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

This study is currently recruiting participants.
Verified April 2013 by University Hospital, Toulouse
Sponsor:
Collaborator:
Fondation de France
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01577992
First received: November 7, 2011
Last updated: April 30, 2013
Last verified: April 2013
History of Changes

November 7, 2011
April 30, 2013
December 2011
June 2013   (final data collection date for primary outcome measure)
Subjective pain threshold [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01577992 on ClinicalTrials.gov Archive Site
Objective nociceptive pain threshold [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]
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
Same as current
Not Provided
Not Provided
 
Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System Atrophy
Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System Atrophy

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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Pain Threshold
  • Multiple System Atrophy
  • Drug: Levodopa test
    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)
  • Procedure: determination of objective and subjective pain threshold
    Test without levodopa intake
  • Experimental: Group 1: MSA disease
    determination of objective and subjective pain threshold before and after levodopa intake
    Intervention: Drug: Levodopa test
  • Experimental: Group 2: Parkinson disease
    determination of objective and subjective pain threshold before and after levodopa intake
    Intervention: Drug: Levodopa test
  • Group 3: healthy volunteers.
    one determination of objective and subjective pain threshold without treatment
    Intervention: Procedure: determination of objective and subjective pain threshold
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
June 2014
June 2013   (final data collection date for primary outcome measure)

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
Both
50 Years to 80 Years
Yes
Contact: Christine Brefel-Courbon, MD (0)5 61 14 59 62 ext 33 christine.brefel-courbon@univ-tlse3.fr
Contact: Claire Thalamas, MD (0)5 61 77 91 03 ext 33 thalamas@toulouse.inserm.fr
France
 
NCT01577992
0931403, HAO 2009
No
University Hospital, Toulouse
University Hospital, Toulouse
Fondation de France
Principal Investigator: Christine Brefel-Courbon, MD University Hospital, Toulouse
University Hospital, Toulouse
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP