Parkinson DiseasePAINinPDNCT03648671
Pain in Parkinson's Disease With Motor Fluctuations.
An observational study of Parkinson Disease, run by Universita di Verona at 1 site in Italy.
Trial summary
Pain (spontaneous pain) is a fundamental non-motor symptom (NMS) of Parkinson's disease (PD) that is prevalent throughout the condition and often unrecognized and undertreated. The study of the scalp laser-evoked potentials (LEPs) (evoked pain) allows a non-invasive exploration of pain central pathways in humans. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- safinamide metansolfonato (12 weeks) and rasagilina mesilato (12 weeks)
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 28 Mar 2018to 30 Nov 2019
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males or females patients with mid-to-late PD aged 30 to 80 years with or without chronic pain symptoms (duration >3 months) and motor fluctuations while receiving L-dopa alone or with other dopaminergic treatments.
Who may be able to join
- PD patients with or without pain willing to participate in this study and able to sign the written informed consent
- To be included in the PD with pain group, the patient's intensity of pain must be moderate to severe over the last month, as reported by a numerical rating scores (NRS≥4) despite the optimal dopaminergic treatment
- No modification of dopaminergic drugs and analgesic therapy with FANS during the 28 days before starting the enrollment in this study.
- Diagnosis of idiopathic PD of ≥3 years duration
- Hoehn and Yahr stage I-III during OFF time
- Motor fluctuations (>1.5 hours' OFF time/day)
- Patients who would have been treated with add-on therapy irrespective to the present protocol
Who cannot join
- Patients under (or with previous assumptions) monoamine oxidase inhibitor therapy.
- Late-stage PD experiencing severe, disabling peak-dose or biphasic dyskinesia, or unpredictable or widely swinging symptom fluctuations
- "de novo" patients, patients in early stage or non-fluctuating patients
- Evidence of dementia (MMSE <24)
- Sign and symptoms suggestive of atypical parkinsonism
- Major psychiatric illnesses
Show all 10Show fewer
- Severe and progressive medical illnesses
- Concomitant diseases potentially causing acute or chronic pain (i.e., rheumatologic conditions, severe polyneuropathy, and spine injuries)
- Treatments with tri-tetracyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (SNRIs), opioids, neuroleptics, barbiturates and phenothiazines, pregabalin and gabapentin
- Any type of retinopathy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda ospedaliera universitaria integrata verona
Verona, 37126
Michele Tinazzi, MD, PhD, 0458027472, michele.tinazzi@univr.it
About this study
Official title: Spontaneous and Evoked Pain in Parkinson's Disease With Motor Fluctuations: an Observational, Prospective, Clinical and Neurophysiological Study in Patients Under L-dopa Add on Therapies.
Pain (spontaneous pain) is a fundamental non-motor symptom (NMS) of Parkinson's disease (PD) that is prevalent throughout the condition and often unrecognized and undertreated. The study of the scalp laser-evoked potentials (LEPs) (evoked pain) allows a non-invasive exploration of pain central pathways in humans. This technique proved useful in elucidating the physiopathology underlying different pain syndromes. This study has been conceived to study spontaneous pain (and/or evoked pain by laser stimulation) in PD patients (with or without pain) with motor fluctuations under drugs-on (Safinamide Metansolfonato or Rasagilina Mesilato).
Read the detailed description
Pain (spontaneous pain) is a fundamental non-motor symptom (NMS) of Parkinson's disease (PD) that is prevalent throughout the condition and often unrecognized and undertreated. Different types of pain have been described in association with PD including musculoskeletal, dystonic, central and neuropathic pain. Although musculoskeletal pain is the most commonly reported, a number of patients experience multiple types of pain which are more frequent and disabling in the intermediate phase of disease and which ultimately have a significant negative impact on the patient's quality of life. Despite its relevance, the pathophysiological mechanisms underlying pain in PD are yet to be fully understood. An abnormal nociceptive input processing in the central nervous system leading to hypersensitivity to evoked pain probably underlies all the different pain types experienced by PD patients and also intervene in pain-free PD patients. Additional factors including female gender, depression, disease duration, motor complications, postural abnormalities, medical conditions associated with painful symptoms (osteoporosis, rheumatic or degenerative joint disease,) probably contribute to the quality and distribution of spontaneous pain. Abnormalities in pain processing may be the consequence of decreased basal ganglia dopaminergic neurotransmission, as dopamine has been demonstrated to modulate pain perception in supraspinal regions involved in the pain pathways, including insula, anterior cingulate cortex, thalamus and periaqueductal grey. Furthermore, a neurodegeneration involving non-dopaminergic systems (such as g-aminobutyric acid, glutamate, noradrenaline, and serotonin) that modulate pain processing in other regions of the central nervous systems may also play a relevant role. The variegated pain dimension experienced by PD patients makes its therapeutic management a demanding challenge for clinicians.
