Spinal Cord InjuriesACTI-MPJ-BMNCT04618978
Periodic Leg Movements' Diagnosis in Spinal Cord Injury: Actigraphy as an Alternative for Polysomnography?
A study testing PSG and actigraphy recording in people with Spinal Cord Injuries and Periodic Limb Movement Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Periodic Limb Movements during Sleep (PLMs) are episodes of repetitive, stereotypical, hallux or foot movements. They could induce sleep disturbance, fatigue, daytime sleepiness and impaired quality of life but also increased cardiovascular risk by rising heart rate and blood pressure at night. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Periodic Limb Movement Disorder
- What is being tested?
- PSG and actigraphy recording
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2021to 17 Jan 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient With Spinal Cord Injury from traumatic or medical aetiology (including patient with multiple sclerosis);
- Motor testing stability for at least 6 months prior to inclusion;
- Patients with complete or incomplete SCI (AIS-A, B, C, D and E);
- Neurological level between C4 and L1;
- Aged >18 years;
- Patients with already scheduled full night polysomnography (PSG);
- Affiliated to social security system;
- Absence of medical intercurrent event.
Who cannot join
- Specific criteria:
- History of lower limbs amputation ;
- Cutaneous lesion compromising actigraphy positioning
- Presence of spinal cord stimulation equipment, Brindley electrodes, history of spinal cord surgery.
- No-specific criteria:
- Patient refusal;
Show all 11Show fewer
- Participation in another interventional study involving human participants
- Unable to sign informed consent form;
- Emergency condition;
- Legal protection (i.e. incompetence to provide consent, guardianship, curator or incarceration);
- No affiliation to a social security system.
Trial locations and contacts
1 site in 1 country.
France1 site
Physiologie, explorations fonctionnelles - Unité des pathologies du sommeil, Hôpital Raymond Poincaré, APHP
Garches, 92380
About this study
Official title: Periodic Leg Movement's Diagnosis in Spinal Cord Injury: Actigraphy as an Alternative for Polysomnography?
Periodic Limb Movements during Sleep (PLMs) are episodes of repetitive, stereotypical, hallux or foot movements. They could induce sleep disturbance, fatigue, daytime sleepiness and impaired quality of life but also increased cardiovascular risk by rising heart rate and blood pressure at night. Gold standard for PLMs diagnosis is based on electromyographic recording of tibialis anterior muscle during full night polysomnography (PSG).
PLMs prevalence is higher in patients with spinal cord injury (SCI) possibly due to a loss of encephalic inhibition on a spinal motion generator. In these patients, PLMs can also be wrongly considered as spasms sometimes leading to the unjustified implantation of an intrathecal Lioresal pump.
Read more
In the general population, drug treatments for PLMs, particularly dopamine agonists, limit the impact of these abnormal movements on sleep fragmentation, daytime alertness and quality of life. Underdiagnosed PLMs in SCI patients can lead to exacerbate cognitive, mood and painful disorders due to the close interaction between sleep disorders and neurocognitive, psychological and painful manifestations.
PLMs appropriate diagnosis appeared mandatory in those patients but accessibility and delayed availability remain challenging. In addition, sleep laboratories are often unable to accommodate with SCI patients.
In this context, actigraphy, an easy-to-use, cheaper and easily renewable diagnostic tool would be interesting. In the general population, sensitivity to diagnose PLMs was between 0.79 and 1 and specificity between 0.6 and 0.83. Due to lower limbs impairment, increased specificity is expected SCI patients (decrease voluntary activity).
The new generation of actigraph (MotionWatchR) could have better characteristics thanks to the development of a specific software which integrate both lower limbs in the same analysis.
As primary objective, this prospective monocentric study aims to evaluate the performances of lower limbs actigraphy for PLMs diagnosis versus gold standard.
Read the detailed description
As secondary objectives, the study aims to:
- Estimate positive and negative predictive values;
- Identify the diagnostic threshold of PLMs index with actigraphy;
- Study concordance between actigraphy and polysomnography to detect lower limbs movements;
- Evaluate reproducibility between 2 readers and with the new PLMs software;
- Study actigraphy reproducibility for this indication over 3 consecutive nights in the same patients (ancillary study);
- Compare diagnostic performance according to SCI completeness (AIS-A vs AIS-B, C, D) and underlying pathology (MS, SCI);
- Compare installation and interpretation times between actigraphy and PSG.
PLMs appropriate diagnosis appeared mandatory in SCI patients however the accessibility and the delay of availability remain challenging for severe SCI complications in care management.
The study team hypothesize that actigraphy could be able to diagnose PLMs with sufficient reliability (AUC (area under the curve) around 80%) compared to the gold standard (polysomnography) in patients with spinal cord injuries.
Intervention: During a scheduled night recording (polysomnography) 3 actigraphs will be added (1 on the wrist, and 1 on each foot).
Equipment: MotionWatch8®, CamNtech® (marking CE Class 1 device; accord FDA (K132764)).
Methods:
All consecutive eligible patients followed in our tertiary care center (for whom a full night polysomnography is already scheduled) will be informed of the study and proposed to participate.
After signing the informed consent form, all subjects will undergo a full-night examinations: polysomnography (already scheduled in usual care) and actigraphy (addition of 3 devices):
- 1 classic actigraph on the wrist to detect light and identify inactivity periods compatible with sleep.
- 2 new generation Actiwatch actigraphs (MotionWatch) placed on the feet. Polysomnography will incorporate tibialis anterior EMG recording and will be scored by one sleep specialist following American Academy of Sleep Medicine (AASM) scoring criteria.
Actigraphy analysis will be provided by:
- An automated software specially developed for this indication (PLMsanalysis software, camNtechR).
- A nurse reading unaware of both software's and PSG results.
- A second reading will be provided by a second nurse, also unaware of the result of the polysomnography.
Actigraphy results will not be communicated to patients or physicians and therefore will not affect patient management.
At the end of the evaluation period, each patient will be offered, if needed, treatment and follow-up in the sleep unit as in usual care.
A study of actigraphy reproducibility will be carried out in a sample of 33 subjects. This study will take place over three consecutive nights during an already scheduled hospitalization (no additional hospitalization night for patients).
Statistical analysis: as described in Outcome Measures.
- Being tested
- PSG and actigraphy recording
- Keywords
- spinal cord injury, multiple sclerosis, periodic leg movements, spasticity, periodic limb movement disorder
- Medical subject headings
- Spinal Cord Injuries, Nocturnal Myoclonus Syndrome, Multiple Sclerosis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSG and actigraphy recordingProcedure or surgery
Gold standard: electromyographic recording of tibialis anterior muscle during full night polysomnography (PSG).
The new generation actigraphs devices Actiwatch will be combined to PSG as a screening tool: MotionWatch will be placed on the dorsum of feet to record).
| Study group | Role | What they receive |
|---|---|---|
| PSG and actigraphy device evaluations | Other | All patients will be evaluated and diagnosed according to the records by Gold standard for PLMs diagnosis and also by the actigraphy devices recording. Receives: Procedure: PSG and actigraphy recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Receiver Operating Characteristic (ROC) analysis
Area under ROC curve of the actimeter (indices of periodic movement of legs, defined by the ratio between the number of periodic movement of low limbs during sleeping time and estimated sleeping duration in hour), compared with polysomnography to have diagnosis of periodic movement of legs during sleeping (period of sleeping defined by absence of light and movement of up limb of the more mobile with actimeter).
Measured: Through study completion, an average of 3 years
Secondary outcomes (8)
Predictive values estimation
Sensitivity, specificity, positive and negative predictive values and likelihood ratio of actigraphy compared to polysomnography to diagnose PLMs
Measured: Through study completion, an average of 3 years
Threshold of PLMs Index
The periodic limb movement index (PLMI), which corresponds to the number of periodic limb movements per hour.
The actigraphy will be used to determinate diagnostic threshold of PLMs Index.
