Case Study. [2021]
The Effects of Adding Transcutaneous Spinal Cord Stimulation (tSCS) to Sit-To-Stand Training in People with Spinal Cord Injury: A Pilot Study. [2020]
Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]
Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. [2022]
Spinal direct current stimulation with locomotor training in chronic spinal cord injury. [2021]
Spinal Cord Stimulation and Augmentative Control Strategies for Leg Movement after Spinal Paralysis in Humans. [2020]
Targeted transcutaneous spinal cord stimulation promotes persistent recovery of upper limb strength and tactile sensation in spinal cord injury: a pilot study. [2023]
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