Safety Study of Carotid Body Neurostimulation to Treat Cerebral Vasospasm
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ClinicalTrials.gov Identifier: NCT02129413
Recruitment Status : Unknown
Verified April 2014 by Samson NeuroSciences. Recruitment status was: Recruiting
Device or procedure related (possibly, probably, or definitely) serious adverse events rate, from the treatment period and up to 30 days. [ Time Frame: 30 days ]
Secondary Outcome Measures :
Decrease Mean Flow Velocity (MFV) of ≥15% below the maximal MVF measured prior to treatment, in at least one of the affected cerebral arteries, in at least one measuring during treatment [ Time Frame: 7 days ]
Increase diameter of ≥15% in at least one of the affected main cerebral arteries, measured by Digital Subtraction Angiography (DSA) or Computed Tomography Angiography (CTA) [ Time Frame: 7 days ]
Increase of ≥20% in PbtO2 above baseline prior to treatment measured by Licox® monitoring system during treatment [ Time Frame: 7 days ]
Increase of ≥20% in CBF above baseline prior to treatment measured by the CerOx monitor system during treatment [ Time Frame: 7 days ]
Mechanical performance of the Delta system [ Time Frame: 7 days ]
Lead shaft mechanical performance (e.g insertion, positioning/re positioning, fixation and retrieval) will be quantitatively measured
Electrical performance of the Delta system [ Time Frame: 7 days ]
Electrical performance of the electrical stimulation unit will be quantitatively measured
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male and female older than 18 years of age and no more than 75 years of age.
aSAH patients with secured aneurysm.
Patient has cerebral vasospasm and is anesthetized and intubated.
Cerebral vasospasm is manifested by:
Mean Flow Velocity (MFV) >120 cm/sec in the intracranial ICA (Internal carotid artery), MCA (middle cerebral artery) or ACA (anterior cerebral artery) or MFV >110 cm/sec in the PCA, or >85 cm/sec in the vertebral or basilar arteries, as measured by TCD (Trans Cranial Doppler).
Extra/intracranial ratio for the carotid watershed (MCA, ACA, intracranial ICA)>3, or a proximal/distal ratio for the vertebrobasilar (VB) system > 2.
Affected/contralateral MCA MFV ratio ≥1.5. Or
Affected / baseline MCA MFV ratio ≥1.5.
Vasoconstriction of at least 33% in at least one of the main cerebral arteries, measured by Angiography (Digital Subtraction Angiography (DSA) or Computed Tomography Angiography (CTA).
Hemodynamically stable, including subjects who are treated for fever, hydrocephalus, rebleeding, infection or metabolic abnormalities and are stable.
For pre-menopausal females - a negative pregnancy test, using an accepted method of birth control and avoid breast feeding for the duration of the trial
A legally Authorized representative have signed informed consent.
WFNS score 5
Unsecured aneurysm or Intracranial/SAH of other than aneurysmal origin.
Signs attributable to serious aneurismal surgical procedure-related complications.
Patient underwent decompressive craniectomy.
S/p Carotid Endarterectomy, or other neck intervention.
Known carotid body tumor, past or present.
Hemodynamic instability due to cardiac arrhythmia or due to any other cause.
Had a myocardial infarction, unstable angina or syncope, congestive heart failure that require hospitalization or ejection fraction ≤ 40% within the past 3 months. Note: Elevated Troponin is expected after aSAH and will not exclude patients.
Had a stroke, within the past 1 year or transient ischemic attack at the last 3 months.
Any anatomical variation or thrombotic finding that according to the physician judgment is not eligible.
Renal insufficiency (Creatinine X2 of the normal).
Allergic to contrast media with no response to steroid pretreatment.
Are unable or unwilling to fulfill the protocol follow-up requirements
Are enrolled in another concurrent clinical trial, without prior approval of Samson NS and the PI.
Have an uncontrolled comorbid medical condition that would adversely affect their health if they are enrolled.