Prospective Study to Compare Results of STN-DBS Between Early Treated and Late-treated PD Patient

Parkinson's Disease Clinical Trial

— DeBraStE  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01274832
• Other study ID #: BG200911
• Status: Not yet recruiting
• Phase: N/A
• First received: January 11, 2011
• Last updated: January 13, 2011
• Start date: February 2011
• Est. completion date: September 2014

Study information

• Verified date: October 2008
• Source: A.O. Ospedale Papa Giovanni XXIII
• Contact: Bruno Ferraro, MD
• Phone: 0039035269411
• Email: alkmane[@]yahoo.it
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• DBS
• Deep Brain Stimulation
• Parkinson Disease
• Parkinson's Disease
• STN

Intervention

Device:
• Deep Brain Stimulation
Deep Brain Stimulation of STN in Parkinsonian patients

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Ospedali Riuniti di Bergamo	Bergamo	Lombardy

Sponsors (2)

Lead Sponsor	Collaborator
A.O. Ospedale Papa Giovanni XXIII	Associazione Italiana Parkinsoniani (AIP)- Sezione Bergamo

Country where clinical trial is conducted

Italy, 

References & Publications (12)

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. — View Citation

Deep-Brain Stimulation for Parkinson's Disease Study Group. 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Lang AE, Lozano AM. Parkinson's disease. First of two parts. N Engl J Med. 1998 Oct 8;339(15):1044-53. Review. — View Citation

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. — View Citation

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. — View Citation

Schrag A, Quinn N. Dyskinesias and motor fluctuations in Parkinson's disease. A community-based study. Brain. 2000 Nov;123 ( Pt 11):2297-305. — View Citation

Schüpbach WM, Maltête D, Houeto JL, du Montcel ST, Mallet L, Welter ML, Gargiulo M, Béhar 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. Ne — View Citation

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. — View Citation

Volkmann J. Deep brain stimulation for the treatment of Parkinson's disease. J Clin Neurophysiol. 2004 Jan-Feb;21(1):6-17. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	after 3 and12 months of stimulation	No
Secondary	Psychiatrical aspects	Evaluation of changes in depression assessed by the Beck Depression Inventory	after 3 and12 months of stimulation	No
Secondary	Quality of Life	Evaluation of changes in quality of life assessed by PDQ39	after 3 and12 months of stimulation	No
Secondary	Medication intake		after 3 and12 months of stimulation	No