BCI-FES System for Quadriplegia

(ReHAB Trial)

Overseen By Jennifer Sweet, M.D.

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?

This trial tests a new system called the BCI and FES (Brain-Computer Interface and Functional Electrical Stimulation) that might help people with severe arm paralysis regain some movement. Researchers place tiny electrodes in the brain and arm to connect the brain's movement intentions to actual muscle activity. The study aims to determine if this system is safe and effective. Individuals with paralysis from a spinal cord injury or stroke for over a year, with stable symptoms, might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could transform paralysis treatment.

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 prior data suggests that this system is safe for people with quadriplegia?

Research has shown that using a brain-computer interface (BCI) with functional electrical stimulation (FES) can be safe for people with paralysis. Studies have found that this system can significantly improve movement in individuals with tetraplegia, which is paralysis of all four limbs. In one study, participants experienced better movement without any serious side effects.

The BCI-FES system works by placing electrodes in the brain and connecting them to the muscles, helping to turn brain signals into muscle movements. Previous trials have demonstrated that participants generally tolerate this combination well, with no major negative effects linked to the technology itself.

Overall, while researchers continue to study this treatment, early results suggest it is generally safe for people with severe paralysis. Participants in similar studies have shown improvements with minimal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BCI-FES system for quadriplegia because it combines brain-computer interface (BCI) technology with functional electrical stimulation (FES) to offer a novel way to restore movement. Unlike traditional treatments that rely on physical therapy or assistive devices, this system directly interfaces with the brain to translate thoughts into actions, which can potentially lead to more natural and precise control of paralyzed limbs. This innovative approach could significantly enhance the quality of life for individuals with quadriplegia by providing them with more independence and control over their movements.

What evidence suggests that the BCI and FES system is effective for quadriplegia?

Studies have shown that brain-computer interfaces (BCI) combined with functional electrical stimulation (FES) can help people with paralysis regain movement. This system uses small electrodes in the brain to detect intended movements and then stimulates the muscles to execute these movements. Research indicates that BCI-FES can lead to significant and lasting improvements in movement recovery. Specifically, patients with spinal cord injuries have experienced better muscle function with this method. Initial findings suggest it may help people with quadriplegia move their arms and hands more effectively. Participants in this trial will receive the BCI and FES system, which involves surgical implantation of the device and testing for 13 months, with an optional 5-year extension study. ^{1 3 4 6 7}

Who Is on the Research Team?

Jennifer Sweet, M.D.

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

I currently have an infection or unexplained fever.

You drink more than one alcoholic drink per day.

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

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7979732/

Brain–computer interface-triggered functional electrical ... The first effort to combine BCI and FES for the restoration of upper extremity function in an individual with tetraplegia was conducted by ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01852279

BCI and FES for Hand Therapy in Spinal Cord Injury This study will assess whether functional recovery of the hand muscles in patients with spinal cord injury is enhanced when electrical stimulation of the ...

3. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/1743-0003-8-49

Brain-Computer Interface Controlled Functional Electrical ... We describe the first successful integration of a noninvasive electroencephalogram (EEG)-based BCI with a noninvasive functional electrical stimulation (FES) ...

4. withpower.com withpower.com/trial/phase-quadriplegia-3-2019-ef28e

BCI-FES System for Quadriplegia (ReHAB 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 ...

5. nature.com nature.com/articles/s41467-018-04673-z

Brain-actuated functional electrical stimulation elicits ... Here we show that BCI coupled to functional electrical stimulation (FES) elicits significant, clinically relevant, and lasting motor recovery in chronic stroke ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10656959/

Boosting brain–computer interfaces with functional ... The clinical evaluation results showed that, while using the system, the user's motor impairments significantly improved, which granted the tetraplegic patient ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715923007547

Invasive Brain Computer Interface for Motor Restoration in ... Invasive techniques of BCI show promise for the treatment of SCI, but there is currently no technology that can restore complete functional autonomy in patients ...