Evaluation of the Effectiveness and Safety of ABAStroke | NCT05979324

Studies
Evaluation of the Effectiveness and Safety of ABAStroke

NCT05979324

Sponsor

ABAStroke Sp. z o.o.

Status

Unknown status

Last Update Posted

Aug 7, 2023Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Stroke

Interventions

ABAStroke Digital Therapeutics

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 13, 2023Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

May 31, 2024Estimated

First Submitted Date

Jul 28, 2023

First Submission Date that Met QC Criteria

Jul 28, 2023

First Posted Date

Aug 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2023

Last Update Posted Date

Aug 7, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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).

Measure	Description	Time Frame
MoCA	Screening tool for detecting cognitive deficits	3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Michał Ryś, Dr	Contact	+48694550816		michal@abastroke.com

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Department of Neurology of the Jagiellonian University Hospital	Recruiting	Krakow			Poland

ID	Term
D020521	Stroke

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

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.