Back to results"Cognitive, Motor and Sleep Evaluation in Patients With Ischemic Stroke of Basal Ganglia After Thrombectomy" (CMS - SBGT)
Primary Purpose
Post-stroke Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
polysomnography
Sponsored by
About this trial
This is an interventional diagnostic trial for Post-stroke Disorders
Eligibility Criteria
Inclusion Criteria: participant's age ≥ 18 years acute ischemic stroke due to occlusion of proximal middle cerebral artery successfully treated with mechanical thrombectomy (mTICI ≥ 2B) signature of specific written informed consent Exclusion Criteria: unstable clinical conditions personal history of cognitive decline before the acute ischemic stroke
Sites / Locations
- Flavia TorlizziRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients affected by acute ischemic stroke treated with mechanical thrombectomy
Arm Description
Outcomes
Primary Outcome Measures
Post-stroke cognitive dysfunction
Assessment through the MoCA (Montreal Cognitive Assessment) score of cognitive dysfunction in patients with acute ischemic stroke treated with mechanical thrombectomy
Secondary Outcome Measures
Full Information
NCT ID
NCT05878002
First Posted
April 26, 2023
Last Updated
May 17, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT05878002
Brief Title
"Cognitive, Motor and Sleep Evaluation in Patients With Ischemic Stroke of Basal Ganglia After Thrombectomy"
Acronym
CMS - SBGT
Official Title
"Cognitive, Motor and Sleep Evaluation in Patients With Ischemic Stroke of Basal Ganglia After Thrombectomy"
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
April 12, 2033 (Anticipated)
Study Completion Date
April 2034 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The goal of this interventional study is to learn about the clinical outcomes of acute ischemic stroke treated with mechanical thrombectomy resulting in a selective ischemia of the basal ganglia. The main question it aims to answer is:
• defining the prevalence and clinical features of possible cognitive, motor and sleep disfuncions occuring after acute ischemic stroke treated with thrombectomy
Participants will be tested for cognitive, movement and sleep disorders in the acute phase and successively in the long term follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Disorders
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients affected by acute ischemic stroke treated with mechanical thrombectomy
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
polysomnography
Intervention Description
Sleep study through polysomnographic examination
Primary Outcome Measure Information:
Title
Post-stroke cognitive dysfunction
Description
Assessment through the MoCA (Montreal Cognitive Assessment) score of cognitive dysfunction in patients with acute ischemic stroke treated with mechanical thrombectomy
Time Frame
Within 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
participant's age ≥ 18 years
acute ischemic stroke due to occlusion of proximal middle cerebral artery successfully treated with mechanical thrombectomy (mTICI ≥ 2B)
signature of specific written informed consent
Exclusion Criteria:
unstable clinical conditions
personal history of cognitive decline before the acute ischemic stroke
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carla Piano
Phone
0630156433
Ext
0039
Email
carla.piano@policlinicogemelli.it
First Name & Middle Initial & Last Name or Official Title & Degree
Flavia Torlizzi
Phone
0630156433
Ext
0039
Email
flavia.torlizzi@policlinicogemelli.it
Facility Information:
Facility Name
Flavia Torlizzi
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavia Torlizzi
Phone
+390630156433
Email
flavia.torlizzi@policlinicogemelli.it
12. IPD Sharing Statement
Learn more about this trial
"Cognitive, Motor and Sleep Evaluation in Patients With Ischemic Stroke of Basal Ganglia After Thrombectomy"
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