Impact of Subthalamic Nucleus Deep Brain Stimulation on Pain in Parkinson Disease

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: Laser-Evoked potential

• Registration Number: NCT02885194
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Pain is a common symptom of Parkinson's disease (PD) but the physiology remains poorly understood. Recent work suggests that subthalamic nucleus deep brain stimulation (STN-DBS) could make a profit on the pain in PD.

The investigator would drive a study with a follow up of PD patients before and after STN-DBS. The pain will be clinically explored by targeted questionnaires and electrophysiological through laser evoked potentials.

The questionnaires are designed to quantify and characterize the pain in these patients. Laser evoked potentials will, through repetitive stimulation, study both the functional status of the afferent nociceptive pathways, their habituation to repetitive nociceptive stimuli, and so better understand any abnormalities of the central processing of nociceptive information.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-08-26
• Study First Posted: 2016-08-31
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• A patient with idiopathic Parkinson's disease
• Age between 30 and 70 inclusive.
• No cognitive decline (MMS greater than or equal to 24)
• Normal brain MRI
• Informed consent signed
• With or without pain sensation

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Exclusion Criteria

• Presence of other neurological pathology that could explain the pain.
• MMS less than 24
• Pregnant or breastfeeding women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients who underwent Deep Brain Stimulation (DBS)	Laser-Evoked potential	Patients who underwent Subthalamic Nucleus (STN)-DBS at Lyon

Primary Outcome Measures

Name	Time	Method
Modification of habituation in percentage, between tests performed before and after DBS	After the second laser evoked potential which occurred around 3 months after STN-DBS	The habituation is the change of amplitude between the first and the second response of the double stimulation during the laser evoked potential. We calculated a percentage

Secondary Outcome Measures

Name	Time	Method
Change in latency of laser evoked potential responses before and after DBS	After the second laser evoked potential which occurred around 3 months after STN-DBS	latency is calculated in millisecond
Change in amplitude of laser evoked potential responses before and after DBS	After the second laser evoked potential which occurred around 3 months after STN-DBS	amplitude is calculated in microvolts

Trial Locations

Locations (1)

Service de Neurologie C, Hôpital Neurologique, HCL; 🇫🇷 Bron, France