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

NCT04618978 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-02-11

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Marie Christine BLANDIN · Physiologie, explorations fonctionnelles - Unité des pathologies du sommeil, Hôpital Raymond Poincaré, APHP

  • Antoine LEOTARD, MD · Physiologie, explorations fonctionnelles - Unité des pathologies du sommeil, Hôpital Raymond Poincaré, APHP

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-25
Primary Completion
2024-07-04
Completion
2025-01-17

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04618978 on ClinicalTrials.gov