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

This study has been completed.
Sponsor:
Information provided by:
Northstar Neuroscience
ClinicalTrials.gov Identifier:
NCT00170703
First received: September 12, 2005
Last updated: September 19, 2007
Last verified: September 2007
  Purpose

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 Intervention Phase
Stroke
Broca's Aphasia
Device: Cortical Electrical Stimulation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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.

Resource links provided by NLM:


Further study details as provided by Northstar Neuroscience:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 8
Study Start Date: December 2004
Study Completion Date: September 2007
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170703

Locations
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00170703     History of Changes
Other Study ID Numbers: V0325
Study First Received: September 12, 2005
Last Updated: September 19, 2007
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 14, 2014