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

Completed · Phase 1

Conditions studied: Stroke, Broca's Aphasia

In brief

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.

Key facts

Study ID

NCT00170703

Run by

Northstar Neuroscience

People needed

8

Starts

2004-12-01

Expected to finish

2007-09-01

Last updated by the study team

2007-09-21

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Rehabilitation Institute of Chicago — Chicago, Illinois, United States
• Univ. of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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