A method to enable the use of a novel biomarker for deep brain stimulation treatments

Unmet Need

Neuromodulation therapies are used to treat a wide variety of clinical conditions. For example, an estimated 150,000 deep brain stimulation (DBS) implants are performed globally to help treat movement disorders like Parkinson’s Disease. One of the primary challenges in implementing neuromodulation therapies is determining the proper “dose” of the therapy due to the lack of a strong clinical biomarker that can inform parameter settings that produce the desired clinical effect without unwanted side effects. Clinicians have historically had to rely solely on patient feedback during treatment. Additionally, the parameters may vary over time due to a variety of factors, including disease progression and the medication status of the patient. The field is moving toward closed-loop devices to adjust parameters automatically in response to biomarker signals. However, these devised typically used spectral biomarkers that are not reliable indicators of symptoms. Cortical evoked potentials (cEP) resulting from DBS are promising biomarkers, but the clinically relevant window to record them is very small. There is a need for improved biomarkers to inform the parameter settings of neuromodulation treatment methods to treat patients more effectively.

Technology

Duke inventors have developed a method to improve the quality of information collected with DBS cortical evoked potentials. This is intended to improve the efficacy of DBS treatments by enabling cEPs as a biomarker to inform electrode placement, electrode contact selection, stimulation parameter selection, and closed-loop control. Specifically, the inventors have developed a method to allow the recording of long-duration cEPs during ongoing clinically effective stimulation. This is a temporal pattern of stimulation with intermittent pauses in stimulation, and these brief suspensions in the delivery of DBS pulses allow the recording of long duration DLEPs, including the longer latency components. This invention has been demonstrated to record cEPs up to 50 ms in duration while maintaining the clinical efficacy of stimulation for 22 human participants diagnosed with Parkinson’s Disease. Please refer to T-006616 to learn more about our cortical evoked potentials biomarker IP.

Advantages

• Can improve the efficacy of DBS treatments by enabling the use of a novel biomarker that is more consistent across time and subjects than currently accepted biomarkers
• Has been demonstrated with human studies
• Improves energy optimization of neuromodulation systems