Assessment of Cortical Stimulation Combined With Rehabilitation to Enhance Recovery in Broca's Aphasia.

Stroke Clinical Trial

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 Broca's Aphasia, Following a Stroke.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170703
• Other study ID #: V0325
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: September 19, 2007
• Start date: December 2004
• Est. completion date: September 2007

Study information

• Verified date: September 2007
• Source: Northstar Neuroscience
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 Broca's aphasia (the inability to speak or to organize the muscular movements for speech), following a stroke.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Subjects must have an ischemic stroke.

• Subjects must have a language dominant left hemisphere.

• Subjects must be diagnosed as having predominantly Broca's aphasia.

• Age 21 years or older.

Exclusion Criteria:

• Primary hemorrhagic stroke.

• Any additional stroke associated with incomplete speech recovery.

• Any neurologic or physical condition that impairs speech function.

• History of seizure disorder.

• Global aphasia or inability to participate in routine speech therapy.

• Untreated or inadequately treated depression.

• History of traumatic brain injury, or spontaneous subdural or epidural hematoma that has resulted in a fixed (stable) speech-language deficit.

• Major active psychiatric illness that may interfere with required study procedures.

• Contraindication to magnetic resonance (MR) imaging.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Broca
• Broca's Aphasia
• Stroke

Intervention

Device:
• Cortical Electrical Stimulation

Locations

Country	Name	City	State
United States	Rehabilitation Institute of Chicago	Chicago	Illinois
United States	Univ. of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northstar Neuroscience

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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