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

Aphasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01924702
• Other study ID #: CATS02EO0801
• Status: Recruiting
• Phase: Phase 2
• First received: August 14, 2013
• Last updated: February 3, 2015
• Start date: January 2011
• Est. completion date: December 2015

Study information

• Verified date: February 2015
• Source: Charité Neurocure AG Flöel
• Contact: Robert Darkow
• Phone: 004930450560395
• Email: robert.darkow[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 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-Finding Impairment)
• Aphasia

Intervention

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

Locations

Country	Name	City	State
Germany	Charite	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charité Neurocure AG Flöel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	naming performance		Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)	No
Secondary	naming performance		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		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		Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)	No
Secondary	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)	No
Secondary	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)	No