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Sleep and Motor Learning in Stroke

Sponsor: University of Oxford

NCT ID: NCT05746260

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 48 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
150
Started
2023-03-01
Last checked
2024-11

Plain English Summary

What is this study?

  • • Testing a new treatment for stroke
  • • Clinical study - 150 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with stroke

Where?

  • • Oxford - Wellcome Centre for Integrative Neuroimaging (WIN)

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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).

Stroke

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

OR a positive

What the study is looking for

  • ✓Aged 18 years or above
  • ✓Within 1 month of onset of stroke affecting the upper limb as confirmed by clinical diagnosis

Who cannot take part

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

Where Is This Study? (1 UK site)

Wellcome Centre for Integrative Neuroimaging (WIN)

Oxford OX3 9DU, United Kingdom

Recruiting
Site contact (verified)
Barbara Robinsonsleep-win@ndcn.ox.ac.uk
Melanie K Fleming, Drmelanie.fleming@ndcn.ox.ac.uk

How to Get in Touch

Melanie K Fleming, Dr

Sponsor contact

CONTACT

01865 611 461 melanie.fleming@ndcn.ox.ac.uk

Barbara Robinson

Sponsor contact

CONTACT

sleep-win@ndcn.ox.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-11