StrokeNCT05979324
Evaluation of the Effectiveness and Safety of ABAStroke
A study testing ABAStroke Digital Therapeutics in people with Stroke, run by ABAStroke Sp. z o.o. at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- ABAStroke Digital Therapeutics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 13 Jul 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Clinical Department of Neurology of the Jagiellonian University Hospital
Krakow
Agnieszka Słowik, Prof., aslowik@su.krakow.pl
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- ABAStroke Digital Therapeutics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABAStroke Digital TherapeuticsDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| ABAStroke Digital Therapeutics | Experimental | 50 patients using ABAStroke with standard treatment after a stroke. Receives: Device: ABAStroke Digital Therapeutics |
| Control group | No intervention | 50 people using standard treatment after a stroke. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MoCA
Screening tool for detecting cognitive deficits
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start13 Jul 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ABAStroke Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979324
- Sponsor's protocol ID
- ABAStroke 1.0
- Status last verified
- Jul 2023
- First submitted
- 28 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Safety of ABAStroke in the Rehabilitation of Cognitive Deficits in Stroke Patients
- ClinicalTrials.gov ID
- NCT05979324
- Acronym / sponsor ID
- ABAStroke 1.0
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ABAStroke Sp. z o.o.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ABAStroke Digital Therapeutics | Experimental | Device: ABAStroke Digital Therapeutics50 patients using ABAStroke with standard treatment after a stroke. |
| Control group | No intervention | –50 people using standard treatment after a stroke. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABAStroke Digital TherapeuticsThe 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). | Device | ABAStroke Digital Therapeutics |
Primary outcome
MoCA
Time frame: 3 months
Screening tool for detecting cognitive deficits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABAStroke Digital Therapeutics in people with Stroke, run by ABAStroke Sp. z o.o. at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michał Ryś, Dr (+48694550816, michal@abastroke.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MoCA (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.