Imiphumela Yasekhaya Ye-Acute Migraine Treatment

I-CEFALY Technology namuhla imemezele imiphumela yocwaningo lomtholampilo olubonisa ukuthi ukwelashwa kwamahora amabili nge-e-TNS CEFALY kuyindlela ephephile futhi ephumelelayo, engeyona eyemithi yokwelashwa okunamandla kokuhlaselwa yi-migraine esimweni esingaphandle kwesibhedlela.

Isivivinyo se-e-TNS socwaningo lwe-Acute treatment of Migraine (TEAM) lwalungelokuqala, olulindelekile, oluyizimpumputhe kabili, olungahleliwe, olulawulwa ngomgunyathi lwe-2-hour e-TNS yokwelashwa kokuhlaselwa kwe-acute migraine ekhaya. isimo. Ucwaningo lwe-TEAM futhi luyisivivinyo esikhulu kunazo zonke esilawulwa nge-sham, somtholampilo esihlola ukusetshenziswa kwanoma yikuphi ukwelashwa kwe-e-TNS yokwelapha ikhanda elibuhlungu.

Isifo sezinzwa esivamile nesiqeda amandla, i-migraine ibalwe nguMhlaba

Inhlangano Yezempilo njengembangela yesibili ehamba phambili emhlabeni yokukhubazeka. Kunemikhawulo eminingana emithini evamile yokulwa ne-migraine. Ngaphezu kwalokho, iziguli eziningi zikhetha ukugwema imithi yokwelapha ikhanda labo elibuhlungu. Ngenxa yalokho, kufika ku-40% weziguli ezine-migraine zinezidingo ezingafinyeleleki zalokhu kwelashwa kwe-migraine.

I-external trigeminal nerve stimulation (i-e-TNS) iyindlela yokwelapha yezokwelapha ehlinzeka ngendlela engeyona eyemithi, indlela engavamile yeziguli ezine-migraine ezikhetha ukugwema imithi, ukubekezelelana kwemithi noma, kudinga ukwelashwa okuhambisanayo ekulawuleni kwabo i-migraine. Igqokwa ebunzini, idivayisi ye-CEFALY e-TNS iletha ukuvuselela kagesi okuthambile ukuze kuncishiswe izimpawu zobuhlungu be-trigeminal nerve, indlela eyinhloko yobuhlungu be-migraine.

Ucwaningo lwe-TEAM lwathatha izinyanga eziyisishiyagalolunye futhi lwenziwa ezikhungweni ezingu-10 kulo lonke elase-United States. Ucwaningo lubhalise iziguli ze-538 ezineminyaka engu-18-65 ezine-episodic migraine, noma ngaphandle kwe-aura, ezazinokuhlasela kwe-migraine okulinganiselwe kuya kokuqina okukhulu izikhathi ezingu-2 kuya kwezingu-8 ngenyanga. Izihloko ezihlangabezane nazo zonke izinqubo zokutadisha zanikezwa ngokungahleliwe kunoma yiliphi iqembu le-verum noma le-sham futhi zanikezwa idayari yekhanda elibuhlungu futhi zafundiswa indlela yokusebenzisa idivayisi ye-CEFALY.

Phakathi nenkathi yezinyanga ze-2, iziguli zafundiswa ukuba zizilawule ngokwazo ukwelashwa kwe-e-TNS, ngokusho kokuqeqeshwa kanye neziyalezo ezizitholile, kungakapheli amahora angu-4 okuqala kwe-migraine noma kungakapheli amahora angu-4 wokuvuswa ngekhanda le-migraine. I-Neurostimulation isetshenziswe ngedivayisi ye-CEFALY e-TNS amahora angu-2, iseshini eqhubekayo.

Eqenjini le-verum, uma kuqhathaniswa neqembu lama-sham:

• Inkululeko yobuhlungu emahoreni angu-2 yayiphezulu ngo-7.2% (25.5% uma kuqhathaniswa ne-18.3%; p = .043)

• Ukuxazululwa kwesibonakaliso esibuhlungu kakhulu esihlobene ne-migraine sasingu-14.1% ephakeme (56.4% uma kuqhathaniswa ne-42.3%; p = 0.001)

• Ukuphumula kobuhlungu emahoreni angu-2 kwakuphakeme ngo-14.3% (69.5% uma kuqhathaniswa no-55.2%; p = 0.001)

• Ukungabikho kwazo zonke izimpawu ezihlobene ne-migraine emahoreni angu-2 kwakuyi-8.4% ephakeme (42.5% uma kuqhathaniswa ne-34.1%; p = 0.044)

• Inkululeko eqhubekayo yobuhlungu nokukhululeka kobuhlungu emahoreni angu-24 kwakuyi-7.0% kanye ne-11.5% ephakeme ku-verum (22.8% kanye ne-45.9%) kune-sham (15.8 ne-34.4%; p = 0.039)

Azikho izehlakalo ezimbi ezimbi ezibikiwe.

Ababhali bocwaningo baphetha ngokuthi ukusetshenziswa kwe-2-hour e-TNS therapy okuzenzela kuyindlela yokwelapha ephephile futhi ephumelelayo, noma ngaphandle kokusebenzisa imithi elwa ne-migraine eqinile.

"Isisetshenziswa se-CEFALY sinikeza iziguli inketho engeyona imithi yokuvimbela nokwelashwa okunamandla kwe-migraine. Kuyasiza ikakhulukazi ukungeza ohlelweni lwemithi noma ukusetshenziswa kubantu abaye baba nesipiliyoni esibi ngemithi ye-migraine, "kusho uDkt. Deena Kuruvilla, omunye wabalobi bocwaningo kanye noMqondisi Wezokwelapha kanye ne-Board Certified Neurologist, i-Westport Headache Institute.

"Abantu abaningi abaphila nobuhlungu be-migraine bafuna isisombululo abangasisebenzisa ngokuphepha ekhaya," kusho uJen Trainor McDermott, oyi-CEO ye-CEFALY Technology. “Njengoba ucwaningo lwe-TEAM lusibonisa, i-CEFALY inikeza ukukhululeka kobuhlungu okunamandla, okuqhubekayo abakudingayo.”