This study will evaluate acupuncture's effect of preventing vasospasm after SAH. A total of 80 participants will be recruited and will be randomized to a study group or a control group. Acupuncture, electroacupuncture and intradermal acupuncture will be done at every session in a study group, while mock transcutaneous electrical nerve stimulation(mock TENS) and sham intradermal acupuncture will be carried out in a control group.
Intervention starts within 96hours after SAH, after ruptured aneurysms have been secured by endovascular coiling or surgical clipping. Intervention is applied once a day, 6 days a week for 2 weeks(total 12 sessions) in addition to standard treatment such as prophylactic HHH therapy and nimodipine. Sterile disposable, stainless steel acupuncture needles are used. Primary outcome measurement is the occurrence of delayed ischemic neurological deficit between the study group and the control group. Moreover, the incidence of angiographic vasospasm, TCD vasospasm, and vasospasm-related infarct on CT or MRI, the change of nitric oxide(NO) and endothelin-1 in plasma, mortality and participant's functional status using mRS will be compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
50
Acupuncture needles are inserted at the acupoints Zusanli(ST 36), Neiguan(PC 6), Gongsun(SP 4), and Xiangu(ST 43) bilaterally.
The electric stimulator will be connected to the handles of each needles on the ST 36 and PC 6 bilaterally with 5Hz.
Intradermal acupuncture needles with tape are inserted on the ST36, PC6, SP4, ST43 bilaterally and maintained until the next session.
Kyung Hee University Hospital at Gangdong
Seoul, Gangdong-gu, South Korea
The occurrence of delayed ischemic neurological deficit
The occurrence of delayed ischemic neurological deficit between the study group and the control group will be compared. DIND is defined as an unaccountable new focal neurological deficit lasting more than 2hours. Any occurrence of DIND will be recorded by the physician and verified by the investigator every day.
Time frame: 14 days
The incidence of angiographic vasospasm
Angiographic vasospasm is defined as focal or generalized reduction of cerebral arterial caliber on conventional cerebral angiogram or computed tomographic angiography confirmed by a neuroradiologist and neurosurgeon.
Time frame: 14 days
The incidence of TCD vasospasm
TCD vasospasm is defined as Peak systolic middle cerebral artery velocity \> 200cm/s and Lindegaard ratio \>3
Time frame: 14 days
The incidence of vasospasm-related infarct on CT or MRI
It is defined as cerebral infarction in the region of angiographic vasospasm or TCD vasospasm is shown on CT or MRI
Time frame: 14 days
The change of nitric oxide(NO) and endothelin-1 in plasma
Blood sample of 3ml is taken from brachial vein and centrifuged by 3000 rpm for 15minutes and kept in a freezer before analysis. Blood sample will be taken twice, before the start of treatment and after the end of treatment. In addition, the level of serum NO and endothelin-1 between patients and healthy controls will be compared.
Time frame: 14days
Mortality
Mortality at the end of treatment and 14days after the treatment(or at discharge)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Electrical insulator are attached on the ST36 and PC6 bilaterally, the same electric stimulator will be connected on the points with the same parameters as the study group, but without current intensity.
Intradermal acupuncture needles are put over the tape not penetrating the skin.
Time frame: 14 days and 28 days
modified Rankin Scale (mRS)
The participan's functional status at the end of treatment and 14days after the treatment
Time frame: 14 days and 28 days