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

C

Centre Hospitalier Universitaire, Amiens

Status and phase

Completed
Early Phase 1

Conditions

Parkinson Disease

Treatments

Device: NIRS EEG HR recording

Study type

Interventional

Funder types

Other

Identifiers

NCT02795663
PI2013_843_0016

Details and patient eligibility

About

  • 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.

Enrollment

15 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

15 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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