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Recruiting NCT05746260

Sleep and Motor Learning in Stroke

Observational Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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).

Primary outcome measures

  • Sleep fragmentation at 1-month [Time frame: 1 month post-stroke]
  • Symptoms of insomnia at 1-month [Time frame: 1 month post-stroke]
  • Upper limb ability [Time frame: 6 month post-stroke]
  • Behavioural motor consolidation [Time frame: 1 month post-stroke]
Secondary outcome measures (6)
  • Whole body motor impairment [Time frame: 6 months post-stroke]
  • Hand dexterity [Time frame: 6 months post-stroke]
  • Mobility [Time frame: 6 months post-stroke]
  • Estimated Total Sleep Time [Time frame: 1 and 6 months post-stroke]
  • Wake After Sleep Onset [Time frame: 1 and 6 months post-stroke]
  • Symptoms of insomnia at 6-months [Time frame: 6 months post-stroke]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • Wellcome Centre for Integrative Neuroimaging (WIN) — Oxford

Publications

  • Weightman M, Robinson B, Mitchell MP, Garratt E, Teal R, Rudgewick-Brown A, Demeyere N, Fleming MK, Johansen-Berg H. Sleep and motor learning in stroke (SMiLES): a longitudinal study investigating sleep-dependent consolidation of motor sequence learning in the context of recovery after stroke. BMJ Open. 2024 Feb 13;14(2):e077442. doi: 10.1136/bmjopen-2023-077442. PMID 38355178

Identifiers

NCT: NCT05746260 · PID 16062

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