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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
NIHSS Assessment
Timeframe: Day 7
2
% of patients with improvement in stroke symptoms during stimulation
. 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
3. Patients with bleeding propensity and/or one of the following: INR \> 1.8, prolonged activated partial thromboplastin time (aPTT) ≥ 45 sec., platelets count \< 75×109/L.
4. Known cerebral arteriovenous malformation, cerebral aneurysm.