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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Charité Neurocure AG Flöel
Sponsor:
Information provided by (Responsible Party):
Charité Neurocure AG Flöel
ClinicalTrials.gov Identifier:
NCT01924702
First received: August 14, 2013
Last updated: October 29, 2013
Last verified: October 2013
  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
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 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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • 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 ]
  • 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 ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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: 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 Charité Berlin
  More Information

No publications provided

Responsible Party: Charité Neurocure AG Flöel
ClinicalTrials.gov Identifier: NCT01924702     History of Changes
Other Study ID Numbers: CATS02EO0801
Study First Received: August 14, 2013
Last Updated: October 29, 2013
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on August 26, 2014