Deep Brain Stimulation and Parkinson's Disease

Parkinson Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02795663
• Other study ID #: PI2013_843_0016
• Status: Completed
• Phase: Early Phase 1
• Start date: September 1, 2014
• Est. completion date: December 2017

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• NIRS EEG HR recording
NIRS EEG HR recording

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)	under " on " and " off " stimulation during delay discounting task.	1 month
Secondary	Study of QUIP score (QUIP scale)		3 month
Secondary	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	1 month
Secondary	Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of STN-DBS stimulation		1 month
Secondary	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.	1 month
Secondary	Study of delayed discounting task (DDT) score		3 months