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Parkinson's DiseaseSTN+SNrNCT02588144

Combined Stimulation of STN and SNr for Resistant Freezing of Gait in Parkinson's Disease

A study testing [standard STN] and [STN+SNr] in people with Parkinson's Disease, run by University Hospital Tuebingen at 10 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

54 patients with idiopathic Parkinson's disease and freezing of gait resistant to subthalamic nucleus stimulation and dopaminergic medication will be included into this multicentre randomised controlled double-blinded parallel group clinical trial. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Parkinson's Disease
What is being tested?
[standard STN] and [STN+SNr]
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
10 sitesin 2 countries
Study dates
Oct 2015to Sep 2017
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

  • Idiopathic Parkinson's disease (according to the "British Brain Bank criteria" (Hughes, 1992) including genetic forms
  • Therapy with STN-DBS (deep brain stimulation) (ACTIVA pulse generators) at least six months from surgery
  • Activa PC (Primary Cell) or Activa RC (Rechargeable Cell) as implanted pulse generator with "Interleaving" programming option
  • Localization of an active electrode contact in the subthalamic nucleus
  • Localization of the caudal electrode contacts in the substantia nigra pars reticulata area (coordinates relative to midcommisural Point (MCP):
  • left: -7mm ≤ x ≤ -12mm; -2mm ≤ y ≤ -6mm; -6mm ≤ z ≤ -10mm right: 7mm ≤ x ≤ 12mm; -2mm ≤ y ≤ -6mm; -6mm ≤ z ≤ -10mm (x = medio-lateral, y = anterio-posterior, z = rostro-caudal)
Show all 13Show fewer
  • ≥ 30% improvement in UPDRS III with 'standard STN' compared to 'stimulation off' in dopaminergic off
  • Freezing of Gait Assessment Course ≥10 and ≤33
  • Patient not wheelchair-bound and possible to move self-dependently outside a freezing episode.
  • Disease duration ≥ 5 years
  • Age: between 18 and 80 years
  • Dopaminergic medication constant for at least four weeks prior to study enrolment
  • Written informed consent

Who cannot join

  • Participation in other clinical trials within the past three months and during enrolment in our study
  • 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
  • Paradoxical levodopa-induced "on" state freezing (Espay et al., 2012)

Trial locations and contacts

10 sites in 2 countries.

Daniel Weiss, MD contact

0049-7071-29-82340

daniel.weiss@uni-tuebingen.de

Alireza Gharabaghi, MD contact

0049-7071-29-83550

alireza.gharabaghi@uni-tuebingen.de

10 sites in 2 countries

Germany9 sites, 9 recruiting

  • Charite- University Hospital Berlin, Departments for Neurology and Neurosurgery

    Berlin, 10117

    Andrea Kühn, MD

    Gerd-Helge Schneider, MD

    Recruiting

  • University Hospital Köln, Department for Neurology and Neurosurgery

    Cologne, North Rhine-Westphalia, 50924

    Michael Barbe, MD

    Veerle Visser-Vandewalle, MD

    Recruiting

  • University Hospital of Düsseldorf, Departments for Neurology and Neurosurgery

    Düsseldorf, North Rhine-Westphalia, 40225

    Alfons Schnitzler, MD

    Jan Vesper, MD

    Recruiting

  • University Hospital Hamburg-Eppendorf, Department for Neurology and Neurosurgery

    Hamburg, 20246

    Monika Pötter-Nerger, MD

    Wolfgang Hamel, MD

    Recruiting

  • University Hospital Kiel, Department for Neurology and Neurosurgery

    Kiel, Schleswig-Holstein, 24105

    Daniela Falk, MD

    Karsten Witt, MD

    Recruiting

  • University Hospital Leipzig, Department for Neurology and Neurosurgery

    Leipzig, Saxony, 04103

    David Weise, MD

    Dirk Winkler, MD

    Recruiting

  • Ludwig-Maximilians-University Munich, Klinikum Großhadern, Department for Neurology and Neurosurgery

    Munich, Bavaria, 81377

    Kai Bötzel, MD

    Jan Mehrkens, MD

    Recruiting

  • University Hospital Regensburg , Department for Neurology and Neurosurgery

    Regensburg, Bavaria, 93053

    Josephine Blume, MD

    Max Lange, MD

    Recruiting

  • Center of Neurology and Hertie Institute for Clinical Brain Research, Department for Neurodegenerative Diseases and Neurosurgery University of Tübingen

    Tübingen, Baden-Wurttemberg, 72076

    Daniel Weiss, MD

    Alireza Gharabaghi, MD

    Recruiting

Other trials in Germany

Luxembourg1 site, 1 recruiting

  • University Hospital Luxembourg, Department for Neurology and Neurosurgery

    Luxembourg, L-4362

    Rejko Krüger, MD

    Frank Hertel, MD

    Recruiting

Other trials in Luxembourg

About this study

Official title: Combined Stimulation of Subthalamic Nucleus and Substantia Nigra Pars Reticulata for Resistant Freezing of Gait in Parkinson's Disease: A Randomized Controlled Multicenter Trial

54 patients with idiopathic Parkinson's disease and freezing of gait resistant to subthalamic nucleus stimulation and dopaminergic medication will be included into this multicentre randomised controlled double-blinded parallel group clinical trial. The treatment consists of two different stimulation settings using (i) conventional stimulation of the subthalamic nucleus [standard STN] as active comparator and (ii) combined stimulation of active electrode contacts located in both the subthalamic nucleus and substantia nigra pars reticulata [STN+SNr].

