CHESTNUT is a feasibility study study designed to assess the safety and effectiveness of the Renova-ST™ Cortical Stimulation System* in treating patients with stroke-related Broca's aphasia. Northstar recently completed enrollment for CHESTNUT. This is an FDA approved clinical research study.

The CHESTNUT study, with principal investigators Steven L. Small, M.D., Ph.D. of the University of Chicago's Department of Neurology and Leora R. Cherney, Ph.D. of the Rehabilitation Institute of Chicago's Center for Aphasia Research, completed patient enrollment in June 2006. The study was comprised of randomly assigned investigational and control patients matched by severity of aphasia. Over a six week period, all participants received intensive speech and language therapy. The investigational group also received cortical stimulation during the speech and language therapy sessions. Cortical stimulation therapy involves the precise delivery of low levels of electricity to the outer layer of the brain via an implanted stimulator system.

Speech and language recovery was measured using the Western Aphasia Battery-Aphasia Quotient (WAB-AQ). A 5-point improvement from baseline is considered a clinically significant outcome. For all CHESTNUT participants, WAB-AQ assessments were performed at various points during the study to assess changes. The investigational group showed a mean WAB-AQ improvement from baseline of 8.0 points both immediately post-therapy and at the 6-week follow-up compared to 4.6 points and 5.5 points for the control group, respectively. Follow-up data at 12 weeks is available for 6 of the 8 patients and indicates that a greater increase occurred in the investigational group, with a mean change of 12.4 points versus a 4.1 points change in the control group.

The principal investigators found that investigational cortical stimulation in combination with intensive speech-language therapy may result in greater language improvement for chronic Broca's aphasia than speech-language therapy alone.

We are not currently enrolling patients for aphasia.

For more information please contact:
Brian Kopell, MD
206 902-1949
bkopell@northstarneuro.com

*Caution: Investigational device. Limited by Federal (or U.S.) law to investigational use.

Please note: All clinical trials have potential benefits and risks. Any prospective participant must sign an informed consent document in which these risks and benefits are outlined and must be discussed with the physician/institution participating in the clinical research. Once the informed consent is signed the patient may be enrolled in the clinical trial. All information collected about patients is subject to protection under a Federal law known as “HIPAA.” More information about informed consent and the protection of the patient’s personal information is provided to prospective clinical trial participants when they inquire about being involved in the clinical trial.