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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Marcus Meinzer, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01221779
First received: October 13, 2010
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Post-Stroke Chronic Aphasia
Anomia (Word-retrieval Impairment)
Behavioral: Intensive language therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chronic Aphasia - Improved by Intensive Training and Electrical Brain

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Boston Naming Test [ Time Frame: Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Boston Naming Test [ Time Frame: Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up) ] [ Designated as safety issue: No ]
    The follow-up will be administered to assess the stability of the treatment gains

  • 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) ] [ Designated as safety issue: No ]
    assessed during overt picture naming task

  • 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) ] [ Designated as safety issue: No ]
    assessed during overt picture naming task


Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: sham tDCS Behavioral: Intensive language therapy
2 weeks of daily computerized naming training, daily, 3 hours
Experimental: anodal tDCS Behavioral: Intensive language therapy
2 weeks of daily computerized naming training, daily, 3 hours

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 we aim to assess whether the outcome of intensive language training can be enhanced by adjuvant non-invasive brain stimulation. We 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. We will also use functional and structural magnetic resonance imaging (MRI) to elucidate language network changes in the two groups.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • right-handedness
  • single first time left-hemisphere stroke
  • fluent- or non-fluent chronic aphasia (more than six months post-stroke)
  • anomia (PR>10 and PR<60 Aachen Aphasia Naming Subtest)
  • native German Speaker

Exclusion Criteria:

  • more than one stroke
  • alcoholism, severe psychiatric conditions, other neurological conditions
  • other non-treated medical problems, severe microangiopathy
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221779

Contacts
Contact: Marcus Meinzer, PhD +49-(0)30-450-560 ext 140 marcus.meinzer@charite.de
Contact: Agnes Flöel, MD +49-(0)30-450-560 ext 284 agnes.floeel@charite.de

Locations
Germany
Charite, University Medicine, Dept. of Neurology Recruiting
Berlin, Germany
Principal Investigator: Marcus Meinzer, PhD         
Principal Investigator: Agnes Flöel, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Marcus Meinzer, PhD Charite, University Medicine, Neurology
Study Director: Agnes Flöel, MD Charite, University Medicine, Neurology
  More Information

Additional Information:
No publications provided

Responsible Party: Marcus Meinzer, Creutzfeldt Fellow, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01221779     History of Changes
Other Study ID Numbers: CATS01EO0801
Study First Received: October 13, 2010
Last Updated: August 26, 2013
Health Authority: Germany: Institutional Review Board

Keywords provided by Charite University, Berlin, Germany:
Intensive language therapy
Anomia
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Aphasia
Communication Disorders
Language Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Speech Disorders

ClinicalTrials.gov processed this record on October 23, 2014