Tablet-based Application for Cognitive Therapy (TACTIC)

Tablet-based Application for Cognitive Therapy In the Care of Brain Injury

Cognitive impairments such as deficits in attention, executive functions, perception, language, speech, arithmetics, and memory are very common symptoms after acquired brain injury, which can be caused by neurological diseases such as stroke, cerebral haemorrhage or traumatic brain injury. Around 83% of patients with brain injury suffer from a sequelae of cognitive impairments.

Since the effects caused by neurological diseases can vary greatly from person to person, intensive and individual neuro-rehabilitation is necessary to help patients return to an independent life in the best possible way. In the DACH area (i.e., in Germany, Austria, and Switzerland), patients with cognitive impairments following brain injuries generally receive this intensive and interdisciplinary treatment while being hospitalised in an inpatient clinic following acute medical care.

However, once they leave inpatient care facilities, there are insufficient treatment options readily available to them due to limitations/shortages in the healthcare system's resources, although studies indicate that an increase in therapy time (both in outpatient settings at home or in care facilities) enables greater, long-term rehabilitation progress and faster reintegration and participation in everyday life. Thanks to recent technical advancements, digital treatment options now promise the availability of sufficiently frequent and intensive treatment outside of clinic settings. In that context, the myReha therapy software (available as an app on iOS ad Android tablets), a certified medical device, was developed to enable patients to receive individualised and intensive therapy regardless of the healthcare system's constraints. To test the effectiveness of the myReha therapy software, in this two-arm, randomised, controlled study, patients in the intervention group receive treatment through the myReha therapy software in addition to their usual standard care (i.e., care-as-usual - CAU), while the control group only receives CAU. Treatment outcomes (i.e., rehabilitation progress) are measured based on the CERAD-plus.

Study Overview

• Status: Recruiting
• Conditions: Brain Injuries
• Intervention / Treatment: Device: Tablet-based neurorehabilitation with myReha

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1210
    • Recruiting
    • Klinik Floridsdorf
    • Contact: Peter Lackner, Prof., MD; Phone Number: 2008 +43 1 27700; Email: peter.lackner@gesundheitsverbund.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Cognitive impairment (deficits in attention, arithmetics, executive functions, memory, language, perception) according to CERAD-plus after a diagnosed brain injury ≥ 4 weeks ago
• No prior experience with a therapy app for neurological deficits
• Motivation to use the therapy software regularly
• Sufficiently good German language skills prior to the brain injury

Exclusion Criteria:

• Being unable to use a tablet without assistance
• Severe visual or hearing impairment that interferes with the performance on psychometric testing procedures
• Any pre-existing speech or language disorder or dementia prior to the onset of brain injury
• An ongoing outpatient or inpatient rehabilitation at the time of study inclusion or planned rehabilitation of the primary disease during the study period
• Serious disabling disease(s) which, in the opinion of the investigator, would preclude participation in the study until the follow-up phase
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Patients allocated to the intervention group receive treatment through the myReha therapy software in addition to their usual standard care (i.e., care-as-usual; CAU)	Device: Tablet-based neurorehabilitation with myReha; The myReha therapy software provides cognitive therapy in the domains attention, executive functions, perception, language, speech, arithmetics, and memory. It automatically creates weekly plans that are individually tailored to a patient's abilities and provides real-time feedback when completing tasks. Intelligent algorithms ensure that the exercises always remain at the optimum level of difficulty.
No Intervention: Control Group; Patients allocated to the control group only receive usual standard care (CAU).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline in CERAD-plus scores	From enrolment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline in BIAS-R scores	From enrolment to the end of treatment at 12 weeks
Mean change from baseline in CETI score	From enrolment to the end of treatment at 12 weeks
Mean change from baseline in HADS-D scores	From enrolment to the end of treatment at 12 weeks
Mean change from baseline in EQ-5D-5L scores	From enrolment to the end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Klinikum Floridsdorf

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: TACTIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No