Status:

UNKNOWN

Evaluation of the Effectiveness and Safety of ABAStroke

Lead Sponsor:

ABAStroke Sp. z o.o.

Conditions:

Stroke

Eligibility:

All Genders

18-70 years

Phase:

NA

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

July 13 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 31 2024

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT05979324

Start Date

July 13 2023

End Date

May 31 2024

Last Update

August 7 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Clinical Department of Neurology of the Jagiellonian University Hospital

Krakow, Poland

Evaluation of the Effectiveness and Safety of ABAStroke | DecenTrialz