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Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation (CATS)

Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation (CATS)

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01924702
Enrollment
24
Registered
2013-08-16
Start date
2011-01-31
Completion date
2015-12-31
Last updated
2015-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anomia (Word-Finding Impairment), Aphasia

Brief summary

The purpose of this study is to determine if non-invasive electrical brain stimulation can enhance the outcome of intensive language therapy in chronic aphasia.

Detailed description

Stroke is the leading cause of death and disability worldwide. Given the increasing average lifespan worldwide, the incidence and prevalence of patients with stroke will dramatically increase in the future. One of the most frequent and devastating conditions after stroke is aphasia, which affects language production and comprehension. High-frequent intensive speech-and-language therapy is currently the treatment of choice in chronic aphasia. However, despite its general effectiveness, treatment effect sizes are only low to moderate. Thus, there is a pressing need to explore novel training-adjuvant therapies to enhance treatment efficacy. Moreover, very little is known about the neurobiology of treatment-induced recovery in chronic aphasia. This is the prerequisite to improve existing and/or develop new treatment paradigms. Thus, in the present project the investigators aim to assess whether the outcome of intensive language training can be enhanced by adjuvant non-invasive brain stimulation. They will be using anodal transcranial direct current stimulation (atDCS) that has previously been shown to enhance (a) language and motor learning in healthy subjects and (b) motor recovery in stroke patients. Specifically, in a longitudinal group comparison design, two matched groups of patients with chronic anomia will receive two weeks of intensive language training with or without atDCS. Treatment effects will be assessed immediately after the two week intervention period and several months after the end of the training. The Investigators will also use functional and structural magnetic resonance imaging (MRI) to elucidate language network changes in the two groups.

Interventions

2 weeks of daily computerized naming training, daily, 3 hours

DEVICEtranscranial direct current stimulation

1mA anodal over M1 primary motor cortex for 20min with 35cm/2 electrode, Cathode (100cm/2) contralateral

Sponsors

Charité Neurocure AG Flöel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* chronic stroke (\> 1 year after event) * aphasia due to stroke with naming impairment * German as first language * first-ever stroke

Exclusion criteria

* more than 1 stroke * history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity * dementia * contraindications for Magnetic Resonance Imaging or transcranial direct current stimulation

Design outcomes

Primary

MeasureTime frame
naming performanceChange of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)

Secondary

MeasureTime frame
naming performanceChange of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)
Naming performance during functional magnetic resonance scanningChange of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)
Naming performance during functional magnetic resonance imagingChange of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)
Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT)Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)

Countries

Germany

Contacts

Primary ContactRobert Darkow
robert.darkow@charite.de004930450560395

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026