AphasRehab: Clinic and Neurophysiology of Aphasia Treatment

Sponsor

Klinik Bavaria (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05572385

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

In the planned study, clinical and electrophysiological features of aphasia recovery in stroke patients are investigated.

Condition or Disease	Intervention/Treatment	Phase
Aphasia, Acquired	Behavioral: CIAT + Conventional neurorehabilitative therapy	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical and Neurophysiological Features of Neurorehabilitation Effects in Cerebrovascular Aphasia

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Patients with aphasia 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.	Behavioral: CIAT + Conventional neurorehabilitative therapy CIAT = Constrained induced aphasia therapy Other Names: Conventional neurorehabilitative therapy
No Intervention: Patients without aphasia Patients with comparable stroke characteristics, but without clinical aphasia.

Arm

Intervention/Treatment

Active Comparator: Patients with aphasia

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.

Behavioral: CIAT + Conventional neurorehabilitative therapy

CIAT = Constrained induced aphasia therapy

Other Names:

Conventional neurorehabilitative therapy

No Intervention: Patients without aphasia

Patients with comparable stroke characteristics, but without clinical aphasia.

Outcome Measures

Primary Outcome Measures

EEG correlates of language reconstitution [3-6 months after stroke]
Identitification of EEG features (N400, P600, Theta band activity) that correlate with clinical outcome of language reconstitution.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients with a cerebrovascular event

Exclusion Criteria:

premorbid brain disorder

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Klinik Bavaria

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Adamaszek, Head Dept. Clinical and Cognitive Neurorehabilitation, Klinik Bavaria

ClinicalTrials.gov Identifier:

NCT05572385

Other Study ID Numbers:

EK-BR-157/20-1

First Posted:

Oct 7, 2022

Last Update Posted:

Oct 7, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Aphasia

Study Results

No Results Posted as of Oct 7, 2022