Spinal Stimulation + Mobility Devices for Cerebral Palsy

Overseen By Katie Landwehr, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Anticoagulants, Osteoporosis medications

Disqualifiers: Hypertension, Seizures, Cancer, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 session

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how non-invasive spinal stimulation (also known as spinal cord stimulation) and mobility devices can improve movement in children with cerebral palsy. Researchers aim to assess the effects of these treatments both separately and together. It is ideal for children with a neurological condition who can follow simple instructions and are willing to share their experiences during the study. The trial does not suit those with major health issues, such as heart problems, or those who have had recent surgeries. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance mobility treatments for children.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have an implanted drug delivery device or are taking medication for osteoporosis, you may not be eligible to participate.

What prior data suggests that these techniques are safe for children with cerebral palsy?

Research has shown that spinal stimulation may help children with cerebral palsy. In a small study, children who received this treatment improved their movement scores by more than 13 points, a significant improvement. This suggests that spinal stimulation could safely enhance mobility.

Regarding mobility devices, studies indicate that both manual and powered wheelchairs can greatly improve the quality of life for children with cerebral palsy. These devices assist with daily activities and social interactions. No major safety concerns have been reported with their long-term use.

In summary, both spinal stimulation and mobility devices have been studied separately and appear safe for children with cerebral palsy. Spinal stimulation has shown positive effects on movement, and mobility devices have enhanced quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of spinal stimulation and mobility devices for cerebral palsy because it offers a novel approach to enhance movement and reduce symptoms. Unlike traditional treatments, which often rely on physical therapy and medications to manage symptoms, spinal stimulation directly targets the nervous system to improve muscle control and function. Additionally, the integration of mobility devices provides tailored physical support, potentially boosting the effectiveness of spinal stimulation. This combination could offer individuals with cerebral palsy more significant improvements in movement and quality of life compared to existing options.

What evidence suggests that spinal stimulation and mobility devices are effective for improving mobility in children with cerebral palsy?

This trial will evaluate the individual and combined effects of spinal stimulation and mobility devices for individuals with neurologic disorders, including cerebral palsy. Research has shown that spinal stimulation can enhance movement in children with cerebral palsy. One study found that children significantly improved their motor skills, as measured by the Gross Motor Function Measure. These improvements exceeded twice the threshold for a meaningful change, indicating a real benefit.

Regarding mobility devices, studies have found they can enhance movement, standing, and self-perception in children with cerebral palsy. Devices like the vertical wheeler have been particularly helpful. Overall, both spinal stimulation and mobility devices appear promising in aiding children with cerebral palsy to move more easily and feel more confident. ^{6 7 8 9 10}

Who Is on the Research Team?

Katherine M Steele, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for children and adults aged 4-70 with cerebral palsy or other brain-related conditions who can follow simple instructions and are medically stable. It's not for those with rheumatic diseases, active cancer, implanted stimulators or drug delivery devices, recent orthopedic surgery in the legs, uncontrolled seizures, severe osteoporosis on treatment, or significant cardiovascular issues.

Inclusion Criteria

I can share my experience and comfort level during lab visits.

I can follow simple instructions and do tasks when guided.

Are volunteering to be involved in this study

Exclusion Criteria

I have a rheumatic disease like rheumatoid arthritis or lupus.

You need help breathing from a machine.

I have seizures that are not controlled by medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive non-invasive spinal stimulation and use mobility devices to evaluate their combined effects on mobility

1 session

1 visit (in-person)

Follow-up

Participants are monitored for changes in muscle strength, spasticity, and muscle coordination

1 session

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mobility Device
• Spinal Stimulation

Trial Overview

The study tests how non-invasive spinal stimulation combined with mobility devices affects movement in people with cerebral palsy. Participants will use these techniques during lab visits to see if there's an immediate improvement in their ability to move.

How Is the Trial Designed?

Group I: Neurologic Disorders Experimental Treatment 2 Interventions

Evaluation of individual and combined effects of mobility devices and spinal stimulation for individuals with neurologic disorders.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+

Published Research Related to This Trial

In a study of 41 patients with chronic neuropathic pain, 100% successfully recharged the Restore neurostimulation system, indicating its ease of use.

After 12 months, patients reported significant pain relief (62% on average), improved quality of life, and high satisfaction rates, with 80.5% experiencing over 50% pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The restore rechargeable, implantable neurostimulator: handling and clinical results of a multicenter study. Van Buyten, JP., Fowo, S., Spincemaille, GH., et al.[2013]

The Department of Health and Social Security has raised safety concerns regarding electrically propelled wheelchairs, prompting outreach to approximately 6,000 users.

This warning indicates potential risks associated with these wheelchairs, highlighting the importance of user safety and the need for further investigation into their safety standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wheelchair safety scare. [2016]

Spinal cord stimulation (SCS) is an effective surgical option for patients suffering from chronic neuropathic pain that does not respond to traditional medical treatments.

The SCS system involves implanting leads in the epidural space, which are connected to a pulse generator, showcasing advancements in technology and surgical techniques for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

History and Future of Spinal Cord Stimulation. Ali, R., Schwalb, JM.[2023]

Spinal cord stimulation (SCS) has evolved with new waveforms like burst stimulation and high-frequency stimulation, which provide effective pain relief with minimal or no paraesthesia, making them suitable for patients who do not respond to traditional tonic SCS.

The development of closed-loop SCS technology shows promise for enhancing patient outcomes in chronic pain management, although more research is needed to fully validate these newer methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding Optimal Neuromodulation for Chronic Pain: Waves, Bursts, and Beyond. Ranjan, M., Kumar, P., Konrad, P., et al.[2022]

In a study of 50 patients with lower back and/or leg pain, the novel closed-loop spinal cord stimulation (SCS) system demonstrated long-term effectiveness, with 76.9% of patients achieving at least 50% pain relief after 12 months.

The system maintained spinal cord activation within a therapeutic window for 84.9% of the time, and 68.8% of patients were able to reduce or eliminate their opioid use, highlighting both safety and efficacy in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained Long-Term Outcomes With Closed-Loop Spinal Cord Stimulation: 12-Month Results of the Prospective, Multicenter, Open-Label Avalon Study. Russo, M., Brooker, C., Cousins, MJ., et al.[2021]

A study involving 12 participants with acute/sub-acute spinal cord injuries showed that using powered exoskeletons for locomotor training is generally safe, although symptomatic hypotension was the most common adverse event reported.

The feasibility of using exoskeletons was demonstrated, with 54% protocol compliance and 58% of participants achieving at least minimal assistance during walking sessions, indicating potential for effective rehabilitation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of exoskeleton-assisted walking during acute/sub-acute SCI in an inpatient rehabilitation facility: A single-group preliminary study. Delgado, AD., Escalon, MX., Bryce, TN., et al.[2021]

In a study of 10 children with severe dyskinetic cerebral palsy using power wheelchairs, dystonia was found to be significantly more prevalent and severe (83.6%) compared to choreoathetosis (34.4%), indicating that dystonia has a greater impact on mobility performance.

The study revealed strong correlations between the severity of arm dystonia and mobility performance, suggesting that as children gain more experience with driving the wheelchair, they develop strategies to manage the effects of their movements on performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dystonia and choreoathetosis presence and severity in relation to powered wheelchair mobility performance in children and youth with dyskinetic cerebral palsy. Bekteshi, S., Konings, M., Nica, IG., et al.[2021]

The developed automatic system successfully detected sudden stops in wheelchairs with over 93% accuracy in real-world settings, which is crucial for preventing falls.

Participants with spinal cord injury reported feeling significantly safer when the system triggered trunk stimulation during sudden stops, indicating its potential effectiveness in enhancing wheelchair safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sudden stop detection and automatic seating support with neural stimulation during manual wheelchair propulsion. Foglyano, KM., Lombardo, LM., Schnellenberger, JR., et al.[2022]

Training interventions for motorized mobility scooter (MMS) drivers can significantly enhance driving skills and performance, including abilities like obstacle avoidance and maneuvering in various environments, based on a review of six clinical studies.

In addition to training, infrastructural assessments and mobility assistance tools can further improve MMS driving performance, although the existing studies have limitations such as small sample sizes and lack of control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motorized mobility scooters: the use of training/intervention and technology for improving driving skills in aging adults - a mini-review. Toosizadeh, N., Bunting, M., Howe, C., et al.[2021]

In a study involving 12 individuals with spinal cord injuries, optimal wheelchair seat heights for improving wheeling efficiency were found to be between 100-130 degrees elbow angle, which reduced physical strain during rehabilitation.

Lower seat heights negatively impacted mechanical efficiency and required greater forces on the hand rims, suggesting that adjusting seat height can enhance manual wheeling performance and comfort for individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seat height: effects on submaximal hand rim wheelchair performance during spinal cord injury rehabilitation. van der Woude, LH., Bouw, A., van Wegen, J., et al.[2014]

Two cases of bone fractures were reported during the use of powered robotic exoskeletons in patients with spinal cord injury, highlighting the potential risks associated with unexpected technical failures.

Proper alignment of the exoskeleton with the user's body is crucial to minimize fracture risks, and additional safety training is recommended for both patients and instructors to handle emergency situations effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Description of two fractures during the use of a powered exoskeleton. van Herpen, FHM., van Dijsseldonk, RB., Rijken, H., et al.[2023]

Spinal cord stimulation (SCS) shows potential effectiveness in treating chronic pain conditions like Complex Regional Pain Syndrome Type I and Failed Back Surgery Syndrome, based on two trials involving 81 patients, although the evidence is limited and more research is needed.

The studies reviewed had varying quality, with one high-quality trial and one low-quality trial, indicating a need for better-designed studies to accurately assess the efficacy and safety of SCS in chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic pain. Mailis-Gagnon, A., Furlan, AD., Sandoval, JA., et al.[2018]

Most patients with traumatic spinal cord injury participated in wheelchair skills training during rehabilitation, with a focus on propulsion and driving skills, indicating a structured approach to enhancing mobility.

Patients reported high satisfaction with their wheelchairs' fit and function one year post-injury, suggesting that clinicians are effectively prescribing and fitting mobility devices based on individual needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns in Wheeled Mobility Skills Training, Equipment Evaluation, and Utilization: Findings from the SCIRehab Project. Taylor, S., Gassaway, J., Heisler-Varriale, LA., et al.[2015]

A case study demonstrated the effectiveness of an electrically powered mobile stand-up device for a patient with a complete spinal cord lesion at cervical level C7, allowing them to perform both sitting and standing tasks in a flower nursery.

This device serves as a practical aid to help individuals with severe spinal cord injuries reintegrate into their work environments, highlighting its potential for improving quality of life and occupational engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Standomobile: a new, electrically powered, mobile stand up device for use in paraplegia. Case report. van den Berg, JP., den Ouden, A., Stam, HJ.[2004]

The pilot study involving two participants with complete spinal cord injury showed that after 8 weeks of training with a powered lower limb exoskeleton, they could don and doff the device independently with less exertion and improved mobility performance compared to traditional orthoses.

No injuries or falls occurred during the training, and participants experienced increased bone mineral density, indicating that the powered exoskeleton is a safe and effective tool for enhancing mobility in individuals with movement deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of gait training using powered lower limb exoskeleton robot on individuals with complete spinal cord injury. Wu, CH., Mao, HF., Hu, JS., et al.[2019]

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