12 Participants Needed

BCI-FES System for Quadriplegia

(ReHAB Trial)

JM
MB
Overseen ByMario Beccera, RN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial does not specify if you must stop taking your current medications, but it excludes those who use certain medications like sedatives, anticoagulants, steroids, or immunosuppressants regularly. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the BCI-FES treatment for quadriplegia?

Research shows that combining brain-computer interfaces (BCI) with functional electrical stimulation (FES) can improve hand function in people with tetraplegia, a condition similar to quadriplegia. Additionally, BCI technology has been used to help patients with neurological conditions regain some motor control and improve their quality of life.12345

Is the BCI-FES system safe for use in humans?

Research on BCI-FES systems, including studies on children with cerebral palsy and adults with stroke, has focused on assessing safety and feasibility, indicating that these systems are generally considered safe for human use.16789

How is the BCI-FES treatment for quadriplegia different from other treatments?

The BCI-FES treatment is unique because it combines brain-computer interface (BCI) technology, which reads motor intent from the brain, with functional electrical stimulation (FES) to restore movement in paralyzed patients. This integration allows for more precise and intuitive control of movement compared to traditional therapies.168910

What is the purpose of this trial?

The purpose of this research study is to examine the feasibility of a system that involves implanting small electrodes in the parts of the brain that control movement and sensation, and combining that with electrodes in the upper arm and shoulder to activate paralyzed muscles of the arm and hand. This system is intended for people with extensive paralysis in their arms. The small electrodes in the brain will be used to attempt to measure intended movements, and the muscles in the arm and hand will be stimulated to attempt to follow those intentions.The study is a prospective, non-randomized, open-label, exploratory safety/feasibility trial of up to 12 subjects. The Primary Endpoint will be evaluation over the first 13 months after implantation, after which the subjects will have the option of removal of the device or continued participation in a long-term study.

Research Team

JM

Jonathan P Miller, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

This trial is for adults aged 22-65 with stable tetraplegia from spinal cord injury or stroke, who live within a three-hour drive of the study site (or can relocate) and have a life expectancy over 13 months. Participants need intact brain motor areas, reliable communication ability, and a strong support system. They must not be pregnant, on certain medications, or have conditions that conflict with the study requirements.

Inclusion Criteria

I have tetraplegia from a spinal cord injury or stroke, affecting my arms' function.
I have had paralysis in all four limbs for over a year with stable condition for the last 3 months.
I am between 22 and 65 years old.
See 10 more

Exclusion Criteria

You drink more than one alcoholic drink per day.
I currently have an infection or unexplained fever.
I do not have any serious health issues that would prevent me from undergoing surgery or participating in tests.
See 20 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Implantation and Initial Testing

Surgical implantation of the ReHAB system and initial testing of the device

1 month
Multiple visits for surgical procedure and post-operative assessments

Device Testing and Evaluation

Participants undergo testing and evaluation of the implanted device for safety, tolerability, and efficacy

12 months
Regular visits for device testing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after the initial 13-month testing period

4 weeks

Long-term Extension (optional)

Participants may opt into a long-term study to continue using the device for up to 5 years

Up to 5 years

Treatment Details

Interventions

  • BCI and FES
Trial Overview The ReHAB System being tested involves implanting electrodes in the brain to detect movement intentions and stimulating arm muscles to mimic these movements in people with arm paralysis. The trial will assess safety/feasibility over 13 months post-implantation with an option for long-term follow-up.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: BCI and FESExperimental Treatment1 Intervention
Surgical implantation of the device and testing for 13 months with an optional 5 year extension study.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jennifer Sweet, MD

Lead Sponsor

Trials
1
Recruited
10+

Jonathan Miller, MD

Lead Sponsor

Trials
1
Recruited
10+

Findings from Research

Brain-computer interfaces (BCI) are promising devices that can help quadriplegic patients regain control by interpreting brain signals to operate physical and virtual prosthetics.
The future of BCI technology aims to include sensory feedback, which will enhance the user experience and effectiveness for patients with neurological injuries.
Brain-Computer Interfaces in Quadriplegic Patients.Lee, MB., Kramer, DR., Peng, T., et al.[2019]
A case study involving a participant with spastic quadriplegic cerebral palsy demonstrated that training with a commercial EEG-based brain-computer interface (BCI) over four weeks led to improved control of distinct EEG patterns, allowing the participant to type a sentence six weeks post-training.
The study emphasized that factors like motivation, fatigue, and concentration significantly affect BCI performance, highlighting the need for engaging and customized training environments to enhance the effectiveness of assistive technologies for individuals with severe disabilities.
Training to use a commercial brain-computer interface as access technology: a case study.Taherian, S., Selitskiy, D., Pau, J., et al.[2017]
Brain-computer interfaces (BCIs) can significantly enhance the quality of life for tetraplegic patients by improving communication and control over their environment, relying on the brain's ability to adapt through practice and feedback.
For BCIs to be effective, they must be safe, reliable, and easy to use, even in distracting environments, and future clinical trials will be essential to assess their impact on patients' quality of life.
Brain-computer interface technology as a tool to augment plasticity and outcomes for neurological rehabilitation.Dobkin, BH.[2018]

References

Brain-Computer Interfaces in Quadriplegic Patients. [2019]
Training to use a commercial brain-computer interface as access technology: a case study. [2017]
Brain-computer interface technology as a tool to augment plasticity and outcomes for neurological rehabilitation. [2018]
Hybrid brain-computer interface and functional electrical stimulation for sensorimotor training in participants with tetraplegia: a proof-of-concept study. [2014]
Brain-Computer Interfaces With Multi-Sensory Feedback for Stroke Rehabilitation: A Case Study. [2018]
Therapeutic effects of brain-computer interface-controlled functional electrical stimulation training on balance and gait performance for stroke: A pilot randomized controlled trial. [2022]
BCI-activated electrical stimulation in children with perinatal stroke and hemiparesis: A pilot study. [2023]
A multichannel FES system for the restoration of motor functions in high spinal cord injury patients: a respiration-controlled system for multijoint upper extremity. [2022]
Merging brain-computer interface and functional electrical stimulation technologies for movement restoration. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Exploring the Use of Brain-Computer Interfaces in Stroke Neurorehabilitation. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security