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

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.

Study Overview

• Status: Unknown
• Conditions: Aphasia; Anomia (Word-Finding Impairment)
• Intervention / Treatment: Behavioral: Intensive language therapy; Device: transcranial direct current stimulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Recruiting
    • Charité
    • Contact: Robert Darkow; Phone Number: 004930450560395; Email: robert.darkow@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
naming performance	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	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	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)	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)	Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)

Collaborators and Investigators

• Sponsor: Charité Neurocure AG Flöel
• Investigators: Principal Investigator: Agnes Floeel, Prof MD, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ANTICIPATED): December 1, 2015
• Study Completion (ANTICIPATED): December 1, 2015

Study Registration Dates

• First Submitted: August 14, 2013
• First Submitted That Met QC Criteria: August 15, 2013
• First Posted (ESTIMATE): August 16, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 4, 2015
• Last Update Submitted That Met QC Criteria: February 3, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: CATS02EO0801