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Parkinson DiseasePhase 4EARLYSTIMNCT00354133

Controlled Trial With Deep Brain Stimulation in Patients With Early Parkinson's Disease

A Phase 4 study testing Kinetra and Soletra (neurostimulator, Medtronic) and Best Medical Treatment in people with Parkinson Disease, run by German Parkinson Study Group (GPS) at 16 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Earlystim Study: Patients are randomized either to medical treatment or subthalamic stimulation. The observation period was 2 years. The primary outcome criterium: PDQ-39. Post study Follow up studies: After the 24 months observation period also BMT patients could be operated and all patients will be observed for 10… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Parkinson Disease
What is being tested?
Kinetra and Soletra (neurostimulator, Medtronic) and Best Medical Treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
251 participants
Where
16 sitesin 2 countries
Study dates
Jul 2006to Mar 2022
Phase
Phase 4
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Idiopathic Parkinson's Disease
  • Hoehn and Yahr stage ≤ 2.5 in the best "on"med condition
  • Disease duration > 4 years
  • Presence of fluctuations and/or dyskinesias for no more than 3 years
  • One of the two following forms of impairment:
  • Impairment in activities of daily living (UPDRS II > 6) due to PD-symptoms despite medical treatment in the "worst" condition or
Show all 10Show fewer
  • Impairment of social and occupational functioning (measured with a modified SOFAS) due to PD-symptoms despite medical treatment (51-80%)
  • PDQ-39 completed
  • Written informed consent
  • For the patients in France a social security number is required

Who cannot join

  • Major depression with suicidal thoughts (Beck Depression Inventory > 25)
  • Dementia (Mattis Score ≤ 130)
  • Acute psychosis
  • Need for nursing care
  • Any medical or psychological problems which may interfere with a smooth conduction of the study protocol (e.g. cancer with a limited life expectancy)
  • Drug or alcohol addiction
Show all 11Show fewer
  • Surgical contraindications
  • Fertile women not using adequate contraceptive methods
  • Women who are pregnant or breast feeding
  • Illiteracy or insufficient language skills (German or French) to complete the questionnaires
  • Simultaneous participation in another clinical trial except that other trial does not affect the Earlystim study as approved and documented by the steering committee

Trial locations and contacts

16 sites in 2 countries.

16 sites in 2 countries

France8 sites

  • Michallon Hospital, CHU Grenoble, Service de Neurologie, BP217

    Grenoble, 38043

  • Service de Neurologie C, Hôpital Neurologique et neurochirurgical Pierre Wertheimer , 59 Bd Pinel 69677 BRON Cedex

    Lyon, 69677

  • Centre hospitalier La Timone, Service de neurologie et pathologie du mouvement,Boulevard Jean Moulin

    Marseille, 13005

  • "Hôpital Nord Laënnec Boulevard Jacques-Monod - Saint-Herblain

    Nantes, 44093

  • CIC, CHU Pitié-Salpêtrière, 47-83 Bd de l'Hôpital

    Paris, 75651

  • Hôpital La Milétrie, Tour Jean Bernard, 350 Av Jacques Cœur, BP 577

    Poitiers, 86021

  • Centre Hospitalo-Universitaire de Rouen, Charles Nicolle, bat. DV, 1 rue de Germont

    Rouen, 76031

  • Centre d'investigation Clinique, Pavillon Riser, Hôpital Purpan,Place du Dr Baylac TSA 40031

    Toulouse, 31059

Other trials in France

Germany8 sites

  • Klinik und Poliklinik für Neurologie, Charite

    Berlin

  • Klinik und Poliklinik für Neurologie

    Cologne, 50924

  • Neurologische Klinik der Universität, Moorenstr. 5

    Düsseldorf, 40225

  • Neurologische Universitätsklinik Freiburg, Breisacher Str. 64

    Freiburg im Breisgau, 79106

  • Paracelsus-Elena-Klinik, Kassel, Klinikstrasse 16

    Kassel, 34128

  • Klinik für Neurologie, Universitätsklinikum Schleswig-Holstein, Schittenhelmstr. 10

    Kiel, 24105

  • Klinikum der Universität München Neurologische Klinik und Poliklinik - Großhadern, Marchioninistr. 15

    München, 81377

  • Universitätsklinikum Tübingen, Klinik für Neurochirurgie, Hoppe-Seyler-Str.3

    Tübingen, 72076

Other trials in Germany

About this study

Official title: The Effect of Deep Brain Stimulation of the Subthalamic Nucleus (STN-DBS) on Quality of Life in Comparison to Best Medical Treatment in Patients With Complicated Parkinson's Disease and Preserved Psychosocial Competence (EARLYSTIM-study)

Earlystim Study: Patients are randomized either to medical treatment or subthalamic stimulation. The observation period was 2 years. The primary outcome criterium: PDQ-39.

Post study Follow up studies: After the 24 months observation period also BMT patients could be operated and all patients will be observed for 10 years or longer to elucidate whether earlier stimulation has advantages (or drawbacks) compared to later stimulation.

Read the detailed description

Parkinsons' disease is one of the most disabling chronic neurological diseases. It can be treated sufficiently until motor complications with fluctuations of mobility and dyskinesias develop. The quality of life and the social and occupational functioning is relentlessly deteriorating with longer disease duration once the complications of conservative therapy develop. High-frequency stimulation of the subthalamic nucleus especially improves the motor complications of Parkinson's disease and preliminary data suggest that also the quality of life and psychosocial handicap are improved. So far this therapy is only used for patients which have already undergone personal, professional and social degradation due to motor complications of the disease. The aim of this study is to assess the use of this therapy in earlier stages of the disease, when motor complications have just developed and before patients are significantly affected in their social and occupational functioning.

The main study (Earlystim) was finished in March 2012 and published in February 2013 (Schuepbach WM, Rau J, Knudsen K, et al. Neurostimulation for Parkinson's disease with early motor complications. N Engl J Med. Feb 14 2013;368(7):610-622.) Patients, who were treated with BMT only in the Earlystim Study were privileged to be operated after the 24 months and a follow up phase of 5 years was planned to elucidate whether earlier stimulation has advantages (or drawbacks) compared to later stimulation.

As operated patients fare better in terms of quality of life and other outcomes (see publication), it will be important to know if patients who are operated earlier keep an advantage in all thoses parameters over those who were operated later or if those operated later will catch up after surgery. Also the pattern of adverse events among earlier and later operated patients may differ. These issues can be addressed with the post-study follow-up (PSFU) studies of the patients of the Earlystim trial. The results of these investigations elucidate longterm issues of DBS in PD and may affect the recommendations of surgery for patients.

Being tested
Kinetra and Soletra (neurostimulator, Medtronic), Best Medical Treatment
Keywords
Parkinson Disease, Deep Brain Stimulation, PDQ-39
Medical subject headings
Parkinson Disease

What participants receive

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

  • Kinetra and Soletra (neurostimulator, Medtronic)Device

    Patients in this arm were implanted with a neurostimulator (Kinetra and Soletra from Medtronic) are stimulated. Additionally the get best medical treatment.

  • Best Medical TreatmentDrug

    Patients in this arm get best medical treatment only

Study groups in NCT00354133
Study groupRoleWhat they receive
DBS treatmentActive comparatorPatients in this arm are treated with Deep Brain Stimulation (DBS) of the Nucleus subthalamicus with the device Kinetra and Soletra (neurostimulator, Medtronic) and addtionally get best medical treatment
Receives: Device: Kinetra and Soletra (neurostimulator, Medtronic)
BMT treatmentActive comparatorPatients in this arm get best medical treatment only.
Receives: Drug: Best Medical Treatment

What is being measured

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

  1. PDQ-39

    Difference in the PDQ-39 summary index at 24 months compared to the baseline assessment.

    Measured: 24 months

Secondary outcomes (20)

  1. UPDRS part III

    Change in the Unified Parkinson's disease Rating Scale (UPDRS) part III

    Measured: 24 months

  2. UPDRS II scale

    Change in the UPDRS II scale

    Measured: 24 months

  3. Safety

    Frequency, type and severity of therapy related adverse events of medication or DBS, Change in medication (L-DOPA equivalents)

    Measured: 24 months

  4. UPDRS VI scale

    Change in the UPDRS VI scale

    Measured: 24 months

  5. SCOPA-PS

    Change in the SCOPA-PS scale

    Measured: 24 months

  6. BDI scale

    Change in the BDI scale

    Measured: 24 months

  7. MADRS scale

    Change in the MADRS scale

    Measured: 24 months

  8. BPRS scale

    Change in the BPRS scale

    Measured: 24 months

  9. Mattis Dementia Scale

    Change in the Mattis Dementia Scale

    Measured: 24 months

  10. Ardouin Behaviour Scale

    Change in the Ardouin Behaviour Scale

    Measured: 24 months

  11. Starkstein-Apathy Scale

    Change in the Starkstein-Apathy Scale

    Measured: 24 months

  12. professional Fitness scale

    Change in the professional Fitness scale

    Measured: 24 months

  13. SF-36 scale

    Change in the SF-36 scale

    Measured: 24 months

  14. pain (VAS) scale,

    Change in the pain (VAS) scale

    Measured: 24 months

  15. clinical global impression (CGI-GI) scale

    change in the clinical global impression (CGI-GI) scale

    Measured: 24 months

  16. "best"-state

    Change in the number of hours per day in the "best"-state

    Measured: 24 months

  17. "best" state dyskinesias

    Frequency and severity of "best" state dyskinesias

    Measured: 24 months

  18. Sleeping-hours per day

    Sleeping-hours per day

    Measured: 24 months

  19. Gait

    Changes in gait

    Measured: 24 months

  20. Speech

    Changes in speech

    Measured: 24 months

Timeline

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

  1. First posted20 Jul 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionMar 2022 (estimated)
  4. Study completionMar 2022 (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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00354133
Sponsor's protocol ID
A 121/06
Acronym
EARLYSTIM
Status last verified
Jun 2018
First submitted
19 Jul 2006
Last updated
26 Jun 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).

Publications

  • Schuepbach WM, Rau J, Knudsen K, Volkmann J, Krack P, Timmermann L, Halbig TD, Hesekamp H, Navarro SM, Meier N, Falk D, Mehdorn M, Paschen S, Maarouf M, Barbe MT, Fink GR, Kupsch A, Gruber D, Schneider GH, Seigneuret E, Kistner A, Chaynes P, Ory-Magne F, Brefel Courbon C, Vesper J, Schnitzler A, Wojtecki L, Houeto JL, Bataille B, Maltete D, Damier P, Raoul S, Sixel-Doering F, Hellwig D, Gharabaghi A, Kruger R, Pinsker MO, Amtage F, Regis JM, Witjas T, Thobois S, Mertens P, Kloss M, Hartmann A, Oertel WH, Post B, Speelman H, Agid Y, Schade-Brittinger C, Deuschl G; EARLYSTIM Study Group. Neurostimulation for Parkinson's disease with early motor complications. N Engl J Med. 2013 Feb 14;368(7):610-22. doi: 10.1056/NEJMoa1205158.

    PubMed 23406026

  • Deuschl G, Schade-Brittinger C, Agid Y; EARLYSTIM Study Group. Neurostimulation for Parkinson's disease with early motor complications. N Engl J Med. 2013 May 23;368(21):2038. doi: 10.1056/NEJMc1303485. No abstract available.

    PubMed 23697520

  • Dams J, Balzer-Geldsetzer M, Siebert U, Deuschl G, Schuepbach WM, Krack P, Timmermann L, Schnitzler A, Reese JP, Dodel R; EARLYSTIM-investigators. Cost-effectiveness of neurostimulation in Parkinson's disease with early motor complications. Mov Disord. 2016 Aug;31(8):1183-91. doi: 10.1002/mds.26740.

