Trial Review

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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
Date results information 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 712 0
Condition category
Condition code
Stroke 789 789 0 0

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] 573 0
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] 1006 0
The primary outcome is change in intensity, particularly in ipsilesional primary somatosensory cortex and bilateral secondary somatosensory cortex.
Timepoint [1] 1006 0
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] 1007 0
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] 1007 0
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] 1897 0
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] 1897 0
These are assessed at 1, 3, 4.5, 6 and 7.5 months post-stroke.
Secondary outcome [2] 1898 0
Neurological function will be measured using the Neurological Institute Stroke Scale and activities of daily living using the Barthel Index.
Timepoint [2] 1898 0
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?
No
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
45
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 874 0
Government body
Name [1] 874 0
NHMRC
Country [1] 874 0
Australia
Primary sponsor type
Other
Name
National Stroke Research Institute
Address
Country
Australia
Secondary sponsor category [1] 740 0
None
Name [1] 740 0
Nil
Address [1] 740 0
Country [1] 740 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2156 0
Austin Health
Ethics committee address [1] 2156 0
Ethics committee country [1] 2156 0
Australia
Date submitted for ethics approval [1] 2156 0
Approval date [1] 2156 0
07/12/2001
Ethics approval number [1] 2156 0
Ethics committee name [2] 2157 0
Northern Health
Ethics committee address [2] 2157 0
Ethics committee country [2] 2157 0
Australia
Date submitted for ethics approval [2] 2157 0
Approval date [2] 2157 0
23/11/2004
Ethics approval number [2] 2157 0
Ethics committee name [3] 2158 0
Eastern Health
Ethics committee address [3] 2158 0
Ethics committee country [3] 2158 0
Australia
Date submitted for ethics approval [3] 2158 0
Approval date [3] 2158 0
12/04/2005
Ethics approval number [3] 2158 0
Ethics committee name [4] 2159 0
Donvale Rehabilitation Hospital
Ethics committee address [4] 2159 0
Ethics committee country [4] 2159 0
Australia
Date submitted for ethics approval [4] 2159 0
Approval date [4] 2159 0
10/08/2005
Ethics approval number [4] 2159 0

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 35639 0
Address 35639 0
Country 35639 0
Phone 35639 0
Fax 35639 0
Email 35639 0
Contact person for public queries
Name 9762 0
Professor Leeanne Carey
Address 9762 0
National Stroke Research Institute
Austin Health
Repatriation Campus
Neurosciences Building
300 Waterdale Road
Heidelberg Heights VIC 3081
Country 9762 0
Australia
Phone 9762 0
+61 3 9496 2586
Fax 9762 0
+61 3 9496 2650
Email 9762 0
[email protected]
Contact person for scientific queries
Name 690 0
Professor Leeanne Carey
Address 690 0
National Stroke Research Institute
Austin Health
Repatriation Campus
Neurosciences Building
300 Waterdale Road
Heidelberg Heights VIC 3081
Country 690 0
Australia
Phone 690 0
+61 3 94962586
Fax 690 0
+61 3 94962650
Email 690 0
[email protected]

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.