The study of the scalp laser-evoked potentials (LEPs) (evoked pain) allows a non-invasive exploration of pain central pathways in humans. This technique proved useful in elucidating the physiopathology underlying different pain syndromes. Some data show that LEPs are altered in PD, in both pain-free PD patients and in PD patients with different kinds of pain, with amplitude reduction in N2/P2 component. Acute levodopa challenge had no effect in normalizing the decreased pain threshold/LEPs observed in PD patients in early Parkinson's disease while in PD patients with motor complications it partially increased pain threshold. This is consistent with the hypothesis that motor complications and pain may share common pathophysiological mechanisms which include not only dopaminergic but also non-dopaminergic systems dysfunction (25).This study has been conceived to study spontaneous pain (and/or evoked pain by laser stimulation) in PD patients (with or without pain) with motor fluctuations under drugs-on (Safinamide Metansolfonato or Rasagilina Mesilato).
- Conditions
- Parkinson Disease
- Being tested
- safinamide metansolfonato (12 weeks), rasagilina mesilato (12 weeks)
- Keywords
- Safinamide, Pain, Parkinson
- Medical subject headings
- Parkinson Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
safinamide metansolfonato (12 weeks)Drug
safinamide metansolfonato
safinamide metansolfonato (12 weeks)Drug
safinamide metansolfonato
rasagilina mesilato (12 weeks)Drug
rasagilina mesilato
rasagilina mesilato (12 weeks)Drug
rasagilina mesilato
| Study group | Role | What they receive |
|---|---|---|
| PD with PAIN | 12 patients will undergo add-on drugs therapy with safinamide metansolfonato. Receives: Drug: safinamide metansolfonato (12 weeks) | |
| PD without PAIN | 12 patients will undergo add-on drugs therapy with safinamide metansolfonato. Receives: Drug: safinamide metansolfonato (12 weeks) | |
| PD with PAIN rasagilina | 12 patients will undergo add-on drugs therapy with rasagilina mesilato. Receives: Drug: rasagilina mesilato (12 weeks) | |
| PD without PAIN rasagilina | 12 patients will undergo add-on drugs therapy with rasagilina mesilato. Receives: Drug: rasagilina mesilato (12 weeks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency (ms) of N1/P1 complex.
Laser-evoked potentials (LEPs) to explore the primary pain pathway will be assessed at each visit (V0 and V1). The technique of LEPs recording will be carried out as previously performed by our research group.
Measured: Change from baseline at 12 weeks
Latency (ms) of N2/P2 complex.
Laser-evoked potentials (LEPs) to explore the primary pain pathway will be assessed at each visit (V0 and V1). The technique of LEPs recording will be carried out as previously performed by our research group.
Measured: Change from baseline at 12 weeks
Amplitude (microvolt) of N1/P1 complex.
Laser-evoked potentials (LEPs) to explore the primary pain pathway will be assessed at each visit (V0 and V1). The technique of LEPs recording will be carried out as previously performed by our research group.
Measured: Change from baseline at 12 weeks
Amplitude (microvolt) of N2/P2 complex.
Laser-evoked potentials (LEPs) to explore the primary pain pathway will be assessed at each visit (V0 and V1). The technique of LEPs recording will be carried out as previously performed by our research group.
