The purpose of this study is to obtain clinical outcome data on safety and effectiveness of the directSTIM DBS system when used on-label, according to the instructions for use. All participants will undergo bilateral implant in the subthalamic nucleus (STN) and data collected in common practice will be recorded during six months post-implant and analyzed.
directSTIM DBS Therapy for Movement Disorders is indicated for patients with disabling tremor or symptoms of Parkinson's disease. Subjects selected to participate in the study will be Parkinson's Disease (PD) patients who are eligible for bilateral DBS for STN therapy and meet the inclusion criteria and none of the exclusion criteria. Primary safety and effectiveness endpoints data will be collected through 6 months of follow-up. The values used for comparison are derived from a review of literature spanning from 2001 to 2019. After completing the 6 month follow-up, subject will exit the study, and continue to be followed by their physician per usual care.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Patients with PD who are eligible to bilateral STN DBS surgery and chose to get directSTIM System implanted will be followed over a 6-month period to evaluate changes in their condition.
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany
RECRUITINGUniversitätsklinikum Freiburg
Freiburg im Breisgau, Germany
RECRUITINGUniversitätsklinikum Hamburg
Hamburg, Germany
Change in UPDRS III score without medication
Part 3 of the Unified Parkinson's Disease Rating Scale (UPDRS III), is a series of questions evaluated by the clinician in presence of the patient, focusing on motor symptoms of PD. Score is expressed on a scale of 0 to 108. This score is evaluated at baseline and 6 months post-implant without any anti-Parkinson medication taken. A decrease at 6 months compared to baseline indicates an improvement. The average difference of scores between the two time points is calculated for the whole study subject population. This value is to be compared to the results of a meta-analysis performed on data extracted during a literature search.
Time frame: 6 months compared to baseline
Materiovigilance
Summary statistics on the occurrence of the following categories of adverse events (AEs): * Device-related AEs * Procedure-related AEs * Stimulation-related AEs
Time frame: 6 months
Therapeutic Window (TW)
The therapeutic window is the difference of electrical current values between the stimulation settings that provide maximum alleviation of motor symptoms and the settings for which the first stimulation-induced side effect appears (e.g., eye deviation, muscle contraction, speech impairment). The wider this window, the more flexibility is offered to the patient for stimulation without causing side-effects.
Time frame: 3 months
UPDRS
Other parts (I, II and IV) of the Unified Parkinson's Disease Scale are evaluated at baseline and 6 months post-implant. Part I is a series of 4 questions assessing Mentation, Behavior and Mood. Patient's score is expressed on a scale of 0 to 16. Part II is a series of 13 questions assessing Quality of Life in daily activities. Patient's score is expressed on a scale of 0 to 52. Part IV is a series of 10 questions assessing Complications of Therapy. Patient's score is expressed on a scale of 0 to 23. A decrease at 6 months compared to baseline indicates an improvement.
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Medizinische Hochschule Hannover
Hanover, Germany
RECRUITINGUniversitätsklinikum Schleswig-Holstein (Kiel)
Kiel, Germany
RECRUITINGUniversitätsklinikum Münster
Münster, Germany
RECRUITINGTime frame: 6 months