NCT00529724

Brief Summary

Chronic bilateral subthalamic stimulation leads a spectacular clinical improvement in patients with motor complications. However, the post-operative body weight gain involved may limit the benefits of surgery and induce critical metabolic disorder. The aim of this study to determine the energy expenditure in usual conditions of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2007

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2015

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

8.1 years

First QC Date

September 13, 2007

Last Update Submit

May 22, 2023

Conditions

Parkinson's Disease

Keywords

Energy metabolism, metabolic syndrome, by chronic bilateral subthalamic stimulation, Parkinson's diseasePatients with Parkinson's disease and will be treated by chronic bilateral subthalamic stimulation.

Outcome Measures

Primary Outcomes (2)

  • heart rate recorded during 7 days in usual conditions of life

    7 days in usual conditions of life

  • energy expenditure recorded during 14 days in usual conditions of life with normalized water (18O 10 %) and Deuterium oxide (99.94 %D)

    14 days in usual conditions of life

Interventions

Energy metabolism by chronic bilateral subthalamic stimulationBEHAVIORAL

Patients will be studied before and after STN-DBS surgery

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18 and 70 years old
  • Diagnosis of Parkinson' disease established for 5 years at least
  • Ldopa effect \> 50 %
  • Hoehn and Yarh score \> 2.5 in On phase

You may not qualify if:

  • Metabolism disorder
  • Biological analysis abnormal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Parkinson DiseaseMetabolic Syndrome

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Franck Durif, Pr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2007

First Posted

September 14, 2007

Study Start

September 3, 2007

Primary Completion

September 21, 2015

Study Completion

June 1, 2018

Last Updated

May 24, 2023

Record last verified: 2023-05

Locations

FR(1)