    PubMed 27506638

  • Lhommee E, Wojtecki L, Czernecki V, Witt K, Maier F, Tonder L, Timmermann L, Halbig TD, Pineau F, Durif F, Witjas T, Pinsker M, Mehdorn M, Sixel-Doring F, Kupsch A, Kruger R, Elben S, Chabardes S, Thobois S, Brefel-Courbon C, Ory-Magne F, Regis JM, Maltete D, Sauvaget A, Rau J, Schnitzler A, Schupbach M, Schade-Brittinger C, Deuschl G, Houeto JL, Krack P; EARLYSTIM study group. Behavioural outcomes of subthalamic stimulation and medical therapy versus medical therapy alone for Parkinson's disease with early motor complications (EARLYSTIM trial): secondary analysis of an open-label randomised trial. Lancet Neurol. 2018 Mar;17(3):223-231. doi: 10.1016/S1474-4422(18)30035-8.

    PubMed 29452685

  • Schupbach WM, Rau J, Houeto JL, Krack P, Schnitzler A, Schade-Brittinger C, Timmermann L, Deuschl G. Myths and facts about the EARLYSTIM study. Mov Disord. 2014 Dec;29(14):1742-50. doi: 10.1002/mds.26080. Epub 2014 Nov 14.

    PubMed 25399678

  • Deuschl G, Schupbach M, Knudsen K, Pinsker MO, Cornu P, Rau J, Agid Y, Schade-Brittinger C. Stimulation of the subthalamic nucleus at an earlier disease stage of Parkinson's disease: concept and standards of the EARLYSTIM-study. Parkinsonism Relat Disord. 2013 Jan;19(1):56-61. doi: 10.1016/j.parkreldis.2012.07.004. Epub 2012 Jul 28.

    PubMed 22841616

  • Pinto S, Nebel A, Rau J, Espesser R, Maillochon P, Niebuhr O, Krack P, Witjas T, Ghio A, Cuartero MC, Timmermann L, Schnitzler A, Hesekamp H, Meier N, Mullner J, Halbig TD, Moller B, Paschen S, Paschen L, Volkmann J, Barbe MT, Fink GR, Becker J, Reker P, Kuhn AA, Schneider GH, Fraix V, Seigneuret E, Kistner A, Rascol O, Brefel-Courbon C, Ory-Magne F, Hartmann CJ, Wojtecki L, Fradet A, Maltete D, Damier P, Le Dily S, Sixel-Doring F, Benecke P, Weiss D, Wachter T, Pinsker MO, Regis J, Thobois S, Polo G, Houeto JL, Hartmann A, Knudsen K, Vidailhet M, Schupbach M, Deuschl G; EARLYSTIM Study Group. Results of a Randomized Clinical Trial of Speech After Early Neurostimulation in Parkinson's Disease. Mov Disord. 2023 Feb;38(2):212-222. doi: 10.1002/mds.29282. Epub 2022 Dec 3.

    PubMed 36461899

  • Schuepbach WMM, Tonder L, Schnitzler A, Krack P, Rau J, Hartmann A, Halbig TD, Pineau F, Falk A, Paschen L, Paschen S, Volkmann J, Dafsari HS, Barbe MT, Fink GR, Kuhn A, Kupsch A, Schneider GH, Seigneuret E, Fraix V, Kistner A, Chaynes PP, Ory-Magne F, Brefel-Courbon C, Vesper J, Wojtecki L, Derrey S, Maltete D, Damier P, Derkinderen P, Sixel-Doring F, Trenkwalder C, Gharabaghi A, Wachter T, Weiss D, Pinsker MO, Regis JM, Witjas T, Thobois S, Mertens P, Knudsen K, Schade-Brittinger C, Houeto JL, Agid Y, Vidailhet M, Timmermann L, Deuschl G; EARLYSTIM study group. Quality of life predicts outcome of deep brain stimulation in early Parkinson disease. Neurology. 2019 Mar 5;92(10):e1109-e1120. doi: 10.1212/WNL.0000000000007037. Epub 2019 Feb 8.

    PubMed 30737338

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Kinetra and Soletra (neurostimulator, Medtronic) and Best Medical Treatment in people with Parkinson Disease, run by German Parkinson Study Group (GPS) at 16 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 10 inclusion and 11 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 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France, 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

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?

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?

PDQ-39 (time frame: 24 months). 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 NCT00354133, which also lists 8 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 26 Jun 2018.

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