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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.
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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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Joined: 2/17/2019
Posts: 302
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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
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Joined: 2/17/2019
Posts: 302
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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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Joined: 2/17/2019
Posts: 302
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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
Ophthalmic nerve (Nervus ophthalmicus)
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.
Lacrimal nerve (Nervus lacrimalis)
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)
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Joined: 2/17/2019
Posts: 302
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Cefaly? for Migraine?
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Joined: 2/17/2019
Posts: 302
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