Parkinson DiseaseRevesParkNSTNCT01886131
Motor Control During Rapid Eye Movement (REM) Sleep Behaviour Disorder
A study testing Synchronised video-polysomnography in people with Parkinson Disease, run by University Hospital, Toulouse at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Synchronised video-polysomnography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital of Purpan
Toulouse, Midi-Pyrénées, 31059
University Hospital of Rangueil
Toulouse, Midi-Pyrénées, 31059
About this study
Official title: Subthalamic Nuclei (STN) Local Field Potentials to Investigate Motor Control During REM Sleep Behaviour Disorder (TCSP) Secondary to Idiopathic Parkinsons Disease (PD)
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.
Read the detailed description
Patient with severe Parkinson's disease (PD) with motor fluctuations are akinetic and bradykinetic during the "off" phases. Their motor status dramatically improves during "on" phases, due to the effect of dopaminergic agents.
In the off phases, the plasmatic levels of dopaminergic drugs are the lowest. The plasmatic levels of dopaminergic drugs are also very low during nocturnal sleep.
Nevertheless, PD patients may show vigorous and rapid movements during REM Behaviour Disorder (RBD). Thirty-three to 46% of the patients with PD have RBD.
Akinesia and bradykinesia are the consequence of a hyperactivity of the SubThalamic Nuclei (STN). The electrophysiological correlate of this hyperactivity causing akinesia and bradykinesia is represented by STN beta activity, recorded by local field potentials.
STN beta activity is not present during the execution of a voluntary movement at an "on" phase. Levodopa therapy, which can revert akinesia and bradykinesia, also suppress STN beta activity in PD patients The STN is the surgical target for Deep Brain Stimulation (DBS) of the basal ganglia to improve the motor symptoms of PD.
The STN has bilateral connections with the laterodorsal nucleus/pedunculopontine tegmentum (LDT/PPN), a key structure for REM sleep regulation.
The investigators hypothesize that during the execution of the phasic motor behaviours of RBD the pattern of discharge of STN differs from the one observed during voluntary movements in the "off" phase, in PD patients. In other terms, we expect the STN beta activity to disappear during the execution of phasic motor behaviors of RBD.
- Conditions
- Parkinson Disease
- Being tested
- Synchronised video-polysomnography
- Keywords
- REM behaviour disorder, Subthalamic nucleus, Local field potential, Motor control
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synchronised video-polysomnographyOther
Also called Synchronised video-polysomnography and STN local field potentials recordings.
We will record the electrical activity of the STN (local field potentials) during the 2 consecutive nights following the implantation of the electrodes in the STN for DBS. In this period, the deep brain stimulator will not yet be connected to the intracranial electrodes.
The intracranial EEG signal from the STN will be synchronised with the scalp EEG and other video-polysomnographic parameters.
The STN recordings during the phasic movements of RBD will be compared to the recordings obtained at the same level during a motor task.
| Study group | Role | What they receive |
|---|---|---|
| Synchronised video-polysomnography | Experimental | Not described Receives: Other: Synchronised video-polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
STN 8-30 Hz mean power
Difference of the mean power of the 8-30 Hz frequency band at the NST during the phasic movements of TCSP and during the execution voluntary movements in the "off" phase.
Measured: Outcome measure is assessed during the 2 nights and the two days following the implantation of the electrode in the STN.
Secondary outcomes (4)
Difference of the mean power of the 8-13 Hz, 14-30 Hz and 60-90 Hz frequency bands at the NST during the phasic movements of TCSP and during the execution voluntary movements in the "off" phase.
Measured: Outcome measures are assessed at days 2 and 3 and nights 1 and 2.
Difference of the mean power of the 8-30 Hz and 60-90 Hz frequency bands at the NST during the phasic movements of TCSP and during the execution voluntary movements in the "on" phase.
Measured: Outcome measures are assessed at days 2 and 3 and nights 1 and 2.
Frequency spectrum at NST REM sleep without atonia and REM sleep with atonia.
Measured: Outcome measures are assessed at days 2 and 3 and nights 1 and 2.
Frequency spectrum at the NST during non REM sleep (N1, N2 and N3 stages), REM sleep (R) and nocturnal wake.
Measured: Outcome measures are assessed at days 2 and 3 and nights 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2014
- Study completionJul 2014
Why it stopped: Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Grenoble Institut des Neurosciences
- Responsible party
- Sponsor
- Investigators
- Pietro-Luca RATTI, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886131
- Sponsor's protocol ID
- 12 388 02
- Other IDs
- AOL2012
- Acronym
- RevesParkNST
- Status last verified
- Feb 2017
- First submitted
- 20 Jun 2013
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
AASM (2005). International classification of sleep disorders, 2nd ed.: Diagnostic and coding manual. Westchester, IL, American Academy of Sleep Medicine.
Benarroch EE. Subthalamic nucleus and its connections: Anatomic substrate for the network effects of deep brain stimulation. Neurology. 2008 May 20;70(21):1991-5. doi: 10.1212/01.wnl.0000313022.39329.65. No abstract available.
PubMed 18490619Boeve BF, Silber MH, Saper CB, Ferman TJ, Dickson DW, Parisi JE, Benarroch EE, Ahlskog JE, Smith GE, Caselli RC, Tippman-Peikert M, Olson EJ, Lin SC, Young T, Wszolek Z, Schenck CH, Mahowald MW, Castillo PR, Del Tredici K, Braak H. Pathophysiology of REM sleep behaviour disorder and relevance to neurodegenerative disease. Brain. 2007 Nov;130(Pt 11):2770-88. doi: 10.1093/brain/awm056. Epub 2007 Apr 5.
PubMed 17412731Brown P, Williams D. Basal ganglia local field potential activity: character and functional significance in the human. Clin Neurophysiol. 2005 Nov;116(11):2510-9. doi: 10.1016/j.clinph.2005.05.009. Epub 2005 Jul 18.
PubMed 16029963Buot, A., M. L. Welter, et al. (2012).
Cassidy M, Mazzone P, Oliviero A, Insola A, Tonali P, Di Lazzaro V, Brown P. Movement-related changes in synchronization in the human basal ganglia. Brain. 2002 Jun;125(Pt 6):1235-46. doi: 10.1093/brain/awf135.
PubMed 12023312De Cock VC, Vidailhet M, Leu S, Texeira A, Apartis E, Elbaz A, Roze E, Willer JC, Derenne JP, Agid Y, Arnulf I. Restoration of normal motor control in Parkinson's disease during REM sleep. Brain. 2007 Feb;130(Pt 2):450-6. doi: 10.1093/brain/awl363.
PubMed 17235126Drouin, N., L. Allard, et al. (2011). Sleep staging using Subdermal Wire Electrodes during intracerebral EEG recordings (abstract 1.133). American Epilepsy Society 65th annual meeting. Baltimore, MD., U.S.A.
Fernandez-Mendoza J, Lozano B, Seijo F, Santamarta-Liebana E, Ramos-Platon MJ, Vela-Bueno A, Fernandez-Gonzalez F. Evidence of subthalamic PGO-like waves during REM sleep in humans: a deep brain polysomnographic study. Sleep. 2009 Sep;32(9):1117-26. doi: 10.1093/sleep/32.9.1117.
PubMed 19750916Fumagalli, M., G. Giannicola, et al. (2011).
Hammond C, Bergman H, Brown P. Pathological synchronization in Parkinson's disease: networks, models and treatments. Trends Neurosci. 2007 Jul;30(7):357-64. doi: 10.1016/j.tins.2007.05.004. Epub 2007 May 25.
PubMed 17532060Hsu, Y. T., H. Y. Lai, et al. (2012).
Iber, C., S. Ancoli-Israel, et al. (2007). The AASM Manual for the Scoring of Sleep and Associated Events. Rules, Terminology and Technical Specifications. Westchester, IL, American Academy of Sleep Medicine.
Kuhn AA, Trottenberg T, Kivi A, Kupsch A, Schneider GH, Brown P. The relationship between local field potential and neuronal discharge in the subthalamic nucleus of patients with Parkinson's disease. Exp Neurol. 2005 Jul;194(1):212-20. doi: 10.1016/j.expneurol.2005.02.010.
PubMed 15899258Levy R, Ashby P, Hutchison WD, Lang AE, Lozano AM, Dostrovsky JO. Dependence of subthalamic nucleus oscillations on movement and dopamine in Parkinson's disease. Brain. 2002 Jun;125(Pt 6):1196-209. doi: 10.1093/brain/awf128.
PubMed 12023310
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subthalamic Nuclei (STN) Local Field Potentials to Investigate Motor Control During REM Sleep Behaviour Disorder (TCSP) Secondary to Idiopathic Parkinsons Disease (PD)
- ClinicalTrials.gov ID
- NCT01886131
- Acronym / sponsor ID
- RevesParkNST / 12 388 02
- Conditions
- Parkinson Disease
- Keywords
- REM behaviour disorder, Subthalamic nucleus, Local field potential, Motor control
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Grenoble Institut des Neurosciences
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patient with severe Parkinson's disease (PD) with motor fluctuations are akinetic and bradykinetic during the "off" phases. Their motor status dramatically improves during "on" phases, due to the effect of dopaminergic agents.
In the off phases, the plasmatic levels of dopaminergic drugs are the lowest. The plasmatic levels of dopaminergic drugs are also very low during nocturnal sleep.
Nevertheless, PD patients may show vigorous and rapid movements during REM Behaviour Disorder (RBD). Thirty-three to 46% of the patients with PD have RBD.
Akinesia and bradykinesia are the consequence of a hyperactivity of the SubThalamic Nuclei (STN). The electrophysiological correlate of this hyperactivity causing akinesia and bradykinesia is represented by STN beta activity, recorded by local field potentials.
STN beta activity is not present during the execution of a voluntary movement at an "on" phase. Levodopa therapy, which can revert akinesia and bradykinesia, also suppress STN beta activity in PD patients The STN is the surgical target for Deep Brain Stimulation (DBS) of the basal ganglia to improve the motor symptoms of PD.
The STN has bilateral connections with the laterodorsal nucleus/pedunculopontine tegmentum (LDT/PPN), a key structure for REM sleep regulation.
The investigators hypothesize that during the execution of the phasic motor behaviours of RBD the pattern of discharge of STN differs from the one observed during voluntary movements in the "off" phase, in PD patients. In other terms, we expect the STN beta activity to disappear during the execution of phasic motor behaviors of RBD.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Synchronised video-polysomnography | Experimental | Other: Synchronised video-polysomnography |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synchronised video-polysomnographyAlso: Synchronised video-polysomnography and STN local field potentials recordings.We will record the electrical activity of the STN (local field potentials) during the 2 consecutive nights following the implantation of the electrodes in the STN for DBS. In this period, the deep brain stimulator will not yet be connected to the intracranial electrodes. The intracranial EEG signal from the STN will be synchronised with the scalp EEG and other video-polysomnographic parameters. The STN recordings during the phasic movements of RBD will be compared to the recordings obtained at the same level during a motor task. | Other | Synchronised video-polysomnography |
Primary outcome
STN 8-30 Hz mean power
Time frame: Outcome measure is assessed during the 2 nights and the two days following the implantation of the electrode in the STN.
Difference of the mean power of the 8-30 Hz frequency band at the NST during the phasic movements of TCSP and during the execution voluntary movements in the "off" phase.
4 secondary outcomes
Difference of the mean power of the 8-13 Hz, 14-30 Hz and 60-90 Hz frequency bands at the NST during the phasic movements of TCSP and during the execution voluntary movements in the "off" phase.
Time frame: Outcome measures are assessed at days 2 and 3 and nights 1 and 2.
Difference of the mean power of the 8-30 Hz and 60-90 Hz frequency bands at the NST during the phasic movements of TCSP and during the execution voluntary movements in the "on" phase.
Time frame: Outcome measures are assessed at days 2 and 3 and nights 1 and 2.
Frequency spectrum at NST REM sleep without atonia and REM sleep with atonia.
