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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02885194
• Other study ID #: 2014.866
• Status: Completed
• Phase: N/A
• First received: August 26, 2016
• Last updated: October 12, 2016
• Start date: January 2015
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
France	Service de Neurologie C, Hôpital Neurologique, HCL	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in latency of laser evoked potential responses before and after DBS	latency is calculated in millisecond	After the second laser evoked potential which occurred around 3 months after STN-DBS	No
Secondary	Change in amplitude of laser evoked potential responses before and after DBS	amplitude is calculated in microvolts	After the second laser evoked potential which occurred around 3 months after STN-DBS	No