Measured: up to 24 hours
Lower limb nocturnal movements evaluation
Number of lower limb nocturnal movements per recording hour
Measured: up to 24 hours
PLMs diagnosis based on the actigraphy
PLMs diagnosis (yes / no) based on the actigraphy results
Measured: Through study completion, an average of 3 years
Kappa coefficient
Kappa coefficient between PLMs diagnoses (yes / no) made by 2 different nurses and between 1 nurse and the automated analysis software
Measured: Through study completion, an average of 3 years
Actigraphy diagnostic performance
Actigraphy diagnostic performance according to:
- the underlying pathology (MS or not)
- and lesion completeness (AIS-A vs AIS-B,C, D)
AIS: American Spinal Injury Association (ASIA) Impairment Scale;
MS: multiple sclerosis.
Measured: Through study completion, an average of 3 years
Installation time
Installation time between actigraphy and PSG
Measured: Through study completion, an average of 3 years
Interpretation time
Time of interpretation between actigraphy and PSG
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start25 Feb 2021
- Primary completion4 Jul 2024
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Christine BLANDIN, Principal investigator, Physiologie, explorations fonctionnelles - Unité des pathologies du sommeil, Hôpital Raymond Poincaré, APHPAntoine LEOTARD, MD, Study director, Physiologie, explorations fonctionnelles - Unité des pathologies du sommeil, Hôpital Raymond Poincaré, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618978
- Sponsor's protocol ID
- APHP200140
- Acronym
- ACTI-MPJ-BM
- Status last verified
- Jan 2025
- First submitted
- 23 Oct 2020
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siddiqui F, Strus J, Ming X, Lee IA, Chokroverty S, Walters AS. Rise of blood pressure with periodic limb movements in sleep and wakefulness. Clin Neurophysiol. 2007 Sep;118(9):1923-30. doi: 10.1016/j.clinph.2007.05.006. Epub 2007 Jun 27.
PubMed 17588809Proserpio P, Lanza A, Sambusida K, Fratticci L, Frigerio P, Sommariva M, Stagni EG, Redaelli T, De Carli F, Nobili L. Sleep apnea and periodic leg movements in the first year after spinal cord injury. Sleep Med. 2015 Jan;16(1):59-66. doi: 10.1016/j.sleep.2014.07.019. Epub 2014 Oct 7.
PubMed 25454844Foschi M, Rizzo G, Liguori R, Avoni P, Mancinelli L, Lugaresi A, Ferini-Strambi L. Sleep-related disorders and their relationship with MRI findings in multiple sclerosis. Sleep Med. 2019 Apr;56:90-97. doi: 10.1016/j.sleep.2019.01.010. Epub 2019 Jan 21.
PubMed 30803830Telles SC, Alves RS, Chadi G. Spinal cord injury as a trigger to develop periodic leg movements during sleep: an evolutionary perspective. Arq Neuropsiquiatr. 2012 Nov;70(11):880-4. doi: 10.1590/s0004-282x2012001100011.
PubMed 23175202Levy J, Hartley S, Mauruc-Soubirac E, Leotard A, Lofaso F, Quera-Salva MA, Bensmail D. Spasticity or periodic limb movements? Eur J Phys Rehabil Med. 2018 Oct;54(5):698-704. doi: 10.23736/S1973-9087.17.04886-9. Epub 2017 Dec 4.
PubMed 29205982Allen R. Dopamine and iron in the pathophysiology of restless legs syndrome (RLS). Sleep Med. 2004 Jul;5(4):385-91. doi: 10.1016/j.sleep.2004.01.012.
PubMed 15222997Guilleminault C, Flagg W. Effect of baclofen on sleep-related periodic leg movements. Ann Neurol. 1984 Mar;15(3):234-9. doi: 10.1002/ana.410150304.
PubMed 6721446Plante DT. Leg actigraphy to quantify periodic limb movements of sleep: a systematic review and meta-analysis. Sleep Med Rev. 2014 Oct;18(5):425-34. doi: 10.1016/j.smrv.2014.02.004. Epub 2014 Feb 17.
PubMed 24726711Kobayashi M, Namba K, Ito E, Nishida S, Nakamura M, Ueki Y, Furudate N, Kagimura T, Usui A, Inoue Y. The validity of the PAM-RL device for evaluating periodic limb movements in sleep and an investigation on night-to-night variability of periodic limb movements during sleep in patients with restless legs syndrome or periodic limb movement disorder using this system. Sleep Med. 2014 Jan;15(1):138-43. doi: 10.1016/j.sleep.2013.08.790. Epub 2013 Oct 31.
PubMed 24269130Ferri R, Fulda S, Manconi M, Hogl B, Ehrmann L, Ferini-Strambi L, Zucconi M. Night-to-night variability of periodic leg movements during sleep in restless legs syndrome and periodic limb movement disorder: comparison between the periodicity index and the PLMS index. Sleep Med. 2013 Mar;14(3):293-6. doi: 10.1016/j.sleep.2012.08.014. Epub 2012 Oct 12.
PubMed 23068780
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodic Leg Movement's Diagnosis in Spinal Cord Injury: Actigraphy as an Alternative for Polysomnography?
- ClinicalTrials.gov ID
- NCT04618978
- Acronym / sponsor ID
- ACTI-MPJ-BM / APHP200140
- Keywords
- spinal cord injury, multiple sclerosis, periodic leg movements, spasticity, periodic limb movement disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 4 Jul 2024 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 6 Nov 2020 (actual)
- 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.
Periodic Limb Movements during Sleep (PLMs) are episodes of repetitive, stereotypical, hallux or foot movements. They could induce sleep disturbance, fatigue, daytime sleepiness and impaired quality of life but also increased cardiovascular risk by rising heart rate and blood pressure at night. Gold standard for PLMs diagnosis is based on electromyographic recording of tibialis anterior muscle during full night polysomnography (PSG).
PLMs prevalence is higher in patients with spinal cord injury (SCI) possibly due to a loss of encephalic inhibition on a spinal motion generator. In these patients, PLMs can also be wrongly considered as spasms sometimes leading to the unjustified implantation of an intrathecal Lioresal pump.
In the general population, drug treatments for PLMs, particularly dopamine agonists, limit the impact of these abnormal movements on sleep fragmentation, daytime alertness and quality of life. Underdiagnosed PLMs in SCI patients can lead to exacerbate cognitive, mood and painful disorders due to the close interaction between sleep disorders and neurocognitive, psychological and painful manifestations.
PLMs appropriate diagnosis appeared mandatory in those patients but accessibility and delayed availability remain challenging. In addition, sleep laboratories are often unable to accommodate with SCI patients.
In this context, actigraphy, an easy-to-use, cheaper and easily renewable diagnostic tool would be interesting. In the general population, sensitivity to diagnose PLMs was between 0.79 and 1 and specificity between 0.6 and 0.83. Due to lower limbs impairment, increased specificity is expected SCI patients (decrease voluntary activity).
The new generation of actigraph (MotionWatchR) could have better characteristics thanks to the development of a specific software which integrate both lower limbs in the same analysis.
As primary objective, this prospective monocentric study aims to evaluate the performances of lower limbs actigraphy for PLMs diagnosis versus gold standard.
Detailed description
As secondary objectives, the study aims to:
- Estimate positive and negative predictive values;
- Identify the diagnostic threshold of PLMs index with actigraphy;
- Study concordance between actigraphy and polysomnography to detect lower limbs movements;
- Evaluate reproducibility between 2 readers and with the new PLMs software;
- Study actigraphy reproducibility for this indication over 3 consecutive nights in the same patients (ancillary study);
- Compare diagnostic performance according to SCI completeness (AIS-A vs AIS-B, C, D) and underlying pathology (MS, SCI);
- Compare installation and interpretation times between actigraphy and PSG.
PLMs appropriate diagnosis appeared mandatory in SCI patients however the accessibility and the delay of availability remain challenging for severe SCI complications in care management.
The study team hypothesize that actigraphy could be able to diagnose PLMs with sufficient reliability (AUC (area under the curve) around 80%) compared to the gold standard (polysomnography) in patients with spinal cord injuries.
Intervention: During a scheduled night recording (polysomnography) 3 actigraphs will be added (1 on the wrist, and 1 on each foot).
Equipment: MotionWatch8®, CamNtech® (marking CE Class 1 device; accord FDA (K132764)).
Methods:
All consecutive eligible patients followed in our tertiary care center (for whom a full night polysomnography is already scheduled) will be informed of the study and proposed to participate.
After signing the informed consent form, all subjects will undergo a full-night examinations: polysomnography (already scheduled in usual care) and actigraphy (addition of 3 devices):
- 1 classic actigraph on the wrist to detect light and identify inactivity periods compatible with sleep.
- 2 new generation Actiwatch actigraphs (MotionWatch) placed on the feet. Polysomnography will incorporate tibialis anterior EMG recording and will be scored by one sleep specialist following American Academy of Sleep Medicine (AASM) scoring criteria.
Actigraphy analysis will be provided by:
- An automated software specially developed for this indication (PLMsanalysis software, camNtechR).
- A nurse reading unaware of both software's and PSG results.
- A second reading will be provided by a second nurse, also unaware of the result of the polysomnography.
Actigraphy results will not be communicated to patients or physicians and therefore will not affect patient management.
At the end of the evaluation period, each patient will be offered, if needed, treatment and follow-up in the sleep unit as in usual care.
A study of actigraphy reproducibility will be carried out in a sample of 33 subjects. This study will take place over three consecutive nights during an already scheduled hospitalization (no additional hospitalization night for patients).
Statistical analysis: as described in Outcome Measures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSG and actigraphy device evaluations | Other | Procedure: PSG and actigraphy recordingAll patients will be evaluated and diagnosed according to the records by Gold standard for PLMs diagnosis and also by the actigraphy devices recording. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient With Spinal Cord Injury from traumatic or medical aetiology (including patient with multiple sclerosis);
- Motor testing stability for at least 6 months prior to inclusion;
- Patients with complete or incomplete SCI (AIS-A, B, C, D and E);
- Neurological level between C4 and L1;
- Aged >18 years;
Key exclusion criteria (11 listed)
- History of lower limbs amputation ;
- Cutaneous lesion compromising actigraphy positioning
- Presence of spinal cord stimulation equipment, Brindley electrodes, history of spinal cord surgery.
- Patient refusal;
- Participation in another interventional study involving human participants
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 |
|---|---|---|
| PSG and actigraphy recordingGold standard: electromyographic recording of tibialis anterior muscle during full night polysomnography (PSG). The new generation actigraphs devices Actiwatch will be combined to PSG as a screening tool: MotionWatch will be placed on the dorsum of feet to record). | Procedure or surgery | PSG and actigraphy device evaluations |
Primary outcome
The Receiver Operating Characteristic (ROC) analysis
Time frame: Through study completion, an average of 3 years
Area under ROC curve of the actimeter (indices of periodic movement of legs, defined by the ratio between the number of periodic movement of low limbs during sleeping time and estimated sleeping duration in hour), compared with polysomnography to have diagnosis of periodic movement of legs during sleeping (period of sleeping defined by absence of light and movement of up limb of the more mobile with actimeter).
8 secondary outcomes
Predictive values estimation
Time frame: Through study completion, an average of 3 years
Threshold of PLMs Index
Time frame: up to 24 hours
Lower limb nocturnal movements evaluation
Time frame: up to 24 hours
PLMs diagnosis based on the actigraphy
Time frame: Through study completion, an average of 3 years
Kappa coefficient
Time frame: Through study completion, an average of 3 years
Actigraphy diagnostic performance
Time frame: Through study completion, an average of 3 years
Installation time
Time frame: Through study completion, an average of 3 years
Interpretation time
Time frame: Through study completion, an average of 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Background: PubMed 17588809Siddiqui F, Strus J, Ming X, Lee IA, Chokroverty S, Walters AS. Rise of blood pressure with periodic limb movements in sleep and wakefulness. Clin Neurophysiol. 2007 Sep;118(9):1923-30. doi: 10.1016/j.clinph.2007.05.006. Epub 2007 Jun 27.
