A Single-center, Randomized, Double-blinded, Double-crossover Trial of Asymmetric Subthalamic Deep Brain Stimulation for Axial Motor Dysfunction in Parkinson's Disease

Status: Completed
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable

This single-center, randomized, quadruple-blinded, double-crossover comparative efficacy trial will study the effects of unilateral 50% voltage reduction in axial motor dysfunction for patients with Parkinson's disease that develop treatment-resistant postural stability gait dysfunction after bilateral subthalamic nucleus deep brain stimulation surgery.

Participation Requirements
Sex: All
Healthy Volunteers: No

• Patients with Parkinson's disease (PD) (previously diagnosed according to the UK brain bank criteria) who develop treatment-resistant postural instability gait dysfunction (PIGD) more than 6 months but less than 5 years after bilateral subthalamic nucleus deep brain stimulation (STN-DBS).

• Treatment-resistant PIGD will be defined as freezing of gait and UPDRS or MDS-UPDRS PIGD subscales of more than 6 points despite optimization of medications and bilateral STN-DBS programming.

Other Locations
Movement disorders Centre, Toronto Western Hospital
Time Frame
Start Date: March 14, 2018
Completion Date: April 15, 2019
Target number of participants: 22
No Intervention: Baseline STN-DBS
Maintenance of baseline bilateral STN-DBS settings.
Experimental: Asymmetric STN-DBS 1
Unilateral 50% reduction of voltage (e.g. right side)
Experimental: Asymmetric STN-DBS 2
Unilateral 50% reduction of voltage (e.g. left side)
Alfonso Fasano, Karlo J Lizarraga
Leads: University of Toronto

This content was sourced from clinicaltrials.gov

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