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Deep Brain Stimulation for Patients With Parkinson's Disease.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03128567
Acronym
STTARTLATE
Enrollment
10
Registered
2017-04-25
Start date
2017-11-27
Completion date
2020-02-06
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Brief 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.

Detailed 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.

Interventions

Stimulation of the subthalamic nucleus

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
69 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PDQ-39 Quality of life questionnaryQuality of life one year after surgeryPDQ-39 : Parkinson's disease quality of life scale questionnaire with 39 questions, grouped into 8 domains. Each item is scored on a scale from 0 to 4, with higher scores indicating greater difficulties. An overall score can be calculated by averaging the eight domain scores. Scores range from 0 to 100 : 0 = best quality of life 100 = worst quality of life

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026