cervella cranial electrotherapy stimulator

www.cervella.us

13295IllinoisStreet,Suite312,Carmel,IN46032+1(855)413-3300|www.cervella.us

FrequentlyAskedQuestions?

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Q: What makes Cervella different from otherCESdevices?

A:We have seamlessly integrated the treatmentelectrodes into high-quality noise-cancellingheadphones so that you can incorporate yourtreatment sessions into your lifestyle, not theother way around. Cervella is also the first app-controlled CES device that automatically recordsyour treatment parameters for you to sharewithyourhealthproviderinordertoimprovetreatmentoutcome. Cervella is the first and only cranialelectrotherapystimulator(CES)thatallowsyoutoreceivetreatmentduringwork,study,orplay!

Q:HowsoonwillIstartfeelingbetter?

A:Most patients start feeling the positive effectsof cranial electrotherapy stimulation within thefirst week. Note that results vary and aredependentonyourcondition.Alwaysconsultyourhealthcare provider before starting Cervella andfollow the treatment plan as directed. Anxiety isoften reduced after a single treatment but mayreoccur so consistent treatment sessions arerecommended. Many patients suffering fromanxietyfinditusefultouseCervellaattheonsetofanxietyorbeforeahighstresssituation.

Patients with depression will often seeimprovementsinafewweeks,butpatientsshouldcontinue to use Cervella as directed by theirhealthcare provider. Insomnia is often reducedafter a single treatment but, like depression,consistent treatment sessions are recommendedevenwhenyouarefeelingbetter.Whenconditionsimprove, please use Cervella at reduced intervalsor on an as-need basis as instructed by yourhealthcareprovider.

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Q:WhoshouldnotuseCervella?

A: Cervella should not be used by childrenwithout supervision. Cervella may affectthe operation of implanted devices (e.g.cardiac pacemakers or defibrillators).Safety of stimulation has not beenestablished for women who are pregnant.Always consult your healthcare providerbeforeusingCervella.

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How does Cranial ElectrotherapyStimulatorwork?

Cranial Electrotherapy Stimulators transmitsmall pulses of electric current acrosspatient’s brain via a pair of conductiveelectrodes placed on patient’s forehead,mastoidorearlobes.CESdeviceshavebeenin existence for several decades and arecleared by the FDA for treatment ofinsomnia, depression, and anxiety. Theyexhibit good efficacy (especially fortreatmentofanxietyandinsomnia)andhavenosignificantcontraindications.CESdevicespresent a very good alternative to drugtreatmentsespeciallyforpatientsthateitherexhibit low efficacy with drug-basedtherapies or experience significant sideeffectswiththedrugs(usuallySSRIs).

During a treatment session, which typicallylasts 30 minutes, patients suffering fromanxiety, insomnia, and depression willexperiencereductionofanxietyimmediatelypost-treatmentandimprovedsleeppatterns(insomnia reduction). Longer-term use hasbeen clinically validated to have a positiveeffect on reducing patient’s depressivemood.

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Results: Analysis of covariancerevealed a significant differencebetween the active CES group andthe sham CES group on anxiety(p=0.001, d=0.94) and ondepression (p=0.001, d=0.78) frombaseline to endpoint of study infavoroftheactiveCESgroup.

Conclusions: CES significantlydecreases anxiety and comorbiddepression. Subjects reported noadverse events during the study.Thelargeeffectsizesfortheeffectsof CES on anxiety and comorbiddepression reveal a favorablerisk/rewardratiosupportingtheuseofCESforthetreatmentofanxietyand comorbid depression inevidence-basedpractice.

cervella is a medical device for non-drug treatment of anxiety, insomnia, and depression

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ClinicalEvidence

Cranial Electrotherapy Stimulationhas been present in medical use forseveraldecades.Consequently,thereis a large body of clinical evidencedocumenting the efficacyofCES fortreatment of anxiety, depression,andinsomnia.

Below, we present a sample of arecent double blind clinical trial(N=115):

BarclayTH,BarclayRD.Aclinicaltrialof cranial electrotherapy stimulationfor anxiety and comorbid depression.Journal of Affective Disorders. 2014;164:171-177.

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WhatisCervella?

Cervella Cranial Electrotherapy Stimulator(CES) is an FDA-cleared medical device fortreatment of anxiety, insomnia, anddepression. The stimulator is powered by aninternalrechargeablebattery.Cervellaprovidesalow-levelcurrentacrossthepatient’scraniumvia a pair of conductive electrodes that areintegrated into ear pads of Bluetooth-enabledstereo noise-canceling headphones allowingpatienttoreceivetreatmentanywhere.

Cervellaiscontrolledviaasoftwareapplication(app) installed on patient’s smart device (e.g.smartphone). The patient uses the app toadjust the intensity level, frequency, anddurationofthetreatment.Theappalsoallowsthe patient to automatically store thetreatment history for review by his or herhealthcareprovider.