Status:
COMPLETED
Asymmetric Subthalamic Deep Brain Stimulation for Axial Motor Dysfunction in Parkinson's Disease
Lead Sponsor:
University of Toronto
Conditions:
Parkinson Disease
Eligibility:
All Genders
Phase:
NA
Brief Summary
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 P...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Treatment-resistant PIGD less than 6 months or more than 5 years after STN-DBS surgery.
- PIGD responsive to optimization of medications and/or bilateral STN-DBS programming.
- Cognitive impairment or psychiatric comorbidities (including substance abuse) that would interfere with the informed consent process, study adherence or outcome assessments.
- Advanced PD or any other neurological, cardiovascular or musculoskeletal co-morbidities that would preclude or require assistance to complete the 10-meter walking test.
- Patients not able to comply with 4-week interval evaluations following their potential enrollment due to personal reasons.
- Serious illness (requiring systemic treatment and/or hospitalization) until subject either completes therapy or is clinically-stable on therapy, in the opinion of the site investigator, for at least 30 days prior to study entry.
- Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
Key Trial Info
Start Date :
March 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03462082
Start Date
March 14 2018
End Date
April 15 2019
Last Update
January 5 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Movement disorders Centre, Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8