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Bob P

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Shut up Bob!

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Vagus Nerve Stimulation - NOT
Sep 6^th, 2016 at 8:54am

Abstract
Objective

To evaluate non-invasive vagus nerve stimulation (nVNS) as an acute cluster headache (CH) treatment.
Background

Many patients with CH experience excruciating attacks at a frequency that is not sufficiently addressed by current symptomatic treatments.
Methods

One hundred fifty subjects were enrolled and randomized (1:1) to receive nVNS or sham treatment for ≤1 month during a double-blind phase; completers could enter a 3-month nVNS open-label phase. The primary end point was response rate, defined as the proportion of subjects who achieved pain relief (pain intensity of 0 or 1) at 15 minutes after treatment initiation for the first CH attack without rescue medication use through 60 minutes. Secondary end points included the sustained response rate (15-60 minutes). Subanalyses of episodic cluster headache (eCH) and chronic cluster headache (cCH) cohorts were prespecified.
Results

The intent-to-treat population comprised 133 subjects: 60 nVNS-treated (eCH, n = 38; cCH, n = 22) and 73 sham-treated (eCH, n = 47; cCH, n = 26). A response was achieved in 26.7% of nVNS-treated subjects and 15.1% of sham-treated subjects (P = .1). Response rates were significantly higher with nVNS than with sham for the eCH cohort (nVNS, 34.2%; sham, 10.6%; P = .008) but not the cCH cohort (nVNS, 13.6%; sham, 23.1%; P = .48). Sustained response rates were significantly higher with nVNS for the eCH cohort (P = .008) and total population (P = .04). Adverse device effects (ADEs) were reported by 35/150 (nVNS, 11; sham, 24) subjects in the double-blind phase and 18/128 subjects in the open-label phase. No serious ADEs occurred.
Conclusions

In one of the largest randomized sham-controlled studies for acute CH treatment, the response rate was not significantly different (vs sham) for the total population; nVNS provided significant, clinically meaningful, rapid, and sustained benefits for eCH but not for cCH, which affected results in the total population. This safe and well-tolerated treatment represents a novel and promising option for eCH. ClinicalTrials.gov identifier: NCT01792817.

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Mrs. Barlow, I never, and I repeat never, ever pissed in your steam iron. "SHUT UP HUB!"

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Potter

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Re: Vagus Nerve Stimulation - NOT
Reply #1 - Sep 6^th, 2016 at 10:33am

Bob P wrote on Sep 6^th, 2016 at 8:54am:

Abstract
Objective

To evaluate non-invasive vagus nerve stimulation (nVNS) as an acute cluster headache (CH) treatment.
Background

Many patients with CH experience excruciating attacks at a frequency that is not sufficiently addressed by current symptomatic treatments.
Methods

One hundred fifty subjects were enrolled and randomized (1:1) to receive nVNS or sham treatment for ≤1 month during a double-blind phase; completers could enter a 3-month nVNS open-label phase. The primary end point was response rate, defined as the proportion of subjects who achieved pain relief (pain intensity of 0 or 1) at 15 minutes after treatment initiation for the first CH attack without rescue medication use through 60 minutes. Secondary end points included the sustained response rate (15-60 minutes). Subanalyses of episodic cluster headache (eCH) and chronic cluster headache (cCH) cohorts were prespecified.
Results

The intent-to-treat population comprised 133 subjects: 60 nVNS-treated (eCH, n = 38; cCH, n = 22) and 73 sham-treated (eCH, n = 47; cCH, n = 26). A response was achieved in 26.7% of nVNS-treated subjects and 15.1% of sham-treated subjects (P = .1). Response rates were significantly higher with nVNS than with sham for the eCH cohort (nVNS, 34.2%; sham, 10.6%; P = .008) but not the cCH cohort (nVNS, 13.6%; sham, 23.1%; P = .48). Sustained response rates were significantly higher with nVNS for the eCH cohort (P = .008) and total population (P = .04). Adverse device effects (ADEs) were reported by 35/150 (nVNS, 11; sham, 24) subjects in the double-blind phase and 18/128 subjects in the open-label phase. No serious ADEs occurred.
Conclusions

In one of the largest randomized sham-controlled studies for acute CH treatment, the response rate was not significantly different (vs sham) for the total population; nVNS provided significant, clinically meaningful, rapid, and sustained benefits for eCH but not for cCH, which affected results in the total population. This safe and well-tolerated treatment represents a novel and promising option for eCH. ClinicalTrials.gov identifier: NCT01792817.

Here we can see clearly where we analyze carefully and thoroughly , can you see from several points of difference and comparison , can be achieved with the central idea that departs from the main argument , and if we analyze the image to my knowledge , since it is a particular case , we can conclude after several scientific studies , through some research that my comment makes no sense .... thank you for your attention.

Potter

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Bob P

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Shut up Bob!

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Clio,California
Gender: male

Re: Vagus Nerve Stimulation - NOT
Reply #2 - Sep 7^th, 2016 at 8:34am

Quote:

Here we can see clearly where we analyze carefully and thoroughly , can you see from several points of difference and comparison , can be achieved with the central idea that departs from the main argument , and if we analyze the image to my knowledge , since it is a particular case , we can conclude after several scientific studies , through some research that my comment makes no sense .... thank you for your attention.

Potter

Exactly!

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Mrs. Barlow, I never, and I repeat never, ever pissed in your steam iron. "SHUT UP HUB!"

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Hoppy CH.com Alumnus Offline LAUGHTER IS THE BEST MEDICINE Posts: 1890 Perth WA Gender:	Re: Vagus Nerve Stimulation - NOT Reply #3 - Sep 7^th, 2016 at 6:14pm Multimedia File Viewing and Clickable Links are available for Registered Members only!! You need to or
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Peter510 CH.com Alumnus Offline Don't give out... But don't give in. Posts: 966 Wexford. Ireland Gender:	Re: Vagus Nerve Stimulation - NOT Reply #4 - Sep 7^th, 2016 at 7:15pm I've been using gammaCore for a number of years Before starting D3 it was my first line of defence and worked very well. I have a unit with me at all times and never go anywhere without it. Mind you, I have only used it over a one week period since starting the D3 regimen. Peter.
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Mike NZ

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Oxygen rocks! D3 too!

Posts: 3785
Auckland, New Zealand
Gender: male

Re: Vagus Nerve Stimulation - NOT
Reply #5 - Sep 8^th, 2016 at 12:10am

Peter510 wrote on Sep 7^th, 2016 at 7:15pm:

I have a unit with me at all times and never go anywhere without it.

Mind you, I have only used it over a one week period since starting the D3 regimen.

This is a great example of not just how D3 does great stuff, but being prepared in case. (This really makes me remember the cub scout motto from quite a few years ago "Be prepared"!).

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