Measured: Change from baseline at 12 weeks
Secondary outcomes (25)
Body localization
The presence of pain (yes/no, dichotomous variable) in one or more body parts: head, upper limbs, lower limbs, shoulders, neck, trunk , lumbar back, pelvis, knees.
Measured: Change from baseline at 12 weeks
King's Pain Scale for Parkinson's Disease
(score)
Measured: Change from baseline at 12 weeks
Italian version of the brief pain inventory short form
(score)
Measured: Change from baseline at 12 weeks
Clinical global impression of change
(score)
Measured: Change from baseline at 12 weeks
The 39-Item Parkinson's Disease Questionnaire (PDQ-39)
(score)
Measured: Change from baseline at 12 weeks
Numeric Rating Scale (NRS)
(score)
Measured: Change from baseline at 12 weeks
Unified Parkinson's Disease Rating Scale
(score)
Measured: Change from baseline at 12 weeks
Total daily off time
Total daily off time will assessed by patient diaries reporting frequency and duration of the off periods (hours)
Measured: Change from baseline at 12 weeks
Off time following the first morning L-dopa dose
(hours)
Measured: Change from baseline at 12 weeks
Age
Age
Measured: One timepoint
Gender
(male/female)
Measured: One timepoint
Schooling
(years)
Measured: One timepoint
Job
type of job
Measured: One timepoint
Weight
(kg)
Measured: One timepoint
Disease duration
(years)
Measured: One timepoint
Age at PD onset
(years)
Measured: One timepoint
Laterality of PD symptom onset
(right, left, bilateral)
Measured: One timepoint
Most Affected Side
(right, left, bilateral)
Measured: One timepoint
Pain symptoms at PD onset
(yes, no)
Measured: One timepoint
Dominant phenotype
(Tremor, Bradikinetic/rigid, Mixed)
Measured: One timepoint
Modified H&Y
(score)
Measured: One timepoint
Pharmacologic therapy for PD
Pharmacologic therapy
Measured: One timepoint
Comorbilities
Comorbilities
Measured: One timepoint
Mini-Mental State Examination
(score)
Measured: One timepoint
Montreal Cognitive Assessment (MoCA)
(score)
Measured: One timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start28 Mar 2018
- Primary completion28 Mar 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona
- Responsible party
- Principal investigator, Michele Tinazzi, MD, PhD, Azienda Ospedaliera Universitaria Integrata Verona
- Investigators
- Michele Tinazzi, MD, PhD, Principal investigator, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648671
- Sponsor's protocol ID
- 1470CESC
- Acronym
- PAINinPD
- Status last verified
- Aug 2018
- First submitted
- 26 Jun 2018
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Defazio G, Berardelli A, Fabbrini G, Martino D, Fincati E, Fiaschi A, Moretto G, Abbruzzese G, Marchese R, Bonuccelli U, Del Dotto P, Barone P, De Vivo E, Albanese A, Antonini A, Canesi M, Lopiano L, Zibetti M, Nappi G, Martignoni E, Lamberti P, Tinazzi M. Pain as a nonmotor symptom of Parkinson disease: evidence from a case-control study. Arch Neurol. 2008 Sep;65(9):1191-4. doi: 10.1001/archneurol.2008.2.
PubMed 18779422Tinazzi M, Recchia S, Simonetto S, Tamburin S, Defazio G, Fiaschi A, Moretto G, Valeriani M. Muscular pain in Parkinson's disease and nociceptive processing assessed with CO2 laser-evoked potentials. Mov Disord. 2010 Jan 30;25(2):213-20. doi: 10.1002/mds.22932.
PubMed 20063386Tinazzi M, Recchia S, Simonetto S, Defazio G, Tamburin S, Moretto G, Fiaschi A, Miliucci R, Valeriani M. Hyperalgesia and laser evoked potentials alterations in hemiparkinson: evidence for an abnormal nociceptive processing. J Neurol Sci. 2009 Jan 15;276(1-2):153-8. doi: 10.1016/j.jns.2008.09.023. Epub 2008 Oct 26.
