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

October 12, 2016 updated by: Hospices Civils de Lyon

Impact of Subthalamic Nucleus Deep Brain Stimulation on Pain in Parkinson Disease : Clinical and Neurophysiological Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Service de Neurologie C, Hôpital Neurologique, HCL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Patients who underwent Deep Brain Stimulation (DBS)
Patients who underwent Subthalamic Nucleus (STN)-DBS at Lyon
Other: Laser-Evoked potential
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modification of habituation in percentage, between tests performed before and after DBS
Time Frame: 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
After the second laser evoked potential which occurred around 3 months after STN-DBS

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

August 26, 2016

First Posted (ESTIMATE)

August 31, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014.866

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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