NCH Health: Surgery to restore mobility in stroke patients

 This was approved August 27, 2021 so nothing is competent about getting new interventions into this hospital!

I think most stroke survivors would rather do the non-invasive approaches. So ask your doctor why surgery; I'm guessing revenue and profits.

Dorset Embarks on Revolutionary Stroke Recovery Trial Utilizing Earpiece Technology

Non-invasive VNS approach could enhance post-stroke recovery outcomes August 2023

The latest here:

NCH Health: Surgery to restore mobility in stroke patients

Paul Hiltz

NCH President & CEO

I am excited to announce a regional first at Naples Comprehensive Health (NCH): The successful implementation of the Vivistim System, a cutting-edge procedure designed to enhance mobility for patients experiencing moderate to severe upper extremity motor deficits following an ischemic stroke.

This innovative treatment has received approval from the U.S. Food and Drug Administration (FDA) and places NCH at the forefront of stroke rehabilitation. We are currently the only facility in Southwest Florida offering this groundbreaking procedure, distinguishing ourselves as one of only five Joint Commission-accredited Comprehensive Stroke Centers in the state and the sole provider on the Gulf Coast.

Ischemic stroke often leaves survivors with significant long-term motor challenges, drastically affecting their quality of life. Traditional treatments have typically offered limited mobility improvements, leaving many patients dependent on others for daily activities.

The Vivistim System is a breakthrough in fostering neuroplasticity, providing renewed hope and significantly shifting the landscape of stroke rehabilitation. It involves the use of an implantable pulse generator (IPG) that delivers mild electrical pulses, implanted under the skin in the chest. A lead wire connects the IPG to electrodes positioned near the vagus nerve on the left side of the neck. This stimulation aims to lessen motor function deficits in the arms and hands, improving patients' independence.

Millions of stroke survivors suffer from continued impairment in their hands and arms at three to six months following a stroke. This is often called a recovery plateau, which means their condition stops improving. Research indicates that moving past the recovery plateau requires neuroplasticity, the ability of the brain to form new neural pathways.

We are proud to be offering this revolutionary treatment to our stroke patients. This accomplishment highlights our unwavering commitment to advancing medical science to enhance patient outcomes.

This milestone not only underscores significant progress in the field of stroke rehabilitation but also emphasizes our commitment to excellence in patient care and medical innovation. As our healthcare system continues to evolve into an Advanced Community Healthcare System™, this achievement solidifies our status as a leader in stroke treatment across the region.

 

New device boosting brain, body communication in stroke survivors

Not new at all, approved in August 2021 and I bet your hospital still doesn't have it.

Or maybe you'd rather have the non-invasive system. But you'll have to claim PTSD from military service since it hasn't been tested in stroke survivors yet.

• gammaCore (2 posts to May 2017)

 

FDA approves stroke rehabilitation system August 2021

The latest here:

New device boosting brain, body communication in stroke survivors

BOSTON —

Ever since his stroke two years ago, David Sullivan has struggled to use his left side.

A 40-year-old father of two young girls, he says a lot goes on inside his head every time he swings a bat or picks up a towel.

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"Extend," Sullivan said out loud, as he placed laundry in a basket at Spaulding Rehabilitation Hospital in Boston. "Now I'm picturing my hand opening up."

After the stroke, Sullivan's brain and body communicate differently — or not well at all.

"I'm working on rotation of the wrist," he said. "Being able to grab something and release easily. A lot of shoulder work reaching to shelves."

Repetition helps, but sometimes it's not enough. Many patients like Sullivan reach a plateau.

"He was highly motivated to continue to improve," said Teresa Jacobson Kimberley, a professor at Mass General Hospital's Institute for Health Professions and an expert in rehab science.

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"So you could be saying, 'Move your hand, move your hand,' and this one won't be moving," she demonstrated. "It's not enough of a signal to make it go."

Kimberley's research led to the development of a device to help boost that signal to the brain.

"It's not just for people who've just had their stroke," she said. "This can be somebody who's had a stroke several years ago, who's been told they've plateaued and not going to get any better. This is now available to them."

It's called the Vivistim System.

To work, a surgeon implants this device just under the skin on the chest. A wire runs along the vagus nerve from the neck to the brain. Once activated either at home or in rehab, the device sends a mild electric pulse through the wire.

"It stimulates the nerve directly, which then sends its message into the brain, helping to release neurotransmitters that help you to form the connections that you need so those nerves can get stronger," Kimberely said.

In clinical trials, patients who used the system during exercises saw their improvement double or even triple within six months.

Sullivan had the procedure in September.

