NCT00529724

CompletedPhase 2

Body Weight Gain, Parkinson, Subthalamic Stimulation

University Hospital, Clermont-Ferrand Source

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Other study identifiers

Sponsor study identifier

CHU-0024

Study Type

interventional

Actual enrollment (reported)

34

Locations

1 country

Sites

1

Timeline

Study Start

September 3, 2007

Actual (reported)

Primary Completion

September 21, 2015

Actual (reported)

Study Completion

June 1, 2018

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 34 participants
Study completion date: June 1, 2018
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 3, 2007
Actual (reported)
First Submitted
September 13, 2007
Actual (reported)
First Posted
September 14, 2007
Actual (reported)
Primary Completion
September 21, 2015
Actual (reported)
Study Completion
June 1, 2018
Actual (reported)

Last Updated: May 24, 2023
Status Verified: May 2023
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

University Hospital, Clermont-Ferrand
Otherlead

Study Sites (1)

CHU

Clermont-Ferrand, 63003, France

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

Enrollment

34 participants (actual enrollment reported by the registry).

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

Actual (reported)

Primary Completion

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Phase 2Unknown

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Phase 2Completed

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.

September 21, 2015

Actual (reported)

Study Completion

June 1, 2018

Actual (reported)

Last Updated

May 24, 2023

Record last verified: 2023-05

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00529724
Data provider: ClinicalTrials.gov
Source updated: 2023-05-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:19 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations