Clinical trial NCT05979324: 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
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: ABAStroke Sp. z o.o.
Sponsor class: INDUSTRY
First posted: 2023-08-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: MoCA
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Clinical Department of Neurology of the Jagiellonian University Hospital
Study officials:
References: