PROSPECT is a feasibility study is designed to assess
the safety and effectiveness of the Renova-DT™
Cortical Stimulation System* in treating patients
diagnosed with major depressive disorder who are not
responsive to other antidepressant treatments. This
is an FDA approved clinical research study.
The primary objective is to assess the safety of
the Renova-DT™ System for treating patients
suffering from a major depressive disorder with targeted
cortical stimulation. The secondary study objective
is to evaluate the effectiveness of targeted electrical
stimulation delivered to the cortex.
Northstar has partnered with three investigational
sites to complete the PROSPECT feasibility study.
• Medical College of Wisconsin, Milwaukee
• University of Pittsburgh, Pittsburgh
• Massachusetts General Hospital, Boston
Patients included in this study suffer from treatment-resistant
depression and have failed routine attempts at controlling
their depression. Patients are screened, imaged, and
evaluated in order to enroll patients appropriate
for stimulation system implant. Northstar intends
to use data from this study in support of subsequent
investigational studies.
We are not currently enrolling patients for this
study.
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.
**The results of this study have not been
shared with the FDA and there can be no definitive
claims of safety and effectiveness until the FDA has
reviewed and approved the labeling for this product.
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.
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