ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12605000585628

Ethics application status

Approved

Date submitted

13/09/2005

Date registered

4/10/2005

Date last updated

2/11/2021

Date data sharing statement initially provided

2/11/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

Brain adaptation associated with spontaneous and training-induced recovery of touch sensation post-stroke.

Scientific title

Brain adaptation associated with spontaneous and training-induced recovery of touch sensation post-stroke.

Universal Trial Number (UTN)

Trial acronym

IN_Touch

Linked study record

Health condition

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

Stroke

Condition category

Condition code

Stroke

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The aim of this project is to locate and compare areas of brain activation associated with spontaneous (Study 1) and training-induced (Study 2) recovery of touch sensation following stroke, using serial functional magnetic resonance imaging (fMRI).
Intervention involves stimulus specific training of touch sensation and includes graded presentation of stimuli, active exploration, feedback and calibration of sensations. Training is conducted for 15 x 45 minute sessions over a 6 week interval.

Intervention code [1]

Rehabilitation

Comparator / control treatment

The control condition involves exposure to similar touch stimuli over the same number of sessions but does not include training principles.

Control group

Placebo

Outcomes

Primary outcome [1]

The primary outcome is change in intensity, particularly in ipsilesional primary somatosensory cortex and bilateral secondary somatosensory cortex.

Timepoint [1]

Assessed between 1 and 6-month scans post-stroke for Study 1 and between 6 and 7.5-month scans post-stroke for Study 2.

Primary outcome [2]

The primary outcome is extent of activation, particularly in ipsilesional primary somatosensory cortex and bilateral secondary somatosensory cortex. This will be assessed between 1 and 6-month scans post-stroke for Study 1 and between 6 and 7.5-month scans post-stroke for Study 2.

Timepoint [2]

Assessed between 1 and 6-month scans post-stroke for Study 1 and between 6 and 7.5-month scans post-stroke for Study 2.

Secondary outcome [1]

Clinical measures of touch sensation, i.e texture discrimination using the Tactile Discrimination Test and detection of touch pressure using the WEST hand monofilaments.

Timepoint [1]

These are assessed at 1, 3, 4.5, 6 and 7.5 months post-stroke.

Secondary outcome [2]

Neurological function will be measured using the Neurological Institute Stroke Scale and activities of daily living using the Barthel Index.

Timepoint [2]

At 1, 6 and 7.5 months.

Eligibility

Key inclusion criteria

Minimum age

Not stated

Maximum age

Not stated

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central randomisation. Independent notification via confidential email.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer random number generator with matching constraints.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/01/2004

Actual

15/05/2004

Date of last participant enrolment

Anticipated

Actual

12/10/2007

Date of last data collection

Anticipated

Actual

12/04/2008

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

Country [1]

Australia

Primary sponsor type

Other

Name

National Stroke Research Institute

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

07/12/2001

Ethics approval number [1]

Ethics committee name [2]

Northern Health

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

23/11/2004

Ethics approval number [2]

Ethics committee name [3]

Eastern Health

Ethics committee address [3]

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

12/04/2005

Ethics approval number [3]

Ethics committee name [4]

Donvale Rehabilitation Hospital

Ethics committee address [4]

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

Approval date [4]

10/08/2005

Ethics approval number [4]

Summary

Brief summary

Trial website

Trial related presentations / publications

Publications

Carey, L.M., Abbott, D.F., Lamp, G., Puce, A., Seitz, R.J. & Donnan, G.A. (2016). Same intervention-different reorganisation: The impact of lesion location on training-facilitated somatosensory recovery after stroke. Neurorehabilitation and Neural Repair, 30(10), 988-1000. doi: 10.1177/1545968316653836

Carey, L.M. (2012). Touch and body sensations. In L. Carey (Ed). Stroke Rehabilitation: Insights from Neuroscience and Imaging. (pp. 157-172). New York, NY: Oxford University Press. ISBN 978-0-19-979788-2.

Carey, L.M., Abbott, D.F., Harvey, M.R., Puce, A., Seitz, R.J. & Donnan, G.A. (2011). Relationship between touch impairment and brain activation after lesions of subcortical and cortical somatosensory regions. Neurorehabilitation and Neural Repair, 25(5), 443-457. doi: 10.1177/154968310395777

Carey, L.M., Abbott, D., Egan, G. & Donnan, G. (2008). Reproducible activation in BA2, 1 and 3b associated with texture discrimination in healthy volunteers over time. Neuroimage 39(1):40-51. 

Carey, L.M., Seitz, R. (2007). Functional Neuroimaging in Stroke Recovery and Neurorehabilitation: Conceptual Issues and Perspectives International Journal of Stroke. 2(4), 245-264. 

Carey, L.M. (2007). Neuroplasticity and learning lead a new era in stroke rehabilitation. (editorial). International Journal of Therapy and Rehabilitation. 14(6), 200-201. 

Carey L.M. (2006). Somatosensory loss. In Selzer M, Clarke S, Cohen L, Duncan P, Gage FH. (eds). Textbook of Neural Repair and Rehabilitation. Vol II. Cambridge: Cambridge Uni Press. (Chapter II.16, pages 231-247). 