Read the detailed description

The primary endpoint of this study is to investigate the efficacy and safety of combined [STN+SNr] stimulation by "interleaving stimulation" as compared to [standardSTN] after 3 months on refractory freezing of gait (FOG). The Trial is designed as superiority study with an 80% power to detect a mean improvement of 4.7 points on the Freezing of Gait Assessment Course (Ziegler et al., 2010) with one-tailed P < 0.2. To this end 54 patients will be studied. After a common baseline assessment in [standardSTN], patients will be randomized to either [standardSTN] or [STN+SNr] in 1:1 ratio (27 per arm). The primary endpoint assessment is scheduled 90 days from baseline assessment (V6). Additional interim visits are scheduled for secondary purpose from baseline at day 2 (V2), day 8 (V3), day 21 (V4), day 42 (V5).

The rationale for this study comes from our previous phase II trial (Weiss et al., 2013) in which we have observed an improvement of freezing of gait from combined STN+SNr stimulation as secondary endpoint compared with standard STN stimulation at three-week follow-up.

Secondary outcome measures include anamnestic assessments on freezing of gait and falls, balance, quality of life, neuropsychiatric symptoms and suicidality.

Being tested
[standard STN], [STN+SNr]
Keywords
Parkinson's disease, freezing of gait, deep brain stimulation, substantia nigra pars reticulata, subthalamic nucleus
Medical subject headings
Parkinson Disease

What participants receive

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

  • [standard STN]Procedure or surgery

    Also called subthalamic deep brain stimulation

    High frequency deep brain stimulation with variable (best individual) stimulation on subthalamic contacts

  • [STN+SNr]Procedure or surgery

    Also called combined subthalamic and nigral stimulation

    high frequency deep brain stimulation of combined (best individual) subthalamic and nigral stimulation

Study groups in NCT02588144
Study groupRoleWhat they receive
[standard STN]Active comparatorDevice: standard stimulation on subthalamic (STN) contacts
Receives: Procedure: [standard STN]
[STN+SNr]ExperimentalDevice: Combined stimulation of the subthalamic nucleus (STN) and the substantia nigra pars reticulata (SNr)
Receives: Procedure: [STN+SNr]

What is being measured

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

  1. Freezing of Gait Assessment Course (FOG-AC)

    Measured: Outcome at day 90 (V6) with reference to baseline (V1)

Secondary outcomes (12)

  1. Timed Walking test from Core Assessment Program for Surgical Interventions in Parkinson's disease (CAPSIT-PD)

    Measured: At baseline, day 2, 8, 21, 42 and 90, respectively

  2. Berg Balance Scale

    Measured: At baseline, day 42 and 90, respectively

  3. Parkinson's disease questionnaire (PDQ-39)

    Measured: At baseline, day 42 and 90, respectively

  4. Freezing of gait questionnaire

    Measured: At baseline, day 42 and 90, respectively

  5. Beck's depression Inventory

    Measured: At baseline, day 42 and 90, respectively

  6. Columbia-Suicide Severity Rating Scale

    Measured: At baseline, day 42 and 90, respectively

  7. Clinical global impression scale

    Measured: At day 42 and 90, respectively

  8. Falls diary

    Measured: At baseline, day 2, 8, 21, 42 and 90, respectively

  9. Movement Disorders Society Unified Parkinson's disease Rating Scale (MDS-UPDRS III)

    Measured: At baseline, day 2, 8, 21, 42 and 90, respectively

  10. Movement Disorders Society Unified Parkinson's disease Rating Scale (MDS-UPDRS II)

    Measured: At baseline, day 42 and 90, respectively

  11. Movement Disorders Society Unified Parkinson's disease Rating Scale (MDS-UPDRS IV)

    Measured: At baseline, day 42 and 90, respectively

  12. Freezing of Gait Assessment Course (FOG-AC)

    To determine treatment kinematics

    Measured: At baseline, day 2, 8, 21, 42 after active treatment (STN vs. STN+SNr), respectively

Timeline

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

  1. First posted27 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionSep 2017 (estimated)
  4. Study completionSep 2017 (estimated)

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
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02588144
Sponsor's protocol ID
IHanci
Acronym
STN+SNr
Status last verified
Jun 2017
First submitted
24 Oct 2015
Last updated
20 Jun 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Weiss D, Walach M, Meisner C, Fritz M, Scholten M, Breit S, Plewnia C, Bender B, Gharabaghi A, Wachter T, Kruger R. Nigral stimulation for resistant axial motor impairment in Parkinson's disease? A randomized controlled trial. Brain. 2013 Jul;136(Pt 7):2098-108. doi: 10.1093/brain/awt122. Epub 2013 Jun 11.

    PubMed 23757762

Questions about this trial

What is this clinical trial studying?

A study testing [standard STN] and [STN+SNr] in people with Parkinson's Disease, run by University Hospital Tuebingen at 10 sites in 2 countries.

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 13 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany, Luxembourg. 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?

Results are not available in the source record.

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

Contact Daniel Weiss, MD (0049-7071-29-82340, daniel.weiss@uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freezing of Gait Assessment Course (FOG-AC) (time frame: Outcome at day 90 (V6) with reference to baseline (V1)). 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 NCT02588144, which also lists 1 linked publication.

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 20 Jun 2017.

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