PubMed 18954878Tinazzi M, Del Vesco C, Defazio G, Fincati E, Smania N, Moretto G, Fiaschi A, Le Pera D, Valeriani M. Abnormal processing of the nociceptive input in Parkinson's disease: a study with CO2 laser evoked potentials. Pain. 2008 May;136(1-2):117-24. doi: 10.1016/j.pain.2007.06.022. Epub 2007 Aug 31.
PubMed 17765400Zambito-Marsala S, Erro R, Bacchin R, Fornasier A, Fabris F, Lo Cascio C, Ferracci F, Morgante F, Tinazzi M. Abnormal nociceptive processing occurs centrally and not peripherally in pain-free Parkinson disease patients: A study with laser-evoked potentials. Parkinsonism Relat Disord. 2017 Jan;34:43-48. doi: 10.1016/j.parkreldis.2016.10.019. Epub 2016 Oct 24.
PubMed 27836714
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spontaneous and Evoked Pain in Parkinson's Disease With Motor Fluctuations: an Observational, Prospective, Clinical and Neurophysiological Study in Patients Under L-dopa Add on Therapies.
- ClinicalTrials.gov ID
- NCT03648671
- Acronym / sponsor ID
- PAINinPD / 1470CESC
- Conditions
- Parkinson Disease
- Keywords
- Safinamide, Pain, Parkinson
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 28 Mar 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 27 Aug 2018 (actual)
- 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.
Pain (spontaneous pain) is a fundamental non-motor symptom (NMS) of Parkinson's disease (PD) that is prevalent throughout the condition and often unrecognized and undertreated. The study of the scalp laser-evoked potentials (LEPs) (evoked pain) allows a non-invasive exploration of pain central pathways in humans. This technique proved useful in elucidating the physiopathology underlying different pain syndromes. This study has been conceived to study spontaneous pain (and/or evoked pain by laser stimulation) in PD patients (with or without pain) with motor fluctuations under drugs-on (Safinamide Metansolfonato or Rasagilina Mesilato).
Detailed description
Pain (spontaneous pain) is a fundamental non-motor symptom (NMS) of Parkinson's disease (PD) that is prevalent throughout the condition and often unrecognized and undertreated. Different types of pain have been described in association with PD including musculoskeletal, dystonic, central and neuropathic pain. Although musculoskeletal pain is the most commonly reported, a number of patients experience multiple types of pain which are more frequent and disabling in the intermediate phase of disease and which ultimately have a significant negative impact on the patient's quality of life. Despite its relevance, the pathophysiological mechanisms underlying pain in PD are yet to be fully understood. An abnormal nociceptive input processing in the central nervous system leading to hypersensitivity to evoked pain probably underlies all the different pain types experienced by PD patients and also intervene in pain-free PD patients. Additional factors including female gender, depression, disease duration, motor complications, postural abnormalities, medical conditions associated with painful symptoms (osteoporosis, rheumatic or degenerative joint disease,) probably contribute to the quality and distribution of spontaneous pain. Abnormalities in pain processing may be the consequence of decreased basal ganglia dopaminergic neurotransmission, as dopamine has been demonstrated to modulate pain perception in supraspinal regions involved in the pain pathways, including insula, anterior cingulate cortex, thalamus and periaqueductal grey. Furthermore, a neurodegeneration involving non-dopaminergic systems (such as g-aminobutyric acid, glutamate, noradrenaline, and serotonin) that modulate pain processing in other regions of the central nervous systems may also play a relevant role. The variegated pain dimension experienced by PD patients makes its therapeutic management a demanding challenge for clinicians.
