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Clinic and Neurophysiology of Aphasia Treatment (AphasRehab)

Primary Purpose

Aphasia, Acquired

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CIAT + Conventional neurorehabilitative therapy
Sponsored by
Klinik Bavaria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia, Acquired

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with a cerebrovascular event

Exclusion Criteria:

  • premorbid brain disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Patients with aphasia

    Patients without aphasia

    Arm Description

    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.

    Patients with comparable stroke characteristics, but without clinical aphasia.

    Outcomes

    Primary Outcome Measures

    EEG correlates of language reconstitution
    Identitification of EEG features (N400, P600, Theta band activity) that correlate with clinical outcome of language reconstitution.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 4, 2022
    Last Updated
    October 6, 2022
    Sponsor
    Klinik Bavaria
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05572385
    Brief Title
    Clinic and Neurophysiology of Aphasia Treatment
    Acronym
    AphasRehab
    Official Title
    Clinical and Neurophysiological Features of Neurorehabilitation Effects in Cerebrovascular Aphasia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Klinik Bavaria

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aphasia, Acquired

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with aphasia
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Patients without aphasia
    Arm Type
    No Intervention
    Arm Description
    Patients with comparable stroke characteristics, but without clinical aphasia.
    Intervention Type
    Behavioral
    Intervention Name(s)
    CIAT + Conventional neurorehabilitative therapy
    Other Intervention Name(s)
    Conventional neurorehabilitative therapy
    Intervention Description
    CIAT = Constrained induced aphasia therapy
    Primary Outcome Measure Information:
    Title
    EEG correlates of language reconstitution
    Description
    Identitification of EEG features (N400, P600, Theta band activity) that correlate with clinical outcome of language reconstitution.
    Time Frame
    3-6 months after stroke

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with a cerebrovascular event Exclusion Criteria: premorbid brain disorder

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Clinic and Neurophysiology of Aphasia Treatment

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