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

NCT02885194 | Completed

• 1 other identifier: 2014.866
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Pain; Deep Brain Stimulation; Laser-Evoked Potentials

Outcome Measures

Primary Outcomes (1)

• Modification of habituation in percentage, between tests performed before and after 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

  After the second laser evoked potential which occurred around 3 months after STN-DBS

Secondary Outcomes (2)

• 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

• 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

Study Arms (1)

Patients who underwent Deep Brain Stimulation (DBS)

OTHER

Patients who underwent Subthalamic Nucleus (STN)-DBS at Lyon

Other: Laser-Evoked potential

Interventions

Laser-Evoked potential OTHER

Laser-Evoked potential can document lesions of spinothalamic tract and lateral brainstem and of thalamo-cortical projections conducting nociceptive signals. The rapid heating of skin by infrared laser pulses stimulate small fibers sensory pathways. The main cortical laser evoked potential is a complex of components N2-P2. Evaluation of the registered potentials includes shape, latency and amplitude.

Patients who underwent Deep Brain Stimulation (DBS)

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Neurologie C, Hôpital Neurologique, HCL

Bron, 69500, France

Location

MeSH Terms

Conditions

Parkinson Disease; Pain

Interventions

Laser-Evoked Potentials

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Evoked Potentials, Somatosensory; Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stéphane THOBOIS, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: August 31, 2016
• Study Start: January 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 13, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)