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

Multiple System Atrophy Clinical Trial

— MSA-DOUL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577992
• Other study ID #: 0931403
• Secondary ID: HAO 2009
• Status: Completed
• Phase: N/A
• First received: November 7, 2011
• Last updated: November 8, 2013
• Start date: December 2011
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Atrophy
• Multiple System Atrophy
• Pain Threshold
• Shy-Drager Syndrome

Intervention

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

Locations

Country	Name	City	State
France	University Hospital, neurology	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Fondation de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes