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Do brain measures predict improvement of hand or arm function following brain stimulation in people with stroke?

Connectivity of the ipsilesional motor network as a marker of response to anodal transcranial direct current stimulation in people with stroke

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000443291
Enrollment
51
Registered
2018-03-28
Start date
2018-04-02
Completion date
2019-09-20
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Stroke is a leading cause of long term disability with around 60,000 people experiencing a stroke each year in Australia. In the acute post-stroke period over two thirds of patients experience some level of reduced upper limb function, while 15-30% of stroke survivors suffer permanent motor impairments despite extensive rehabilitation. Although extensive research has been devoted to establishing novel treatment modalities, few have made significant and reliable improvements to stroke rehabilitation and recovery. Brain based interventions which target affected brain networks are likely to be highly effective. Transcranial direct current stimulation (TDCS), a form of non-invasive brain stimulation, has demonstrated some promise for improving upper limb function post stroke. TDCS can facilitate motor learning by increasing network excitability. This raises the possibility that combining TDCS with therapy may lead to functional recovery beyond that normally achieved by therapy alone. However inconsistencies of both physiological and behavioural responses to TDCS suggests a ‘one-size-fits-all’ treatment might not be optimal. The neural sequelae arising from stroke are highly heterogeneous with the extent of subsequent impairment dependent upon lesion location and disruption of brain networks. Therefore individual differences in residual integrity of the lesioned motor network may contribute, at least in part, to variable TDCS responses. Motor network connectivity may be a valuable predictor of those who will benefit from TDCS application in general, or alternatively, benefit for different stimulation approaches (e.g. facilitatory vs inhibitory TDCS or ipsilesional vs contralesional stimulation). Biomarkers predictive of TDCS response would be beneficial to improve clinical translation of this ‘state-of-the-art’ intervention capable of substantially transforming stroke therapy and improving recovery. We hypothesise connectivity of the lesioned motor network will be greater in stroke patients who demonstrate a strong response to TDCS combined with upper limb exercise therapy.

Interventions

All participants will be provided with a home exercise program using the Graded Repetitive Arm Supplementary Program (GRASP). The GRASP level (grade 1-3) will be individualised by a qualified Occupational Therapist based on impairment of the upper limb. GRASP will be performed for 1 hour daily over a two week period (14 sessions). Participants will record exercise compliance using an exercise diary. All participants will be provided with an iPad to video link with the research team to ensure com

All participants will be provided with a home exercise program using the Graded Repetitive Arm Supplementary Program (GRASP). The GRASP level (grade 1-3) will be individualised by a qualified Occupational Therapist based on impairment of the upper limb. GRASP will be performed for 1 hour daily over a two week period (14 sessions). Participants will record exercise compliance using an exercise diary. All participants will be provided with an iPad to video link with the research team to ensure compliance, provide motivation, progress GRASP grade and troubleshoot any issues. Participants randomised to the 'Active' arm of the study will also receive transcranial direct current stimulation (tDCS) while simultaneously performing the GRASP exercises. TDCS will be delivered for 20 minutes at the start of the 1 hour GRASP program. TDCS involves weak direct current passing between two surface electrodes placed on the scalp. In this study, the electrodes will be positioned with the anode over the ipsilesional M1 and cathode over the contralateral supraorbital region. TDSC will be applied at intensity of 1mA for 20 minutes daily for two weeks (total of 14 sessions) at home. Stimulation will be ramped up from 0mA to 1mA over the first 30 seconds and down from 1mA to 0mA over the final 30 seconds. Compliance with tDCS use will be monitored using iPad's to video conference with the research team, supportive family members, information sheets and training for tDCS home use from a physiotherapist with extensive experience in brain stimulation.

Sponsors

University of South Australia (UNISA)
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

At least three months post first ischemic stroke with motor impairment Mild to moderate impairment of the upper limb Supportive family, friends or carers willing to actively assist and motivate across the two week intervention Active wrist extension of at least 5 degrees Active index finger flexion of at least 10 degrees Modified Ashworth score of <4

Exclusion criteria

TMS and tDCS safety exclusion criteria MRI safety exclusion criteria Neglect, apraxia, shoulder pain (>4 out of 10 on pain VAS) that would affect the ability to undertake a 1 hour upper limb exercise program Language of cognitive impairment that would limit ability to communicate with the research team via video conference Participation in a concurrent research study or clinical program for upper limb rehabilitation

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 5, 2026