Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2025-12-24 @ 2:25 PM
NCT ID:
NCT00826059
Eligibility Criteria:
Inclusion Criteria:
1. Age: Between 40 years and 80 years for male and 85 for female subjects
2. Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior Cerebral Artery territories
3. Imaging findings demonstrating signs of ischemia in the anterior circulation, consistent with the clinical diagnosis
4. Baseline NIHSS ≥ 7 and ≤ 18 within 2 hours prior to implantation.
5. Ability to initiate treatment within 8- 24 hours from stroke onset
6. Signed informed consent from patient him/herself or legally authorized representative if applicable
Exclusion Criteria:
1. Intracranial hemorrhage or hemorrhagic transformation
2. Massive stroke
3. Acute ischemic stroke in the posterior circulation
4. Minor stroke
5. Treated with IV-tPA (intravenous tissue Plasminogen Activator) ,IA-tPA (intra-arterial tissue Plasminogen Activator) or neurothrombectomy devices for the current stroke
6. Previous stroke in the last 6 months or pre-existing disability
7. Patients with bleeding propensity or any condition in the oral cavity that prevents implantation
8. Clinical signs and symptoms or imaging evidence of bilateral stroke.
9. Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke.
10. Known cerebral arteriovenous malformation, cerebral aneurysm.
11. Clinical suspicion of septic embolus.
12. Uncontrolled hypertension (systolic \>185 mmHg and/or diastolic \>110 mmHg)
13. Serious systemic infection.
14. Women known to be pregnant or having a positive or indeterminate pregnancy test.
15. Patients with other implanted neural stimulator/ electronic devices (pacemakers).
16. Life expectancy \< 1 year from causes other than stroke.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT00826059
Study Brief:
Protocol Section:
NCT00826059