Subthalamic Steering for Therapy Optimization in Parkinson's Disease (SANTOP)

University Hospital Tuebingen

Status: Unknown

Conditions: Parkinson Disease

Treatments: Device: Directional Deep Brain Stimulation of STN; Device: Omnidirectional Deep Brain Stimulation of STN

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03548506

SANTOP

Details and patient eligibility

About

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].

Full 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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

STN_O

Active Comparator group

Description:

Omnidirectional Deep Brain Stimulation of STN

Treatment:

Device: Omnidirectional Deep Brain Stimulation of STN

STN_D

Experimental group

Description:

Directional Deep Brain Stimulation of STN

Treatment:

Device: Directional Deep Brain Stimulation of STN