Periodic Leg Movements' Diagnosis in Spinal Cord Injury: Actigraphy as an Alternative for Polysomnography?

Spinal Cord Injuries Clinical Trial

— ACTI-MPJ-BM  

Official title:

Periodic Leg Movement's Diagnosis in Spinal Cord Injury: Actigraphy as an Alternative for Polysomnography?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04618978
• Other study ID #: APHP200140
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2021
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Antoine LEOTARD, MD
• Phone: +33 (0)1 47 10 79 40
• Email: antoine.leotard[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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;

• 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.

Related Conditions & MeSH terms

• Movement Disorders
• Nocturnal Myoclonus Syndrome
• Periodic Limb Movement Disorder
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Procedure:
• PSG and actigraphy recording
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).

Locations

Country	Name	City	State
France	Physiologie, explorations fonctionnelles - Unité des pathologies du sommeil, Hôpital Raymond Poincaré, APHP	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (10)

Allen 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. — View Citation

Ferri 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. — View Citation

Foschi 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. — View Citation

Guilleminault 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. — View Citation

Kobayashi 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. — View Citation

Levy 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. — View Citation

Plante 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. — View Citation

Proserpio 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. — View Citation

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. — View Citation

Telles 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Through study completion, an average of 3 years
Secondary	Predictive values estimation	Sensitivity, specificity, positive and negative predictive values and likelihood ratio of actigraphy compared to polysomnography to diagnose PLMs	Through study completion, an average of 3 years
Secondary	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.	up to 24 hours
Secondary	Lower limb nocturnal movements evaluation	Number of lower limb nocturnal movements per recording hour	up to 24 hours
Secondary	PLMs diagnosis based on the actigraphy	PLMs diagnosis (yes / no) based on the actigraphy results	Through study completion, an average of 3 years
Secondary	Kappa coefficient	Kappa coefficient between PLMs diagnoses (yes / no) made by 2 different nurses and between 1 nurse and the automated analysis software	Through study completion, an average of 3 years
Secondary	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.	Through study completion, an average of 3 years
Secondary	Installation time	Installation time between actigraphy and PSG	Through study completion, an average of 3 years
Secondary	Interpretation time	Time of interpretation between actigraphy and PSG	Through study completion, an average of 3 years