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

NCT01577992 | Completed

• 2 other identifiers: 0931403HAO 2009
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Threshold; Multiple System Atrophy

Keywords

subjective pain; Multiple System Atrophy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Objective nociceptive pain threshold

  15 minutes

Study Arms (3)

Group 1: MSA disease

EXPERIMENTAL

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

Drug: Levodopa test

Group 2: Parkinson disease

EXPERIMENTAL

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

Drug: Levodopa test

Group 3: healthy volunteers.

OTHER

one determination of objective and subjective pain threshold without treatment

Procedure: determination of objective and subjective pain threshold

Interventions

Levodopa test DRUG

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 1: MSA disease; Group 2: Parkinson disease

determination of objective and subjective pain threshold PROCEDURE

Test without levodopa intake

Group 3: healthy volunteers.

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Fondation de France: collaborator

Study Sites (1)

University Hospital, neurology

Toulouse, France

Location

Related Publications (1)

• 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.

  PMID: 29254664 RESULT

MeSH Terms

Conditions

Multiple System Atrophy

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Christine Brefel-Courbon, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: April 16, 2012
• Study Start: December 1, 2011
• Primary Completion: June 30, 2013
• Study Completion: November 30, 2013
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

FR (1)