Researchers at The Feinstein Institute for Medical Research have used a new image-based strategy to identify and measure placebo effects in randomized clinical trials for brain disorders. The research team, led by David Eidelberg, MD, developed a method to identify brain patterns that are abnormal or indicate disease using imaging techniques. According to a news report from Science Daily, the approach has been used successfully to identify specific networks in the brain that indicates a patient has, or is at risk for, neurodegenerative disorders, such as Parkinson’s.
The researchers used their network mapping technique to identify specific brain circuits underlying the response to sham surgery in Parkinson’s disease patients participating in a gene therapy trial. The expression of this network measured under blinded conditions correlated with the sham subjects’ clinical outcome; the network changes were reversed when the subjects learned of their sham treatment status, as indicated on the Science Daily news report. An individual subject’s network expression value was measured before the treatment predicted their subsequent blinded response to sham treatment.
The Science Daily news report notes that this suggests that the image-based measure of the sham-related network can help reduce the number of subjects assigned to sham treatment in randomized clinical trials for brain disorders by excluding those subjects who are more likely to display placebo effects under blinded conditions.
Eidelberg explains, “One of the major challenges in developing new treatments for neurodegenerative disorders such as Parkinson’s disease is that it is common for patients participating in clinical trials to experience a placebo or sham effect.”
Eidelberg adds, “When patients involved in a clinical trial commonly experience benefits from placebo, it’s difficult for researchers to identify if the treatment being studied is effective. In a new study conducted by my colleagues and myself, we have used a new image-based strategy to identify and measure placebo effects in brain disorder clinical trials.”
[Sources: Science Daily, North Shore-Long Island Jewish (LIJ) Health System]
