AzTrials
AzTrials

Parkinson DiseaseSANTOPNCT03548506

Subthalamic Steering for Therapy Optimization in Parkinson's Disease

A study testing Omnidirectional Deep Brain Stimulation of STN and Directional Deep Brain Stimulation of STN in people with Parkinson Disease, run by University Hospital Tuebingen at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
Omnidirectional Deep Brain Stimulation of STN and Directional Deep Brain Stimulation of STN
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteGermany
Study dates
19 Apr 2018to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Germany1 site

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

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

About this study

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].

Read the 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).

Being tested
Omnidirectional Deep Brain Stimulation of STN, Directional Deep Brain Stimulation of STN
Keywords
STN, DBS, steering, segmented electrode leads
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omnidirectional Deep Brain Stimulation of STNDevice

    Deep Brain Stimulation

  • Directional Deep Brain Stimulation of STNDevice

    Deep Brain Stimulation

Study groups in NCT03548506
Study groupRoleWhat they receive
STN_OActive comparatorOmnidirectional Deep Brain Stimulation of STN
Receives: Device: Omnidirectional Deep Brain Stimulation of STN
STN_DExperimentalDirectional Deep Brain Stimulation of STN
Receives: Device: Directional Deep Brain Stimulation of STN

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle Rigidity

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

    Measured: 6 months post-operatively

Secondary outcomes (20)

  1. Clinical motor and non-motor symptoms (1)

    MDS-UPDRS I

    Measured: 6 months post-operatively

  2. Clinical motor and non-motor symptoms (2)

    MDS-UPDRS II

    Measured: 6 months post-operatively

  3. Clinical motor and non-motor symptoms (3)

    MDS-UPDRS III

    Measured: 6 months post-operatively

  4. Clinical motor and non-motor symptoms (4)

    MDS-UPDRS IV

    Measured: 6 months post-operatively

  5. Clinical motor and non-motor symptoms (5)

    Bradykinesia evaluation

    Measured: 6 months post-operatively

  6. Clinical motor and non-motor symptoms (6)

    Tremor evaluation

    Measured: 6 months post-operatively

  7. Clinical motor and non-motor symptoms (7)

    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

    Measured: 6 months post-operatively

  8. Clinical motor and non-motor symptoms (8)

    Clinical global impression self

    Measured: 6 months post-operatively

  9. Neurocognitive and non-motor symptoms (1)

    Modulation range

    Measured: 6 months post-operatively

  10. Neurocognitive and non-motor symptoms (2)

    Spatial with a visual Odd-Ball test

    Measured: 6 months post-operatively

  11. Neurocognitive and non-motor symptoms (3)

    Verbal Working Memory with an auditory Odd-Ball test

    Measured: 6 months post-operatively

  12. Neurocognitive and non-motor symptoms (4)

    Power of Attention (Cognitive Drug Research Battery)

    Measured: 6 months post-operatively

  13. Neurocognitive and non-motor symptoms (5)

    Digit Vigilance Accuracy (Cognitive Drug Research Battery)

    Measured: 6 months post-operatively

  14. Neurocognitive and non-motor symptoms (6)

    Executive functions with One Touch Tower of London (Cambridge Neuropsychological Test Automated Battery, CANTAB)

    Measured: 6 months post-operatively

  15. Neurocognitive and non-motor symptoms (7)

    Montreal Cognitive Assessment (MoCA)

    Measured: 6 months post-operatively

  16. Neuropsychiatric symptoms (1)

    Beck Depression Inventory (BDI)

    Measured: 6 months post-operatively

  17. Neuropsychiatric symptoms (2)

    Apathy Scale/Lille Apathy rating scale/Neuropsychiatric inventory

    Measured: 6 months post-operatively

  18. Freezing of gait (1)

    Capsit-PD

    Measured: 6 months post-operatively

  19. Freezing of gait (2)

    Freezing of Gait Assessment Course

    Measured: 6 months post-operatively

  20. Quality of Life

    Parkinson's Disease Questionaire (PDQ-39)

    Measured: 6 months post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2018
  2. Study start19 Apr 2018
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03548506
Sponsor's protocol ID
SANTOP
Acronym
SANTOP
Status last verified
Jun 2026
First submitted
18 Apr 2018
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 18855925

  • Keute M, Wang T, Miranda Montenegro S, Scherer M, Bookjans P, Brunnett B, Cebi I, Milosevic L, Weiss D, Gharabaghi A. Subthalamic stimulation modulates working memory-related cortical dynamics in Parkinson's disease. Brain Commun. 2026 Aug 31;8(5):fcag328. doi: 10.1093/braincomms/fcag328. eCollection 2026.

    PubMed 42712895

  • 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.

    PubMed 39461964

Questions about this trial

What is this clinical trial studying?

A study testing Omnidirectional Deep Brain Stimulation of STN and Directional Deep Brain Stimulation of STN in people with Parkinson Disease, run by University Hospital Tuebingen at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle Rigidity (time frame: 6 months post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03548506, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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