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

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ClinicalTrials.gov Identifier: NCT01577992
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : November 11, 2013
Sponsor:
Collaborator:
Fondation de France
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE November 7, 2011
First Posted Date  ICMJE April 16, 2012
Last Update Posted Date November 11, 2013
Study Start Date  ICMJE December 2011
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2012)
Subjective pain threshold [ Time Frame: 60 minutes ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01577992 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2012)
Objective nociceptive pain threshold [ Time Frame: 15 minutes ]
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System Atrophy
Official Title  ICMJE Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System Atrophy
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Pain Threshold
  • Multiple System Atrophy
Intervention  ICMJE
  • 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
Study Arms
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2012)
42
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date November 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01577992
Other Study ID Numbers  ICMJE 0931403
HAO 2009 ( Other Identifier: CHU de Toulouse )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Fondation de France
Investigators  ICMJE
Principal Investigator: Christine Brefel-Courbon, MD University Hospital, Toulouse
PRS Account University Hospital, Toulouse
Verification Date November 2013

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