Aphasia, AcquiredAphasRehabNCT05572385
Clinic and Neurophysiology of Aphasia Treatment
A study testing CIAT + Conventional neurorehabilitative therapy in people with Aphasia, Acquired, run by Klinik Bavaria.
Trial summary
In the planned study, clinical and electrophysiological features of aphasia recovery in stroke patients are investigated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aphasia, Acquired
- What is being tested?
- CIAT + Conventional neurorehabilitative therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with a cerebrovascular event
Who cannot join
- premorbid brain disorder
About this study
Official title: Clinical and Neurophysiological Features of Neurorehabilitation Effects in Cerebrovascular Aphasia
In the planned study, clinical and electrophysiological features of aphasia recovery in stroke patients are investigated.
Read the detailed description
Clinical neurorehabilitation faces a major challenge of functional recovery in aphasia, i.e. guiding the structural and temporal dynamics of reorganization within responsible neural networks. Here, according to current research, relevant neural factors affecting the treatment and thus the functional recovery of aphasia patients after stroke are of interest, highlighting structural as well as functional neuroanatomical features. Of particular interest are not only the functional localization of affected cerebral regions, but more the clinical and neurophysiological patterns which might help to factorize and predict the therapeutic outcome. In the planned study, the clinical and neurophysiological characteristics of the dynamics of language function recovery in relation to the intensity of professional speech therapy (constraint induced aphasia therapie - CIAT) will be recorded in 40 patients with aphasia resulting from a cerebrovascular event. The aim of this study is to test the value of neurophysiological aspects based on electroencephalographic (EEG) parameters such as event-related potentials (N400, P600, theta band activity) for the identification of specific neuronal markers, which in turn support predictive statements for individual therapy planning of logopedic treatment in neurorehabilitation.
- Conditions
- Aphasia, Acquired
- Being tested
- CIAT + Conventional neurorehabilitative therapy
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIAT + Conventional neurorehabilitative therapyBehavioural
Also called Conventional neurorehabilitative therapy
CIAT = Constrained induced aphasia therapy
| Study group | Role | What they receive |
|---|---|---|
| Patients with aphasia | Active comparator | Patients with a clinical aphasia (20 receptive, 20 expressive) with a specific logopedic treatment, with specific EEG measurement at start and end of treatment schedule. Receives: Behavioral: CIAT + Conventional neurorehabilitative therapy |
| Patients without aphasia | No intervention | Patients with comparable stroke characteristics, but without clinical aphasia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG correlates of language reconstitution
Identitification of EEG features (N400, P600, Theta band activity) that correlate with clinical outcome of language reconstitution.
Measured: 3-6 months after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start1 Jul 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphasia, AcquiredStudies 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinik Bavaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Adamaszek, Klinik Bavaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572385
- Sponsor's protocol ID
- EK-BR-157/20-1
- Acronym
- AphasRehab
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2022
- Last updated
- 7 Oct 2022
- 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 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Neurophysiological Features of Neurorehabilitation Effects in Cerebrovascular Aphasia
- ClinicalTrials.gov ID
- NCT05572385
- Acronym / sponsor ID
- AphasRehab / EK-BR-157/20-1
- Conditions
- Aphasia, Acquired
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Klinik BavariaUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Oct 2022 (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.
In the planned study, clinical and electrophysiological features of aphasia recovery in stroke patients are investigated.
Detailed description
Clinical neurorehabilitation faces a major challenge of functional recovery in aphasia, i.e. guiding the structural and temporal dynamics of reorganization within responsible neural networks. Here, according to current research, relevant neural factors affecting the treatment and thus the functional recovery of aphasia patients after stroke are of interest, highlighting structural as well as functional neuroanatomical features. Of particular interest are not only the functional localization of affected cerebral regions, but more the clinical and neurophysiological patterns which might help to factorize and predict the therapeutic outcome. In the planned study, the clinical and neurophysiological characteristics of the dynamics of language function recovery in relation to the intensity of professional speech therapy (constraint induced aphasia therapie - CIAT) will be recorded in 40 patients with aphasia resulting from a cerebrovascular event. The aim of this study is to test the value of neurophysiological aspects based on electroencephalographic (EEG) parameters such as event-related potentials (N400, P600, theta band activity) for the identification of specific neuronal markers, which in turn support predictive statements for individual therapy planning of logopedic treatment in neurorehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with aphasia | Active comparator | Behavioral: CIAT + Conventional neurorehabilitative therapyPatients with a clinical aphasia (20 receptive, 20 expressive) with a specific logopedic treatment, with specific EEG measurement at start and end of treatment schedule. |
| Patients without aphasia | No intervention | –Patients with comparable stroke characteristics, but without clinical aphasia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with a cerebrovascular event
Key exclusion criteria (1 listed)
- premorbid brain disorder
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 |
|---|---|---|
| CIAT + Conventional neurorehabilitative therapyAlso: Conventional neurorehabilitative therapyCIAT = Constrained induced aphasia therapy | Behavioural | Patients with aphasia |
Primary outcome
EEG correlates of language reconstitution
Time frame: 3-6 months after stroke
Identitification of EEG features (N400, P600, Theta band activity) that correlate with clinical outcome of language reconstitution.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Individual participant dataSharing planned: No
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Impact of Group Participation on Adults With Aphasia
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Not yet recruitingPhase 3
EFFECT OF ANODAL TRANSCRANIAL DIRECT CURRENT STIMULATION ON NAMING IN APHASIC PATIENTS WITH ACUTE ISCHEMIC STROKE
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CIAT + Conventional neurorehabilitative therapy in people with Aphasia, Acquired, run by Klinik Bavaria.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG correlates of language reconstitution (time frame: 3-6 months after stroke). 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 Oct 2022.