The study of the scalp laser-evoked potentials (LEPs) (evoked pain) allows a non-invasive exploration of pain central pathways in humans. This technique proved useful in elucidating the physiopathology underlying different pain syndromes. Some data show that LEPs are altered in PD, in both pain-free PD patients and in PD patients with different kinds of pain, with amplitude reduction in N2/P2 component. Acute levodopa challenge had no effect in normalizing the decreased pain threshold/LEPs observed in PD patients in early Parkinson's disease while in PD patients with motor complications it partially increased pain threshold. This is consistent with the hypothesis that motor complications and pain may share common pathophysiological mechanisms which include not only dopaminergic but also non-dopaminergic systems dysfunction (25).This study has been conceived to study spontaneous pain (and/or evoked pain by laser stimulation) in PD patients (with or without pain) with motor fluctuations under drugs-on (Safinamide Metansolfonato or Rasagilina Mesilato).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PD with PAIN | – | Drug: safinamide metansolfonato (12 weeks)12 patients will undergo add-on drugs therapy with safinamide metansolfonato. |
| PD without PAIN | – | Drug: safinamide metansolfonato (12 weeks)12 patients will undergo add-on drugs therapy with safinamide metansolfonato. |
| PD with PAIN rasagilina | – | Drug: rasagilina mesilato (12 weeks)12 patients will undergo add-on drugs therapy with rasagilina mesilato. |
| PD without PAIN rasagilina | – | Drug: rasagilina mesilato (12 weeks)12 patients will undergo add-on drugs therapy with rasagilina mesilato. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males or females patients with mid-to-late PD aged 30 to 80 years with or without chronic pain symptoms (duration >3 months) and motor fluctuations while receiving L-dopa alone or with other dopaminergic treatments.
Key inclusion criteria (7 listed)
- PD patients with or without pain willing to participate in this study and able to sign the written informed consent
- To be included in the PD with pain group, the patient's intensity of pain must be moderate to severe over the last month, as reported by a numerical rating scores (NRS≥4) despite the optimal dopaminergic treatment
- No modification of dopaminergic drugs and analgesic therapy with FANS during the 28 days before starting the enrollment in this study.
- Diagnosis of idiopathic PD of ≥3 years duration
- Hoehn and Yahr stage I-III during OFF time
Key exclusion criteria (10 listed)
- Patients under (or with previous assumptions) monoamine oxidase inhibitor therapy.
- Late-stage PD experiencing severe, disabling peak-dose or biphasic dyskinesia, or unpredictable or widely swinging symptom fluctuations
- "de novo" patients, patients in early stage or non-fluctuating patients
- Evidence of dementia (MMSE <24)
- Sign and symptoms suggestive of atypical parkinsonism
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 |
|---|---|---|
| safinamide metansolfonato (12 weeks)safinamide metansolfonato | Drug | PD with PAIN |
| safinamide metansolfonato (12 weeks)safinamide metansolfonato | Drug | PD without PAIN |
| rasagilina mesilato (12 weeks)rasagilina mesilato | Drug | PD with PAIN rasagilina |
| rasagilina mesilato (12 weeks)rasagilina mesilato | Drug | PD without PAIN rasagilina |
Primary outcome
Latency (ms) of N1/P1 complex.
Time frame: Change from baseline at 12 weeks
Laser-evoked potentials (LEPs) to explore the primary pain pathway will be assessed at each visit (V0 and V1). The technique of LEPs recording will be carried out as previously performed by our research group.
Latency (ms) of N2/P2 complex.
Time frame: Change from baseline at 12 weeks
Laser-evoked potentials (LEPs) to explore the primary pain pathway will be assessed at each visit (V0 and V1). The technique of LEPs recording will be carried out as previously performed by our research group.
Amplitude (microvolt) of N1/P1 complex.
Time frame: Change from baseline at 12 weeks
Laser-evoked potentials (LEPs) to explore the primary pain pathway will be assessed at each visit (V0 and V1). The technique of LEPs recording will be carried out as previously performed by our research group.
Amplitude (microvolt) of N2/P2 complex.
Time frame: Change from baseline at 12 weeks
Laser-evoked potentials (LEPs) to explore the primary pain pathway will be assessed at each visit (V0 and V1). The technique of LEPs recording will be carried out as previously performed by our research group.
