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Periodic Leg Movements' Diagnosis in Spinal Cord Injury: Actigraphy as an Alternative for Polysomnography? (ACTI-MPJ-BM)

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ClinicalTrials.gov Identifier: NCT04618978
Recruitment Status : Recruiting
First Posted : November 6, 2020
Last Update Posted : July 14, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Periodic Limb Movement Disorder Procedure: PSG and actigraphy recording Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Periodic Leg Movement's Diagnosis in Spinal Cord Injury: Actigraphy as an Alternative for Polysomnography?
Actual Study Start Date : February 25, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
PSG and actigraphy device evaluations
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

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).


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Predictive values estimation [ Time Frame: Through study completion, an average of 3 years ]
    Sensitivity, specificity, positive and negative predictive values and likelihood ratio of actigraphy compared to polysomnography to diagnose PLMs

  2. Threshold of PLMs Index [ Time Frame: up to 24 hours ]

    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.


  3. Lower limb nocturnal movements evaluation [ Time Frame: up to 24 hours ]
    Number of lower limb nocturnal movements per recording hour

  4. PLMs diagnosis based on the actigraphy [ Time Frame: Through study completion, an average of 3 years ]
    PLMs diagnosis (yes / no) based on the actigraphy results

  5. Kappa coefficient [ Time Frame: Through study completion, an average of 3 years ]
    Kappa coefficient between PLMs diagnoses (yes / no) made by 2 different nurses and between 1 nurse and the automated analysis software

  6. Actigraphy diagnostic performance [ Time Frame: Through study completion, an average of 3 years ]

    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.


  7. Installation time [ Time Frame: Through study completion, an average of 3 years ]
    Installation time between actigraphy and PSG

  8. Interpretation time [ Time Frame: Through study completion, an average of 3 years ]
    Time of interpretation between actigraphy and PSG


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04618978


Contacts
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Contact: Antoine LEOTARD, MD +33 (0)1 47 10 79 40 antoine.leotard@aphp.fr
Contact: Marie Christine BLANDIN +33 (0)1 47 10 79 40 laboratoire.sommeil.rpc@aphp.fr

Locations
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France
Physiologie, explorations fonctionnelles - Unité des pathologies du sommeil, Hôpital Raymond Poincaré, APHP Recruiting
Garches, France, 92380
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Marie Christine BLANDIN Physiologie, explorations fonctionnelles - Unité des pathologies du sommeil, Hôpital Raymond Poincaré, APHP
Study Director: Antoine LEOTARD, MD Physiologie, explorations fonctionnelles - Unité des pathologies du sommeil, Hôpital Raymond Poincaré, APHP
More Information
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Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04618978    
Other Study ID Numbers: APHP200140
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
spinal cord injury
multiple sclerosis
periodic leg movements
spasticity
periodic limb movement disorder
Additional relevant MeSH terms:
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Spinal Cord Injuries
Movement Disorders
Nocturnal Myoclonus Syndrome
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias