Stimulator Implant for Stroke Recovery
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byNathan Makowski, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: MetroHealth Medical Center
Disqualifiers: Non-English, Low bone density, Cardiovascular, Uncontrolled diabetes, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing a small implanted device that helps stroke survivors walk better by sending electrical signals to their muscles. The device is surgically placed and helps the muscles contract, making it easier to walk. This method has been shown to improve walking ability in stroke patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the treatment IRS-8, Implanted Stimulator for Walking After Stroke, IRS-8, IST 12 & IST 16, IST 12 & IST 16, Brain-Computer Interface (BCI) Implant, Neurostimulation Device for stroke recovery?
Research shows that brain-computer interfaces (BCIs) can improve movement in stroke patients by strengthening brain connections, leading to better walking speed and motor function. Additionally, combining BCIs with functional electrical stimulation (FES) has been shown to enhance brain activation and motor control in stroke recovery.
12345Is the Stimulator Implant for Stroke Recovery generally safe for humans?
There is no specific safety data available for the Stimulator Implant for Stroke Recovery under the names provided. However, a systematic review on non-invasive electrical brain stimulation in stroke patients found that while there is potential for therapeutic benefits, comprehensive evaluation of adverse events is lacking.
25678How is the Stimulator Implant for Stroke Recovery treatment different from other stroke recovery treatments?
The Stimulator Implant for Stroke Recovery is unique because it combines a brain-computer interface (BCI) with a neurostimulation device to directly interact with the brain's sensory-motor system, potentially improving motor function after a stroke. This approach is different from traditional therapies as it aims to reintegrate the brain's control over movement, which is not typically addressed by conventional treatments.
910111213Eligibility Criteria
This trial is for stroke survivors aged 21-75 who walk slower than normal due to the stroke. They should be at least 6 months post-stroke, have certain levels of muscle stiffness and motor function, and not need more than one person's help to walk. Participants must also be neurologically stable, speak English, not pregnant, without severe cognitive issues or medical conditions that increase fall risk.Inclusion Criteria
I can walk with help from no more than one person.
My leg and lower back muscles respond normally to stimulation.
Willingness to comply with follow-up procedures
+9 more
Exclusion Criteria
I have complications from a stroke that make me more likely to fall.
I have severe bone or joint issues like scoliosis or dislocations.
I have severe difficulties in thinking and communicating.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Implantation, Controller Development, and Evaluation
Participants undergo surgery to implant a stimulator and electrodes, followed by training to use the device for walking assistance. Advanced controllers for walking are developed and evaluated over several months.
44 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with evaluations at 18 and 44 weeks post-implant.
44 weeks
Participant Groups
The study tests an implanted stimulator device designed to improve walking in people with gait disorders after a stroke. It involves screening candidates for eligibility, implanting the device, setting up home use controllers for walking improvement and evaluating its effects over several months.
1Treatment groups
Experimental Treatment
Group I: Implantation, controller development, and evaluationExperimental Treatment2 Interventions
This phase includes installing the device and setting the individual up for home use, creating advanced controllers for walking and evaluating the effect of the device over several months.
IRS-8 is already approved in United States for the following indications:
🇺🇸 Approved in United States as IRS-8 for:
- Improving walking in stroke survivors
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Louis Stokes Cleveland Veterans Affairs Medical CenterCleveland, OH
MetroHealth Medical CenterCleveland, OH
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Who Is Running the Clinical Trial?
MetroHealth Medical CenterLead Sponsor
Cleveland State UniversityCollaborator
Case Western Reserve UniversityCollaborator
Louis Stokes VA Medical CenterCollaborator
References
Efficient neuroplasticity induction in chronic stroke patients by an associative brain-computer interface. [2022]Brain-computer interfaces (BCIs) have the potential to improve functionality in chronic stoke patients when applied over a large number of sessions. Here we evaluated the effect and the underlying mechanisms of three BCI training sessions in a double-blind sham-controlled design. The applied BCI is based on Hebbian principles of associativity that hypothesize that neural assemblies activated in a correlated manner will strengthen synaptic connections. Twenty-two chronic stroke patients were divided into two training groups. Movement-related cortical potentials (MRCPs) were detected by electroencephalography during repetitions of foot dorsiflexion. Detection triggered a single electrical stimulation of the common peroneal nerve timed so that the resulting afferent volley arrived at the peak negative phase of the MRCP (BCIassociative group) or randomly (BCInonassociative group). Fugl-Meyer motor assessment (FM), 10-m walking speed, foot and hand tapping frequency, diffusion tensor imaging (DTI) data, and the excitability of the corticospinal tract to the target muscle [tibialis anterior (TA)] were quantified. The TA motor evoked potential (MEP) increased significantly after the BCIassociative intervention, but not for the BCInonassociative group. FM scores (0.8 ± 0.46 point difference, P = 0.01), foot (but not finger) tapping frequency, and 10-m walking speed improved significantly for the BCIassociative group, indicating clinically relevant improvements. Corticospinal tract integrity on DTI did not correlate with clinical or physiological changes. For the BCI as applied here, the precise coupling between the brain command and the afferent signal was imperative for the behavioral, clinical, and neurophysiological changes reported. This association may become the driving principle for the design of BCI rehabilitation in the future. Indeed, no available BCIs can match this degree of functional improvement with such a short intervention.