25 secondary outcomes
Body localization
Time frame: Change from baseline at 12 weeks
King's Pain Scale for Parkinson's Disease
Time frame: Change from baseline at 12 weeks
Italian version of the brief pain inventory short form
Time frame: Change from baseline at 12 weeks
Clinical global impression of change
Time frame: Change from baseline at 12 weeks
The 39-Item Parkinson's Disease Questionnaire (PDQ-39)
Time frame: Change from baseline at 12 weeks
Numeric Rating Scale (NRS)
Time frame: Change from baseline at 12 weeks
Unified Parkinson's Disease Rating Scale
Time frame: Change from baseline at 12 weeks
Total daily off time
Time frame: Change from baseline at 12 weeks
Off time following the first morning L-dopa dose
Time frame: Change from baseline at 12 weeks
Age
Time frame: One timepoint
Gender
Time frame: One timepoint
Schooling
Time frame: One timepoint
Job
Time frame: One timepoint
Weight
Time frame: One timepoint
Disease duration
Time frame: One timepoint
Age at PD onset
Time frame: One timepoint
Laterality of PD symptom onset
Time frame: One timepoint
Most Affected Side
Time frame: One timepoint
Pain symptoms at PD onset
Time frame: One timepoint
Dominant phenotype
Time frame: One timepoint
Modified H&Y
Time frame: One timepoint
Pharmacologic therapy for PD
Time frame: One timepoint
Comorbilities
Time frame: One timepoint
Mini-Mental State Examination
Time frame: One timepoint
Montreal Cognitive Assessment (MoCA)
Time frame: One timepoint
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Background: PubMed 18779422Defazio G, Berardelli A, Fabbrini G, Martino D, Fincati E, Fiaschi A, Moretto G, Abbruzzese G, Marchese R, Bonuccelli U, Del Dotto P, Barone P, De Vivo E, Albanese A, Antonini A, Canesi M, Lopiano L, Zibetti M, Nappi G, Martignoni E, Lamberti P, Tinazzi M. Pain as a nonmotor symptom of Parkinson disease: evidence from a case-control study. Arch Neurol. 2008 Sep;65(9):1191-4. doi: 10.1001/archneurol.2008.2.
- Background: PubMed 20063386Tinazzi M, Recchia S, Simonetto S, Tamburin S, Defazio G, Fiaschi A, Moretto G, Valeriani M. Muscular pain in Parkinson's disease and nociceptive processing assessed with CO2 laser-evoked potentials. Mov Disord. 2010 Jan 30;25(2):213-20. doi: 10.1002/mds.22932.
- Background: PubMed 18954878Tinazzi M, Recchia S, Simonetto S, Defazio G, Tamburin S, Moretto G, Fiaschi A, Miliucci R, Valeriani M. Hyperalgesia and laser evoked potentials alterations in hemiparkinson: evidence for an abnormal nociceptive processing. J Neurol Sci. 2009 Jan 15;276(1-2):153-8. doi: 10.1016/j.jns.2008.09.023. Epub 2008 Oct 26.
- Background: PubMed 17765400Tinazzi M, Del Vesco C, Defazio G, Fincati E, Smania N, Moretto G, Fiaschi A, Le Pera D, Valeriani M. Abnormal processing of the nociceptive input in Parkinson's disease: a study with CO2 laser evoked potentials. Pain. 2008 May;136(1-2):117-24. doi: 10.1016/j.pain.2007.06.022. Epub 2007 Aug 31.
- Background: PubMed 27836714Zambito-Marsala S, Erro R, Bacchin R, Fornasier A, Fabris F, Lo Cascio C, Ferracci F, Morgante F, Tinazzi M. Abnormal nociceptive processing occurs centrally and not peripherally in pain-free Parkinson disease patients: A study with laser-evoked potentials. Parkinsonism Relat Disord. 2017 Jan;34:43-48. doi: 10.1016/j.parkreldis.2016.10.019. Epub 2016 Oct 24.
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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.
Michele Tinazzi, MD, PhD principal investigator
Azienda Ospedaliera Universitaria Integrata Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Universita di Verona at 1 site in Italy.
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 27 Aug 2018. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michele Tinazzi, MD, PhD (0458027472 ext. +39, michele.tinazzi@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency (ms) of N1/P1 complex. (time frame: Change from baseline at 12 weeks). The study lists 4 primary outcomes in all. 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 NCT03648671, which also lists 5 linked publications.
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 27 Aug 2018.