Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00170703
Status:
COMPLETED
Last Update Posted:
2007-09-21
First Post:
2005-09-12
Brief Title:
Assessment of Cortical Stimulation Combined With Rehabilitation to Enhance Recovery in Brocas Aphasia
Sponsor:
Northstar Neuroscience
Organization:
Northstar Neuroscience
Study Overview
Official Title:
Assessment of the Safety and Effectiveness of Targeted Sub-Threshold Epidural Cortical Stimulation Delivered Concurrent With Speech-Language Rehabilitation to Enhance Recovery in Patients Suffering From Brocas Aphasia Following a Stroke
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Brocas aphasia the inability to speak or to organize the muscular movements for speech following a stroke
Detailed Description:
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 US is approximately 48 million with approximately 700000 additional strokes occurring annually Approximately 150000 to 250000 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 Brocas aphasia a condition in which the patient is unable to speak normally as they cannot effectively organize the muscular movements required for speech Brocas 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 speechlanguage 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 Brocas 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 Brocas 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 Brocas aphasia patients This study proposes to evaluate the safety and effectiveness of such cortical electrical stimulation in study subjects with Brocas 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
A common neurological deficit among these stroke survivors and thus a substantial contributor to post-stroke disability is Brocas aphasia a condition in which the patient is unable to speak normally as they cannot effectively organize the muscular movements required for speech Brocas 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 speechlanguage 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 Brocas 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 Brocas 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 Brocas aphasia patients This study proposes to evaluate the safety and effectiveness of such cortical electrical stimulation in study subjects with Brocas 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None