Clinical trial NCT03548506: Subthalamic Steering for Therapy Optimization in Parkinson's Disease
Official title: Subthalamic Steering for Therapy Optimization in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: STN
DBS
steering
segmented electrode leads
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2018-06-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Twenty patients with idiopathic Parkinson's disease (PD) will be included into this single center randomized controlled double-blind clinical trial (RCT) in a cross-over design. The treatment consists of two different stimulation settings using (i) conventional omnidirectional stimulation of the subthalamic nucleus \[STN_O\] as active comparator and (ii) directional steering of STN stimulation via a segmented electrode contact \[STN_D\].

Detailed description: Twenty PD patients will be enrolled in this cross-over double-blind RCT to evaluate both the safety and efficacy of directional STN stimulation \[STN_D\] compared with standard omnidirectional STN stimulation \[STN_O\]. The primary outcome measure is objectively quantified muscle rigidity of the upper extremity, i.e., surface EMG recordings of the biceps and triceps muscle during standardized extension/flexion of the elbow joint (Levin et al., 2009) assessed 6 months after implantation in cross-over design. The trial is designed to detect with an 80% power a change of 0.27 mA of the therapeutic stimulation threshold with two-tailed P \< 0.05 (Wilcoxon rank sum test). Secondary outcome measures address clinical motor, non-motor, neurocognitive and neuropsychiatric symptoms, freezing of gait, and quality of life. Visits are scheduled at weeks 1 (V1), 6 (V2), 24 (V3), 27 (V4), and 30 (V5) from baseline (V0).

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Idiopathic Parkinson's disease (according to the "British Brain Bank criteria" (Hughes, 1992) including genetic forms

Exclusion Criteria:

* Cognitive impairment (Mini Mental State Exam \< 20)
* Suicidality, Psychosis
* Other severe pathological chronic condition that might confound treatment effects or interpretation of the data
* Pregnancy

Primary outcomes:
measure: Muscle Rigidity
timeFrame: 6 months post-operatively
Secondary outcomes:
measure: Clinical motor and non-motor symptoms (1)
timeFrame: 6 months post-operatively
measure: Clinical motor and non-motor symptoms (2)
timeFrame: 6 months post-operatively
measure: Clinical motor and non-motor symptoms (3)
timeFrame: 6 months post-operatively
measure: Clinical motor and non-motor symptoms (4)
timeFrame: 6 months post-operatively
measure: Clinical motor and non-motor symptoms (5)
timeFrame: 6 months post-operatively
measure: Clinical motor and non-motor symptoms (6)
timeFrame: 6 months post-operatively
measure: Clinical motor and non-motor symptoms (7)
timeFrame: 6 months post-operatively
measure: Clinical motor and non-motor symptoms (8)
timeFrame: 6 months post-operatively
measure: Neurocognitive and non-motor symptoms (1)
timeFrame: 6 months post-operatively
measure: Neurocognitive and non-motor symptoms (2)
timeFrame: 6 months post-operatively
measure: Neurocognitive and non-motor symptoms (3)
timeFrame: 6 months post-operatively
measure: Neurocognitive and non-motor symptoms (4)
timeFrame: 6 months post-operatively
measure: Neurocognitive and non-motor symptoms (5)
timeFrame: 6 months post-operatively
measure: Neurocognitive and non-motor symptoms (6)
timeFrame: 6 months post-operatively
measure: Neurocognitive and non-motor symptoms (7)
timeFrame: 6 months post-operatively
measure: Neuropsychiatric symptoms (1)
timeFrame: 6 months post-operatively
measure: Neuropsychiatric symptoms (2)
timeFrame: 6 months post-operatively
measure: Freezing of gait (1)
timeFrame: 6 months post-operatively
measure: Freezing of gait (2)
timeFrame: 6 months post-operatively
measure: Quality of life
timeFrame: 6 months post-operatively
Other outcomes:
measure: Electroencephalography
timeFrame: up to 6 months post-operatively
measure: Electromyography
timeFrame: up to 6 months post-operatively
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen, Dep. of Neurosurgery (Functional Neurosurgery) and Neurology (Neurodegenerative Diseases)
state: Baden-Wuerttemberg
Study officials:
affiliation: Division of Functional and Restorative Neurosurgery, Department of Neurosurgery, Tuebingen, Germany
name: Alireza Gharabaghi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department for Neurodegenerative Diseases, Centre for Neurology, Tuebingen, Germany, and Hertie-Institute for Clinical Brain Research
name: Daniel Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levin J, Krafczyk S, Valkovic P, Eggert T, Claassen J, Botzel K. Objective measurement of muscle rigidity in Parkinsonian patients treated with subthalamic stimulation. Mov Disord. 2009 Jan 15;24(1):57-63. doi: 10.1002/mds.22291.