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NCT Number: NCT02885194

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

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.

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Key information

Conditions

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

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Neurologie C, Hôpital Neurologique, HCL

Bron, 69500, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 31, 2016
Registry last updated
Oct 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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