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Standard upper limb therapy treatment with or without non-invasive brain stimulation to assist recovery after stroke

A pilot investigation of the effect of cathodal transcranial direct current stimulation (ctDCS) plus standard upper limb rehabilitation to augment motor recovery post acute stroke.

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000109707
Enrollment
37
Registered
2013-01-29
Start date
2013-02-04
Completion date
2013-12-31
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

A stroke occurs when the blood flow to the brain is suddenly stopped which causes brain cells in the area to die (infarct) because they are no longer receiving the oxygen and nutrients that they need to function. A stroke can have a devastating effect on the person because the brain controls the way we move, think, speak, and perform different tasks. It is very important to treat people after a stroke as soon as possible so that they are able to recover movement in the affected body parts and look after themselves without having to be dependent on others. Normally movement of the arm and leg is controlled by the opposite side of the brain. After stroke, the unaffected side of the brain may exert a dampening effect on the stroke affected side, preventing it from being active and controlling the opposite side of the body. This study aims to (1) Look at how easy it will be, over a 9 month period, to recruit 40 people presenting to SCGH who have had a particular type of stroke and as a result are unable to use their hand/arm; (2) record techniques used by physiotherapists and occupational therapists to help these people to use their affected arm after stroke; (3) study the effects of a safe low current electrical stimulation (transcranial direct current stimulation - tDCS) to the healthy side of the brain to reduce its dampening down effect on activity in the stroke affected brain. Stimulation, via electrodes placed on the scalp, will be applied at the same time as the affected arm is being treated. This study will recruit patients within 1 week after their stroke. They will be randomly split into two groups: group 1 will receive treatment to their arm plus tDCS to the healthy side of the brain and group 2 will receive treatment to their arm plus ‘pretend electrical stimulation’ (sham tDCS) to the brain.

Interventions

This study aims to (1) Look at how easy it will be, over a 9 month period, to recruit 34 to 40 people presenting to Sir Charles Gairdner Hospital (SCGH) who have had a particular type of stroke and as a result are unable to use their hand/arm; (2) record techniques used by physiotherapists and occupational therapists to help these people to use their affected arm after stroke; (3) study the effects of a safe low current electrical stimulation (transcranial direct current stimulation - tDCS) to t

This study aims to (1) Look at how easy it will be, over a 9 month period, to recruit 34 to 40 people presenting to Sir Charles Gairdner Hospital (SCGH) who have had a particular type of stroke and as a result are unable to use their hand/arm; (2) record techniques used by physiotherapists and occupational therapists to help these people to use their affected arm after stroke; (3) study the effects of a safe low current electrical stimulation (transcranial direct current stimulation - tDCS) to the healthy side of the brain to reduce its dampening down effect on activity in the stroke affected brain. Stimulation, via electrodes placed on the scalp, will be applied at the same time as the affected arm is being treated. This study will recruit patients within 1 week after their stroke. They will be randomly split into two groups: group 1 will receive treatment to their affected arm plus tDCS to the healthy side of the brain and group 2 will receive treatment to their affected arm plus ‘pretend electrical stimulation’ (sham tDCS) to the brain. Both groups will receive 10 rehabilitation sessions over a period of 2 weeks (i.e. 5 days of treatment, 2 days rest, 5 days of treatment). All sessions will last for 30 minutes consisting of upper limb rehabilitation plus ctDCS or sham tDCS respectively. Transcranial direct current stimulation (tDCS) is a commonly used non-invasive stimulation technique, which modulates cortical excitability by applying a weak direct current (1-2 mA) to the scalp overlying the area of the brain that it is intended to stimulate. 2 tDCS is usually applied via saline-soaked sponge electrodes applied to the skin.which are connected to a battery driven direct current stimulator. tDCS is a painless procedure which has been shown to have no major adverse effects, it uses relatively inexpensive equipment and is easy to apply in a clinical setting. Three different tDCS electrode montages are used to enhance upper limb recovery after stroke: (1) anodal stimulation (atDCS) to increase excitability of intact parts of the damaged hemisphere (stroke side); (2) cathodal stimulation (ctDCS) to decrease excitability of the brain tissue on the contralesional hemisphere (healthy side), (3) bihemispheric tDCS which involves an anode electrode over the affected side (to increase excitability), with a cathode electrode on the unaffected side (to decrease excitability and therefore enhance the effect of the anodal electrode). For the purposes of this study we will be investigating the effects of ctDCS over the unaffected hemisphere during standard upper limb rehabilitation. A total of 10 sessions over a period of 2 weeks, each session lasting for 30 minutes. Follow up assessments will last for 3 months after the 2-week intervention phase. "Standard upper limb therapy" will be defined in phases I & II of this study. The principal investigator will conduct a retrospective notes audit of all MCA ischaemic strokes admitted at SCGH between January - September 2011. Documentation from therapists will be collated as key phrases. In phase II the principal investigator will conduct focus groups with relevant therapists in the area in order to define key terminology and obtain and document a consensus outlining what truly is standard upper limb rehabilitation. This standard package of care will then be followed in Phase III as upper limb rehabilitation.

Sponsors

Sir Charles Gairdner Hospital
Lead SponsorHospital

Study design

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

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

All ischaemic strokes admitted to Sir Charles Gairdner Hospital under a consultant neurologist will be screened. A total of 37- 40 participants will be recruited for this study. All subjects must meet the following inclusion criteria: 1. First ever ischaemic stroke (cortical or subcortical involving the territory of the middle cerebral artery (MCA) based on imaging findings. 2. Stroke onset less than 1 week prior to study enrolment. 3. Moderate to severe hemiparesis based on the Fugl Meyer Upper Extremity assessment (35-52 moderate and less than 35 severe upper limb deficit). 4. Detectable motor evoked potentials (MEPs) in the affected hand muscles via TMS assessment. 5. Stable blood pressure parameters within limits approved by treating neurologist. 6. Age between 18 to 80 years old. 7. MMSE greater than 24

Exclusion criteria

Exclusion criteria: 1. Pre-existing upper limb impairment causing functional limitation 2. Hemiplegic shoulder pain 3. Metallic foreign body implant (pacemaker or artificial cochlea) 4. History of seizure or another unstable medical condition 5. Pregnancy 6. Severe language disturbance (Frenchay Aphasia Screening Test will be used to identify participants with communication difficulties; a more detailed evaluation will be performed by a speech pathologist to determine severity of language impairment). 7. English as a second language 8. Severe Neglect (score of < 44 out of 54 points on the Star Cancellation test) 9. History of depression, alcohol or drug abuse 10. Coexistent neurological or psychiatric disease 11. Current treatment with antidepressants, antipsychotics or benzodiazepines 12. Current treatment with Na+ or Ca 2+ Channel blockers or N-methyl-D-aspartate (NMDA) receptor antagonists.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026