An interventional study of SPG stimulation in Ischemic Stroke, sponsored by BrainsGate. Status unknown at 4 sites in Georgia. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-10-30.
Sponsored by BrainsGate · Not applicable, Interventional, and Treatment
The primary objective of the study is to demonstrate that SPG (Sphenopalatine Ganglion) stimulation started within 6 hours from stroke onset slows the expansion of the infarct core volume in acute ischemic stroke.
The goal of this study is to identify Acute Ischemic Stroke patients who have a potentially salvageable penumbra and to test if 6 hours of SPG (Sphenopalatine Ganglion) stimulation may "freeze" the volume of the penumbra and reduce the extent of tissue death.
Following a minimally-invasive implantation of the ISS injectable implant, patients will be randomized to either the Treated or Control arm in a 1:1 ratio. Randomization will be dynamic according to the patient's baseline covariates of core volume, total volume, Hypoperfusion Intensity Ratio (HIR), time to baseline imaging, age, NIHSS. Patients in the Treated arm will be treated with active SPG stimulation while patients in the Control arm will undergo sham treatment. After treatment/sham treatment, patients in both groups will undergo a follow up brain non-contrast CT, CT perfusion and CT angiography imaging, 6:45hrs±15min after baseline CTP initiation.
In the case the patient is cooperative, hand strength (pinch and grasp) evaluations should be assessed before and during the 1st treatment/ sham SPG stimulation session.
Following the assessment of the penumbra (after 6 hours) patients will be treated or sham treated for 5 additional consecutive sessions (4 hours each), the first starting within 18-24 hours from stroke onset and the others 18-26 hours from previous treatment initiation and will be followed for 90 days to assess their clinical outcome. In one session (preferably at day 2) Common Carotid Doppler examination is performed to evaluate blood flow dynamics before and during the treatment/sham session.
After the last treatment session, the implant is removed.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →BrainsGate is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Treated arm patients will be implanted and treated with one session of SPG stimulation for 6 hours and 5 additional consecutive sessions (4 hours each) of SPG stimulation, the first starting within 18-24 hours from stroke onset and the others 18-26 hours from previous treatment initiation.
Device: SPG stimulation
Control arm patients will be implanted and receive 6 hours of sham stimulation and 5 additional consecutive sessions (4 hours each) of sham stimulation, the first starting within 18-24 hours from stroke onset and the others 18-26 hours from previous treatment initiation.
Device: SPG stimulation
The BrainsGate Ischemic Stroke System (ISS) consists of an implantable neurostimulator designed to deliver electrical stimulation to the sphenopalatine ganglion (SPG) and/or nerves within the greater palatine canal and pterygopalatine fossa.
Volume of core expansion
The primary outcome measure is the volume of core expansion (in milliliters) in 6:45h±15 min. Core expansion is the difference of two volumes: Core volume (CBF\<38%) in follow up CTP (at 6:45h±15 min) and Core volume (CBF\<38%) in baseline CTP. The difference in the mean core expansion between the Treated and Control groups will be assessed as a continuous variable with adjustment for baseline covariates (Core volume, Total volume, HIR, Time to baseline imaging). The two-sided significance level is 0.05. Handling of missing data in the primary analysis: Patients who die before the 6:45h±15 min follow-up imaging will be assigned a final core volume that equal the baseline total volume. Patients with non-interpretable follow-up imaging will be excluded from the analysis.
Time frame: Day 1
Difference in infarct volume between baseline CTP core volume and follow up NCCT infarct volume.
Difference in infarct volume (in milliliters) between baseline CTP core volume (CBF\<38%) and follow up 6:45h±15 min NCCT infarct volume, adjusted using stratification parameters (Core volume, Total volume, HIR, Time to baseline imaging).
Time frame: Day 1
Difference in infarct volume between baseline CTP core volume and Day-5 NCCT infarct volume
Difference in infarct volume (in milliliters) between baseline CTP core volume (CBF\<38%) and Day-5 NCCT infarct volume, adjusted using stratification parameters (Core volume, Total volume, HIR, Time to baseline imaging).
Time frame: Day 5
3 months mRS
mRS at 90-day: 1. Utility weighted mRS 2. mRS Dichotomy 0-2 3. mRS Dichotomy 0-3
Time frame: Day 90±7
Increased blood flow in Common Carotid Doppler
Increased blood flow in Common Carotid Doppler (if available).
Time frame: Day 2-6
Improvement in hand motor performance
Improvement in hand motor performance (if available) using a hand dynamometer (Baseline Hydraulic Hand Dynamometers, Fabrication Enterprises Inc, White Plains NY, USA).
Time frame: Day 1
Safety Data Between the Treatment and Control Arms - Serious Adverse Events
Incidence of Serious Adverse Events
Time frame: Day 90±7
Safety Data Between the Treatment and Control Arms - Mortality
Incidence of Mortality
Time frame: Day 90±7
Safety Data Between the Treatment and Control Arms - Symptomatic Intracranial hemorrhage (sICH) SAEs
Incidence of symptomatic intracranial hemorrhage (sICH) SAEs
Time frame: Day 5
Safety Data Between the Treatment and Control Arms - Pain
Incidence of Pain adverse events during stimulation
Time frame: Day 1 to 5
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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