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

A.O. Ospedale Papa Giovanni XXIII

Status: Unknown

Conditions: Parkinson's Disease; STN; Deep Brain Stimulation; DBS

Treatments: Device: Deep Brain Stimulation

Study type: Observational

Funder types: Other

Identifiers

NCT01274832

BG200911

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Late-treated PD patients

Description:

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

Treatment:

Device: Deep Brain Stimulation

Early-treated PD patients

Description:

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

Treatment:

Device: Deep Brain Stimulation