Actively Recruiting
Cognitive, Motor and Sleep Evaluation in Patients With Ischemic Stroke of Basal Ganglia After Thrombectomy
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2023-05-26
300
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients who have had an acute ischemic stroke affecting the basal ganglia and were treated with mechanical thrombectomy. The study aims to understand how often and in what ways cognitive, motor, and sleep problems occur after this treatment. The main focus is on defining these possible dysfunctions in the short and long term after stroke treatment. The study involves patients who have undergone mechanical thrombectomy for stroke in the proximal middle cerebral artery. Participants will be evaluated using tests for cognitive function, movement abilities, and sleep disorders. Specifically, sleep will be studied through polysomnographic examinations. Assessments occur in the acute phase soon after treatment and continue through long-term follow-up. Participants will undergo testing for cognitive, motor, and sleep function within 72 hours after their stroke treatment and at later points to monitor changes over time. The primary outcome is the presence of post-stroke cognitive dysfunction measured shortly after treatment. The research team will closely observe clinical outcomes related to movement and sleep as well. The study is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS and involves adult participants starting from age 18.
CONDITIONS
Brief Title
"Cognitive, Motor and Sleep Evaluation in Patients With Ischemic Stroke of Basal Ganglia After Thrombectomy"
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant's age 18 years or older
- Acute ischemic stroke due to occlusion of proximal middle cerebral artery treated successfully with mechanical thrombectomy (mTICI 2B)
- Signed specific written informed consent
You will not qualify if you...
- Unstable clinical conditions
- Personal history of cognitive decline before the acute ischemic stroke
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 72 hours
Participants undergo cognitive, motor, and sleep assessments including polysomnography shortly after thrombectomy.
1 visit (in-person)
Duration - Up to 12 months
Participants are observed for long-term outcomes following ischemic stroke and thrombectomy.
Follow-up visits as scheduled
Trial Site Locations
Total: 1 location
1
Flavia Torlizzi
Rome, Italy, 00168
Actively Recruiting
Research Team
C
Carla Piano
F
Flavia Torlizzi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Frequently Asked Questions
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