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Deep Brain Stimulation and Parkinson's Disease

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02795663
Acronym
SCP TCI NIRS
Enrollment
15
Registered
2016-06-10
Start date
2014-09-01
Completion date
2017-12-31
Last updated
2025-09-19

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

Conditions

Parkinson Disease

Keywords

Near-InfraRed Spectroscopy (NIRS), Deep brain stimulation of SubThalamic Nucleus (DBS)

Brief summary

* 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.

Interventions

DEVICENIRS EEG HR recording

NIRS EEG HR recording

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)1 month,under on and off stimulation during a motor task.

Secondary

MeasureTime frameDescription
Study of QUIP score (QUIP scale)3 month
Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with the localisation of the contact use for STN-DBS stimulation1 monthbetween patient with ICD and patient without ICD
Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)1 monthunder on and off stimulation during delay discounting task.
Study of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of NonSTN-DBS stimulation1 monthunder 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.
Study of delayed discounting task (DDT) score3 months
Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of STN-DBS stimulation1 month

Countries

France

Outcome results

None listed

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