Background and purpose This study evaluated the safety and feasibility of targeted epidural cortical stimulation delivered concurrently with intensive speech–language therapy for treatment of chronic non-fluent aphasia.
Methods Eight stroke survivors with non-fluent aphasia received intensive behavioural therapy for 3 h daily for 6 weeks using a combination of articulation drills, oral reading and conversational practice. Four of these participants (investigational participants) also underwent functional MRI guided surgical implantation of an epidural stimulation device which was activated only during therapy sessions. Behavioural data were collected before treatment, immediately after treatment and at 6 and 12 weeks following termination of therapy. Imaging data were collected before and after treatment.
Results Investigational participants showed a mean Aphasia Quotient change of 8.0 points immediately post-therapy and at the 6 week follow-up, and 12.3 points at 12 weeks. The control group had changes of 4.6, 5.5 and 3.6 points, respectively. Similar changes were noted on subjective caregiver ratings. Functional imaging suggested increased consolidation of activity in interventional participants.
Conclusions Behavioural speech–language therapy improves non-fluent aphasia, independent of cortical stimulation. However, epidural stimulation of the ipsilesional premotor cortex may augment this effect, with the largest effects after completion of therapy. The neural mechanisms underlying these effects are manifested in the brain by decreases in the volume of activity globally and in particular regions. Although the number of participants enrolled in this trial precludes definitive conclusions, targeted epidural cortical stimulation appears safe and may be a feasible adjunctive treatment for non-fluent aphasia, particularly when the aphasia is more severe.
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Funding Northstar Neuroscience Corporation, Seattle, Washington, USA, funded the study but the authors have no financial interest in the company and serve in no consultative capacities with this company.
Competing interests None.
Ethics approval This study was conducted with the approval of the US Food and Drug Administration under an Investigational Device Exemption and by the institutional review boards of both Northwestern University and the University of Chicago.
Provenance and peer review Not commissioned; externally peer reviewed.
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