Evaluation of the Effectiveness and Safety of ABAStroke

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Device: ABAStroke Digital Therapeutics

• Registration Number: NCT05979324
• Lead Sponsor: ABAStroke Sp. z o.o.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-13
• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-07-28
• Last Update Submitted: 2023-07-28
• Study First Posted: 2023-08-07
• Last Update Posted: 2023-08-07
• Primary Completion: 2023-12-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABAStroke Digital Therapeutics	ABAStroke Digital Therapeutics	50 patients using ABAStroke with standard treatment after a stroke.

Primary Outcome Measures

Name	Time	Method
MoCA	3 months	Screening tool for detecting cognitive deficits

Trial Locations

Locations (1)

Clinical Department of Neurology of the Jagiellonian University Hospital; 🇵🇱 Kraków, Poland