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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02885194
Enrollment
26
Registered
2016-08-31
Start date
2015-01-31
Completion date
2016-05-31
Last updated
2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

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

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.

Interventions

OTHERLaser-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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Modification of habituation in percentage, between tests performed before and after DBSAfter the second laser evoked potential which occurred around 3 months after STN-DBSThe 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

MeasureTime frameDescription
Change in latency of laser evoked potential responses before and after DBSAfter the second laser evoked potential which occurred around 3 months after STN-DBSlatency is calculated in millisecond
Change in amplitude of laser evoked potential responses before and after DBSAfter the second laser evoked potential which occurred around 3 months after STN-DBSamplitude is calculated in microvolts

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026