Deans' stroke musings: FDA grants breakthrough designation for device to treat PTSD

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Saturday, January 15, 2022

FDA grants breakthrough designation for device to treat PTSD

You'll have to ask your doctor if the PTSD you get from your stroke can be treated with this.

You do have a 23% chance of stroke survivors getting PTSD.

The latest here:

FDA grants breakthrough designation for device to treat PTSD

The FDA has granted breakthrough device designation to electroCore Inc. for its gammaCore device to be used in the treatment of PTSD in military personnel, according to a company release.
“We appreciate the thorough and timely review by the FDA of our Breakthrough Device Request for gammaCore for the treatment of PTSD,” said Eric Liebler, senior vice president of neurology at electroCore. “The ability of (non-invasive vagus nerve stimulation [nVNS]) to target several of the underlying causes of PTSD such as autonomic dysfunction, stress and inflammation, safely and effectively supports its potential as a breakthrough treatment for PTSD.”

The portable device is a noninvasive, hand-held therapy. When applied at the neck, it treats migraine and cluster headaches through deliverance of mild electrical stimulation to the vagus nerve, which can lead to pain reduction. GammaCore can be self-administered by patients, as needed, without possible side effects from commonly prescribed drugs.

The breakthrough device designation was supported by research conducted by a joint effort between physicians from Emory University and Georgia Tech, led by J. Douglas Bremner, MD and Omer T. Inan, PhD. Their study demonstrated how nVNS blocks sympathetic and inflammatory responses to memories of traumatic events in patients with PTSD, modulates brain responses to traumatic memory and reduced symptoms by 31% compared with a sham stimulation.

“Current treatments for PTSD involving medication and psychotherapy have limitations due to limited efficacy, possible side effects and the unwillingness of many PTSD patients to engage in therapies that involve reliving traumatic memories,” Bremner said in the release.

“GammaCore represents a new class of treatment separate from medication or psychotherapy that is safe, relatively free of side effects, and does not involve costly and invasive procedures for implantation, like previous VNS devices approved by the FDA for treatment of refractory depression.”

FDA approves stroke rehabilitation system
FDA grants 510(k) clearance for vagus nerve stimulation device in adolescent migraine

GammaCore had been previously cleared by the FDA for auxiliary use to prevent cluster headache in adults, for acute treatment of pain resulting from episodic cluster headache in adults, as well as for acute and preventive treatment of migraines in patients aged 12 or above.