NCT01274832

Brief Summary

The aim of this study is to investigate the impact of DBS not only no motor outcomes, but also on neuropsychological and psychiatric aspects and on quality of life in young patients with a short history of disease.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2011

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

January 14, 2011

Status Verified

October 1, 2008

Enrollment Period

2.2 years

First QC Date

January 11, 2011

Last Update Submit

January 13, 2011

Conditions

Parkinson's DiseaseDBSDeep Brain StimulationSTN

Keywords

ParkinsonDBS of STNPDDeep Brain stimulation of STNEarly treatment

Outcome Measures

Primary Outcomes (1)

  • percentage of improvement in motor aspects

    The primary objective of the study is calculates as: (UPDRS III 12 months - UPDRS III baseline)/UPDRS III baseline where UPDRS III 12 months means the score of this test in "medication off , stimulation on" condition at 12 months after implant, while UPDRS III baseline means the score of this test in "medication off " condition.

    after 12 months of stimulation

Secondary Outcomes (4)

  • Neuropsychological aspects

    after 3 and12 months of stimulation

  • Psychiatrical aspects

    after 3 and12 months of stimulation

  • Quality of Life

    after 3 and12 months of stimulation

  • Medication intake

    after 3 and12 months of stimulation

Study Arms (2)

Late-treated PD patients

Patients affected by Parkinson Disease, implanted with STN DBS and with an history of disease \> 10 years

Device: Deep Brain Stimulation

Early-treated PD patients

Patients affected by Parkinson Disease, implanted with STN DBS and with an history of disease \<7 years

Device: Deep Brain Stimulation

Interventions

Deep Brain StimulationDEVICE

Deep Brain Stimulation of STN in Parkinsonian patients

Also known as: DBS
Early-treated PD patientsLate-treated PD patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This prospective clinical study will enroll 40 patients affected by PD. Patients enrolled will be divided into two groups based on the duration of disease. The first group will be composed by patients with PD duration of 5, while the second group will be composed by patients with a duration of disease longer than 10 years.

You may qualify if:

  • suffering from PD of \> 10 years and with LTS (long term L-dopa syndrome), or with a duration of PD of 5 years
  • age\< 70 years
  • normal brain MRI
  • absence of dementia (Mini Mental State Examination ≥ 24)
  • absence of severe psychiatric diseases
  • Signed informed consent form
  • Absence of allergy to metal
  • Italian native speaker
  • Absence of communicative or perceptive deficits

You may not qualify if:

  • Any form of familiar PD
  • Presence of neoplasia
  • Presence of HIV
  • Presence of severe metabolic diseases
  • Severe cardiac/respiratory/renal or hepatic diseases
  • Ongoing treatment with immunodepressive/ immunomodulate drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Ospedali Riuniti di Bergamo

Bergamo, Lombardy, 24128, Italy

Location

Related Publications (12)

  • Lang AE, Lozano AM. Parkinson's disease. First of two parts. N Engl J Med. 1998 Oct 8;339(15):1044-53. doi: 10.1056/NEJM199810083391506. No abstract available.

    PMID: 9761807BACKGROUND

  • Schrag A, Quinn N. Dyskinesias and motor fluctuations in Parkinson's disease. A community-based study. Brain. 2000 Nov;123 ( Pt 11):2297-305. doi: 10.1093/brain/123.11.2297.

    PMID: 11050029BACKGROUND

  • Kumar R, Lozano AM, Kim YJ, Hutchison WD, Sime E, Halket E, Lang AE. Double-blind evaluation of subthalamic nucleus deep brain stimulation in advanced Parkinson's disease. Neurology. 1998 Sep;51(3):850-5. doi: 10.1212/wnl.51.3.850.

    PMID: 9748038BACKGROUND

  • Moro E, Scerrati M, Romito LM, Roselli R, Tonali P, Albanese A. Chronic subthalamic nucleus stimulation reduces medication requirements in Parkinson's disease. Neurology. 1999 Jul 13;53(1):85-90. doi: 10.1212/wnl.53.1.85.

    PMID: 10408541BACKGROUND

  • Vingerhoets FJ, Villemure JG, Temperli P, Pollo C, Pralong E, Ghika J. Subthalamic DBS replaces levodopa in Parkinson's disease: two-year follow-up. Neurology. 2002 Feb 12;58(3):396-401. doi: 10.1212/wnl.58.3.396.

    PMID: 11839838BACKGROUND

  • Deep-Brain Stimulation for Parkinson's Disease Study Group; Obeso JA, Olanow CW, Rodriguez-Oroz MC, Krack P, Kumar R, Lang AE. Deep-brain stimulation of the subthalamic nucleus or the pars interna of the globus pallidus in Parkinson's disease. N Engl J Med. 2001 Sep 27;345(13):956-63. doi: 10.1056/NEJMoa000827.

    PMID: 11575287BACKGROUND

  • Houeto JL, Damier P, Bejjani PB, Staedler C, Bonnet AM, Arnulf I, Pidoux B, Dormont D, Cornu P, Agid Y. Subthalamic stimulation in Parkinson disease: a multidisciplinary approach. Arch Neurol. 2000 Apr;57(4):461-5. doi: 10.1001/archneur.57.4.461.

    PMID: 10768618BACKGROUND

  • Mesnage V, Houeto JL, Welter ML, Agid Y, Pidoux B, Dormont D, Cornu P. Parkinson's disease: neurosurgery at an earlier stage? J Neurol Neurosurg Psychiatry. 2002 Dec;73(6):778-9. doi: 10.1136/jnnp.73.6.778. No abstract available.

    PMID: 12438494BACKGROUND

  • Carlesimo GA, Caltagirone C, Gainotti G. The Mental Deterioration Battery: normative data, diagnostic reliability and qualitative analyses of cognitive impairment. The Group for the Standardization of the Mental Deterioration Battery. Eur Neurol. 1996;36(6):378-84. doi: 10.1159/000117297.

    PMID: 8954307BACKGROUND

  • Volkmann J. Deep brain stimulation for the treatment of Parkinson's disease. J Clin Neurophysiol. 2004 Jan-Feb;21(1):6-17. doi: 10.1097/00004691-200401000-00003.

    PMID: 15097290RESULT

  • Diamond A, Jankovic J. The effect of deep brain stimulation on quality of life in movement disorders. J Neurol Neurosurg Psychiatry. 2005 Sep;76(9):1188-93. doi: 10.1136/jnnp.2005.065334.

    PMID: 16107348RESULT

  • Schupbach WM, Maltete D, Houeto JL, du Montcel ST, Mallet L, Welter ML, Gargiulo M, Behar C, Bonnet AM, Czernecki V, Pidoux B, Navarro S, Dormont D, Cornu P, Agid Y. Neurosurgery at an earlier stage of Parkinson disease: a randomized, controlled trial. Neurology. 2007 Jan 23;68(4):267-71. doi: 10.1212/01.wnl.0000250253.03919.fb. Epub 2006 Dec 6.

    PMID: 17151341RESULT

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Bruno Ferraro, MD

    Azienda Ospedaliera Ospedali Riuniti di Bergamo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno Ferraro, MD

CONTACT

0039035269411alkmane@yahoo.it

Dario Alimonti, MD

CONTACT

0039035269414alimonti@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 11, 2011

First Posted

January 12, 2011

Study Start

February 1, 2011

Primary Completion

April 1, 2013

Study Completion

September 1, 2014

Last Updated

January 14, 2011

Record last verified: 2008-10

Locations

IT(1)