Brodtman, A, Darby, D. & Carey, L. (2003). Functional MRI and stroke. In Davis, S., Fisher, M & Warach, S (eds). Magnetic Resonance Imaging and Stroke. Cambridge University Press, UK. pp 251-262. 


Presentations

Carey, LM, Abbott, DF., Lamp, G., Puce, A., Seitz, RJ, Donnan, GA. (2012) Imaging neuroplasticity of touch after stroke: training-facilitated changes following intervention. Organization for Human Brain Mapping 2012. Beijing China, June 10-14. 2012.

Abbott, D.F., Palmer, S.M., Low, E., Jackson, G.D., Carey, L.M. (2012) An fMRI study of the relative laterality of dominant and non-dominant hand sensory function. International Society for Magnetic Resonance and Imaging (ISMRM).

Carey, L, Alexander, B, Bannister, L, Gavrilescu, M. (2010) Task-related Connectivity of Sensory Networks after Cortical and Subcortical Somatosensory Lesions. 16th Annual Meeting of the Organization for Human Brain Mapping. Barcelona. June 6-10. 

Carey, L.M., Abbott, A., Harvey, M., Puce, A, Seitz, R. (2009) Brain Activation Differs Markedly following Cortical or Subcortical Lesions Causing Somatosensory Impairment Post-Stroke. Organization for Human Brain Mapping 15th Annual Meeting. June 18-23. San Francisco, CA. Neuroimage 47: Supplement 1: S94 

Carey L.M. (2008) Brain activation in sensory and motor recovery post-stroke. Stroke Satellite Meeting. Organization for Human Brain Mapping 14th Annual Meeting. June 14. Melbourne, Australia. 

Carey, L.M. (2008) How to use fMRI to answer clinical research questions. Specialist Certificate in Clinical Research (Neuroscience) and Pre-conference course ‘Introduction to Neuroimaging for Clinical Researchers’. Organization for Human Brain Mapping 14th Annual Meeting. June 15-19. Melbourne, Australia.
 
Carey, L.M., Abbott, A., Harvey, M., Puce, A, Seitz, R. (2008) Post-stroke somatosensory impairment inversely correlates with touch discrimination related BOLD signal in contralesional thalamus. Organization for Human Brain Mapping 14th Annual Meeting. June 15-19. Melbourne, Australia. (invited oral presentation and conference highlight.) Neuroimage 41: Supplement 1: S135
 
Carey, L.M. (2007) Neurorehabilitation and Recovery. Washington State University, St Louis, Departmental presentation. 

Carey, L.M. (2007) Touch, Space and Body Awareness: Rehabilitation. Cognitive Neuroscience and Rehabilitation: Touch, Space and Body Awareness Conference Workshop. Boston, USA. Oct 31- Nov 2 (presentation at highly selected international meeting). Supported by James S Macdonnell Foundation. 

Carey, LM, Abbott, DF, Seitz, R, Harvey, M, Puce A. (2007). Dynamics of neural plasticity in recovery of touch sensation after stroke. Human Brain Mapping. Chicago, USA, June 10-14. 

Carey, LM, Abbott, DF, Puce A, Seitz, R. (2006). Brain adaptation associated with spontaneous and treatment-facilitated recovery of touch sensation after stroke. 14th International Congress of the World Federation of Occupational Therapists. Sydney, Australia 23-28 July.

Carey, LM, Abbott, DF, Puce A, Seitz, R, Harvey, M, Donnan, GA. (2006). IN_Touch: Imaging Neuroplasticity of Touch post-stroke with moderate and severe touch impairment. Human Brain Mapping. Florence, Italy, June 11-15. 

Carey, L.M., Abbott, D.F., Egan, G.F., Donnan, G.A. (2006). Long-term reproducibility of brain activation associated with touch discrimination in older healthy volunteers: a serial PET study. Human Brain Mapping. Florence, Italy, June 11-15. 

Carey, L.M. (2005). Imaging recovery from stroke: treatment facilitated recovery. Imaging Recovery from Stroke: Second International Workshop. Hamburg, Germany. (May 23-24) (invited) 

Carey, LM, Abbott, DA, Chapman, H, Harvey, M. (2005). Recovery of touch sensation after stroke: Clinical and neuroanatomical outcomes associated with spontaneous and training-facilitated recovery: A case study. 14th European stroke conference. Bologna, Italy. 25-28 May. Abstract: Cerebrovascular Diseases, 19 (Suppl 2). 

Carey, L.M. (2004). Neural plasticity after stroke: Evidence and implications for rehabilitation. Stroke Society of Australasia Annual Scientific Meeting. Hobart, Tasmania.13-15 October. (invited paper)

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Professor Leeanne Carey

Address

National Stroke Research Institute
Austin Health
Repatriation Campus
Neurosciences Building
300 Waterdale Road
Heidelberg Heights VIC 3081

Country

Australia

Phone

+61 3 9496 2586

Fax

+61 3 9496 2650

lcarey@nsri.org.au

Contact person for scientific queries

Name

Professor Leeanne Carey

Address

National Stroke Research Institute
Austin Health
Repatriation Campus
Neurosciences Building
300 Waterdale Road
Heidelberg Heights VIC 3081

Country

Australia

Phone

+61 3 94962586

Fax

+61 3 94962650

lcarey@nsri.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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