Brain-Computer Interfaces With Multi-Sensory Feedback for Stroke Rehabilitation: A Case Study. [2018]Conventional therapies do not provide paralyzed patients with closed-loop sensorimotor integration for motor rehabilitation. This work presents the recoveriX system, a hardware and software platform that combines a motor imagery (MI)-based brain-computer interface (BCI), functional electrical stimulation (FES), and visual feedback technologies for a complete sensorimotor closed-loop therapy system for poststroke rehabilitation. The proposed system was tested on two chronic stroke patients in a clinical environment. The patients were instructed to imagine the movement of either the left or right hand in random order. During these two MI tasks, two types of feedback were provided: a bar extending to the left or right side of a monitor as visual feedback and passive hand opening stimulated from FES as proprioceptive feedback. Both types of feedback relied on the BCI classification result achieved using common spatial patterns and a linear discriminant analysis classifier. After 10 sessions of recoveriX training, one patient partially regained control of wrist extension in her paretic wrist and the other patient increased the range of middle finger movement by 1 cm. A controlled group study is planned with a new version of the recoveriX system, which will have several improvements.
Effect of functional electrical stimulation plus body weight-supported treadmill training for gait rehabilitation in patients with poststroke: a retrospective case-matched study. [2020]Functional electrical stimulation (FES) plus body weight-supported treadmill training (BWSTT) provide effective gait training for poststroke patients with abnormal gait. These features promote a successful active motor relearning of ambulation in stroke survivors.
Gait training of patients after stroke using an electromechanical gait trainer combined with simultaneous functional electrical stimulation. [2016]This case report describes the implementation of gait training intervention that used an electromechanical gait trainer with simultaneous functional electrical stimulation (FES) for 2 patients with acute ischemic stroke.
Effects of brain-computer interface-based functional electrical stimulation on brain activation in stroke patients: a pilot randomized controlled trial. [2022][Purpose] This study sought to determine the effects of brain-computer interface-based functional electrical stimulation (BCI-FES) on brain activation in patients with stroke. [Subjects] The subjects were randomized to in a BCI-FES group (n=5) and a functional electrical stimulation (FES) group (n=5). [Methods] Patients in the BCI-FES group received ankle dorsiflexion training with FES for 30 minutes per day, 5 times under the brain-computer interface-based program. The FES group received ankle dorsiflexion training with FES for the same amount of time. [Results] The BCI-FES group demonstrated significant differences in the frontopolar regions 1 and 2 attention indexes, and frontopolar 1 activation index. The FES group demonstrated no significant differences. There were significant differences in the frontopolar 1 region activation index between the two groups after the interventions. [Conclusion] The results of this study suggest that BCI-FES training may be more effective in stimulating brain activation than only FES training in patients recovering from stroke.
Wearable Integrated Volitional Control Electrical Stimulation Device as Treatment for Paresis of the Upper Extremity in Early Subacute Stroke Patients: A Randomized Controlled Non-inferiority Trial. [2023]To investigate the effect of a wearable integrated volitional control electrical stimulation (WIVES) device that has been developed as more compact and simpler to use in daily life compared with conventional integrated volitional control electrical stimulation (IVES) devices.
An adaptive fall-free rehabilitation mechanism for ischemic stroke rat patients. [2020]Today's commercial forced exercise platforms had been validated not as a well-designed rehabilitation environment for rats with a stroke, for the reason that rat with a stroke cannot take exercise at a constant intensity for a long period of time. In light of this, this work presented an adaptive, fall-free ischemic stroke rehabilitation mechanism in an animal model, which was implemented in an infrared-sensing adaptive feedback control running wheel (IAFCRW) platform. Consequently, rats with a stroke can be safely rehabilitated all the time, and particularly at full capacity for approximately one third of a training duration, in a completely fall-free environment according to individual physical differences by repeated use of an acceleration/deceleration mechanism. The performance of this platform was assessed using an animal ischemic stroke model. The IAFCRW therapy regimen was validated to outperform a treadmill and a conventional running wheel counterpart with respect to the reduction in the neurobehavioral deficits caused by middle cerebral artery occlusion (MCAo). IAFCRW is the first adaptive forced exercise training platform short of electrical stimulation-assistance in the literature, and ischemic stroke rats benefit more in terms of the behavioral tests run at the end of a 3-week rehabilitation program after a stroke thereby.
