IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)

NCT03396419 | Terminated

• 1 other identifier: CLP1050611
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the ImpACT-24col sub-study is to explore effect of SPG stimulation on the augmentation of collateral blood flow and to relate it to the subject's cerebral blood flow status, the extent of the collateral vessel potency prior to the stimulation and the relation of the vessel occlusion site to the vasodilatory effect by using digital subtraction angiography (DSA), the gold standard imaging technique to demonstrate collateral blood flow dynamics. The results of this study will further promote the knowledge towards optimization of SPG stimulation to treat acute ischemic stroke patients.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Collateral blood flow grades difference following SPG stimulation.

  The difference between the collateral blood flow grades, assessed by DSA, at baseline and following SPG stimulation.

  Day 1

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with Acute Ischemic Stroke in the anterior circulation enrolled to the ImpACT-24B study.

You may not qualify if:

• Additionally, subjects will be excluded from the ImpACT-24col sub-study if DSA is contraindicated (such as allergy to the contract media, etc.).
• 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
• 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.

Sponsors & Collaborators

• BrainsGate: lead

Study Sites (1)

High Technology Medical Center University Clinic LTD.

Tbilisi, 0144, Georgia

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yoram Slolberg, Dr.

  BrainsGate

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: January 11, 2018
• Study Start: September 25, 2017
• Primary Completion: June 3, 2018
• Study Completion: June 3, 2018
• Last Updated: April 24, 2019

Record last verified: 2019-04

Locations

GE (1)