Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation

Anomia (Word-retrieval Impairment) Clinical Trial

— CATS  

Official title:

Chronic Aphasia - Improved by Intensive Training and Electrical Brain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01221779
• Other study ID #: CATS01EO0801
• Status: Recruiting
• Phase: Phase 2
• First received: October 13, 2010
• Last updated: August 26, 2013
• Start date: January 2011
• Est. completion date: December 2014

Study information

• Verified date: August 2013
• Source: Charite University, Berlin, Germany
• Contact: Marcus Meinzer, PhD
• Phone: +49-(0)30-450-560
• Email: marcus.meinzer[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anomia (Word-retrieval Impairment)
• Aphasia
• Post-Stroke Chronic Aphasia

Intervention

Behavioral:
• Intensive language therapy
2 weeks of daily computerized naming training, daily, 3 hours
• Intensive language therapy
2 weeks of daily computerized naming training, daily, 3 hours

Locations

Country	Name	City	State
Germany	Charite, University Medicine, Dept. of Neurology	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Naming Test		Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)	No
Secondary	Boston Naming Test	The follow-up will be administered to assess the stability of the treatment gains	Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)	No
Secondary	Naming performance during functional magnetic resonance scanning	assessed during overt picture naming task	Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)	No
Secondary	Naming performance during functional magnetic resonance imaging	assessed during overt picture naming task	Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)	No