Safety and Adverse Events following Non-invasive Electrical Brain Stimulation in Stroke: A Systematic Review. [2023]Label="BACKGROUND">Noninvasive electrical stimulation (ES) could have therapeutic potential in stroke recovery. However, there is no comprehensive evaluation of adverse events. This study systematically searched the literature to document frequency and prevalence of adverse events. A secondary aim was to explore associations between adverse events and ES parameters or participant characteristics.Methods: Databases were searched for studies evaluating ES in adults with stroke. All included studies were required to report on adverse events. Extracted data were: (1) study design; (2) adverse events; (3) participant characteristics; (4) ES parameters.
Motor imagery based brain-computer interfaces: An emerging technology to rehabilitate motor deficits. [2019]When the sensory-motor integration system is malfunctioning provokes a wide variety of neurological disorders, which in many cases cannot be treated with conventional medication, or via existing therapeutic technology. A brain-computer interface (BCI) is a tool that permits to reintegrate the sensory-motor loop, accessing directly to brain information. A potential, promising and quite investigated application of BCI has been in the motor rehabilitation field. It is well-known that motor deficits are the major disability wherewith the worldwide population lives. Therefore, this paper aims to specify the foundation of motor rehabilitation BCIs, as well as to review the recent research conducted so far (specifically, from 2007 to date), in order to evaluate the suitability and reliability of this technology. Although BCI for post-stroke rehabilitation is still in its infancy, the tendency is towards the development of implantable devices that encompass a BCI module plus a stimulation system.
Evaluation of gait with multichannel electrical stimulation. [2022]Short, intensive multichannel electrical stimulation therapy was evaluated in 14 hemiplegics after stroke or head injury. The stimulation of the peroneal nerve, soleus, quadriceps, hamstring, gluteus maximus, and triceps brachii muscles with individually preprogrammed sequences was applied by surface electrodes at the beginning of gait rehabilitation. The patients started walking with the support of a therapist, gradually increased the walking distance and all reached independent ambulation with a crutch after an average of 14 stimulation sessions. A portable microprocessor six-channel stimulator/stride analyzer enabled the collection of gait parameters and recording of statistical mean values of stride time, gait symmetry, right and left stance times, and their standard deviations. Without additional equipment, several hundred stimulated strides were measured during each stimulation session.
Brain-computer interface driven functional electrical stimulation system for overground walking in spinal cord injury participant. [2021]The current treatment for ambulation after spinal cord injury (SCI) is to substitute the lost behavior with a wheelchair; however, this can result in many co-morbidities. Thus, novel solutions for the restoration of walking, such as brain-computer interfaces (BCI) and functional electrical stimulation (FES) devices, have been sought. This study reports on the first electroencephalogram (EEG) based BCI-FES system for overground walking, and its performance assessment in an individual with paraplegia due to SCI. The results revealed that the participant was able to purposefully operate the system continuously in real time. If tested in a larger population of SCI individuals, this system may pave the way for the restoration of overground walking after SCI.
The Vienna functional electrical stimulation system for restoration of walking functions in spastic paraplegia. [2019]An eight-channel stimulation system, currently intended for stimulation of lower extremities, was developed and is introduced. The major development goals were easy handling, modularity to make the system easily adaptable for other functional electrical stimulation (FES) applications, and a wide stimulation parameter range for application-specific parameter optimization. For paraplegic stepping, the system worn by the patient consists of 2 four-channel stimulation modules, a central unit holding the battery and circuitry for power management and communication control, a wireless remote control unit, and a palmtop computer as the main control and input device. A software package for Microsoft Windows supports the design and optimization of stimulation sequences in the rehabilitation center. First tests with patients familiar with FES showed smoother movements during stepping and acceptable good handling. In combination with the PC software, the required stimulation sequences could be created in a very short time.
Effect of brain-computer interface training based on non-invasive electroencephalography using motor imagery on functional recovery after stroke - a systematic review and meta-analysis. [2020]Training with brain-computer interface (BCI) technology in the rehabilitation of patients after a stroke is rapidly developing. Numerous RCT investigated the effects of BCI training (BCIT) on recovery of motor and brain function in patients after stroke.