New Clinical Trial Aims to Determine Effectiveness of Shunting for iNPH Patients

Patients diagnosed with idiopathic Normal Pressure Hydrocephalus (iNPH), a type of hydrocephalus most commonly seen in older adults for which the cause is unknown, are typically treated by having a shunt placed surgically. However, there is still controversy in the medical field as to whether or not shunts are an effective form of treatment for iNPH patients. Through a new clinical trial, researchers at the Johns Hopkins Cerebral Fluid Center in the Department of Neurosurgery hope to change that. The research is being conducted in partnership with HA’s Adult Hydrocephalus Clinical Research Network (AHCRN).

In the Placebo-Controlled Effectiveness in INPH Shunting (PENS) Trial, iNPH patients who are planning on having shunt implantation will undergo surgery for a shunt. In some of the patients, the shunt will be open (on), while in others the shunt will remain closed (off) – only the surgeon will know if the shunt is open or closed. Through evaluations before and after surgery, researchers will determine if symptoms such as walking speed, cognition, mood, and bladder control, were alleviated in study participants and assess the effectiveness of treatment. After four months, patients in the closed group will have their shunts opened.

“This study is important because right now some in the medical community are not convinced that shunts are an effective treatment for NPH. Much of this uncertainty is due to the lack of a high-quality randomized controlled trial.” said Dr. Mark Luciano, Neurosurgeon and Director of the Cerebral Fluid Center at Johns Hopkins Hospital, and a founding member of the AHCRN. “We hope that by the end of our study we’ll have solid evidence telling us whether shunt surgery significantly helps the sufferers of NPH.”

Dr. Luciano will serve as lead investigator in the PENS Trial, with most of the investigators from the AHCRN involved in the study.

Click here to learn more about the PENS Trial and the eligibility criteria.