"So two months out, I've noticed for the arm or the shoulder some gains," he said. "So that's encouraging. The hand is definitely slower, but I expected that."

The success so far motivates Sullivan to do more, but so do his girls.

"This is my job right now," he said. "Every day. Multiple times a day. It's constant."

Right now, the Vivistim System is only approved to treat motor function in the upper extremities, but new research is underway to evaluate its impact on other areas, such as the legs and even speech.

Patients interested in learning more about the treatment can contact the MGH Neurorecovery Clinic.

FDA approves stroke rehabilitation therapy created at UT Dallas

How many time does this exact same research need to be published before your hospital does ONE DAMN THING with it? 

• Vivistim® System (3 posts to February 2015)

• Vivistim™ (1 post to June 2018)

The latest here:

FDA approves stroke rehabilitation therapy created at UT Dallas

The FDA approval is being called ‘the most significant success’ in the Biomedical Device Center’s nine-year history.

A stroke rehabilitation system created at the University of Texas at Dallas recently received approval from the Food and Drug Administration.(Ben Torres / Special Contributor)

By Cecilia Lenzen

9:55 AM on Sep 15, 2021 CDT — Updated at 9:53 AM on Sep 16, 2021 CDT

Updated at 9:53 a.m. Thursday to clarify what received FDA approval.

A stroke rehabilitation method invented at the University of Texas at Dallas recently received approval from the Food and Drug Administration.

The system that treats chronic ischemic stroke survivors is the first of its kind, according to a UT Dallas press release.

Most strokes (87%) are ischemic strokes, which are often caused by blood clots, according to the Centers for Disease Control and Prevention. An ischemic stroke happens when blood flow through the artery that supplies oxygen-filled blood to the brain becomes blocked.

The Vivistim Paired VNS System was produced and commercialized by MicroTransponder, a company started by UT Dallas graduates, according to the release. Patients with arm and hand weakness after a stroke were studied while pairing the rehabilitation system with rehabilitation exercises. The study showed that those patients improved two to three times more than the control group patients, who received rehab alone, the release said.

Every year, more than 795,000 people in the U.S. experience a stroke, according to the CDC. Increasing the effectiveness of physical rehabilitation for mobility and motor skills could help improve quality of life for many stroke victims, according to the release.

Dr. Michael Kilgard, interim executive director of the Biomedical Device Center, said in the release that the FDA’s approval of this rehabilitation system is “the most significant success” in the center’s nine-year history.

“This announcement means that stroke survivors all over the country can soon begin receiving a safe and effective therapy to improve their recovery,” Kilgard said in the release.

For more information on the rehabilitation system, click here.

CORRECTION, 9:53 a.m., Sept. 16, 2021: An earlier version of this story and the headline indicated that the center received FDA approval, rather than the rehabilitation system.

FDA approves stroke rehabilitation system

 

 Really? You mean you haven't been doing this for survivors for 9 years already?

• vagus nerve (53 posts to July 2012)

FDA approves stroke rehabilitation system

The FDA approved the Vivistim System, a drug-free rehabilitation system using vagus nerve stimulation for treating moderate and severe upper extremity mobility loss caused by chronic ischemic stroke.

“People who have lost mobility in their hands and arms due to ischemic stroke are often limited in their treatment options for regaining motor function,” Christopher M. Loftus, MD, acting director of the FDA’s Center for Devices and Radiological Health’s office of neurological and physical medicine devices, said in a press release. “Today’s approval of the Vivistim Paired VNS System offers the first stroke rehabilitation option using vagus nerve stimulation.”

MicroTransponder’s Vivistim Paired VNS System (Vivistim System) used in conjunction with rehabilitation therapy helps improve motor function in the hands and arms following ischemic stroke, according to the release. The system uses an implanted pulse generator to electrically stimulate the vagus nerve, which connects the brain and abdomen. The system can be used in clinical settings and at home.

The FDA granted approval based on a clinical study of 108 patients in the U.S. and the U.K., which found patients treated with the Vivistim System had more improved mobility than patients in the control group.

“Used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke,” Loftus said in the release.

 

Potential improvements in stroke recovery through nerve stimulation

Just who the fuck is incompetent enough to not know of all the previous vagus nerve research that they approved this new one? Names please, we need to embarrass the hell out of these people and get them out of the stroke world.

