N/A
Completed N=40
CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation
Source: ClinicalTrials.gov NCT01896115 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcomePrimary: Therapeutic Window — 3.81; 2.32 mA
Summary
The objective of the study is to compare different deep brain stimulation (DBS) settings using the commercially approved Boston Scientific Neuromodulation Vercise system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Therapeutic Window |
3.81; 2.32 | — |
| PRIMARY Unified Parkinson's Disease Rating Scale III |
31.9; 31.3 | — |
| SECONDARY Side Effect Thresholds - Single Contact vs. Steering |
5.3; 5.2 | — |
| SECONDARY Resting Tremor Severity - Single Contact vs. Steering |
0.2; 0.2 | — |
| SECONDARY Finger Tapping Amplitude - Single Contact vs. Steering |
2.2; 2.3 | — |
Eligibility Criteria
Inclusion Criteria
- Implanted bilaterally in STN with a Vercise DBS system for Parkinson's disease for at least three months with programming optimized according to standard of care.
- UPDRS subset III score of ≥30 in the in the pre-operative meds off state.
- DBS must improve PD symptoms by ≥30% in the meds off state, as measured by UPDRS subset III score.
- Medical and mental fitness to comply with programming visit and study related procedures.
- Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
- Off symptom rigidity score of ≥2 in the evaluated arm as determined by the UPDRS-III.
Exclusion Criteria
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months.
- Resting and/or action tremor score of ≥3 on the evaluated side as determined by the UPDRS-III in pre-operative meds off condition.
Data sourced from ClinicalTrials.gov (NCT01896115). 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. Informational only — not medical advice.