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Parkinson's DiseasePhase 2STN/SNrNCT01355835

Combined STN/SNr-DBS for the Treatment of Refractory Gait Disorders in Parkinson's Disease

A Phase 2 study testing deep brain stimulation (ACTIVA PC, Medtronic) in people with Parkinson's 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

12 patients with idiopathic Parkinson's disease and refractory gait disturbances under best individual subthalamic nucleus stimulation and dopaminergic medication will be included into this randomised double-blind cross-over two-armed 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?
deep brain stimulation (ACTIVA PC, Medtronic)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteGermany
Study dates
Feb 2011to Aug 2012
Phase
Phase 2
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
  • Age: between 18 and 80 years
  • Idiopathic Parkinson's disease (according to the "British Brain Bank criteria" (Hughes, 1992) including genetic forms and therapy with STN-DBS (ACTIVA pulse generators) at least six months from surgery
  • Optimized subthalamic stimulation at study enrolment (refer 'treatment' section)
  • Gait disturbance refractory on best individual STN-DBS (STNmono) and dopaminergic therapy: 'gait score' in the best clinical [MedOn/STNmono] condition ≥ 12
  • Clinical and image-guided (and facultatively electrophysiological) confirmation of (i) one of the two rostral contacts of the quadripolar electrode localized in the STN area, and (ii) the caudal contacts in the border zone of STN and SNr.
  • Dopaminergic medication constant for at least four weeks prior to study enrolment
  • Disease duration ≥ 5 years

Who cannot join

  • Cognitive impairment (Mini Mental State Exam < 25)
  • Participation in other clinical trials within the past three months and during enrolment in our study
  • Suicidality, Psychosis
  • Other severe pathological chronic condition that might confound treatment effects or interpretation of the data
  • Pregnancy
  • Acute adverse events from stimulation on contacts in the caudal STN / SNr border interfering with the intended stimulation protocol

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

About this study

Official title: Combined STN/SNr-DBS for the Treatment of Refractory Gait Disorders in Parkinson's Disease: Design of a Two-armed Double-blind Cross-over Study

12 patients with idiopathic Parkinson's disease and refractory gait disturbances under best individual subthalamic nucleus stimulation and dopaminergic medication will be included into this randomised double-blind cross-over two-armed clinical trial. The treatment consists of two different stimulation settings using (i) conventional stimulation of the subthalamic nucleus [STNmono] and (ii) combined stimulation of distant electrode contacts located in the subthalamic nucleus and caudal border zone of STN and substantia nigra pars reticulata [STN+SNr].

Read the detailed description

A composite 'axial score' including the major clinical and anamnestic items on gait, posture and balance function from UPDRSII (items 13-15) and UPDRS III (items 27-31) constitutes the primary outcome measure. Secondary outcome measures include specified clinical and anamnestic assessments on freezing of gait, balance, quality of life, non-motor symptoms, impulsivity, impulse control and neuropsychiatric symptoms. The aim of the present trial is to investigate the efficacy and safety of combined stimulation on subthalamic and nigral electrode contacts [STN+SNr] in refractory hypokinetic gait disturbances compared with [STNmono] (active comparator). The results will clarify, whether the combined [STN+SNr] stimulation improves otherwise refractory gait disturbances in PD.

Being tested
deep brain stimulation (ACTIVA PC, Medtronic)
Keywords
Parkinson's disease, 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.

  • deep brain stimulation (ACTIVA PC, Medtronic)Device

    Also called Neurostimulation with ACTIVA PC, Medtronic

    High frequent deep brain stimulation with variable (best individual) stimulation on subthalamic contacts and standard parameters on nigral contacts (125 Hz, 60µs, best individual amplitude)

Study groups in NCT01355835
Study groupRoleWhat they receive
[STNmono]Active comparatorConventional stimulation on subthalamic contacts
Receives: Device: deep brain stimulation (ACTIVA PC, Medtronic)
[STN+SNr]ExperimentalCombined subthalamic and nigral stimulation
Receives: Device: deep brain stimulation (ACTIVA PC, Medtronic)

What is being measured

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

  1. 'Axial score'

    The composite 'axial score' is built by 8 items from the UPDRS II and III, all 5-point rated (0 to 4) representing increasing levels of pathology. The 'axial score' will be scored by the sum of the ratings across the 8 items (Range 0 to 32). As change in UPDRS scores is a common primary efficacy outcome measure in Parkinson's disease and only items of the original UPDRS are required for the definition of the primary endpoint, the statistical evaluation methods should be based on the psychometric validation of the UPDRS and no own validation studies are necessary.

    Safety: falls

    Measured: Three weeks after active treatment (STN vs. STN+SNr), respectively

Secondary outcomes (11)

  1. CAPSIT-PD

    Measured: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

  2. Freezing of gait assessment course

    Measured: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

  3. Freezing of gait questionnaire

    Measured: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

  4. Berg Balance Scale

    Measured: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

  5. Non-motor symptoms scale

    Measured: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

  6. Non-motor symptoms quest

    Measured: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

  7. Beck's depression scale index

    Measured: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

  8. Minnesota Impulsive Disorders Interview

    Measured: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

  9. Barratt Impulsiveness Scale

    Measured: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

  10. UPDRS I-IV

    Measured: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

  11. PDQ-39

    Measured: At baseline and three weeks 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 posted18 May 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionAug 2012
  4. Study completionAug 2012

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01355835
Sponsor's protocol ID
AKF 259-0-0
Acronym
STN/SNr
Status last verified
Aug 2012
First submitted
13 May 2011
Last updated
8 Aug 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Weiss D, Breit S, Wachter T, Plewnia C, Gharabaghi A, Kruger R. Combined stimulation of the substantia nigra pars reticulata and the subthalamic nucleus is effective in hypokinetic gait disturbance in Parkinson's disease. J Neurol. 2011 Jun;258(6):1183-5. doi: 10.1007/s00415-011-5906-3. Epub 2011 Feb 2. No abstract available.

    PubMed 21287187

  • Weiss D, Wachter T, Meisner C, Fritz M, Gharabaghi A, Plewnia C, Breit S, Kruger R. Combined STN/SNr-DBS for the treatment of refractory gait disturbances in Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2011 Oct 11;12:222. doi: 10.1186/1745-6215-12-222.

    PubMed 21989388

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing deep brain stimulation (ACTIVA PC, Medtronic) in people with Parkinson's 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 8 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: finished, as of the sponsor's last update on 8 Aug 2012. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

'Axial score' (time frame: Three weeks after active treatment (STN vs. STN+SNr), respectively). 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 NCT01355835, which also lists 2 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 8 Aug 2012.

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