The primary objective of this feasibility study is to evaluate the safety and effectiveness of targeted sub-threshold epidural cortical stimulation delivered concurrent with speech-language rehabilitation activities to enhance recovery in study subjects suffering from Broca's aphasia (the inability to speak or to organize the muscular movements for speech), following a stroke.
Stroke is the third leading cause of death and the most common cause of disability in the United States. According to the American Stroke Association, the prevalence of stroke in the U.S. is approximately 4.8 million with approximately 700,000 additional strokes occurring annually. Approximately 150,000 to 250,000 stroke survivors becoming severely and permanently disabled each year.
A common neurological deficit among these stroke survivors, and thus a substantial contributor to post-stroke disability is Broca's aphasia, a condition in which the patient is unable to speak normally, as they cannot effectively organize the muscular movements required for speech. Broca's aphasia is often referred to as "non-fluent" or "motor" aphasia as essentially the patient has impaired motor abilities for speech and thus, become non-fluent in speech/language. The loss of speech for these patients is extremely debilitating and has enormous social and economic impact to the quality of life for these patients. Presently, the only treatment available for patients with Broca's aphasia is speech-language rehabilitation. However, with rehabilitation only, many patients achieve a less than satisfactory improvement in speech-language function and thus, are left with significant disability.
Since Broca's aphasia is largely due to an impairment of language-related motor function, researchers and clinicians believe it is very likely that cortical stimulation in conjunction with speech rehabilitation may also enhance recovery of language motor function for Broca's aphasia patients. This study proposes to evaluate the safety and effectiveness of such cortical electrical stimulation in study subjects with Broca's aphasia after stroke, delivered concurrent with speech-language rehabilitation.
In addition to evaluating changes from baseline level, safety and efficacy measures will be compared to patients who undergo the same speech-language rehabilitation activities but without cortical stimulation. The two study groups will be compared to determine the degree to which the aphasia can be improved beyond rehabilitation alone by epidural stimulation of a targeted cortical region.
- Electrical stimulation Device
Intervention Desc: This category includes any form of electrical stimulation intended to improve motor function or pain after stroke.
- Cortical Electrical Stimulation Device
- Allocation: Randomized
- Masking: Single Blind
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Functional magnetic resonance imaging (fMRI) is used to identify the left hemisphere cortical stimulation target; all eligible patients are then randomized to one of two treatment groups. Patients randomized to the investigational study arm will undergo a surgery to place an electrode on the layer covering the brain (the dura) over the area identified in the fMRI scan. The electrode will be connected to an implantable pulse generator (IPG, similar to a pacemaker) implanted below the collarbone that will administer stimulation below the level of sensation (or movement) during speech language treatment only and will be removed during follow up.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Aphasia Quotient on the Western Aphasia Battery (WAB-AQ), Measures of speech rate obtained from Language Sample Analysis at week 1.|
|Secondary||Serious Adverse Event rate at follow-up weeks 1, 6 & 12-week; Aphasia Quotient on the Western Aphasia Battery (WAB-AQ) at follow-up weeks 6 & 12; Measures of speech rate obtained from Language Sample Analysis at follow-up weeks 6 & 12.|
|Primary||Aphasia Quotient on the Western Aphasia Battery (WAB-AQ) at follow-up week 1|
|Primary||Measures of speech rate obtained from Language Sample Analysis at follow-up week 1|
|Secondary||Serious Adverse Event rate at follow-up weeks 1, 6 & 12-week|
|Secondary||Aphasia Quotient on the Western Aphasia Battery (WAB-AQ) at follow-up weeks 6 & 12|
|Secondary||Measures of speech rate obtained from Language Sample Analysis at follow-up weeks 6 & 12|