- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03396419
IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)
A Sub-Study of the ImpACT-24B Trial (CLP1000500) Assessing Brain Collateral Blood Flow Enhancement Following Spheno-Palatine Ganglion (SPG) Stimulation in Subjects With Acute Ischemic Stroke
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tbilisi, Georgia, 0144
- High Technology Medical Center University Clinic LTD.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
The Inclusion/Exclusion criteria are those of the ImpACT-24B trial (CLP1000500).
Additionally, subjects will be excluded from the ImpACT-24col sub-study if DSA is contraindicated (such as allergy to the contract media, etc.).
Inclusion Criteria:
- Age: Between 40 years and 80 years for male and 85 for female subjects
- Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior Cerebral Artery territories
- Imaging findings demonstrating signs of ischemia in the anterior circulation, consistent with the clinical diagnosis
- Baseline NIHSS ≥ 7 and ≤ 18 within 2 hours prior to implantation.
- Ability to initiate treatment within 8- 24 hours from stroke onset
- Signed informed consent from patient him/herself or legally authorized representative if applicable
Exclusion Criteria:
- Intracranial hemorrhage or hemorrhagic transformation
- Massive stroke
- Acute ischemic stroke in the posterior circulation
- Minor stroke
- Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke
- Previous stroke in the last 6 months or pre-existing disability
- Patients with bleeding propensity or any condition in the oral cavity that prevents implantation
- Clinical signs and symptoms or imaging evidence of bilateral stroke.
- Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke.
- Known cerebral arteriovenous malformation, cerebral aneurysm.
- Clinical suspicion of septic embolus.
- Uncontrolled hypertension (systolic >185 mmHg and/or diastolic >110 mmHg)
- Serious systemic infection.
- Women known to be pregnant or having a positive or indeterminate pregnancy test.
- Patients with other implanted neural stimulator/ electronic devices (pacemakers).
- Life expectancy < 1 year from causes other than stroke.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Acute Isch. Stk pts treat. w/SPG stimul.
Following implantation (according to the ImpACT-24B protocol), subjects will be transferred to the angio suite. A baseline brain digital subtraction angiography (DSA) will then be performed by a trained physician prior to initiation of SPG stimulation according to the ImpACT-24B protocol. Following the first SPG stimulation cycle of 4 minutes, a post-stimulation DSA will be performed. Based on the results of the post-stimulation DSA, the physician may perform an additional DSA following the second SPG stimulation cycle. The subject will then be transferred to the stroke department and will continue treatment according the ImpACT-24B protocol. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Collateral blood flow grades difference following SPG stimulation.
Time Frame: Day 1
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The difference between the collateral blood flow grades, assessed by DSA, at baseline and following SPG stimulation.
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Day 1
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yoram Slolberg, Dr., BrainsGate
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLP1050611
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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