Brain InjuriesTACTICNCT06462703
Tablet-based Application for Cognitive Therapy
A study testing Tablet-based neurorehabilitation with myReha in people with Brain Injuries, run by Klinikum Floridsdorf at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Tablet-based neurorehabilitation with myReha
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- 2 Mar 2023to 1 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Klinik Floridsdorf
Vienna, 1210
Peter Lackner, Prof., MD, +43 1 27700 ext. 2008, peter.lackner@gesundheitsverbund.at
About this study
Official title: 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.
- Conditions
- Brain Injuries
- Being tested
- Tablet-based neurorehabilitation with myReha
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet-based neurorehabilitation with myRehaDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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) Receives: Device: Tablet-based neurorehabilitation with myReha |
| Control Group | No intervention | Patients allocated to the control group only receive usual standard care (CAU). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in CERAD-plus scores
Measured: From enrolment to the end of treatment at 12 weeks
Secondary outcomes (4)
Mean change from baseline in BIAS-R scores
Measured: From enrolment to the end of treatment at 12 weeks
Mean change from baseline in CETI score
Measured: From enrolment to the end of treatment at 12 weeks
Mean change from baseline in HADS-D scores
Measured: From enrolment to the end of treatment at 12 weeks
Mean change from baseline in EQ-5D-5L scores
Measured: From enrolment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start2 Mar 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum Floridsdorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Lackner, Klinikum Floridsdorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462703
- Sponsor's protocol ID
- TACTIC
- Acronym
- TACTIC
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tablet-based Application for Cognitive Therapy In the Care of Brain Injury
- ClinicalTrials.gov ID
- NCT06462703
- Acronym / sponsor ID
- TACTIC / TACTIC
- Conditions
- Brain Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Klinikum FloridsdorfUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 17 Jun 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Tablet-based neurorehabilitation with myRehaPatients 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) |
| Control Group | No intervention | –Patients allocated to the control group only receive usual standard care (CAU). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Tablet-based neurorehabilitation with myRehaThe 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. | Device | Intervention Group |
Primary outcome
Mean change from baseline in CERAD-plus scores
Time frame: From enrolment to the end of treatment at 12 weeks
4 secondary outcomes
Mean change from baseline in BIAS-R scores
Time frame: From enrolment to the end of treatment at 12 weeks
Mean change from baseline in CETI score
Time frame: From enrolment to the end of treatment at 12 weeks
Mean change from baseline in HADS-D scores
Time frame: From enrolment to the end of treatment at 12 weeks
Mean change from baseline in EQ-5D-5L scores
Time frame: From enrolment to the end of treatment at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
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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 Tablet-based neurorehabilitation with myReha in people with Brain Injuries, run by Klinikum Floridsdorf at 1 site in Austria.
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 6 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 17 Jun 2024. 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 Austria. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in CERAD-plus scores (time frame: From enrolment to the end of treatment at 12 weeks). 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 17 Jun 2024.