NCT04223427

Effects of Directional Subthalamic Deep Brain Stimulation on Gait and Balance in Parkinson's Disease Patients

Effects of Directional Subthalamic Deep Brain Stimulation on Gait and Balance in Parkinson's Disease Patients - MApping Gait and Balance Issues With Current Shaping

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Deep brain stimulation of the NST is effective for cardinal motor signs in patients with idiopathic Parkinson's disease (IPD), its effects on gait disturbances, especially freezing of gait-FOG, and falls are variable from one patient to another, in part depending on the location of the NST-stimulating contact. The ability to change the shape of the current field, and thus the volume of activated tissue, with a directional stimulation electrode is a new treatment option for NSC SCP patients with Parkinson's disease. In this pilot research program, the main objective is to determine the impact of directional DBS on gait and balance issues for PD patients implanted in the STN, using previously described anatomical and functional data for gait disturbances to guide directional programming. Ten patients with Patients with severe form of Parkinson's disease eligible to deep brain stimulation of the subthalamic nucleus, will be included in two French sites.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
PROCEDURE	Directional and single ring STN-DBS on gait	Surgery for STN-DBS and STN-LFP recordings during gait initiation (M1): 15 days * Surgery for STN-DBS electrodes implantation * Placement of stimulation electrodes according to the usual procedure, including a MRI with contrast product * Intraoperative electrophysiological recordings * Intraoperative clinical evaluation * Intraoperative identification of the electrodes and final position with X-Ray * Post-operative 3D helical TDM without iode injection * STN-LFP recordings during gait initiation performed 3 to 5 days after surgery * Placement of the neurostimulator (5 days after surgery) * Acute testing of STN-DBS for first parameters setting programming Follow-up of the patient with outpatient visits as usually performed in PD patients operated for STN-DBS with progressive adaptation of parameters settings using single-ring stimulation. Directional and single ring STN-DBS on gait (M7)

Timeline

• Start date: 2020-01-14
• Primary completion: 2025-07-07
• Completion: 2025-07-07
• First posted: 2020-01-10
• Last updated: 2026-02-06

Locations

1 site across 1 country: France