Deep Brain Stimulation and Parkinson's Disease

Early Phase 1

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT02795663
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-01
• Study First Submitted: 2016-05-26
• Study First Submitted QC: 2016-06-09
• Study First Posted: 2016-06-10
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)	1 month	under " on " and " off " stimulation during delay discounting task.
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	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	1 month
Study of QUIP score (QUIP scale)	3 month
Study of delayed discounting task (DDT) score	3 months
Study of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of NonSTN-DBS stimulation	1 month	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.

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France