THE IMPACT- 24M TRIAL (IMPlant Augmenting Cerebral Blood Flow in Mild Strokes Trial 24 Hours From Stroke Onset)
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      Study Population:

      Subjects with Mild Acute Ischemic Stroke in the anterior circulation within 24 hours from
      onset.

      Study objectives:

        1. Identify the personal stimulation level for each patient based on physiological
           biomarkers

        2. Identify improvement in stroke symptoms during ISS treatment at the personal stimulation
           level
    

Detailed description: 
      A Multicenter, Single Arm Trial to Assess Safety and Signal of Efficacy of the Ischemic
      Stroke System (ISS), as an Adjunct to Standard of Care in Subjects with Mild Acute Ischemic
      Stroke

      Study Duration:

      The expected total duration of the study for each subject is up to 10 days as follows:

      Enrollment: up to 24 hours Treatment: Implantation, 5 Days of SPG stimulation and Standard of
      care Final Visit: 7 days after enrollment

      Study Population:

      Subjects with Mild Acute Ischemic Stroke in the anterior circulation within 24 hours from
      onset.

      Study Objectives:

        1. Identify the personal stimulation level for each patient based on physiological
           biomarkers

        2. Identify improvement in stroke symptoms during ISS treatment at the personal stimulation
           level

      Study Design:

      This will be a multi-center, adjunctive to Standard of Care, single arm study, which includes
      the following steps:

        1. Screening (day 1)

        2. Implantation (day 1)

        3. Treatment and symptom assessment (days 1-5)

        4. Device Positioning and Removal (day 5)

        5. Discharge/Final Visit (day 7-10)

      Outcome Measures:

      Primary Outcome Measures:

        1. The difference in NIHSS between baseline and Day 7 vs. Historical Controls

        2. % of patients with improvement in stroke symptoms (motor and/or sensory deficits) during
           stimulation

      Additional Efficacy Outcome Measures:

        1. Existence of physiologic surrogates of the Personal Stimulation Level

        2. Improvement in stroke symptoms (motor and/or sensory deficits)

      Safety Outcome Measures:

        1. Comparative 7-day safety data between the ISS stimulation group of this study and of the
           ImpACT-24B study:

             1. Incidence of Serious Adverse Events

             2. Implantation Complications

             3. Stimulation-related Adverse Events

        2. 7-day mortality

        3. Neurological deterioration

        4. Symptomatic intracranial hemorrhage (sICH)

      Implantation Accuracy Outcome Measures:

      1. % of procedures with positive indication of reaching the sphenopalatine fossa
    

Intervention name(s): ISS SPG stimulation
Intervention type(s): Device
Intervention description(s): The ISS is intended to deliver electrical stimulation to the nerves within the greater palatine canal and pterygopalatine fossa (SPG).
Intervention model: Single Group Assignment
Intervention model description: This will be a multi-center, adjunctive to Standard of Care, single arm study, which includes the following steps:
Screening (day 1)
Implantation (day 1)
Treatment and symptom assessment (days 1-5)
Device Positioning and Removal (day 5)
Discharge/Final Visit (day 7-10)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ischemic Stroke; Mild Acute Ischemic Stroke; Safety; Signal of Efficacy