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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Laser-Evoked potential
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease focused on measuring Parkinson Disease, Pain, Deep Brain Stimulation, Laser-Evoked Potentials

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Exclusion Criteria:

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

Sites / Locations

  • Service de Neurologie C, Hôpital Neurologique, HCL

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients who underwent Deep Brain Stimulation (DBS)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in latency of laser evoked potential responses before and after DBS
latency is calculated in millisecond
Change in amplitude of laser evoked potential responses before and after DBS
amplitude is calculated in microvolts

Full Information

First Posted
August 26, 2016
Last Updated
October 12, 2016
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02885194
Brief Title
Impact of Subthalamic Nucleus Deep Brain Stimulation on Pain in Parkinson Disease
Official Title
Impact of Subthalamic Nucleus Deep Brain Stimulation on Pain in Parkinson Disease : Clinical and Neurophysiological Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Pain, Deep Brain Stimulation, Laser-Evoked Potentials

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients who underwent Deep Brain Stimulation (DBS)
Arm Type
Other
Arm Description
Patients who underwent Subthalamic Nucleus (STN)-DBS at Lyon
Intervention Type
Other
Intervention Name(s)
Laser-Evoked potential
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modification of habituation in percentage, between tests performed before and after DBS
Description
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
Time Frame
After the second laser evoked potential which occurred around 3 months after STN-DBS
Secondary Outcome Measure Information:
Title
Change in latency of laser evoked potential responses before and after DBS
Description
latency is calculated in millisecond
Time Frame
After the second laser evoked potential which occurred around 3 months after STN-DBS
Title
Change in amplitude of laser evoked potential responses before and after DBS
Description
amplitude is calculated in microvolts
Time Frame
After the second laser evoked potential which occurred around 3 months after STN-DBS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 Exclusion Criteria: Presence of other neurological pathology that could explain the pain. MMS less than 24 Pregnant or breastfeeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane THOBOIS, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Neurologie C, Hôpital Neurologique, HCL
City
Bron
ZIP/Postal Code
69500
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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