THE IMPACT- 24M TRIAL (IMPlant Augmenting Cerebral Blood Flow in Mild Strokes Trial 24 Hours From Stroke Onset)
NCT03551093 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2019-07-24
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
Conditions
Interventions
- DEVICE
-
ISS SPG stimulation
The ISS is intended to deliver electrical stimulation to the nerves within the greater palatine canal and pterygopalatine fossa (SPG).
Sponsors & Collaborators
-
BrainsGate
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-04-02
- Primary Completion
- 2018-09-11
- Completion
- 2018-09-11
Countries
- Georgia
Study Locations
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