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

NCT ID: NCT01577992

Last Updated: 2013-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-11-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group 1: MSA disease

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

Group Type: EXPERIMENTAL

Levodopa test

Intervention Type: 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 2: Parkinson disease

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

Group Type: EXPERIMENTAL

Levodopa test

Intervention Type: 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 3: healthy volunteers.

one determination of objective and subjective pain threshold without treatment

Group Type: OTHER

determination of objective and subjective pain threshold

Intervention Type: PROCEDURE

Test without levodopa intake

Interventions

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)

Intervention Type: DRUG

determination of objective and subjective pain threshold

Test without levodopa intake

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondation de France

OTHER

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Brefel-Courbon, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital, neurology

Toulouse, , France

Countries

France

Other Identifiers

HAO 2009

Identifier Type: OTHER

Identifier Source: secondary_id

0931403

Identifier Type: -

Identifier Source: org_study_id