Subthalamic Steering for Therapy Optimization in Parkinson's Disease

NCT ID: NCT03548506

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-19
• Study Completion Date: 2022-04-30

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).

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

STN_O

Omnidirectional Deep Brain Stimulation of STN

Group Type: ACTIVE_COMPARATOR

Omnidirectional Deep Brain Stimulation of STN

Intervention Type: DEVICE

Deep Brain Stimulation

STN_D

Directional Deep Brain Stimulation of STN

Group Type: EXPERIMENTAL

Directional Deep Brain Stimulation of STN

Intervention Type: DEVICE

Deep Brain Stimulation

Interventions

Omnidirectional Deep Brain Stimulation of STN

Deep Brain Stimulation

Intervention Type: DEVICE

Directional Deep Brain Stimulation of STN

Deep Brain Stimulation

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Alireza Gharabaghi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alireza Gharabaghi, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Functional and Restorative Neurosurgery, Department of Neurosurgery, Tuebingen, Germany

Daniel Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Department for Neurodegenerative Diseases, Centre for Neurology, Tuebingen, Germany, and Hertie-Institute for Clinical Brain Research

Locations

University Hospital Tuebingen, Dep. of Neurosurgery (Functional Neurosurgery) and Neurology (Neurodegenerative Diseases)

Tübingen, Baden-Wurttemberg, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 18855925 (View on PubMed)

Gharabaghi A, Cebi I, Leavitt D, Scherer M, Bookjans P, Brunnett B, Milosevic L, Weiss D. Randomized crossover trial on motor and non-motor outcome of directional deep brain stimulation in Parkinson's disease. NPJ Parkinsons Dis. 2024 Oct 26;10(1):204. doi: 10.1038/s41531-024-00812-0.

Reference Type: DERIVED

PMID: 39461964 (View on PubMed)

Other Identifiers

SANTOP

Identifier Type: -

Identifier Source: org_study_id