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

Recruiting

Phase 2 Results N/A

Trial Description

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.

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.

Conditions

Interventions

  • Transcranial direct current stimulation Device
    Intervention Desc: 1mA anodal over M1 primary motor cortex for 20min with 35cm/2 electrode, Cathode (100cm/2) contralateral
    ARM 1: Kind: Experimental
    Label: anodal tDCS
    Description: Intensive language therapy with anodal transcranial direct current stimulation
    ARM 2: Kind: Experimental
    Label: sham tDCS
    Description: Intensive language therapy with Sham-tDCS
  • Intensive language therapy Behavioral
    Intervention Desc: 2 weeks of daily computerized naming training, daily, 3 hours
    ARM 1: Kind: Experimental
    Label: anodal tDCS
    Description: Intensive language therapy with anodal transcranial direct current stimulation
    ARM 2: Kind: Experimental
    Label: sham tDCS
    Description: Intensive language therapy with Sham-tDCS
  • Intensive language therapy 2 weeks of daily computerized naming training, daily, 3 hours Behavioral
    ARM 1: Kind: Experimental
    Label: anodal tDCS
    Description: Intensive language therapy with anodal transcranial direct current stimulation
    ARM 2: Kind: Experimental
    Label: sham tDCS
    Description: Intensive language therapy with Sham-tDCS

Trial Design

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

Outcomes

Type Measure 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 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

Sponsors