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Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System Atrophy (MSA-DOUL)

Primary Purpose

Pain Threshold, Multiple System Atrophy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Levodopa test
determination of objective and subjective pain threshold
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain Threshold focused on measuring subjective pain, Multiple System Atrophy

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients from 50 to 80 years old (Male and female)
  • Patients suffering of a diagnosis possible or probable MSA-P with the international criteria (2008).
  • Patients with clinical diagnosis of Parkinson's disease according to the criteria of the UKPDSBB (Gibb et Lees, 1988; Hughes et al, 1992)
  • Patients with no cognitive troubles
  • Patients who give their informed and signed consent.
  • Patients affiliated to a social protection program

Exclusion Criteria:

  • Patient suffering from an other parkinson syndrome than MSA and PD, by example progressive supranuclear palsy, corticobasal degeneration…
  • Patient suffering of a diagnosis possible or probable MSA-C with the international criteria
  • Patient suffering from another pathology causing chronic pain (rheumatic disease, traumatic or orthopedic pathologies…)
  • Patient under tutelage, curatella or law protection

Sites / Locations

  • University Hospital, neurology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Group 1: MSA disease

Group 2: Parkinson disease

Group 3: healthy volunteers.

Arm Description

determination of objective and subjective pain threshold before and after levodopa intake

determination of objective and subjective pain threshold before and after levodopa intake

one determination of objective and subjective pain threshold without treatment

Outcomes

Primary Outcome Measures

Subjective pain threshold
Subjective pain threshold determined using thermal stimulation (Thermotest) with the method of levels, before and after levodopa intake for MSA patients and PD patients and once for healthy volunteers

Secondary Outcome Measures

Objective nociceptive pain threshold
Objective nociceptive pain threshold thanks to reflex of flexion (reflex RIII)before and after levodopa intake for MSA patients and PD patients and once for healthy volunteers

Full Information

First Posted
November 7, 2011
Last Updated
November 8, 2013
Sponsor
University Hospital, Toulouse
Collaborators
Fondation de France
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1. Study Identification

Unique Protocol Identification Number
NCT01577992
Brief Title
Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System Atrophy
Acronym
MSA-DOUL
Official Title
Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System Atrophy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Fondation de France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Multiple system atrophy (MSA) is a sporadic neurodegenerative disorder. MSA is dominated by autonomic/urogenital failure which may be associated with either Parkinsonism (MSA-P subtype) or with cerebellar ataxia (MSA-C subtype). The prognostic of this disease is bad because it ended with the patient's death few years later. No neuroprotective treatment has shown a real efficacy. 50% of patients suffering of MSA frequently experienced painful sensation. The origin of this pain is unknown. In Parkinson disease (PD) ; arguments suggest the implication of dopamine neuromediator pathway in integration and modulation of pain. Several studies suggest the existence of various influences with dopamine implication in the appearance of painful sensation and that would be inhibitory. That's why observed painful symptoms in MSA and PD could be due to a decrease of pain appearance threshold, secondary to a lost of control of sensitizes centres, to Parkinson control. It is interesting to determine if MSA as PD is responsible for a decrease of pain threshold and to characterise the levodopa effect on the patient's pain threshold. Better physiopathology knowledge of pain in MSA is necessary to improve the therapeutic care. Because the efficacy of others treatments is low, it's important to improve the research for a better comfort of patients with a better understanding, analysing and treating of the pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Threshold, Multiple System Atrophy
Keywords
subjective pain, Multiple System Atrophy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: MSA disease
Arm Type
Experimental
Arm Description
determination of objective and subjective pain threshold before and after levodopa intake
Arm Title
Group 2: Parkinson disease
Arm Type
Experimental
Arm Description
determination of objective and subjective pain threshold before and after levodopa intake
Arm Title
Group 3: healthy volunteers.
Arm Type
Other
Arm Description
one determination of objective and subjective pain threshold without treatment
Intervention Type
Drug
Intervention Name(s)
Levodopa test
Intervention Description
Each patients with PD and MSA will be evaluated in two conditions : OFF (without dopaminergic treatment since 12h) and ON condition (after a L-DOPA dose. This dose will be 150% of the DOPA morning dose. The healthy volunteers will be evaluated in only one condition (without L-DOPA administration)
Intervention Type
Procedure
Intervention Name(s)
determination of objective and subjective pain threshold
Intervention Description
Test without levodopa intake
Primary Outcome Measure Information:
Title
Subjective pain threshold
Description
Subjective pain threshold determined using thermal stimulation (Thermotest) with the method of levels, before and after levodopa intake for MSA patients and PD patients and once for healthy volunteers
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Objective nociceptive pain threshold
Description
Objective nociceptive pain threshold thanks to reflex of flexion (reflex RIII)before and after levodopa intake for MSA patients and PD patients and once for healthy volunteers
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients from 50 to 80 years old (Male and female) Patients suffering of a diagnosis possible or probable MSA-P with the international criteria (2008). Patients with clinical diagnosis of Parkinson's disease according to the criteria of the UKPDSBB (Gibb et Lees, 1988; Hughes et al, 1992) Patients with no cognitive troubles Patients who give their informed and signed consent. Patients affiliated to a social protection program Exclusion Criteria: Patient suffering from an other parkinson syndrome than MSA and PD, by example progressive supranuclear palsy, corticobasal degeneration… Patient suffering of a diagnosis possible or probable MSA-C with the international criteria Patient suffering from another pathology causing chronic pain (rheumatic disease, traumatic or orthopedic pathologies…) Patient under tutelage, curatella or law protection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Brefel-Courbon, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, neurology
City
Toulouse
Country
France

12. IPD Sharing Statement

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Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System Atrophy

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