ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614000022662

Ethics application status

Not yet submitted

Date submitted

29/10/2013

Date registered

9/01/2014

Date last updated

9/01/2014

Type of registration

Prospectively registered

Titles & IDs

Public title

Yawn induced limb movements in stroke patients with arm weakness

Scientific title

Establishing the neuro-anatomical basis for extrapyramidal yawning movements observed in stroke patients with arm weakness

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

Yawning Induced Movements in Stroke Study ( YIMSS)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Yawning Induced Movements in an otherwise paralysed limb

Condition category

Condition code

Neurological

Other neurological disorders

Stroke

Ischaemic

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

Target follow-up type

Months

Description of intervention(s) / exposure

Observation Study:
1. Observe incidence of YIMS (yawning induced movements in stroke survivors) - subjects will be asked to complete regular surveys noting how frequently they observed autonomous movements associated with yawning.
2. Clinical survey upon admission to tertiary hospital for stroke for up to 6 months following a first stroke
3. Subjects will complete a survey upon admission and at 2 weeks, 1 and 3 and 6 months to determine their individual functional level and incidence of yawning induced movements
4. Subjects will be given a survey kit with the two week and 1,3 and 6 month survey forms, information pack and return prepaid envelopes
5. Investigators provide a reminder phone call prior to each survey to improve adherence
6.As secondary aim, wish to compare neuroanatomical stroke lesions between patients with YIMs against those without YIMs. Identifying these lesions will involve going through Head imaging taken during the diagnosis of stoke and potential fMRI in future studies

Intervention code [1]

Not applicable

Comparator / control treatment

N/A - This is an observational study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

1. Determine Incidence of Yawning Induced Arm Movements in stroke survivors
Incidence will be determined by participant observation and recollection.

Timepoint [1]

At admission and at 2 weeks, 1 month, 3 months and 6 months

Secondary outcome [1]

1. Establish (if possible) neuroanatomical correlations between subjects with YIMs compared to subjects without YIMs
This will be assessed through comparison of head imaging done at time of diagnosis and possibly fMRI as a separate study in the future

Timepoint [1]

1. Secondary time point for each patient is 6 months

Eligibility

Key inclusion criteria

Age >18
Cerebrovascular Accident (aka Stroke) presenting in 3-13 days
Stroke associated with motor deficit (paralysis) of the upper limbs
Able to give consent/assent
Family member able to give assent on behalf of patient

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Severe stroke or co-morbidities that make early death more likely
Previous Stroke
Significant movement disorders ( Parkinson’s Disease, Multiple Sclerosis, Motor Neuron Disease)

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Predicted sample size of 200-300 subjects

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/02/2014

Actual

Date of last participant enrolment

Anticipated

31/01/2015

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

300

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Sir Charles Gairdner Hospital - Nedlands

Recruitment postcode(s) [1]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Benjamin Mulo

Address

Sir Charles Gairdner Hospital
Department of Neurology
Hospital Avenue
Nedlands 6009
Western Australia, Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

SCGH Human Ethics Research Committee

Ethics committee address [1]

SCGH HREC
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
Western Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/11/2013

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

For many years the phenomenon of involuntary movements provoked by yawning, has been observed in stroke patients with paralysed limbs, particularly the arm. More than a hundred years ago, an analysis suggested that removal of inhibitory pathways, unmasked the associated movements of yawning and limb movements, which had an evolutionary link related back to the swim bladder and pectoral fins of fish. In healthy individuals, yawning is often accompanied by generalised stretching, which may include elevation of the arms, known as pandiculation.  The paralysed arm of stroke patients can be seen to move during a yawn, often bringing the hand towards the mouth, before suddenly dropping again at the end of the yawn. Walusinski coined this, “parakinesia brachialis oscitans”.  The observation appears to have been regarded as a curiosity, with some texts almost derisively regarding it as something that could potentially give false hope to stroke patients.

There has been some investigation into the neural basis of yawning in healthy subjects, with interest in the possible involvement of the mirror neurone pathways, and other regions distant to the motor cortex, including the ventromedial posterior prefrontal cortex. Movement of the paralysed limb during yawning in patients with pyramidal tract lesions, has been suggested to provide evidence for an independent “emotional motor” system, separate to the corticospinal motor tracts. Recruitment of these areas and pathways might provide a potential mechanism for recovery of motor function after stroke, particularly in the arm. There may thus be some potential for somehow utilising arm movements associated with yawning to stimulate upper limb recovery.  

Another fascinating aspect of yawning, is the common observation that witnessing yawning in others may result in another individual yawning; so called “contagious” yawning. This does not appear to be related to hypoxia or hypercarbia8. Some 42-55% of humans witnessing images of subjects yawning, will yawn themselves and the act of thinking of yawning may provoke yawning. 33% of adult chimpanzees yawned in response to seeing videos of other chimps yawning, possibly inferring advanced self awareness and empathy in this species. It is possible, therefore that yawning could be “evoked”, and thus used as a potential means for stimulating upper limb movements in paralysed patients. The exciting potential could be that yawning could thus be utilised as a neurorehabilitation therapy

The primary purpose of the study is determine the incidence of Yawning Induced Movements in stroke survivors. We hope to use this data to guide the development of future studies with the aim of determining if these movements can have an application in the rehabilitation of stroke survivors

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof David Blacker

Address

Department of Neurology
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
Western Australia

Country

Australia

Phone

+61 8 9346 3333

Fax

David.Blacker@health.wa.gov.au

Contact person for public queries

Name

Benjamin Mulo

Address

Department of Neurology
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
Western Australia

Country

Australia

Phone

+61 8 9346 3333

Fax

b_mulo@hotmail.com

Contact person for scientific queries

Name

Benjamin Mulo

Address

Department of Neurology
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
Western Australia

Country

Australia

Phone

+61 8 9346 3333

Fax

b_mulo@hotmail.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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