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

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ClinicalTrials.gov Identifier: NCT03548506
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Prof. Dr. Alireza Gharabaghi, University Hospital Tuebingen

Study Description
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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].

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Omnidirectional Deep Brain Stimulation of STN Device: Directional Deep Brain Stimulation of STN Not Applicable

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Subthalamic Steering for Therapy Optimization in Parkinson's Disease
Actual Study Start Date : April 19, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: STN_O
Omnidirectional Deep Brain Stimulation of STN
 Device: Omnidirectional Deep Brain Stimulation of STN
Deep Brain Stimulation
Experimental: STN_D
Directional Deep Brain Stimulation of STN
 Device: Directional Deep Brain Stimulation of STN
Deep Brain Stimulation


Outcome Measures
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Primary Outcome Measures :
  1. Muscle Rigidity [ Time Frame: 6 months post-operatively ]
    Surface-Electromyography (EMG) of M. biceps brachii and M. triceps brachii


Secondary Outcome Measures :
  1. Clinical motor and non-motor symptoms (1) [ Time Frame: 6 months post-operatively ]
    MDS-UPDRS I

  2. Clinical motor and non-motor symptoms (2) [ Time Frame: 6 months post-operatively ]
    MDS-UPDRS II

  3. Clinical motor and non-motor symptoms (3) [ Time Frame: 6 months post-operatively ]
    MDS-UPDRS III

  4. Clinical motor and non-motor symptoms (4) [ Time Frame: 6 months post-operatively ]
    MDS-UPDRS IV

  5. Clinical motor and non-motor symptoms (5) [ Time Frame: 6 months post-operatively ]
    Bradykinesia evaluation

  6. Clinical motor and non-motor symptoms (6) [ Time Frame: 6 months post-operatively ]
    Tremor evaluation

  7. Clinical motor and non-motor symptoms (7) [ Time Frame: 6 months post-operatively ]

    Deep brain stimulation impairment scale (DBS-IS):

    • the scale consists of 22 questions and 6 subscales;
    • subscales: 1. postural instability and gait difficulties (range 0-20), 2. cognitive impaiment (range 0-20), 3. speaking problems (range 0-12), 4. apathy (range 0-12), 5. impulsivity (range 0-12), and 6. difficulties related to DBS device (range 0-12);
    • Ʃ 1-6 DBS-IS total range: 0-88;
    • Ʃ 1-5 DBS-IS total range: 0-76;
    • higher values represent worsening of symptoms

  8. Clinical motor and non-motor symptoms (8) [ Time Frame: 6 months post-operatively ]
    Clinical global impression self

  9. Neurocognitive and non-motor symptoms (1) [ Time Frame: 6 months post-operatively ]
    Modulation range

  10. Neurocognitive and non-motor symptoms (2) [ Time Frame: 6 months post-operatively ]
    Spatial with a visual Odd-Ball test

  11. Neurocognitive and non-motor symptoms (3) [ Time Frame: 6 months post-operatively ]
    Verbal Working Memory with an auditory Odd-Ball test

  12. Neurocognitive and non-motor symptoms (4) [ Time Frame: 6 months post-operatively ]
    Power of Attention (Cognitive Drug Research Battery)

  13. Neurocognitive and non-motor symptoms (5) [ Time Frame: 6 months post-operatively ]
    Digit Vigilance Accuracy (Cognitive Drug Research Battery)

  14. Neurocognitive and non-motor symptoms (6) [ Time Frame: 6 months post-operatively ]
    Executive functions with One Touch Tower of London (Cambridge Neuropsychological Test Automated Battery, CANTAB)

  15. Neurocognitive and non-motor symptoms (7) [ Time Frame: 6 months post-operatively ]
    Montreal Cognitive Assessment (MoCA)

  16. Neuropsychiatric symptoms (1) [ Time Frame: 6 months post-operatively ]
    Beck Depression Inventory (BDI)

  17. Neuropsychiatric symptoms (2) [ Time Frame: 6 months post-operatively ]
    Apathy Scale/Lille Apathy rating scale/Neuropsychiatric inventory

  18. Freezing of gait (1) [ Time Frame: 6 months post-operatively ]
    Capsit-PD

  19. Freezing of gait (2) [ Time Frame: 6 months post-operatively ]
    Freezing of Gait Assessment Course

  20. Quality of life [ Time Frame: 6 months post-operatively ]
    Parkinson's Disease Questionaire (PDQ-39)


Other Outcome Measures:
  1. Electroencephalography [ Time Frame: up to 6 months post-operatively ]
    Electroencephalography (EEG)

  2. Electromyography [ Time Frame: up to 6 months post-operatively ]
    Electromyography (EMG)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548506


Contacts
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Contact: Alireza Gharabaghi, MD +49707129 ext 85197 alireza.gharabaghi@uni-tuebingen.de
Contact: Daniel Weiss, MD +49707129 ext 82340 daniel.weiss@uni-tuebingen.de

Locations
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Germany
University Hospital Tuebingen, Dep. of Neurosurgery (Functional Neurosurgery) and Neurology (Neurodegenerative Diseases) Recruiting
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Contact: Alireza Gharabaghi, MD    +49707129 ext 85197    alireza.gharabaghi@uni-tuebingen.de   
Contact: Daniel Weiss, MD    +49707129 ext 82340    daniel.weiss@uni-tuebingen.de   
Principal Investigator: Alireza Gharabaghi, MD         
Principal Investigator: Daniel Weiss, MD         
Sponsors and Collaborators
University Hospital Tuebingen
Abbott
Investigators
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Principal Investigator: 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
More Information
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Publications:

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Responsible Party: Prof. Dr. Alireza Gharabaghi, Professor, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03548506     History of Changes
Other Study ID Numbers: SANTOP
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Prof. Dr. Alireza Gharabaghi, University Hospital Tuebingen:
STN
DBS
steering
segmented electrode leads

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases