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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2015 by Charité Neurocure AG Flöel.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01924702
First Posted: August 16, 2013
Last Update Posted: February 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Charité Neurocure AG Flöel
  Purpose
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.

Condition Intervention Phase
Aphasia Anomia (Word-Finding Impairment) Behavioral: Intensive language therapy Device: transcranial direct current stimulation Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation (CATS)

Resource links provided by NLM:


Further study details as provided by Charité Neurocure AG Flöel:

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

Secondary Outcome Measures:
  • 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) ]

Estimated Enrollment: 24
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: anodal tDCS
Intensive language therapy with anodal transcranial direct current stimulation
Behavioral: Intensive language therapy
2 weeks of daily computerized naming training, daily, 3 hours
Device: transcranial direct current stimulation
1mA anodal over M1 primary motor cortex for 20min with 35cm/2 electrode, Cathode (100cm/2) contralateral
Sham Comparator: sham tDCS
Intensive language therapy with Sham-tDCS
Behavioral: Intensive language therapy
2 weeks of daily computerized naming training, daily, 3 hours
Device: transcranial direct current stimulation
1mA anodal over M1 primary motor cortex for 20min with 35cm/2 electrode, Cathode (100cm/2) contralateral

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924702


Contacts
Contact: Robert Darkow 004930450560395 robert.darkow@charite.de

Locations
Germany
Charite Recruiting
Berlin, Germany
Contact: Robert Darkow    004930450560395    robert.darkow@charite.de   
Sponsors and Collaborators
Charité Neurocure AG Flöel
Investigators
Principal Investigator: Agnes Floeel, Prof MD Charite University, Berlin, Germany
  More Information

Responsible Party: Charité Neurocure AG Flöel
ClinicalTrials.gov Identifier: NCT01924702     History of Changes
Other Study ID Numbers: CATS02EO0801
First Submitted: August 14, 2013
First Posted: August 16, 2013
Last Update Posted: February 4, 2015
Last Verified: February 2015

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


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