Evaluation of the Effectiveness and Safety of ABAStroke

NCT05979324 | Unknown

• 1 other identifier: ABAStroke 1.0
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• MoCA

  Screening tool for detecting cognitive deficits

  3 months

Study Arms (2)

ABAStroke Digital Therapeutics

EXPERIMENTAL

50 patients using ABAStroke with standard treatment after a stroke.

Device: ABAStroke Digital Therapeutics

Control group

NO INTERVENTION

50 people using standard treatment after a stroke.

Interventions

ABAStroke Digital Therapeutics DEVICE

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).

ABAStroke Digital Therapeutics

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• nootropics (pro-cognitive): cerebrolysin, citicoline, vinpocetine, nicergoline, piracetam, Gingo Biloba preparations, lecithin, cholinesterase inhibitors: donepezil, rivastigmine, galantamine, NMDA receptor antagonist: memantine.

Sponsors & Collaborators

• ABAStroke Sp. z o.o.: lead

Study Sites (1)

Clinical Department of Neurology of the Jagiellonian University Hospital

Krakow, Poland

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Michał Ryś, Dr

CONTACT

+48694550816; michal@abastroke.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 7, 2023
• Study Start: July 13, 2023
• Primary Completion: December 31, 2023
• Study Completion: May 31, 2024
• Last Updated: August 7, 2023

Record last verified: 2023-07

Locations

PL (1)