- Background: PubMed 25454844Proserpio P, Lanza A, Sambusida K, Fratticci L, Frigerio P, Sommariva M, Stagni EG, Redaelli T, De Carli F, Nobili L. Sleep apnea and periodic leg movements in the first year after spinal cord injury. Sleep Med. 2015 Jan;16(1):59-66. doi: 10.1016/j.sleep.2014.07.019. Epub 2014 Oct 7.
- Background: PubMed 30803830Foschi M, Rizzo G, Liguori R, Avoni P, Mancinelli L, Lugaresi A, Ferini-Strambi L. Sleep-related disorders and their relationship with MRI findings in multiple sclerosis. Sleep Med. 2019 Apr;56:90-97. doi: 10.1016/j.sleep.2019.01.010. Epub 2019 Jan 21.
- Background: PubMed 23175202Telles SC, Alves RS, Chadi G. Spinal cord injury as a trigger to develop periodic leg movements during sleep: an evolutionary perspective. Arq Neuropsiquiatr. 2012 Nov;70(11):880-4. doi: 10.1590/s0004-282x2012001100011.
- Background: PubMed 29205982Levy J, Hartley S, Mauruc-Soubirac E, Leotard A, Lofaso F, Quera-Salva MA, Bensmail D. Spasticity or periodic limb movements? Eur J Phys Rehabil Med. 2018 Oct;54(5):698-704. doi: 10.23736/S1973-9087.17.04886-9. Epub 2017 Dec 4.
- Background: PubMed 15222997Allen R. Dopamine and iron in the pathophysiology of restless legs syndrome (RLS). Sleep Med. 2004 Jul;5(4):385-91. doi: 10.1016/j.sleep.2004.01.012.
- Background: PubMed 6721446Guilleminault C, Flagg W. Effect of baclofen on sleep-related periodic leg movements. Ann Neurol. 1984 Mar;15(3):234-9. doi: 10.1002/ana.410150304.
- Background: PubMed 24726711Plante DT. Leg actigraphy to quantify periodic limb movements of sleep: a systematic review and meta-analysis. Sleep Med Rev. 2014 Oct;18(5):425-34. doi: 10.1016/j.smrv.2014.02.004. Epub 2014 Feb 17.
- Background: PubMed 24269130Kobayashi M, Namba K, Ito E, Nishida S, Nakamura M, Ueki Y, Furudate N, Kagimura T, Usui A, Inoue Y. The validity of the PAM-RL device for evaluating periodic limb movements in sleep and an investigation on night-to-night variability of periodic limb movements during sleep in patients with restless legs syndrome or periodic limb movement disorder using this system. Sleep Med. 2014 Jan;15(1):138-43. doi: 10.1016/j.sleep.2013.08.790. Epub 2013 Oct 31.
- Background: PubMed 23068780Ferri R, Fulda S, Manconi M, Hogl B, Ehrmann L, Ferini-Strambi L, Zucconi M. Night-to-night variability of periodic leg movements during sleep in restless legs syndrome and periodic limb movement disorder: comparison between the periodicity index and the PLMS index. Sleep Med. 2013 Mar;14(3):293-6. doi: 10.1016/j.sleep.2012.08.014. Epub 2012 Oct 12.
- Individual participant dataSharing planned: No
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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.
Marie Christine BLANDIN principal investigator
Physiologie, explorations fonctionnelles - Unité des pathologies du sommeil, Hôpital Raymond Poincaré, APHP
Antoine LEOTARD, MD study director
Physiologie, explorations fonctionnelles - Unité des pathologies du sommeil, Hôpital Raymond Poincaré, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSG and actigraphy recording in people with Spinal Cord Injuries and Periodic Limb Movement Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 8 inclusion and 11 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: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Receiver Operating Characteristic (ROC) analysis (time frame: Through study completion, an average of 3 years). 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 NCT04618978, which also lists 10 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 11 Feb 2025.