Ignite Creation Date:
2024-05-06 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03648671
Status:
UNKNOWN
Last Update Posted:
2018-08-27
First Post:
2018-06-26
Brief Title:
Pain in Parkinsons Disease With Motor Fluctuations
Sponsor:
Universita di Verona
Organization:
Universita di Verona
Study Overview
Official Title:
Spontaneous and Evoked Pain in Parkinsons Disease With Motor Fluctuations an Observational Prospective Clinical and Neurophysiological Study in Patients Under L-dopa Add on Therapies
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAINinPD
Brief Summary:
Pain spontaneous pain is a fundamental non-motor symptom NMS of Parkinsons 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 andor 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 Parkinsons 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 patients 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 N2P2 component Acute levodopa challenge had no effect in normalizing the decreased pain thresholdLEPs observed in PD patients in early Parkinsons 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 25This study has been conceived to study spontaneous pain andor evoked pain by laser stimulation in PD patients with or without pain with motor fluctuations under drugs-on Safinamide Metansolfonato or Rasagilina Mesilato
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 N2P2 component Acute levodopa challenge had no effect in normalizing the decreased pain thresholdLEPs observed in PD patients in early Parkinsons 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 25This study has been conceived to study spontaneous pain andor evoked pain by laser stimulation in PD patients with or without pain with motor fluctuations under drugs-on Safinamide Metansolfonato or Rasagilina Mesilato
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None