NCT03548506

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 \[STN\_D\].

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

April 19, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

3.6 years

First QC Date

April 18, 2018

Last Update Submit

September 28, 2021

Conditions

Parkinson Disease

Keywords

STNDBSsteeringsegmented electrode leads

Outcome Measures

Primary Outcomes (1)

  • Muscle Rigidity

    Surface-Electromyography (EMG) of M. biceps brachii and M. triceps brachii

    6 months post-operatively

Secondary Outcomes (20)

  • Clinical motor and non-motor symptoms (1)

    6 months post-operatively

  • Clinical motor and non-motor symptoms (2)

    6 months post-operatively

  • Clinical motor and non-motor symptoms (3)

    6 months post-operatively

  • Clinical motor and non-motor symptoms (4)

    6 months post-operatively

  • Clinical motor and non-motor symptoms (5)

    6 months post-operatively

  • +15 more secondary outcomes

Other Outcomes (2)

  • Electroencephalography

    up to 6 months post-operatively

  • Electromyography

    up to 6 months post-operatively

Study Arms (2)

STN_O

ACTIVE COMPARATOR

Omnidirectional Deep Brain Stimulation of STN

Device: Omnidirectional Deep Brain Stimulation of STN

STN_D

EXPERIMENTAL

Directional Deep Brain Stimulation of STN

Device: Directional Deep Brain Stimulation of STN

Interventions

Omnidirectional Deep Brain Stimulation of STNDEVICE

Deep Brain Stimulation

STN_O
Directional Deep Brain Stimulation of STNDEVICE

Deep Brain Stimulation

STN_D

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (2)

  • 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.

    PMID: 18855925BACKGROUND

  • 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.

    PMID: 39461964DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Alireza Gharabaghi, MD

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

    PRINCIPAL INVESTIGATOR

  • Daniel Weiss, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 18, 2018

First Posted

June 7, 2018

Study Start

April 19, 2018

Primary Completion

December 1, 2021

Study Completion

April 1, 2022

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations

DE(1)