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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00170703
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : September 21, 2007
Information provided by:
Northstar Neuroscience

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

Condition or disease Intervention/treatment Phase
Stroke Broca's Aphasia Device: Cortical Electrical Stimulation Phase 1

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 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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
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.
Study Start Date : December 2004
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Aphasia Quotient on the Western Aphasia Battery (WAB-AQ) at follow-up week 1
  2. Measures of speech rate obtained from Language Sample Analysis at follow-up week 1

Secondary Outcome Measures :
  1. Serious Adverse Event rate at follow-up weeks 1, 6 & 12-week
  2. Aphasia Quotient on the Western Aphasia Battery (WAB-AQ) at follow-up weeks 6 & 12
  3. Measures of speech rate obtained from Language Sample Analysis at follow-up weeks 6 & 12

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00170703

United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
Univ. of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
Northstar Neuroscience

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00170703     History of Changes
Other Study ID Numbers: V0325
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 21, 2007
Last Verified: September 2007

Keywords provided by Northstar Neuroscience:
Cortical Electrical Stimulation
Ischemic Stroke
Broca's Aphasia
Speech Rehabilitation
Functional MRI

Additional relevant MeSH terms:
Communication Disorders
Aphasia, Broca
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Speech Disorders
Language Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms