CompletedNCT02795663SCP TCI NIRSUpdated Sep 19, 2025

Deep Brain Stimulation and Parkinson's Disease

An Early Phase 1 interventional study of NIRS EEG HR recording in Parkinson Disease, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Centre Hospitalier Universitaire, Amiens · Early Phase 1, Interventional, and Diagnostic

From the registry’s dates

Registered 1 year 8 months after the study started (first participant enrolled Sep 2014, registered May 2016).

Phase: Early Phase 1
Study type: Interventional
Enrollment: 15
Allocation: Non-randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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.

Conditions studied

Parkinson Disease

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Parkinson Disease 4,487

Keywords

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

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 15 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts 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

Exclusion Criteria:

Patients who cannot be treated by DBS

Study design

Phase: Early Phase 1
Primary purpose: Diagnostic
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 15 participants (actual)

Study arms

Experimental
parkinson's patient stimulated at STN level
15 parkinson's disease patients stimulated at STN level NIRS EEG HR recording
Device: NIRS EEG HR recording
Experimental
non STN
5 Parkinson's Disease patients who received stimulation in another target that the STN NIRS EEG HR recording
Device: NIRS EEG HR recording
Experimental
control
20 control patients undergoing DBS for the treatment of OCD NIRS EEG HR recording
Device: NIRS EEG HR recording

Interventions

DeviceNIRS EEG HR recording
NIRS EEG HR recording

What researchers measure

Primary outcomes

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

Secondary outcomes

Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)
under " on " and " off " stimulation during delay discounting task.
Time frame: 1 month
Study of QUIP score (QUIP scale)
Time frame: 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 stimulation
between patient with ICD and patient without ICD
Time frame: 1 month
Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of STN-DBS stimulation
Time frame: 1 month
Study of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of NonSTN-DBS stimulation
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.
Time frame: 1 month
Study of delayed discounting task (DDT) score
Time frame: 3 months

Study locations

1 site

CHU Amiens
Amiens, 80054, France

References and documents

Publications

Mahmoudzadeh M, Wallois F, Tir M, Krystkowiak P, Lefranc M. Cortical hemodynamic mapping of subthalamic nucleus deep brain stimulation in Parkinsonian patients, using high-density functional near-infrared spectroscopy. PLoS One. 2021 Jan 25;16(1):e0245188. doi: 10.1371/journal.pone.0245188. eCollection 2021. PubMed 33493171 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02795663
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Responsible party: Sponsor
First posted: Jun 10, 2016
Start date: Sep 1, 2014
Primary completion: Dec 2017
Completion: Dec 2017
Last update: Sep 19, 2025

Study contacts

Michel LEFRANC, MD

principal investigator · CHU Amiens

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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