TerminatedNot Applicable

Motor Control During Rapid Eye Movement (REM) Sleep Behaviour Disorder

Stopped: Recruitment

France3 participantsStarted 2013-06

Plain-language summary

To compare the electrical activity of SubThalamic Nuclei (STN), by mean of local field potentials recordings, during the phasic behaviours of RBD with the electrical activity recorded at this level during the execution of voluntary movements during the "off" and the "on" phases in patients with RBD secondary to PD.

Who can participate

Age range

35 Years – 70 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: * Men and women, 35 to 70 years old, with idiopathic PD (UKPDSBB criteria) with motor fluctuations * having RBD according to the International Classification of Sleep Disorders, 2nd edition (ICSD-2) criteria * Eligible to neurosurgical treatment of PD by implantation of intracranial electrodes for the DBS of STN * Giving a written informed consent * Affiliated to the French social security program Exclusion Criteria: * Atypical or secondary parkinsonian syndrome * Cognitive impairment which may compromise the understanding and patient's participation to the protocol (Mattis dementia rating scale score ≥ 136) * Patient under guardianship, trusteeship or judicial protection * Pregnancy or breastfeeding * Patient participating to another clinical research study in the same period

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

STN 8-30 Hz mean power

Timeframe: Outcome measure is assessed during the 2 nights and the two days following the implantation of the electrode in the STN.

Trial details

NCT IDNCT01886131

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06

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