Sleep and Motor Learning in Stroke (SMiLES)

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

Study Overview

• Status: Recruiting
• Conditions: Stroke

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).

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Melanie K Fleming, Dr; Phone Number: 01865 611 461; Email: melanie.fleming@ndcn.ox.ac.uk
• Study Contact Backup: Name: Barbara Robinson; Email: sleep-win@ndcn.ox.ac.uk

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 9DU
    • Recruiting
    • Wellcome Centre for Integrative Neuroimaging (WIN)
    • Contact: Barbara Robinson; Email: sleep-win@ndcn.ox.ac.uk
    • Contact: Melanie K Fleming, Dr; Email: melanie.fleming@ndcn.ox.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with stroke affecting the upper limb

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms of insomnia at 1-month	Assessed using the Sleep Condition Indicator, a questionnaire assessing self-reported insomnia symptoms (range 0-32, higher scores indicate fewer symptoms of insomnia)	1 month post-stroke
Upper limb ability	Assessed using the Action Research Arm Test (range 0-57, higher score indicates better upper limb ability)	6 month post-stroke
Behavioural motor consolidation	Assessed as change in motor performance on a sequential button pressing task (movement time, in seconds) from training to retest	1 month post-stroke
Sleep fragmentation at 1-month	Assessed using actigraphy (wearable activity monitor) over 7-nights (more fragmentation indicates worse sleep).	1 month post-stroke

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole body motor impairment	Assessed using the Fugl-Meyer Assessment, range 0-100 (higher score indicates better functional mobility)	6 months post-stroke
Hand dexterity	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)	6 months post-stroke
Mobility	Assessed using the Rivermead Mobility Index, range 0-15 (higher score indicates better functional mobility)	6 months post-stroke
Estimated Total Sleep Time	Assessed using actigraphy (wearable activity monitor) over 7-nights	1 and 6 months post-stroke
Symptoms of insomnia at 6-months	Assessed using the Sleep Condition Indicator, a questionnaire assessing self-reported insomnia symptoms (range 0-32, higher scores indicate fewer symptoms of insomnia)	6 months post-stroke
Wake After Sleep Onset	Assessed using actigraphy (wearable activity monitor) over 7-nights (higher amount of wake after sleep onset indicates worse sleep)	1 and 6 months post-stroke

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mood (Depression)	Assessed using the Patient Health Questionnaire (8-item), range 0-24 (higher values indicate more depressive symptoms)	1 and 6 months post-stroke
Risk of Obstructive Sleep Apnoea	Assessed using the STOP BANG questionnaire, range 0-8 (higher values indicate higher risk)	1 month post-stroke
Presence of Sleep Disorders	Assessed using the Sleep Disorders Screening questionnaire. Positive responses within sub-groups of questions indicate potential presence of specific sleep disorders.	1 month post-stroke
Stroke severity	Assessed using the modified Rankin Scale, range 0-6 (higher values indicate more severe stroke)	1 and 6 months post-stroke
Stroke severity	Assessed using the National Institute for Health Stroke Scale (NIHSS), range 0-42 (higher values indicate greater severity)	Baseline
Physical activity	Assessed using actigraphy (wearable activity monitor) over 5 days	1 and 6 months post-stroke
Electroencephalography (EEG) Sleep Measures	At home electroencephalography (EEG) headband for assessing sleep measures (e.g. sleep spindle amplitude, spindle density, sleep staging, cross-frequency coupling)	1 month post-stroke

Collaborators and Investigators

• Sponsor: University of Oxford
• Investigators: Principal Investigator: Heidi Johansen-Berg, Professor, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Motor Consolidation
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: PID 16062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data are available upon reasonable request
• IPD Sharing Time Frame: Following publication of results
• IPD Sharing Access Criteria: Available upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No