N/A
N=22
Asymmetric Subthalamic Deep Brain Stimulation for Axial Motor Dysfunction in Parkinson's Disease
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT03462082 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Change in Gait Velocity — 0.941; -0.069; -0.016 m/s — p=0.163
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Asymmetric STN-DBS (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Toronto
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Gait Velocity |
0.941; -0.069; -0.016 | 0.163 |
| SECONDARY Change in Motor Function |
1.032; 10.058; 1.277; 1.080; 4.582; 1.636 | 0.031 sig |
| SECONDARY Change in Axial Motor Function (1) |
0.967; -0.017; 1.557 | 0.984 |
| SECONDARY Change in Axial Motor Function (2) |
0.909; -0.549; -1.414 | 0.440 |
| SECONDARY Change in Axial Motor Function (3) |
0.837; -0.056; -1.888 | 0.945 |
| SECONDARY Change in Quantitative Gait Analysis (1) |
0.814; -6.635; -1.254 | 0.097 |
| SECONDARY Change in Quantitative Gait Analysis (2) |
0.975; -3.097; -3.191; 0.899; -2.867; -3.800 | 0.128 |
| SECONDARY Change in Quantitative Gait Analysis (3) |
1.214; -0.011; 0.002; 0.934; 0.421; -0.420 | 0.874 |
| SECONDARY Change in Quantitative Speech Analysis (1) |
0.434; 16.864; 1.176; 0.735; -146.413; -78.213 | 0.040 sig |
| SECONDARY Change in Quantitative Speech Analysis (2) |
0.003; 0.549; 0.138; 0.218; 0.619; -0.003 | 0.487 |
| SECONDARY Change in Quantitative Speech Analysis (3) |
1.263; 0.135; 0.063 | 0.388 |
| SECONDARY Change in Quantitative Speech Analysis (4) |
0.630; -0.095; 0.185 | 0.850 |
| SECONDARY Change in Quality of Life |
0.792; 1.701; -3.148 | 0.501 |
| SECONDARY Change in Select Cognitive Tasks |
-0.30; 0.50; -0.85; -0.45; -0.75; -1.40 | >0.05 |
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 Parkinson's disease that develop treatment-resistant postural stability gait dysfunction after bilateral subthalamic nucleus deep brain stimulation surgery.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03462082). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.