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

This study has been completed.
Sponsor:
Collaborator:
Fondation de France
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01577992
First received: November 7, 2011
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Pain Threshold
Multiple System Atrophy
Drug: Levodopa test
Procedure: determination of objective and subjective pain threshold

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System Atrophy

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 42
Study Start Date: December 2011
Study Completion Date: November 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: MSA disease
determination of objective and subjective pain threshold before and after levodopa intake
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)
Experimental: Group 2: Parkinson disease
determination of objective and subjective pain threshold before and after levodopa intake
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)
Group 3: healthy volunteers.
one determination of objective and subjective pain threshold without treatment
Procedure: determination of objective and subjective pain threshold
Test without levodopa intake

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01577992

Locations
France
University Hospital, neurology
Toulouse, France
Sponsors and Collaborators
University Hospital, Toulouse
Fondation de France
Investigators
Principal Investigator: Christine Brefel-Courbon, MD University Hospital, Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01577992     History of Changes
Other Study ID Numbers: 0931403, HAO 2009
Study First Received: November 7, 2011
Last Updated: November 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
subjective pain
Multiple System Atrophy

Additional relevant MeSH terms:
Atrophy
Multiple System Atrophy
Shy-Drager Syndrome
Autonomic Nervous System Diseases
Nervous System Diseases
Central Nervous System Diseases
Central Nervous System Agents
Pathological Conditions, Anatomical
Primary Dysautonomias
Basal Ganglia Diseases
Brain Diseases
Movement Disorders
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014