CompletedEarly Phase 1

Deep Brain Stimulation and Parkinson's Disease

France15 participantsStarted 2014-09-01

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 month,

Trial details

NCT IDNCT02795663

SponsorCentre Hospitalier Universitaire, Amiens

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12

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