search
Back to results

Deep Brain Stimulation and Parkinson's Disease (SCP TCI NIRS)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Early Phase 1
Locations
France
Study Type
Interventional
Intervention
NIRS EEG HR recording
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson Disease focused on measuring Near-InfraRed Spectroscopy (NIRS), Deep brain stimulation of SubThalamic Nucleus (DBS)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

parkinson's patient stimulated at STN level

non STN

control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)
under " on " and " off " stimulation during delay discounting task.
Study of QUIP score (QUIP scale)
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
Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of STN-DBS stimulation
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.
Study of delayed discounting task (DDT) score

Full Information

First Posted
May 26, 2016
Last Updated
August 9, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
search

1. Study Identification

Unique Protocol Identification Number
NCT02795663
Brief Title
Deep Brain Stimulation and Parkinson's Disease
Acronym
SCP TCI NIRS
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2014 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Near-InfraRed Spectroscopy (NIRS), Deep brain stimulation of SubThalamic Nucleus (DBS)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
parkinson's patient stimulated at STN level
Arm Type
Experimental
Arm Description
15 parkinson's disease patients stimulated at STN level NIRS EEG HR recording
Arm Title
non STN
Arm Type
Experimental
Arm Description
5 Parkinson's Disease patients who received stimulation in another target that the STN NIRS EEG HR recording
Arm Title
control
Arm Type
Experimental
Arm Description
20 control patients undergoing DBS for the treatment of OCD NIRS EEG HR recording
Intervention Type
Device
Intervention Name(s)
NIRS EEG HR recording
Intervention Description
NIRS EEG HR recording
Primary Outcome Measure Information:
Title
Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)
Description
under " on " and " off " stimulation during a motor task.
Time Frame
1 month,
Secondary Outcome Measure Information:
Title
Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)
Description
under " on " and " off " stimulation during delay discounting task.
Time Frame
1 month
Title
Study of QUIP score (QUIP scale)
Time Frame
3 month
Title
Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with the localisation of the contact use for STN-DBS stimulation
Description
between patient with ICD and patient without ICD
Time Frame
1 month
Title
Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of STN-DBS stimulation
Time Frame
1 month
Title
Study of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of NonSTN-DBS stimulation
Description
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
Title
Study of delayed discounting task (DDT) score
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel LEFRANC, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

Learn more about this trial

Deep Brain Stimulation and Parkinson's Disease

We'll reach out to this number within 24 hrs