Subthalamic Steering for Therapy Optimization in Parkinson's Disease (SANTOP)
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ClinicalTrials.gov Identifier: NCT03548506 |
Recruitment Status : Unknown
Verified June 2018 by Prof. Dr. Alireza Gharabaghi, University Hospital Tuebingen.
Recruitment status was: Recruiting
First Posted : June 7, 2018
Last Update Posted : June 12, 2018
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Condition or disease | Intervention/treatment | Phase |
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Parkinson Disease | Device: Omnidirectional Deep Brain Stimulation of STN Device: Directional Deep Brain Stimulation of STN | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: STN_O
Omnidirectional Deep Brain Stimulation of STN
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Device: Omnidirectional Deep Brain Stimulation of STN
Deep Brain Stimulation |
Experimental: STN_D
Directional Deep Brain Stimulation of STN
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Device: Directional Deep Brain Stimulation of STN
Deep Brain Stimulation |
- Muscle Rigidity [ Time Frame: 6 months post-operatively ]Surface-Electromyography (EMG) of M. biceps brachii and M. triceps brachii
- Clinical motor and non-motor symptoms (1) [ Time Frame: 6 months post-operatively ]MDS-UPDRS I
- Clinical motor and non-motor symptoms (2) [ Time Frame: 6 months post-operatively ]MDS-UPDRS II
- Clinical motor and non-motor symptoms (3) [ Time Frame: 6 months post-operatively ]MDS-UPDRS III
- Clinical motor and non-motor symptoms (4) [ Time Frame: 6 months post-operatively ]MDS-UPDRS IV
- Clinical motor and non-motor symptoms (5) [ Time Frame: 6 months post-operatively ]Bradykinesia evaluation
- Clinical motor and non-motor symptoms (6) [ Time Frame: 6 months post-operatively ]Tremor evaluation
- 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
- Clinical motor and non-motor symptoms (8) [ Time Frame: 6 months post-operatively ]Clinical global impression self
- Neurocognitive and non-motor symptoms (1) [ Time Frame: 6 months post-operatively ]Modulation range
- Neurocognitive and non-motor symptoms (2) [ Time Frame: 6 months post-operatively ]Spatial with a visual Odd-Ball test
- Neurocognitive and non-motor symptoms (3) [ Time Frame: 6 months post-operatively ]Verbal Working Memory with an auditory Odd-Ball test
- Neurocognitive and non-motor symptoms (4) [ Time Frame: 6 months post-operatively ]Power of Attention (Cognitive Drug Research Battery)
- Neurocognitive and non-motor symptoms (5) [ Time Frame: 6 months post-operatively ]Digit Vigilance Accuracy (Cognitive Drug Research Battery)
- 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)
- Neurocognitive and non-motor symptoms (7) [ Time Frame: 6 months post-operatively ]Montreal Cognitive Assessment (MoCA)
- Neuropsychiatric symptoms (1) [ Time Frame: 6 months post-operatively ]Beck Depression Inventory (BDI)
- Neuropsychiatric symptoms (2) [ Time Frame: 6 months post-operatively ]Apathy Scale/Lille Apathy rating scale/Neuropsychiatric inventory
- Freezing of gait (1) [ Time Frame: 6 months post-operatively ]Capsit-PD
- Freezing of gait (2) [ Time Frame: 6 months post-operatively ]Freezing of Gait Assessment Course
- Quality of life [ Time Frame: 6 months post-operatively ]Parkinson's Disease Questionaire (PDQ-39)
- Electroencephalography [ Time Frame: up to 6 months post-operatively ]Electroencephalography (EEG)
- Electromyography [ Time Frame: up to 6 months post-operatively ]Electromyography (EMG)

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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 |
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

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
Contact: Alireza Gharabaghi, MD | +49707129 ext 85197 | alireza.gharabaghi@uni-tuebingen.de | |
Contact: Daniel Weiss, MD | +49707129 ext 82340 | daniel.weiss@uni-tuebingen.de |
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 |
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 |
Responsible Party: | Prof. Dr. Alireza Gharabaghi, Professor, University Hospital Tuebingen |
ClinicalTrials.gov Identifier: | NCT03548506 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |
STN DBS steering segmented electrode leads |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |