Iziphumo zoNyango lwe-Acute Migraine eKhaya

I-CEFALY Technology namhlanje ibhengeze iziphumo zophando lweklinikhi olubonisa ukuba unyango lweeyure ezimbini kunye ne-e-TNS CEFALY isixhobo yindlela ekhuselekileyo nesebenzayo, engeyiyo yonyango yonyango olunzima lokuhlaselwa kwe-migraine kwindawo engaphandle kwesibhedlele.

Uvavanyo lwe-e-TNS lwe-Acute unyango lwe-Migraine (i-TEAM) isifundo yayiyeyokuqala, ilindelekileyo, i-double-blind-blind, i-randomized, i-sham-controlled controlled trial trial of 2-hour e-TNS unyango lwe-acute migraine attack kwi-home. imeko. Uphononongo lwe-TEAM lubuye lube lolona vavanyo lukhulu lwe-sham-controlled, uvavanyo lweklinikhi oluvavanya ukusetyenziswa kwayo nayiphi na i-e-TNS yonyango yonyango lwentloko ye-migraine.

Ingxaki eqhelekileyo kunye neyonakeleyo ye-neurological disorder, i-migraine ibekwe kwi-World

Umbutho wezeMpilo njengowesibini unobangela wokukhubazeka. Kukho imida emininzi kumayeza aqhelekileyo okulwa ne-migraine. Ukongeza, izigulana ezininzi zikhetha ukuphepha amayeza ukunyanga iintloko zabo eziqaqambayo. Ngenxa yoko, ukuya kuthi ga kwi-40% yezigulane ze-migraine zineemfuno ezingafezekanga zolu nyango lwe-migraine.

I-external trigeminal nerve stimulation (i-e-TNS) yonyango lwesixhobo sonyango esinika i-non-pharmacological, i-non-invasive approach for izigulane ezine-migraine ezikhetha ukuphepha amayeza, ukunyanzeliswa kweyeza okanye, zifuna unyango oluncedisayo ekulawuleni i-migraine yabo. Inxitywe ebunzi, isixhobo se-CEFALY e-TNS sihambisa uvuselelo oluthambileyo lombane lokunciphisa imiqondiso yentlungu ye-trigeminal nerve, indlela ephambili yeentlungu ze-migraine.

Uphononongo lweTEAM lwathatha iinyanga ezilithoba kwaye lwaqhutywa kumaziko ali-10 kulo lonke elaseUnited States. Uphononongo lubhalise izigulane ze-538 ezineminyaka eyi-18-65 kunye ne-episodic migraine, kunye okanye ngaphandle kwe-aura, ababenokuhlaselwa kwe-migraine ephakathi ukuya kwi-intensiteten 2 ukuya kwii-8 ngenyanga. Izifundo eziye zadibana nazo zonke iikhrayitheriya zokufunda zabelwa ngokungenamkhethe nokuba yi-verum okanye iqela le-sham kwaye zanikwa idayari yentloko kwaye zafundiswa ngendlela yokusebenzisa isixhobo seCEFALY.

Ngethuba leenyanga ze-2, izigulane zafundiswa ukuba zizenzele unyango lwe-e-TNS, ngokuhambelana noqeqesho kunye nomyalelo abawufumeneyo, kwiiyure ze-4 ze-migraine ukuqala okanye kwiiyure ze-4 zokuvuswa kwentloko ye-migraine. I-Neurostimulation isetyenziswe kunye nesixhobo se-CEFALY e-TNS kwi-2-yure, iseshoni eqhubekayo.

Kwiqela le-verum, xa kuthelekiswa neqela le-sham:

• Intlungu yentlungu kwiiyure ze-2 yayiyi-7.2% ephezulu (25.5% xa kuthelekiswa ne-18.3%; p = .043)

• Isisombululo sesona sibonakaliso esixhaphake kakhulu se-migraine esichaphazelekayo sasiyi-14.1% ephezulu (56.4% xa kuthelekiswa ne-42.3%; p = 0.001)

• Ukunciphisa iintlungu kwiiyure ze-2 kwakuyi-14.3% ephezulu (69.5% xa kuthelekiswa ne-55.2%; p = 0.001)

• Ukungabikho kwazo zonke iimpawu ezinxulumene ne-migraine kwiiyure ze-2 kwakuyi-8.4% ephezulu (42.5% xa kuthelekiswa ne-34.1%; p = 0.044)

• Inkululeko eqhubekayo yeentlungu kunye neentlungu kwiiyure ze-24 yayingu-7.0% kunye ne-11.5% ephezulu kwi-verum (22.8% kunye ne-45.9%) kune-sham (15.8 kunye ne-34.4%; p = 0.039)

Akukho ziganeko ezimbi kakhulu ezichazwe.

Ababhali bophononongo bagqibe kwelokuba ukusetyenziswa kwe-2-hour e-TNS yonyango ye-e-TNS yindlela ekhuselekileyo nesebenzayo yonyango, kunye okanye ngaphandle kokusetyenziswa kweyeza elichasayo le-migraine.

"Isixhobo se-CEFALY sibonelela izigulana ngenketho engeyiyo amayeza okuthintela kunye nonyango oluqatha lwe-migraine. Kunceda ngokukhethekileyo ukongeza kwi-regimen yonyango okanye ukusetyenziswa kubantu abaye bafumana amava angalunganga ngamayeza e-migraine, "kusho uDkt Deena Kuruvilla, omnye wababhali bokufunda kunye noMlawuli wezoNyango kunye neBhodi eQinisekisiweyo ye-Neurologist, i-Westport Headache Institute.

"Abantu abaninzi abahlala ne-migraine intlungu banqwenela isisombululo abangasisebenzisa ngokukhuselekileyo ekhaya," kusho uJen Trainor McDermott, i-CEO ye-CEFALY Technology. "Njengoko isifundo seQELA sibonisa, iCEFALY ibonelela ngamandla, isiqabu seentlungu esizidingayo."