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

NCT04618978 | Completed DMC

• 1 other identifier: APHP200140
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries; Periodic Limb Movement Disorder

Keywords

spinal cord injury; multiple sclerosis; periodic leg movements; spasticity; periodic limb movement disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Predictive values estimation

  Through study completion, an average of 3 years

• Threshold of PLMs Index

  up to 24 hours

• Lower limb nocturnal movements evaluation

  up to 24 hours

• PLMs diagnosis based on the actigraphy

  Through study completion, an average of 3 years

• Kappa coefficient

  Through study completion, an average of 3 years

Study Arms (1)

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.

Procedure: PSG and actigraphy recording

Interventions

PSG and actigraphy recording PROCEDURE

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).

PSG and actigraphy device evaluations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient With Spinal Cord Injury from traumatic or medical aetiology (including patient with multiple sclerosis);
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Physiologie, explorations fonctionnelles - Unité des pathologies du sommeil, Hôpital Raymond Poincaré, APHP

Garches, 92380, France

Location

Related Publications (10)

• 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.

  PMID: 17588809 BACKGROUND

• 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.

  PMID: 25454844 BACKGROUND

• 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.

  PMID: 30803830 BACKGROUND

• 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.

  PMID: 23175202 BACKGROUND

• 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.

  PMID: 29205982 BACKGROUND

• 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.

  PMID: 15222997 BACKGROUND

• 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.

  PMID: 6721446 BACKGROUND

• 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.

  PMID: 24726711 BACKGROUND

• 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.

  PMID: 24269130 BACKGROUND

• 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.

  PMID: 23068780 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Nocturnal Myoclonus Syndrome; Multiple Sclerosis; Muscle Spasticity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie Christine BLANDIN

  Physiologie, explorations fonctionnelles - Unité des pathologies du sommeil, Hôpital Raymond Poincaré, APHP

  PRINCIPAL INVESTIGATOR

• Antoine LEOTARD, MD

  Physiologie, explorations fonctionnelles - Unité des pathologies du sommeil, Hôpital Raymond Poincaré, APHP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 6, 2020
• Study Start: February 25, 2021
• Primary Completion: July 4, 2024
• Study Completion: January 17, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)