Back to resultsEvaluation of the Effectiveness and Safety of ABAStroke
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
ABAStroke Digital Therapeutics
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria: Men and/or women between the ages of 18 and 70 Condition after an ischemic or hemorrhagic stroke that occurred within the last 6 months before the start of the study. MoCA score >14 and <26 points. Signing of the informed consent form by each study participant. Exclusion Criteria: Vision disorders of various etiologies, which, in the opinion of the researcher, prevent the efficient use of a device using electronic displays. Psychotic episodes and/or manic episodes and/or severe depression (Beck score 26 or higher) in the past year. History of alcohol abuse or physical dependence on opioids in the past 2 years. Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social circumstances) that could affect the patient's ability to attend scheduled appointments and use the investigational technology as determined by the investigator. MoCA score <15 or >25 points. Treatment of procognitive drug therapy in the last 6 months before inclusion in the study: nootropics (pro-cognitive): cerebrolysin, citicoline, vinpocetine, nicergoline, piracetam, Gingo Biloba preparations, lecithin, cholinesterase inhibitors: donepezil, rivastigmine, galantamine, NMDA receptor antagonist: memantine.
Sites / Locations
- Clinical Department of Neurology of the Jagiellonian University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ABAStroke Digital Therapeutics
Control group
Arm Description
50 patients using ABAStroke with standard treatment after a stroke.
50 people using standard treatment after a stroke.
Outcomes
Primary Outcome Measures
MoCA
Screening tool for detecting cognitive deficits
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05979324
Brief Title
Evaluation of the Effectiveness and Safety of ABAStroke
Official Title
Evaluation of the Effectiveness and Safety of ABAStroke in the Rehabilitation of Cognitive Deficits in Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ABAStroke Sp. z o.o.
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 aim of the project is to confirm the effectiveness and safety of the ABAStroke technology, which uses the principles of Applied Behavior Analysis (ABA) in the rehabilitation of cognitive deficits in patients after strokes. The study is comparative in nature, where a group of 100 patients will be included in this randomized study, divided equally into a study group and a control group. The purpose of the study is also to demonstrate that this non-invasive new rehabilitation technology based on the ABAStroke computer software supports the process of rehabilitation in the field of cognitive functions together with standard pharmacological therapy, including the possibility of using rehabilitation (as recommended by researchers and other doctors conducting rehabilitation of a patient after a stroke brain). ABAStroke can lead to improved cognitive functions (such as abstraction, short-term memory, visuospatial functions, executive functions, language, verbal fluency, allopsychic orientation, and attention) and is delivered via a mobile device app that can be used at home.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention will take place over a maximum of 104 days, i.e. 15 weeks, a minimum of 13 weeks, i.e. 91 days. During this period, it is recommended to use the ABAstroke technology (app) for a maximum of 91 days along with standard therapy, including the possibility of using rehabilitation (as recommended by researchers or other physicians rehabilitating a patient after a stroke). The study is planned as a superiority study. Patients in the control group will be on standard stroke therapy.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ABAStroke Digital Therapeutics
Arm Type
Experimental
Arm Description
50 patients using ABAStroke with standard treatment after a stroke.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
50 people using standard treatment after a stroke.
Intervention Type
Device
Intervention Name(s)
ABAStroke Digital Therapeutics
Intervention Description
The total time of the study is 30 weeks in total, i.e. 15 weeks of patient recruitment and then a maximum of another 15 weeks until the end of the observation of the last patient. Within 2 weeks from the last patient, the last Monitor's visit will be performed to close the study. The patient will use the ABAStroke application for a maximum of 91 days (the minimum time is 28 days) and standard therapy, including rehabilitation (as recommended by researchers or other physicians rehabilitating a patient after a stroke).
Primary Outcome Measure Information:
Title
MoCA
Description
Screening tool for detecting cognitive deficits
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and/or women between the ages of 18 and 70
Condition after an ischemic or hemorrhagic stroke that occurred within the last 6 months before the start of the study.
MoCA score >14 and <26 points.
Signing of the informed consent form by each study participant.
Exclusion Criteria:
Vision disorders of various etiologies, which, in the opinion of the researcher, prevent the efficient use of a device using electronic displays.
Psychotic episodes and/or manic episodes and/or severe depression (Beck score 26 or higher) in the past year.
History of alcohol abuse or physical dependence on opioids in the past 2 years.
Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social circumstances) that could affect the patient's ability to attend scheduled appointments and use the investigational technology as determined by the investigator.
MoCA score <15 or >25 points.
Treatment of procognitive drug therapy in the last 6 months before inclusion in the study:
nootropics (pro-cognitive): cerebrolysin, citicoline, vinpocetine, nicergoline, piracetam, Gingo Biloba preparations, lecithin, cholinesterase inhibitors: donepezil, rivastigmine, galantamine, NMDA receptor antagonist: memantine.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michał Ryś, Dr
Phone
+48694550816
Email
michal@abastroke.com
Facility Information:
Facility Name
Clinical Department of Neurology of the Jagiellonian University Hospital
City
Kraków
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnieszka Słowik, Prof.
Email
aslowik@su.krakow.pl
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Effectiveness and Safety of ABAStroke
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