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NCT Number: NCT02795663

Deep Brain Stimulation and Parkinson's Disease

* Background : Deep brain stimulation of SubThalamic Nucleus (STN-DBS) is an effective treatment for a large variety of movement disorders. However, the efficacy of STN-DBS relies on unclear mechanisms. * Purpose: In this study, using optical imaging, the investigators will evaluate the cortical hemodynamic changes induced by STN-DBS of parkinsonian patients during motor task and delay discounting task. the investigators will perform an optical imaging study using Near-InfraRed Spectroscopy (NIRS) in a parkinsonian patient after STN-DBS. The investigators will measure bilateral local cortical hemodynamic changes under "On" and "Off" stimulation conditions and during a motor task (left hand movement) and delay discounting task Relative concentration changes of oxy-Hb, deoxy-Hb, and total Hb will be continuously analyze. * Primary outcome: Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb) under " on " and " off " stimulation during a motor task.

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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 Parkinsonian Disorders Synucleinopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

CHU Amiens

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients presenting Parkinson disease and treated by STN-DBS.
  • For comparison patients: Patients treated by DBS in other target.

Exclusion criteria

  • Patients who cannot be treated by DBS

Treatment and study plan

NIRS EEG HR recording

Device

NIRS EEG HR recording

Primary outcomes

  1. Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)

    Time frame: 1 month,

    under " on " and " off " stimulation during a motor task.

Secondary outcomes

  1. Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)

    Time frame: 1 month

    under " on " and " off " stimulation during delay discounting task.

  2. Study of QUIP score (QUIP scale)

    Time frame: 3 month

  3. Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with the localisation of the contact use for STN-DBS stimulation

    Time frame: 1 month

    between patient with ICD and patient without ICD

  4. Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of STN-DBS stimulation

    Time frame: 1 month

  5. Study of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of NonSTN-DBS stimulation

    Time frame: 1 month

    under " on " and " off " stimulation during a motor task and a delay discounting task (in order to obtain a qualitative comparison between GPi-DBS and STN-DBS.

  6. Study of delayed discounting task (DDT) score

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

Deep Brain Stimulation and Parkinson's Disease: Analysis of the Modifications of the Cortical Activation During Driving Tasks and During Tasks Involving the Control of the Impulses by Means of the Optical Imaging and of the Technique of Delay Discounting Task

Acronym: SCP TCI NIRS

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 10, 2016
Registry last updated
Sep 19, 2025

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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