Sleep and Motor Learning in Stroke

Stroke Clinical Trial

— SMiLES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05746260
• Other study ID #: PID 16062
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: March 2027

Study information

• Verified date: August 2022
• Source: University of Oxford
• Contact: Melanie K Fleming, Dr
• Phone: 01865 611 461
• Email: melanie.fleming[@]ndcn.ox.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 week of stroke onset from stroke wards. At baseline (≤ 7 days 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 7 days 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)

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
United Kingdom	Wellcome Centre for Integrative Neuroimaging (WIN)	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Risk of Obstructive Sleep Apnoea	Assessed using the STOP BANG questionnaire, range 0-8 (higher values indicate higher risk)	1 month post-stroke
Other	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
Other	Stroke severity	Assessed using the modified Rankin Scale, range 0-6 (higher values indicate more severe stroke)	1 and 6 months post-stroke
Other	Stroke severity	Assessed using the National Institute for Health Stroke Scale (NIHSS), range 0-42 (higher values indicate greater severity)	Baseline
Other	Physical activity	Assessed using actigraphy (wearable activity monitor) over 5 days	1 and 6 months post-stroke
Primary	Sleep fragmentation at 1-month	Assessed using actigraphy (wearable activity monitor) over 7-nights (more fragmentation indicates worse sleep).	1 month post-stroke
Primary	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
Primary	Upper limb ability	Assessed using the Action Research Arm Test (range 0-57, higher score indicates better upper limb ability)	6 month post-stroke
Primary	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
Secondary	Whole body motor impairment	Assessed using the Fugl-Meyer Assessment, range 0-100 (higher score indicates better functional mobility)	6 months post-stroke
Secondary	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
Secondary	Mobility	Assessed using the Rivermead Mobility Index, range 0-15 (higher score indicates better functional mobility)	6 months post-stroke
Secondary	Estimated Total Sleep Time	Assessed using actigraphy (wearable activity monitor) over 7-nights	1 and 6 months post-stroke
Secondary	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
Secondary	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