We were at the end of our apparatus...and if it weren't for PatientWing finding our patients, the whole study may have stopped there and never continued to where it is today.
Dr. Nicholas Schiff, head of the Laboratory for Cognitive Neuromodulation, Weill Cornell Medicine
What an amazing accomplishment for the Schiff lab and collaborators to complete their Phase I study! This has been such a rewarding collaboration, and we are excited about the next steps of this research. This Phase I study on deep brain stimulation (DBS) for traumatic brain injury investigated DBS within the central lateral thalamus and associated tract in six patients with moderate-to-severe TBI. All participants were safely implanted, and five completed the study. Remarkably, participants showed a 15-52% improvement in processing speed, exceeding the 10% benchmark. This promising research paves the way for larger studies and potential breakthroughs in TBI treatment.
See below to learn more about how PatientWing enrolled 100% of the study’s patients by implementing a tailored solution.
Congratulations to Dr. Nicholas Schiff and the Weill Cornell and Stanford teams on this great achievement, which shows tremendous promise for traumatic brain injury (TBI) patients.
As head of the Laboratory for Cognitive Neuromodulation at Weill Cornell Medical College in New York City, Dr. Schiff has been dedicated to improving the lives of TBI patients through deep brain stimulation (DBS), first described in this 2007 Nature paper, Behavioural improvements with thalamic stimulation after severe traumatic brain injury.
The recent publication of the Phase I clinical study use of DBS in patients who had suffered from moderate to severe TBI has provided early evidence that DBS targeting the central thalamus may help improve cognitive function in patients suffering from long-term deficits.
This study involved participants who had experienced a TBI between 3 and 18 years prior and continued to struggle with impaired executive function, attention, and processing speed despite being in the chronic recovery phase. The participants underwent surgery to implant electrodes into the central lateral thalamic region, which plays a key role in regulating frontal lobe brain networks involved in cognition. After three months of receiving 12 hours of DBS each day, five of the six participants showed significant improvements of 15-52% on tests of processing speed and executive control.
Some participants and their families also reported notable improvements in quality of life, ability to work, and social functioning. While still an early feasibility study, the findings suggest DBS could help rehabilitate cognitive abilities even years after a brain injury when recovery was thought to have plateaued.
PatientWing is proud to have enrolled 100% of the patients for this pivotal study in the TBI field. Using our direct-to-patient approach, the study had 419 patient inquiries which were phone screened by our in-house Patient Enrollment Center that facilitated the enrollment, consent and randomization of the study’s six participants.
Knowing and understanding the TBI patient population helped PatientWing develop relevant materials and engage with patients directly. Working with Dr. Schiff and the team at Weill Cornell, we navigated each patient's eligibility for the study while bridging relationships with each patient and their caregivers. PatientWing is excited to follow and support this work in any future studies.
At PatientWing, we understand that while the clinical study process offers great promise to many patients for a better life, it is a substantial investment for the patient and their support community. Therefore, we take the time to listen, educate and assist each patient through their clinical study journey. We have found that this mutualistic relationship between patient-sponsor and PatientWing significantly improves enrollment and the patient's experience.
To learn more about how PatientWing can help support your study, set up a time to talk with our Solutions team today!