Deep Brain Stimulation for Patients With Parkinson's Disease.

Parkinson Disease Clinical Trial

— STTARTLATE  

Official title:

Effets de la Stimulation cérébrale Profonde Chez Les Patients âgés Avec Maladie de Parkinson : Essai contrôlé randomisé Multicentrique

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03128567
• Other study ID #: C 14-01
• Status: Not yet recruiting
• Phase: N/A
• First received: February 23, 2017
• Last updated: June 1, 2017
• Start date: June 2017
• Est. completion date: March 2021

Study information

• Verified date: November 2016
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Deep brain stimulation of the sub thalamic nucleus (STN-DBS) is an efficient treatment to improve motor and non motor signs of Parkinson's disease (PD). In people aged more 70 years, an increased rate of side effects such as post-operative cognitive decline and/or postural instability with falls has been suspected with less improvement in the quality of life. Here, Investigators aim further explore the effects of STN-DBS in 50 patients with PD people aged more 69 years in a randomized parallel controlled study.

Description:

The effects of combined bilateral deep brain stimulation of the subthalamic nucleus and medical treatment on the quality of life will be evaluated in 25 PD patients aged more 69 years in comparison to 25 PD patients aged more 69 years that only received medical drug treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2021
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 69 Years to 75 Years

Eligibility

Inclusion Criteria:

• Parkinson's disease

• disease duration > 5 years

• levodopa related motor complications

• dopasensitivity > 50%

• signed informed written consent

• medical social insurance

Exclusion Criteria:

• dementia

• contra-indication to neurosurgery

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Stimulation of the subthalamic nucleus
Stimulation of the subthalamic nucleus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	PDQ-39 scale	Quality of life one year after surgery