THE IMPACT- 24M TRIAL (IMPlant Augmenting Cerebral Blood Flow in Mild Strokes Trial 24 Hours From Stroke Onset)
Georgia50 participantsStarted 2018-04-02
Plain-language 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
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age: ≥ 18 years and ≤ 80 years
✓. Clinical diagnosis of anterior circulation stroke
✓. Baseline NIHSS ≥ 1 and ≤ 6 or lacunar stroke of any severity
✓. Motor and/or sensory deficits
✓. Ability to initiate treatment within 24 hours from stroke onset
✓. Signed informed consent from patient him/herself or legally authorized representative if applicable.
Exclusion criteria
✕. Neuro-imaging evidence of any intracranial hemorrhage or hemorrhagic transformation of brain infarct or other significant abnormality (e.g. tumor, abscess, suspect for subarachnoid hemorrhage).
✕. Massive stroke, defined as acute parenchymal lesion with effacement of cerebral sulci in over 2/3 of the MCA territory.
✕. Clinical signs and symptoms or evidence for a relevant lesion by neuro-imaging of an acute ischemic stroke in the posterior circulation (Vertebral, Basilar and/or Posterior Cerebral Artery territories), including but not limited to brain-stem findings and/or cerebellar findings and/or isolated homonymous hemianopia or cortical blindness.
✕0. NIHSS level of consciousness score ≥ 2.
✕1. Inability to communicate fluently and express symptoms
✕2. Previous motor and/or sensory deficits that will eliminate the ability to identify the response to SPG stimulation
What they're measuring
1
NIHSS Assessment
Timeframe: Day 7
2
% of patients with improvement in stroke symptoms during stimulation