Clinical trial NCT05746260: Sleep and Motor Learning in Stroke
Official title: Investigating Consolidation of Motor Learning in the Context of Recovery After Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: Rehabilitation
Motor Consolidation
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with stroke affecting the upper limb

Brief summary: 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).

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)

Primary outcomes:
measure: Sleep fragmentation at 1-month
timeFrame: 1 month post-stroke
measure: Symptoms of insomnia at 1-month
timeFrame: 1 month post-stroke
measure: Upper limb ability
timeFrame: 6 month post-stroke
measure: Behavioural motor consolidation
timeFrame: 1 month post-stroke
Secondary outcomes:
measure: Whole body motor impairment
timeFrame: 6 months post-stroke
measure: Hand dexterity
timeFrame: 6 months post-stroke
measure: Mobility
timeFrame: 6 months post-stroke
measure: Estimated Total Sleep Time
timeFrame: 1 and 6 months post-stroke
measure: Wake After Sleep Onset
timeFrame: 1 and 6 months post-stroke
measure: Symptoms of insomnia at 6-months
timeFrame: 6 months post-stroke
Other outcomes:
measure: Electroencephalography (EEG) Sleep Measures
timeFrame: 1 month post-stroke
measure: Mood (Depression)
timeFrame: 1 and 6 months post-stroke
measure: Risk of Obstructive Sleep Apnoea
timeFrame: 1 month post-stroke
measure: Presence of Sleep Disorders
timeFrame: 1 month post-stroke
measure: Stroke severity
timeFrame: 1 and 6 months post-stroke
measure: Stroke severity
timeFrame: Baseline
measure: Physical activity
timeFrame: 1 and 6 months post-stroke
Locations:
city: Oxford
country: United Kingdom
facility: Wellcome Centre for Integrative Neuroimaging (WIN)
Study officials:
affiliation: University of Oxford
name: Heidi Johansen-Berg, Professor
role: PRINCIPAL_INVESTIGATOR
References: