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

Trial Summary

What is the purpose of this trial?

This research study will combine non-invasive spinal stimulation with mobility devices to examine the acute impact of the individual and combined effects of these innovative techniques on mobility in children with cerebral palsy.

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 data supports the effectiveness of the treatment Spinal Stimulation + Mobility Devices for Cerebral Palsy?

Research shows that power wheelchairs and mobility devices can improve independence in children with severe movement challenges, like those with dyskinetic cerebral palsy. Additionally, powered exoskeletons have been found to enhance mobility in individuals with spinal cord injuries, suggesting potential benefits for improving movement in cerebral palsy as well. ^{1 2 3 4 5}

Is spinal stimulation and mobility device use generally safe for humans?

There are safety concerns with electrically propelled wheelchairs, as they may be unsafe. A system using neural stimulation during wheelchair use showed improved safety for users with spinal cord injuries. Exoskeleton-assisted walking can be safe but may cause adverse events like hypotension (low blood pressure) and fractures, requiring careful monitoring and training. Motorized mobility scooters also pose risks, including injuries and deaths. ^{6 7 8 9 10}

How is the Spinal Stimulation + Mobility Devices treatment for Cerebral Palsy different from other treatments?

This treatment is unique because it combines spinal cord stimulation, which uses electrical pulses to target specific areas of the spinal cord, with mobility devices to potentially improve movement in individuals with cerebral palsy. Unlike traditional treatments that may focus solely on physical therapy or medication, this approach integrates advanced technology to directly influence the nervous system. ^{11 12 13 14 15}

Research Team

Katherine M Steele, PhD

Principal Investigator

University of Washington

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The effects of gait training using powered lower limb exoskeleton robot on individuals with complete spinal cord injury. [2019]

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

Patterns in Wheeled Mobility Skills Training, Equipment Evaluation, and Utilization: Findings from the SCIRehab Project. [2015]

3. England 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. [2021]

4. Sweden pubmed.ncbi.nlm.nih.gov

Seat height: effects on submaximal hand rim wheelchair performance during spinal cord injury rehabilitation. [2014]

5. England pubmed.ncbi.nlm.nih.gov

The Standomobile: a new, electrically powered, mobile stand up device for use in paraplegia. Case report. [2004]

6. England 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. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Case Report: Description of two fractures during the use of a powered exoskeleton. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Wheelchair safety scare. [2016]

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

Sudden stop detection and automatic seating support with neural stimulation during manual wheelchair propulsion. [2022]

10. Switzerland 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. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic pain. [2018]

12. India pubmed.ncbi.nlm.nih.gov

Finding Optimal Neuromodulation for Chronic Pain: Waves, Bursts, and Beyond. [2022]

13. United States 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. [2021]

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

The restore rechargeable, implantable neurostimulator: handling and clinical results of a multicenter study. [2013]

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

History and Future of Spinal Cord Stimulation. [2023]