Time frame: Outcome measures are assessed at days 2 and 3 and nights 1 and 2.
Frequency spectrum at the NST during non REM sleep (N1, N2 and N3 stages), REM sleep (R) and nocturnal wake.
Time frame: Outcome measures are assessed at days 2 and 3 and nights 1 and 2
Results and safety
The study was stopped early (reason given: Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- BackgroundAASM (2005). International classification of sleep disorders, 2nd ed.: Diagnostic and coding manual. Westchester, IL, American Academy of Sleep Medicine.
- Background: PubMed 18490619Benarroch EE. Subthalamic nucleus and its connections: Anatomic substrate for the network effects of deep brain stimulation. Neurology. 2008 May 20;70(21):1991-5. doi: 10.1212/01.wnl.0000313022.39329.65. No abstract available.
- Background: PubMed 17412731Boeve BF, Silber MH, Saper CB, Ferman TJ, Dickson DW, Parisi JE, Benarroch EE, Ahlskog JE, Smith GE, Caselli RC, Tippman-Peikert M, Olson EJ, Lin SC, Young T, Wszolek Z, Schenck CH, Mahowald MW, Castillo PR, Del Tredici K, Braak H. Pathophysiology of REM sleep behaviour disorder and relevance to neurodegenerative disease. Brain. 2007 Nov;130(Pt 11):2770-88. doi: 10.1093/brain/awm056. Epub 2007 Apr 5.
- Background: PubMed 16029963Brown P, Williams D. Basal ganglia local field potential activity: character and functional significance in the human. Clin Neurophysiol. 2005 Nov;116(11):2510-9. doi: 10.1016/j.clinph.2005.05.009. Epub 2005 Jul 18.
- BackgroundBuot, A., M. L. Welter, et al. (2012).
- Background: PubMed 12023312Cassidy M, Mazzone P, Oliviero A, Insola A, Tonali P, Di Lazzaro V, Brown P. Movement-related changes in synchronization in the human basal ganglia. Brain. 2002 Jun;125(Pt 6):1235-46. doi: 10.1093/brain/awf135.
- Background: PubMed 17235126De Cock VC, Vidailhet M, Leu S, Texeira A, Apartis E, Elbaz A, Roze E, Willer JC, Derenne JP, Agid Y, Arnulf I. Restoration of normal motor control in Parkinson's disease during REM sleep. Brain. 2007 Feb;130(Pt 2):450-6. doi: 10.1093/brain/awl363.
- BackgroundDrouin, N., L. Allard, et al. (2011). Sleep staging using Subdermal Wire Electrodes during intracerebral EEG recordings (abstract 1.133). American Epilepsy Society 65th annual meeting. Baltimore, MD., U.S.A.
- Background: PubMed 19750916Fernandez-Mendoza J, Lozano B, Seijo F, Santamarta-Liebana E, Ramos-Platon MJ, Vela-Bueno A, Fernandez-Gonzalez F. Evidence of subthalamic PGO-like waves during REM sleep in humans: a deep brain polysomnographic study. Sleep. 2009 Sep;32(9):1117-26. doi: 10.1093/sleep/32.9.1117.
- BackgroundFumagalli, M., G. Giannicola, et al. (2011).
- Background: PubMed 17532060Hammond C, Bergman H, Brown P. Pathological synchronization in Parkinson's disease: networks, models and treatments. Trends Neurosci. 2007 Jul;30(7):357-64. doi: 10.1016/j.tins.2007.05.004. Epub 2007 May 25.
- BackgroundHsu, Y. T., H. Y. Lai, et al. (2012).
Related trials for Parkinson Disease
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Parkinson's Disease (PD)
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Not yet recruiting
Cognitive-Motor Training for Gait Adaptability in Parkinson Disease
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pietro-Luca RATTI, MD principal investigator
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synchronised video-polysomnography in people with Parkinson Disease, run by University Hospital, Toulouse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STN 8-30 Hz mean power (time frame: Outcome measure is assessed during the 2 nights and the two days following the implantation of the electrode in the STN.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01886131, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.