BCI-FES System for Quadriplegia

(ReHAB Trial)

Overseen By Mario Beccera, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jennifer Sweet, MD

Must not be taking: Sedatives, Anticoagulants, Steroids, others

Disqualifiers: Pacemaker, Active infection, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{1 2 4 5 6}

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. ^{2 7 8 9 10}

Who Is on the Research Team?

Jonathan P Miller, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: BCI and FES Experimental Treatment 1 Intervention

Surgical implantation of the device and testing for 13 months with an optional 5 year extension study.

Who Is Running the Clinical Trial?

Jennifer Sweet, MD

Lead Sponsor

Trials

1

Recruited

10+

Jonathan Miller, MD

Lead Sponsor

Trials

1

Recruited

10+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain-computer interface technology as a tool to augment plasticity and outcomes for neurological rehabilitation. Dobkin, BH.[2018]

A proof-of-concept study involving two participants with subacute tetraplegia showed that a hybrid brain-computer interface (BCI) could effectively control functional electrical stimulation (FES) to improve hand function, achieving high classification accuracy of 83.5% to 83.8% for hand movements based on motor imagery.

Participant 1 experienced moderate improvement in muscle strength after 10 sessions of BCI-FES therapy, indicating potential benefits of this approach, while participant 2 showed no change, highlighting the need for further research with more participants to better understand the effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid brain-computer interface and functional electrical stimulation for sensorimotor training in participants with tetraplegia: a proof-of-concept study. Vučković, A., Wallace, L., Allan, DB.[2014]

The recoveriX system, which integrates a brain-computer interface with functional electrical stimulation and visual feedback, was tested on two chronic stroke patients, showing promising results in motor rehabilitation.

After 10 training sessions, one patient regained partial control of wrist extension, while the other improved finger movement, indicating the system's potential for enhancing motor recovery in paralyzed patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain-Computer Interfaces With Multi-Sensory Feedback for Stroke Rehabilitation: A Case Study. Irimia, DC., Cho, W., Ortner, R., et al.[2018]

In a study of 25 individuals with chronic hemiparetic stroke, those who received brain-computer interface-controlled functional electrical stimulation (BCI-FES) showed significant improvements in gait velocity and cadence compared to those who received standard functional electrical stimulation (FES).

BCI-FES also led to a greater increase in step length on the less-affected side, suggesting that this innovative approach may enhance walking abilities more effectively than traditional FES.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effects of brain-computer interface-controlled functional electrical stimulation training on balance and gait performance for stroke: A pilot randomized controlled trial. Chung, E., Lee, BH., Hwang, S.[2022]

The pilot clinical trial involving 13 children with hemiparetic cerebral palsy demonstrated that Brain Computer Interface-activated Functional Electrical Stimulation (BCI-FES) is safe and well-tolerated, with no serious adverse events reported.

Participants showed good competency with the BCI system, achieving mean classification accuracies of approximately 79% during training and 73% during rehabilitation, indicating the potential for this technology to enhance upper extremity function in children with limited rehabilitation options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BCI-activated electrical stimulation in children with perinatal stroke and hemiparesis: A pilot study. Jadavji, Z., Kirton, A., Metzler, MJ., et al.[2023]

A multichannel functional electrical stimulation (FES) system was developed to help restore upper extremity function in quadriplegic patients, allowing a C4 quadriplegic patient to independently drink canned tea.

The system enables versatile control through voluntary respiratory signals and provides fine motor control by using stimulation data based on normal muscle activity, showcasing its potential for improving daily activities in individuals with severe mobility impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multichannel FES system for the restoration of motor functions in high spinal cord injury patients: a respiration-controlled system for multijoint upper extremity. Hoshimiya, N., Naito, A., Yajima, M., et al.[2022]

Recent advancements in brain-computer interface (BCI) and functional electrical stimulation (FES) technologies are showing promise in restoring movement for paralyzed patients, highlighting their potential in rehabilitation.

The integration of implantable BCIs with advanced neural decoding algorithms and FES systems has led to significant improvements in the precision of neural recordings and the effectiveness of movement restoration efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Merging brain-computer interface and functional electrical stimulation technologies for movement restoration. Bouton, CE.[2020]

Brain-computer interfaces (BCIs) are emerging as a promising technology in the rehabilitation of stroke patients, enabling innovative 'top-down' approaches to neurorehabilitation.

Recent advancements in BCI technology have shown potential benefits across various rehabilitation areas, including motor, sensory, speech, and cognitive functions, although challenges remain in their implementation and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Use of Brain-Computer Interfaces in Stroke Neurorehabilitation. Yang, S., Li, R., Li, H., et al.[2021]

Citations

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

Brain-Computer Interfaces in Quadriplegic Patients. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Training to use a commercial brain-computer interface as access technology: a case study. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Brain-computer interface technology as a tool to augment plasticity and outcomes for neurological rehabilitation. [2018]

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

Hybrid brain-computer interface and functional electrical stimulation for sensorimotor training in participants with tetraplegia: a proof-of-concept study. [2014]

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

Brain-Computer Interfaces With Multi-Sensory Feedback for Stroke Rehabilitation: A Case Study. [2018]

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

Therapeutic effects of brain-computer interface-controlled functional electrical stimulation training on balance and gait performance for stroke: A pilot randomized controlled trial. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

BCI-activated electrical stimulation in children with perinatal stroke and hemiparesis: A pilot study. [2023]

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

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]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Merging brain-computer interface and functional electrical stimulation technologies for movement restoration. [2020]

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

Exploring the Use of Brain-Computer Interfaces in Stroke Neurorehabilitation. [2021]