It is so easy, here are 34 posts on vagus nerve. If I, a stroke addled survivor can pull them up in 1 minute, your stroke leaders should be able to do it in one quarter that time.

https://www.medicaldevice-network.com/comment/potential-improvements-stroke-recovery-nerve-stimulation/

A new clinical trial at The Ohio State University is aiming to shorten the recovery period of motor skills for stroke patients via vagus nerve stimulation (VNS), drastically improving patients’ post-stroke outcomes and quality of life. Vivistim, a device developed by the Dallas-based company MicroTransponder, works by pairing VNS with muscle movement during rehabilitation. The pairing leads to strengthening of the neural circuits in the brain associated with motor function, learning, and memory.

As one of the leading causes of disability worldwide, acute ischemic stroke (AIS) is becoming increasingly prevalent due to both the growing aging population and an increase in risk factors such as high blood pressure, diabetes, high cholesterol, and obesity. Stroke, particularly in older adults, can lead to loss of motor function in multiple areas, such as movement, balance, and coordination; however, early treatment has been shown to reduce the chances of poor post-stroke outcome.

With the rising rate of stroke, focus has been placed on improving the prevention, intervention, and rehabilitation stages of stroke care. Neurovascular thrombectomy is positioned to be the new gold standard of treatment for stroke, as studies have shown that patients who received thrombectomy were “more likely to be functionally independent than those who received tPA [tissue plasminogen activator] alone” (Kulkarni, 2015). GlobalData expects the number of thrombectomy procedures to grow to 100,000 by 2027, which would lead to a decrease in post-stroke disability. Utilizing nerve stimulation for rehabilitation in combination with effective interventions would limit the impact of complications following an event.

The new application of nerve stimulation within stroke care could drastically improve the quality of life and recovery for stroke patients. If the Vivistim shows positive results in stroke patients regaining motor function earlier, many doors for potential rehabilitative treatment and reducing the burden of stroke on healthcare systems could be opened for the device.

MicroTransponder Presents Long Term Stroke Trial Data at INS and Announces a 120 Patient Pivotal Stroke Trial

Ask your doctor if this non-invasive stimulation of the vagus nerve would be better. I don't care that this wasn't tested in stroke yet. Does no one have any brains to rub two neurons together to run this non-invasive one thru stroke clinical trials?

FDA Releases gammaCore®, the First Non-Invasive Vagus Nerve Stimulation Therapy Applied at the Neck for Acute Treatment of Pain Associated with Episodic Cluster Headache in Adult Patients

http://www.marketwired.com/press-release/microtransponder-presents-long-term-stroke-trial-data-ins-announces-120-patient-pivotal-2219173.htm

Late Breaking Long Term Clinical Study Results at the International Neuromodulation Society Conference Show Continued Improvement for Stroke Patients and a New 120 Patient Stroke Trial Will Begin Enrollment this Summer

DALLAS, TX--(Marketwired - May 30, 2017) - MicroTransponder, Inc., (www.microtransponder.com) today unveiled new positive long-term positive clinical trial results from the Vivistim™ Stroke Rehabilitation trial. The objective of this multicenter, double-blind, randomized, active-controlled trial was to improve upper limb mobility in stroke survivors suffering chronic disability. The data was presented by Jesse Dawson M.D., University of Glasgow Hospital, and Teresa Kimberley, PhD, University of Minnesota Hospital. They presented the data to the clinicians gathered at the International Neuromodulation Society (INS) conference in Edinburgh, UK. The data showed 75% of patients had a clinically meaningful response on the Fugl-Meyer Upper Extremity Scale (FMUE) at the end of a six weeks of physical therapy compared to 33% for the control group. 90 days after the six weeks of physical therapy ended 88% of VNS patients had responded compared to 33% in the control arm. And during the long-term portion of the study average FMUE scores continued to increase, with the 6 month and 9 month data showing further gains. All responders indicated they believed their overall health had improved and were satisfied with the therapy.
"We saw remarkable improvement in some patients' upper limb function over the course of this trial," said Dr. Dawson. "For many patients, this included important daily activities such as feeding, grooming, driving, and dressing themselves. Some patients were able to resume their higher-level hobbies, such as photography, practicing piano, hosting large family events, and playing golf. Overall, my patients were able to integrate the at- home-therapy component of the program quite easily into their lives."
The Stroke Rehabilitation trial featured the Vivistim® System, which is a neurostimulation based system with a small implanted battery and wires that internally connect to the vagus nerve in the neck. As the patient performs physical therapy exercises, they receive a small burst of neurostimulation to their vagus nerve. This Paired VNS® (Vagus Nerve Stimulation) method is based on decades of neuroscience research and takes advantage of the brain's ability to rewire itself (neuroplasticity). When stimulated, the vagus nerve causes the release of neurochemicals in the brain that encourage neuroplasticity. More information can be found on www.MicroTransponder.com.
In addition to the presentation of the long-term data, Frank McEachern, CEO of MicroTransponder; also spoke at the INS. McEachern announced that MicroTransponder had received IDE approval from the FDA to run a 120-patient pivotal trial. The stroke rehabilitation trial will include 12 U.S. and 3 UK centers and will begin enrolling patients this Summer. "There are currently very few options for chronic stroke survivors and our committed team of physicians, researchers, and engineers hope to deliver a meaningful option that will make a significant difference for these survivors and their families," noted McEachern. "We experienced an outpouring of interest from many academic centers to participate in our clinical trials once we presented our initial stroke rehabilitation data at the International Stroke Conference earlier this year. We are pleased to announce that our 120-patient clinical trial is now approved and includes many prestigious institutions and some of the best stroke and neurostimulation researchers worldwide. Enrollment will begin this Summer and additional clinical trial information can be found by visiting www.vnsstroketrial.com."
About MicroTransponder, Inc.
MicroTransponder Inc. (www.microtransponder.com) is a medical device development company with a strong neuroscience research focus. An experienced team of scientists and engineers has developed neurostimulation technology platforms to treat various forms of neurological diseases, including post stroke motor rehabilitation and tinnitus. MicroTransponder has a sizeable neurostimulation-focused R&D program which is able to quickly translate scientific discoveries into clinical therapies.

