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

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.

Study Overview

• Status: Completed
• Conditions: Multiple System Atrophy; Pain Threshold
• Intervention / Treatment: Drug: Levodopa test; Procedure: determination of objective and subjective pain threshold

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • University Hospital, neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	15 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Fondation de France
• Investigators: Principal Investigator: Christine Brefel-Courbon, MD, University Hospital, Toulouse

Publications and helpful links

General Publications

• Ory-Magne F, Pellaprat J, Harroch E, Galitzsky M, Rousseau V, Pavy-Le Traon A, Rascol O, Gerdelat A, Brefel-Courbon C. Abnormal pain perception in patients with Multiple System Atrophy. Parkinsonism Relat Disord. 2018 Mar;48:28-33. doi: 10.1016/j.parkreldis.2017.12.001. Epub 2017 Dec 8.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2011
• Primary Completion (Actual): June 30, 2013
• Study Completion (Actual): November 30, 2013

Study Registration Dates

• First Submitted: November 7, 2011
• First Submitted That Met QC Criteria: April 12, 2012
• First Posted (Estimated): April 16, 2012

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Multiple System Atrophy; subjective pain
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Basal Ganglia Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Multiple System Atrophy; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Levodopa
• Other Study ID Numbers: 0931403; HAO 2009 (Other Identifier: CHU de Toulouse)