NCT02795663

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at P25-P50 for early_phase_1 parkinson-disease

Timeline
Completed

Started Sep 2014

Typical duration for early_phase_1 parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

3.3 years

First QC Date

May 26, 2016

Last Update Submit

September 16, 2025

Conditions

Parkinson Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

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

    1 month,

Secondary Outcomes (6)

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

    1 month

  • 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 stimulation

    1 month

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

    1 month

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

    1 month

  • +1 more secondary outcomes

Study Arms (3)

parkinson's patient stimulated at STN level

EXPERIMENTAL

15 parkinson's disease patients stimulated at STN level NIRS EEG HR recording

Device: NIRS EEG HR recording

non STN

EXPERIMENTAL

5 Parkinson's Disease patients who received stimulation in another target that the STN NIRS EEG HR recording

Device: NIRS EEG HR recording

control

EXPERIMENTAL

20 control patients undergoing DBS for the treatment of OCD NIRS EEG HR recording

Device: NIRS EEG HR recording

Interventions

NIRS EEG HR recordingDEVICE

NIRS EEG HR recording

controlnon STNparkinson's patient stimulated at STN level

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients who cannot be treated by DBS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

Related Publications (1)

  • 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.

    PMID: 33493171RESULT

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Michel LEFRANC, MD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2016

First Posted

June 10, 2016

Study Start

September 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations

FR(1)