Parkinson's DiseaseDeBraStENCT01274832
Prospective Study to Compare Results of STN-DBS Between Early Treated and Late-treated PD Patient
An observational study of Parkinson's Disease and DBS, run by A.O. Ospedale Papa Giovanni XXIII at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Parkinson's Disease, DBS, Deep Brain Stimulation
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2011to Sep 2014
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- Absence of allergy to metal
- Italian native speaker
- Absence of communicative or perceptive deficits
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera Ospedali Riuniti di Bergamo
Bergamo, Lombardy, 24128
About this study
Official title: Prospective Study to Compare the Impact on Motor, Neuropsychological, Psychiatric Outcomes and Quality of Life of STN-DBS Between Early Treated and Late-treated PD Patients.
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.
Read the detailed description
Bilateral STN DBS is a powerful treatment for advanced Parkinson disease with Levodopa induced motor complications. The beneficial effects of STN stimulation on motor disability and quality of life have been proved. However, the mean delay before neurosurgery is currently 14 years after diagnosis, when medical treatment no longer controls PD symptoms and quality of life is already severely impaired.
Aim of this study is to prospectively assess the effects of bilateral STN stimulation on motor signs, psychological and psychiatric aspects and quality of life in a group of 20 patients with PD who underwent surgery after 5 years from the onset of the disease. These results will be compared with those of a group of 20 patients with a PD history from more than 10 years.
The two groups of patients will be evaluated at baseline and after 3 and 12 months from DBS implant; at each visit neurological and motor examinations were assessed and dedicated neuropsychological and psychiatric tests will be performed.
Neurosurgery may be considered superior to medical treatment alone even in mild to moderate PD of 10 years duration, rather than a last resort in very advanced stages of the disease. Thanks to this study we could compare motor outcomes and cognitive aspects between DBS patients with a short and with long history of disease
- Conditions
- Parkinson's Disease, DBS, Deep Brain Stimulation, STN
- Being tested
- Deep Brain Stimulation
- Keywords
- Parkinson, DBS of STN, PD, Deep Brain stimulation of STN, Early treatment
- 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 StimulationDevice
Also called DBS
Deep Brain Stimulation of STN in Parkinsonian patients
| Study group | Role | What they receive |
|---|---|---|
| Late-treated PD patients | Patients affected by Parkinson Disease, implanted with STN DBS and with an history of disease > 10 years Receives: 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 Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 12 months of stimulation
Secondary outcomes (4)
Neuropsychological aspects
Evaluation of changes in the
- global cognitive efficiency
- short tem memory
- attention
- logical/executive functions
- abstract reasoning
- verbal fluency tasks
- visuospatial and visuoconstructional abilities
Measured: after 3 and12 months of stimulation
Psychiatrical aspects
Evaluation of changes in depression assessed by the Beck Depression Inventory
Measured: after 3 and12 months of stimulation
Quality of Life
Evaluation of changes in quality of life assessed by PDQ39
Measured: after 3 and12 months of stimulation
Medication intake
Measured: after 3 and12 months of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2013 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIII
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Italiana Parkinsoniani (AIP)- Sezione Bergamo
- Investigators
- Bruno Ferraro, MD, Principal investigator, Azienda Ospedaliera Ospedali Riuniti di Bergamo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274832
- Sponsor's protocol ID
- BG200911
- Acronym
- DeBraStE
- Status last verified
- Oct 2008
- First submitted
- 11 Jan 2011
- Last updated
- 14 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9761807Schrag 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.
PubMed 11050029Kumar 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.
PubMed 9748038Moro 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.
PubMed 10408541Vingerhoets 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.
PubMed 11839838Deep-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.
PubMed 11575287Houeto 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.
PubMed 10768618Mesnage 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.
PubMed 12438494Carlesimo 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.
PubMed 8954307Volkmann 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.
PubMed 15097290Diamond 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.
PubMed 16107348Schupbach 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.
