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NCT Number: NCT05746260

Sleep and Motor Learning in Stroke

This study will explore whether sleep disruption in the sub-acute phase of stroke explains variation in clinical motor outcomes, and whether this relationship is mediated by variation in behavioural measures of overnight consolidation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wellcome Centre for Integrative Neuroimaging (WIN)

Oxford, OX3 9DU, United Kingdom

Location status: Recruiting

Location contact

Barbara Robinson

CONTACT

[email protected]

Melanie K Fleming, Dr

CONTACT

[email protected]

About this study

Rehabilitation of movement after stroke depends on motor learning. Motor learning involves not only improvement during practice but also improvement between sessions, known as consolidation of learning. Consolidation of learning depends on good sleep quality. However, there is growing evidence that sleep is disrupted after stroke, and it was recently shown that patients with poorer sleep show slower recovery of function and worse motor outcomes. This might occur because sleep disruption impairs consolidation directly or might reflect other factors that influence both sleep and clinical outcomes. This study aims to test whether the relationship between sleep disruption and clinical outcomes after stroke depends on consolidation of motor learning.

In people with stroke affecting the upper limb, the investigators will (1) test whether sleep measures in the sub-acute phase explains variation in clinical motor outcomes, taking into account recovery potential (as per the PREP2 algorithm(Predict REcovery Potential; www.presto.auckland.ac.nz)), demographic factors (age and sex) and other covariates as required (e.g. stroke severity, presence of sleep disorders, mood, physical activity), and (2) test whether this relationship is mediated by variation in behavioural measures of overnight motor consolidation.

The design is a longitudinal observational study. Participants will be recruited within 1 month of stroke onset from stroke wards. At baseline (≤ 1 month post-stroke), the investigators will use the PREP2 algorithm (www.presto.auckland.ac.nz) to ascertain expected upper limb recovery potential. This involves an assessment of arm movement and, for some participants, Transcranial Magnetic Stimulation to assess corticospinal tract integrity. The investigators will also record participant demographics, stroke severity (National Institute for Health Stroke Scale; NIHSS), and medications.

At approximately 1 month post-stroke the investigators will obtain sleep measures (actigraphy, electroencephalography, and questionnaires), assess mood (questionnaire) and test for motor consolidation (using an upper limb motor learning task). The investigators will also record medications, stroke severity (modified Rankin Scale questionnaire), and assess the possible presence of sleep disorders (sleep screening questionnaires), physical activity (actigraphy). The investigators will collect information about how much, if any, motor rehabilitation and sleep therapy the participants have received (questionnaire).

At 6 months post-stroke the investigators will obtain sleep measures (actigraphy, and questionnaire) and assess motor outcomes (upper limb ability, whole body motor impairment, hand dexterity, and mobility). The investigators will also record medications and assess mood (questionnaire), stroke severity (modified Rankin Scale questionnaire), physical activity (actigraphy), and information about how much, if any, motor rehabilitation and sleep therapy the participants have had (questionnaire).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant is willing and able to give informed consent for participation in the study OR a positive opinion from a consultee is provided by a family member or carer (relative or friend) willing to provide personal consultee (PC) advice
  • Aged 18 years or above
  • Within 1 month of onset of stroke affecting the upper limb as confirmed by clinical diagnosis

Exclusion criteria

  • Other neurological condition affecting movement (such as Parkinson's disease, Multiple Sclerosis)

Treatment and study plan

Primary outcomes

  1. Sleep fragmentation at 1-month

    Time frame: 1 month post-stroke

    Assessed using actigraphy (wearable activity monitor) over 7-nights (more fragmentation indicates worse sleep).

  2. Symptoms of insomnia at 1-month

    Time frame: 1 month post-stroke

    Assessed using the Sleep Condition Indicator, a questionnaire assessing self-reported insomnia symptoms (range 0-32, higher scores indicate fewer symptoms of insomnia)

  3. Upper limb ability

    Time frame: 6 month post-stroke

    Assessed using the Action Research Arm Test (range 0-57, higher score indicates better upper limb ability)

  4. Behavioural motor consolidation

    Time frame: 1 month post-stroke

    Assessed as change in motor performance on a sequential button pressing task (movement time, in seconds) from training to retest

Secondary outcomes

  1. Whole body motor impairment

    Time frame: 6 months post-stroke

    Assessed using the Fugl-Meyer Assessment, range 0-100 (higher score indicates better functional mobility)

  2. Hand dexterity

    Time frame: 6 months post-stroke

    Assessed using the Nine Hole Peg Test, scored as the number of pegs placed in 30 seconds (greater number of pegs indicates better hand dexterity)

  3. Mobility

    Time frame: 6 months post-stroke

    Assessed using the Rivermead Mobility Index, range 0-15 (higher score indicates better functional mobility)

  4. Estimated Total Sleep Time

    Time frame: 1 and 6 months post-stroke

    Assessed using actigraphy (wearable activity monitor) over 7-nights

  5. Wake After Sleep Onset

    Time frame: 1 and 6 months post-stroke

    Assessed using actigraphy (wearable activity monitor) over 7-nights (higher amount of wake after sleep onset indicates worse sleep)

  6. Symptoms of insomnia at 6-months

    Time frame: 6 months post-stroke

    Assessed using the Sleep Condition Indicator, a questionnaire assessing self-reported insomnia symptoms (range 0-32, higher scores indicate fewer symptoms of insomnia)

Other outcomes

  1. Electroencephalography (EEG) Sleep Measures

    Time frame: 1 month post-stroke

    At home electroencephalography (EEG) headband for assessing sleep measures (e.g. sleep spindle amplitude, spindle density, sleep staging, cross-frequency coupling)

  2. Mood (Depression)

    Time frame: 1 and 6 months post-stroke

    Assessed using the Patient Health Questionnaire (8-item), range 0-24 (higher values indicate more depressive symptoms)

  3. Risk of Obstructive Sleep Apnoea

    Time frame: 1 month post-stroke

    Assessed using the STOP BANG questionnaire, range 0-8 (higher values indicate higher risk)

  4. Presence of Sleep Disorders

    Time frame: 1 month post-stroke

    Assessed using the Sleep Disorders Screening questionnaire. Positive responses within sub-groups of questions indicate potential presence of specific sleep disorders.

  5. Stroke severity

    Time frame: 1 and 6 months post-stroke

    Assessed using the modified Rankin Scale, range 0-6 (higher values indicate more severe stroke)

  6. Stroke severity

    Time frame: Baseline

    Assessed using the National Institute for Health Stroke Scale (NIHSS), range 0-42 (higher values indicate greater severity)

  7. Physical activity

    Time frame: 1 and 6 months post-stroke

    Assessed using actigraphy (wearable activity monitor) over 5 days

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Robinson

CONTACT

[email protected]

Melanie K Fleming, Dr

CONTACT

[email protected]

01865 611 461

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

Investigating Consolidation of Motor Learning in the Context of Recovery After Stroke

Acronym: SMiLES

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2023
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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