NCT04725045

Investigating the Use of Complex Pulse Shapes for DBS in Movement Disorders

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Parkinson's disease and essential tremor are chronic movement disorders for which there is no cure. When medication is no longer effective, deep brain stimulation (DBS) is recommended. Standard DBS is a neuromodulation method that uses a simple monophasic pulse, delivered from an electrode to stimulate neurons in a target brain area. This monophasic pulse spreads out from the electrode creating a broad, electric field that stimulates a large neural population. This can often effectively reduce motor symptoms. However, many DBS patients experience side effects - caused by stimulation of non-target neurons - and suboptimal symptom control - caused by inadequate stimulation of the correct neural target. The ability to carefully manipulate the stimulating electric field to target specific neural subpopulations could solve these problems and improve patient outcomes. The use of complex pulse shapes, specifically biphasic pulses and asymmetric pre-pulses, can control the temporal properties of the stimulation field. Evidence suggests that temporal manipulations of the stimulation field can exploit biophysical differences in neurons to target specific subpopulations. Therefore, our aim is to evaluate the effectiveness of complex pulse shapes to reduce side effects and improve symptom control in DBS movement patients.

Detailed description

The study had three stages. In the first stage, a wide range of investigatory pulse shapes in a small number of patients. The effect of the pulses on the therapeutic window will be assessed. Stage 2 will perform a short-term chronic evaluation in a larger number of patients of the complex pulse shape selected as most interesting from stage 1. * ET patients will first be assessed after 3 hours of the cathodic or complex pulse (double-blind design). * PD patients will only be assessed after 1 week of each pulse. Stage 3 will then focus on long-term evaluation (upto 2 years). Outcomes: see stage 2.

Conditions

• Parkinson Disease
• Essential Tremor

Interventions

Type	Name	Description
DEVICE	Boston Scientific: Study tool computer	compare clinical outcome measurements of complex pulse shapes to standard clinical pulse shape

Timeline

• Start date: 2019-02-12
• Primary completion: 2022-04-14
• Completion: 2022-04-14
• First posted: 2021-01-26
• Last updated: 2022-04-29

Locations

1 site across 1 country: Belgium