PubMed 17151341
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Compare the Impact on Motor, Neuropsychological, Psychiatric Outcomes and Quality of Life of STN-DBS Between Early Treated and Late-treated PD Patients.
- ClinicalTrials.gov ID
- NCT01274832
- Acronym / sponsor ID
- DeBraStE / BG200911
- Conditions
- Parkinson's Disease, DBS, Deep Brain Stimulation, STN
- Keywords
- Parkinson, DBS of STN, PD, Deep Brain stimulation of STN, Early treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIIIUniversity, hospital or other
- Collaborators
- Associazione Italiana Parkinsoniani (AIP)- Sezione Bergamo
- Study start
- Feb 2011
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 12 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Bilateral STN DBS is a powerful treatment for advanced Parkinson disease with Levodopa induced motor complications. The beneficial effects of STN stimulation on motor disability and quality of life have been proved. However, the mean delay before neurosurgery is currently 14 years after diagnosis, when medical treatment no longer controls PD symptoms and quality of life is already severely impaired.
Aim of this study is to prospectively assess the effects of bilateral STN stimulation on motor signs, psychological and psychiatric aspects and quality of life in a group of 20 patients with PD who underwent surgery after 5 years from the onset of the disease. These results will be compared with those of a group of 20 patients with a PD history from more than 10 years.
The two groups of patients will be evaluated at baseline and after 3 and 12 months from DBS implant; at each visit neurological and motor examinations were assessed and dedicated neuropsychological and psychiatric tests will be performed.
Neurosurgery may be considered superior to medical treatment alone even in mild to moderate PD of 10 years duration, rather than a last resort in very advanced stages of the disease. Thanks to this study we could compare motor outcomes and cognitive aspects between DBS patients with a short and with long history of disease
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Late-treated PD patients | – | Device: Deep Brain StimulationPatients affected by Parkinson Disease, implanted with STN DBS and with an history of disease > 10 years |
| Early-treated PD patients | – | Device: Deep Brain StimulationPatients affected by Parkinson Disease, implanted with STN DBS and with an history of disease <7 years |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- Any form of familiar PD
- Presence of neoplasia
- Presence of HIV
- Presence of severe metabolic diseases
- Severe cardiac/respiratory/renal or hepatic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain StimulationAlso: DBSDeep Brain Stimulation of STN in Parkinsonian patients | Device | Early-treated PD patients, Late-treated PD patients |
Primary outcome
percentage of improvement in motor aspects
Time frame: after 12 months of stimulation
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.
4 secondary outcomes
Neuropsychological aspects
Time frame: after 3 and12 months of stimulation
Psychiatrical aspects
Time frame: after 3 and12 months of stimulation
Quality of Life
Time frame: after 3 and12 months of stimulation
Medication intake
Time frame: after 3 and12 months of stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2011.
- Background: PubMed 9761807Lang 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.
- Background: PubMed 11050029Schrag 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.
- Background: PubMed 9748038Kumar 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.
- Background: PubMed 10408541Moro 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.
- Background: PubMed 11839838Vingerhoets 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.
- Background: PubMed 11575287Deep-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.
- Background: PubMed 10768618Houeto 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.
- Background: PubMed 12438494Mesnage 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.
- Background: PubMed 8954307Carlesimo 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.
- Results publication: PubMed 15097290Volkmann 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.
- Results publication: PubMed 16107348Diamond 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.
- Results publication: PubMed 17151341Schupbach 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Ferraro, MD principal investigator
Azienda Ospedaliera Ospedali Riuniti di Bergamo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and DBS, run by A.O. Ospedale Papa Giovanni XXIII at 1 site in Italy.
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 9 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 14 Jan 2011. 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 Italy. 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 Bruno Ferraro, MD (0039035269411, alkmane@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of improvement in motor aspects (time frame: after 12 months of stimulation). 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 NCT01274832, which also lists 12 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 14 Jan 2011.