Pain ThresholdMSA-DOULNCT01577992
Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System Atrophy
A study testing Levodopa test and determination of objective and subjective pain threshold in people with Pain Threshold and Multiple System Atrophy, run by University Hospital, Toulouse at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Threshold, Multiple System Atrophy
- What is being tested?
- Levodopa test and determination of objective and subjective pain threshold
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2011to 30 Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Levodopa test, determination of objective and subjective pain threshold
- Keywords
- subjective pain, Multiple System Atrophy
- Medical subject headings
- Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levodopa testDrug
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)
determination of objective and subjective pain thresholdProcedure or surgery
Test without levodopa intake
| Study group | Role | What they receive |
|---|---|---|
| Group 1: MSA disease | Experimental | determination of objective and subjective pain threshold before and after levodopa intake Receives: Drug: Levodopa test |
| Group 2: Parkinson disease | Experimental | determination of objective and subjective pain threshold before and after levodopa intake Receives: Drug: Levodopa test |
| Group 3: healthy volunteers. | Other | one determination of objective and subjective pain threshold without treatment Receives: Procedure: determination of objective and subjective pain threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 minutes
Secondary outcomes (1)
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
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study start1 Dec 2011
- Primary completion30 Jun 2013
- Study completion30 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ThresholdStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France
- Responsible party
- Sponsor
- Investigators
- Christine Brefel-Courbon, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577992
- Sponsor's protocol ID
- 0931403
- Other IDs
- HAO 2009
- Acronym
- MSA-DOUL
- Status last verified
- Apr 2026
- First submitted
- 7 Nov 2011
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29254664
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System Atrophy
- ClinicalTrials.gov ID
- NCT01577992
- Acronym / sponsor ID
- MSA-DOUL / 0931403
- Conditions
- Pain Threshold, Multiple System Atrophy
- Keywords
- subjective pain, Multiple System Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Fondation de France
- Study start
- 1 Dec 2011 (actual)
- Primary completion
- 30 Jun 2013 (actual)
- Study completion
- 30 Nov 2013 (actual)
- First posted
- 16 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: MSA disease | Experimental | Drug: Levodopa testdetermination of objective and subjective pain threshold before and after levodopa intake |
| Group 2: Parkinson disease | Experimental | Drug: Levodopa testdetermination of objective and subjective pain threshold before and after levodopa intake |
| Group 3: healthy volunteers. | Other | Procedure: determination of objective and subjective pain thresholdone determination of objective and subjective pain threshold without treatment |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levodopa testEach 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) | Drug | Group 1: MSA disease, Group 2: Parkinson disease |
| determination of objective and subjective pain thresholdTest without levodopa intake | Procedure or surgery | Group 3: healthy volunteers. |
Primary outcome
Subjective pain threshold
Time frame: 60 minutes
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
1 secondary outcome
Objective nociceptive pain threshold
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Results publication: PubMed 29254664Ory-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Brefel-Courbon, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levodopa test and determination of objective and subjective pain threshold in people with Pain Threshold and Multiple System Atrophy, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective pain threshold (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01577992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.