Evaluating ABAStroke for cognitive rehabilitation after stroke

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

This study is testing a new digital therapy called ABAStroke to see if it can help stroke patients improve their thinking skills and memory better than standard care alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: ABAStroke Sp. z o.o. (Industry-sponsored)
• Locations: 1 site (Kraków)
• Trial ID: NCT05979324 on ClinicalTrials.gov

What this trial studies

This project aims to confirm the effectiveness and safety of ABAStroke technology, which utilizes Applied Behavior Analysis principles to rehabilitate cognitive deficits in stroke patients. The study will involve 100 participants, randomly assigned to either a treatment group using ABAStroke or a control group receiving standard care. The goal is to demonstrate that this non-invasive digital therapeutic can enhance cognitive functions alongside traditional pharmacological therapies. Participants will be monitored for improvements in cognitive abilities such as memory, language, and executive functions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 who have experienced an ischemic or hemorrhagic stroke within the last 6 months and have a MoCA score between 15 and 25.

Not a fit: Patients with severe vision disorders, recent psychotic episodes, or significant depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve cognitive rehabilitation outcomes for stroke patients.

How similar studies have performed: While the use of digital therapeutics in rehabilitation is gaining traction, the specific application of ABAStroke is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

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.

Where this trial is running

Kraków

• Clinical Department of Neurology of the Jagiellonian University Hospital — Kraków, Poland (Recruiting)

Study contacts

• Study coordinator: Michał Ryś, Dr

Conditions Stroke