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

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Charité Neurocure AG Flöel

Current Primary Outcome: naming performance [ Time Frame: Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • naming performance [ Time Frame: Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up) ]
  • Naming performance during functional magnetic resonance scanning [ Time Frame: Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing) ]
  • Naming performance during functional magnetic resonance imaging [ Time Frame: Change 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) [ Time Frame: Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing) ]
  • Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT) [ Time Frame: Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up) ]


Original Secondary Outcome: Same as current

Information By: Charité Neurocure AG Flöel

Dates:
Date Received: August 14, 2013
Date Started: January 2011
Date Completion: December 2015
Last Updated: February 3, 2015
Last Verified: February 2015