Contact Information

• 
  
  Jordan Curnes
  jordan@microtransponder.com469-225-9268

MicroTransponder Invited to Present Stroke Clinical Trial Results at the International Stroke Conference, with U.S. Stroke Study to Follow

Vagus nerve stimulation. If you are close to one of the study sites I'm 100% positive your doctor will not be telling you about it. You are on your own with your recovery. Some movement would disqualify me and anyone else whose upper limb is in the dead brain area.

MicroTransponder Invited to Present Stroke Clinical Trial Results at the International Stroke Conference, with U.S. Stroke Study to Follow

MicroTransponder, Inc., (http://www.microtransponder.com) a privately-held medical device company is pleased to announce the successful completion of its 20-patient stroke trial using the Vivistim® System. The results of this ground breaking clinical trial for stroke patients who experience limited upper limb mobility following a stroke will be presented during an oral presentation at the International Stroke Conference on Feb. 12 at 2:42 PM in Nashville, Tennessee. The International Stroke Conference is one of the largest gathering of stroke clinicians in the world and is sponsored by the American Heart Association. (http://www.strokeconference.org)
The 20-patient study focused on stroke patients with limited upper limb function following their stroke. The lack of upper limb mobility impeded the ability to do daily tasks and live independently. The study was conducted at 2 stroke centers in the United Kingdom. The principle investigator for the study was Dr. Jesse Dawson, and he explained, “We saw dramatic improvements in these patients over the 6-week treatment period. Some patients were able to resume daily activities like driving, swimming, grocery shopping, cooking, and taking care of young children.”
Based on these successful trial results, MicroTransponder has planned a 20-patient follow up U.S. stroke study. The initial sites will be in Dallas, Texas, Houston, Texas, and Minneapolis, Minnesota. Enrollment is now open and the sites are seeking stroke patients who have recently had a stroke and are still experiencing upper limb movement limitations although they must still have some movement. More information is available at http://www.vnsstroketrial.com.
The Vivistim® System has been developed to treat stroke patients that experience an upper-limb deficit following their stroke. It consists of a small implanted battery and wires that internally connect to the vagus nerve in the neck. During the rehabilitative therapy, the patient receives a small amount of neurostimulation to the vagus nerve to strengthen the neural pathways in the brain. This paired treatment method is based on years of neuroscience research published in peer-reviewed academic journals. More information can be found on http://www.MicroTransponder.com
The invitation for an oral presentation at the International Stroke Conference is an important milestone for the Company notes CEO Frank McEachern, “We are honored to be able to present our clinical trial results to one of the largest gatherings of stroke clinicians in the world. Our mission is to bring this therapy to as many stroke patients as possible. Currently, they have very few options if traditional therapy is not effective.” To support additional U.S. clinical trials and further commercialization work, MicroTransponder plans to raise $5 million in funding this summer. Additional information can be found at http://www.MicroTransponder.com
About MicroTransponder, Inc.
MicroTransponder Inc. (http://www.microtransponder.com) is a medical device development company with a strong neuroscience research focus. An experienced team of scientists and engineers has developed and continue developing neurostimulation technology platforms to treat various forms of neurological diseases, including post stroke motor rehabilitation and tinnitus. MicroTransponder has a substantial neurostimulation-focused R&D program which is able to quickly translate scientific discoveries into clinical therapies.