Friday, March 11, 2022

PathMaker begins MyoRegulator trial to treat post-stroke spasticity

While spasticity of my leg and foot are problems I would prefer fixing the spasticity of my hand first.

You'll have to ask your doctor what happened to riluzole for treating spasticity. Phase II clinical trials were supposed to be completed in 2018. 

PathMaker begins MyoRegulator trial to treat post-stroke spasticity

 

The trial will assess the safety and efficacy of post-stroke lower-limb spasticity treatment with MyoRegulator.

PathMaker Neurosystems has commenced the multi-centre clinical trial of MyoRegulator for the non-invasive treatment of post-stroke spasticity in the US.

The non-invasive neuromodulation device is designed to suppress hyperexcitable spinal motor neurons.

It uses the company’s DoubleStim technology, which enables simultaneous stimulation at spinal and peripheral sites.

The randomised, sham-controlled, multi-centre, double-blind clinical trial is designed to assess the safety and efficacy of post-stroke lower-limb spasticity treatment with MyoRegulator in sham-treated and active participants.

It is being conducted with the Spaulding Rehabilitation Hospital in Charlestown, Massachusetts, and is expected to recruit 76 subjects.

The National Institute of Neurological Disorders and Stroke (NINDS) is providing a $4.9m NINDS Cooperative Research to Enable and Advance Translational Enterprises for Devices (CREATE Devices) grant for the pivotal clinical study.


Outsourcing your wire components for stimulation therapy

PathMaker CEO and president Nader Yaghoubi said: “The launch of this multi-centre trial is an important milestone in the development of our first-in-class product, MyoRegulator.

“We are very

pleased to be working with the world-class team at Spaulding, and are grateful to have the support of NINDS as we advance this product towards commercial launch.”

MyoRegulator is claimed to be the first and only neuromodulation device developed to treat muscle spasticity without using drugs or surgery.

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