Evaluation of the Effectiveness and Safety of ABAStroke

Evaluation of the Effectiveness and Safety of ABAStroke in the Rehabilitation of Cognitive Deficits in Stroke Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: ABAStroke Digital Therapeutics

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michał Ryś, Dr; Phone Number: +48694550816; Email: michal@abastroke.com

Study Locations

• Poland
  • Kraków, Poland
    • Recruiting
    • Clinical Department of Neurology of the Jagiellonian University Hospital
    • Contact: Agnieszka Słowik, Prof.; Email: aslowik@su.krakow.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Men and/or women between the ages of 18 and 70
2. Condition after an ischemic or hemorrhagic stroke that occurred within the last 6 months before the start of the study.
3. MoCA score >14 and <26 points.
4. Signing of the informed consent form by each study participant.

Exclusion Criteria:

1. Vision disorders of various etiologies, which, in the opinion of the researcher, prevent the efficient use of a device using electronic displays.
2. Psychotic episodes and/or manic episodes and/or severe depression (Beck score 26 or higher) in the past year.
3. History of alcohol abuse or physical dependence on opioids in the past 2 years.
4. 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.
5. MoCA score <15 or >25 points.
6. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABAStroke Digital Therapeutics; 50 patients using ABAStroke with standard treatment after a stroke.	Device: ABAStroke Digital Therapeutics; 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).
No Intervention: Control group; 50 people using standard treatment after a stroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MoCA	Screening tool for detecting cognitive deficits	3 months

Collaborators and Investigators

• Sponsor: ABAStroke Sp. z o.o.

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Dermatologic Agents; Keratolytic Agents; Coal Tar
• Other Study ID Numbers: ABAStroke 1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No