Humanitarian Use Device Studies

A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.  IRB approval is required in all cases, but physicians and sites do not collect research data and are not compensated monetarily for the regulatory support they offer.  These devices are offered for the benefit of the patient only.

If you think you may qualify for one of these studies, please contact CNI’s Research Department at 303-806-7416 or jstucky@thecni.org.

Medtronic DBS Therapy for Dystonia: Deep Brain Stimulation (DBS) therapy delivers electrical stimulation to areas in the brain to help control symptoms of various movement disorders such as chronic, intractable (drug refractory) dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis).
Principal Investigator: Adam Hebb, MD
Sub-Investigator:   Sara Hanrahan, PhD

Synapse Biomedical – NeuRx Diaphragm Pacing System: Surgical placement of a device (called NeuRx Diaphragm Pacing System) into the chest to help people with ALS to keep breathing on their own without mechanical assistance like a breathing machine.
Principal Investigator: James Fenton, MD, FCCP
Sub-Investigator: Marc Treihaft, MD, FAAN


 

 

Colorado Neurological Insitute