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ActiPatch does a study on migraines
HowDoYouDeal
Posted: Saturday, November 16, 2019 6:46 PM
Joined: 2/17/2019
Posts: 316


https://www.clinicaltrials.gov/ct2/show/NCT03166046?term=actipatch&draw=2&rank=2

Supraorbital neurostimulation (tSNS) of the upper branches of the trigeminal nerves was found superior to sham stimulation for episodic migraine prevention in a previous randomized trial in a large cohort of patients with migraine. 

In this study the pulsed shortwave device will be incorporated in a wrap which will enable easy placement of the device in the desired located which will be over the supratrochlear and supraorbital branches of the ophthalmic nerve.

Study Design
Go to  sections

 

Study Type  : Interventional  (Clinical Trial) Actual Enrollment  : 45 participants Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomized, double blind, placebo controlled trial using an active pulsed shortwave therapy device or placebo pulsed shortwave therapy device Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: Coded devices that are identical in appearance and function. Placebo device does not emit electromagnetic field. Active device electromagnetic field is sub-sensory. Primary Purpose: Treatment Official Title: Migraine Prevention Using Pulsed Shortwave Therapy Actual Study Start Date  : June 1, 2017 Actual Primary Completion Date  : April 1, 2018 Actual Study Completion Date  : April 30, 2018
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Posted: Sunday, November 24, 2019 7:33 PM
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Overview

This trial has been completed.

Condition migraine Treatments pulsed shortwave therapy, placebo pulsed shortwave therapy Sponsor BioElectronics Corporation Start date June 2017 End date April 2018 Trial size 45 participants Trial identifier NCT03166046, SAIRB-17-0021

Summary

Chronic pain is now widely understood to be due to central sensitization, which leads to exaggerated pain perception. Migraine is no exception, since it is well known that sensitization of the trigeminovascular pain pathway can occur during a migraine attach. There is early evidence that ActiPatch can help mitigate this sensitization, so this study is being conducted to determine the efficacy of ActiPatch in preventing chronic, episodic migraines.

Location Institution Status Indianapolis, IN  Eppley Group completed

Study Design

Allocation randomized Intervention model parallel assignment Intervention model description randomized, double blind, placebo controlled trial using an active pulsed shortwave therapy device or placebo pulsed shortwave therapy device Primary purpose treatment Masking quadruple (participant, care provider, investigator, outcomes assessor) Masking description coded devices that are identical in appearance and function. placebo device does not emit electromagnetic field. active device electromagnetic field is sub-sensory. Arm
(Active Comparator)
Subjects will use the active pulsed shortwave therapy device (ActiPatch) as a prophylactic treatment for episodic migraine
pulsed shortwave therapy ActiPatch Stimulation of the supratrochlear and supraorbital branches of the ophthalmic nerve.
(Placebo Comparator)
Subjects will use the placebo pulsed shortwave therapy device (Placebo ActiPatch) as a prophylactic treatment for episodic migraine
placebo pulsed shortwave therapy Placebo ActiPatch Placebo Stimulation of the supratrochlear and supraorbital branches of the ophthalmic nerve.

Primary Outcomes

Measure
Migraine frequency
time frame: 4 weeks
Migraine duration
time frame: 4 weeks

Secondary Outcomes

Measure
Migraine intensity measured with Visual Analogue Pain Score
time frame: 4 weeks
Headache disability measured with Headache Impact Test
time frame: 4 weeks

HowDoYouDeal
Posted: Sunday, November 24, 2019 7:34 PM
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Posts: 316


The ophthalmic nerve is a sensory nerve mostly carrying general somatic afferent fibers that transmit sensory information to the CNS from structures of the eyeball, the skin of the upper face and anterior scalp, the lining of the upper part of the nasal cavity and air cells, and the meninges of the anterior cranial ...

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Posted: Sunday, November 24, 2019 7:43 PM
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Anatomy

The ophthalmic nerve is the most superior branch of the trigeminal ganglion, and it is exclusively sensory. It provides sensory information to the following structures:

  • The eyes
  • Conjunctiva and orbital contents including the lacrimal gland
  • Nasal cavity, frontal sinus, ethmoidal cells
  • Falx cerebri
  • Dura mater of the anterior cranial fossa
  • Superior parts of the tentorium cerebelli
  • Upper eyelid
  • Dorsum of the nose
  • Anterior part of the scalp

During its pathway, this nerve also receives sympathetic fibers that project to the autonomous ciliary ganglion. Some authors describe this ganglion as belonging to the oculomotor nerve.

Recommended video: Ophthalmic nerve
Course and branches of the ophthalmic branch of the trigeminal nerve.

Course and relations

The ophthalmic nerve arises from the anterior edge of the trigeminal ganglion and then extends forward through the lateral wall of the dura mater of the cavernous sinus. Superior to the ophthalmic nerve is the trochlear nerve, whereas inferolateral to it is the maxillary nerve. Medial to all of these three nerves is located the internal carotid artery that goes through the cavernous sinus.

After leaving the cavernous sinus, the ophthalmic nerve goes through the superior orbital fissure, where it is usually already divided into its three terminal branches:

  • Lacrimal nerve
  • Frontal nerve
  • Nasociliary nerve

Branches

Along its pathway, the ophthalmic nerve extends to a number of lateral branches. The most important of them is the recurrent tentorial nerve that courses backward and innervates the tentorium cerebelli. Besides this branch, most of the significance is given to the terminal branches of the ophthalmic nerve.

Lacrimal nerve

This is the most lateral and thinnest branch of the ophthalmic nerve. It extends forward and laterally, across the roof of the orbit and travels towards the lacrimal gland that is located in the upper lateral angle of the orbit. Before it reaches the gland, the lacrimal nerve extends to several branches. These branches either terminate in the lacrimal gland, or they pass through the gland and end in the upper eyelid.

Just behind the lacrimal gland, the lacrimal nerve extends a communicant branch for the zygomatic nerve. Through this anastomosis, the parasympathetic fibers from the pterygopalatine ganglion reach the lacrimal gland. These fibers originate from the petrosal nerve of the facial nerve.

Frontal nerve

This is the middle and thickest branch of the ophthalmic nerve. It courses forwards, directly beneath the roof of the orbit and superiorly to the superior palpebral levator muscle. Inside the orbit, the nerve extends to both of its terminal branches:

  • The supraorbital nerve is the lateral branch and splits into two of its own terminal branches: the lateral branch and the medial branch.
  •  
  •   These two terminal branches leave the orbit through the incisures on the anterior edge of the frontal bone, and then send sensory fibers that innervate the skin of the forehead and the upper eyelid. Precisely, the lateral branch exits the orbit along with the supraorbital artery through the same named, supraorbital incisure. On the other hand, the medial branch reaches the forehead by coursing through the frontal incisure together with the supratrochlear artery.
  •  
  • The supratrochlear nerve is placed medial to the supraorbital nerve. It courses medially and forward, traveling to the superior medial angle of the orbit. It extends to the superior and inferior branches that innervate the skin of the dorsum of the nose and adjacent skin of the upper eyelid.
Supraorbital nerve (Nervus supraorbitalis)

HowDoYouDeal
Posted: Sunday, November 24, 2019 7:46 PM
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  Cefaly? for Migraine?

 

Fig. 1 The electrical impulses generated by the Cefaly device are transmitted via an electrode to excite the upper branches of the ophthalmic nerve (V1). These pictures are the property of Cefaly Technology
Fig. 1 The electrical impulses generated by the Cefaly device are transmitted via an electrode to excite the upper branches of the ophthalmic nerve (V1). These pictures are the property of Cefaly Technology 

Published in Pain and Therapy 2015

Transcutaneous Supraorbital Nerve Stimulation (t-SNS) with the Cefaly® Device for Migraine Prevention: A Review of the Available Data

Franz Riederer, Sophie Penning, Jean Schoenen

 

Table 1 Compliance of returned Cefaly devices after the rental period
Table 1 Compliance of returned Cefaly devices after the rental period 
 

Published in Pain and Therapy 2015

Transcutaneous Supraorbital Nerve Stimulation (t-SNS) with the Cefaly® Device for Migraine Prevention: A Review of the Available Data

Franz Riederer, Sophie Penning, Jean Schoenen

 

Fig. 2 Results of the PREMICE study. Results are presented as means or means ± standard deviations where appropriate. Baseline and treatment period were compared using the Wilcoxon signed rank test for paired samples.
Fig. 2 Results of the PREMICE study. Results are presented as means or means ± standard deviations where appropriate. Baseline and treatment period were compared using the Wilcoxon signed rank test for paired samples. 
 

Published in Pain and Therapy 2015

Transcutaneous Supraorbital Nerve Stimulation (t-SNS) with the Cefaly® Device for Migraine Prevention: A Review of the Available Data

Franz Riederer, Sophie Penning, Jean Schoenen

 

ttps://www.semanticscholar.org/paper/Transcutaneous-Supraorbital-Nerve-Stimulation-with-Riederer-Penning/e33d0660b16e2b15f9961b62ee163b3d60389bfd

 

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HowDoYouDeal
Posted: Sunday, November 24, 2019 8:05 PM
Joined: 2/17/2019
Posts: 316



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