Clinical trial NCT01405378: Non-invasive Brain Stimulation for People With Stroke
Official title: Combining Transcranial Direct Current Stimulation (tDCS) With Robot Therapy for the Impaired Upper Limb in Stroke Rehabilitation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Stroke
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2011-07-29
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Every five minutes someone in the UK has a stroke. It is the main cause of long-term disability among adults in the UK despite a fall in age-specific stroke incidence, with a growing number of survivors remaining dependent for activities of daily living. While most people with stroke regain walking ability, upper limb problems with no voluntary arm and hand activity, affecting a third of people after stroke, has a poor prognosis. Transcranial direct current stimulation (tDCS) is a non-invasive procedure used to polarise brain regions through the application of weak direct currents and has the potential to develop into a useful aid to treatment strategies in neurorehabilitation. Recent literature into the application of tDCS in people with arm and hand impairments after stroke has shown promising results on upper limb function measures like the Jebsen-Taylor hand function test. Furthermore, a recent pilot study evaluated a six-week training programme combining tDCS with robot-assisted hand training and reported significant improvements in upper limb function. However, the robot in the latter study focused on single-plane distal movements only and long-term effects of the tDCS were not assessed. Recent robotic developments included robots with three rotational degrees-of-freedom for the upper limb, but the effectiveness of this type of robot combined with tDCS in early stroke settings is unknown. Ethical Approval was sought from NHS NRES Committee South Central- Southampton B (Ref: 11/SC/0345) to conduct this study.


Eligibility criteria: Inclusion Criteria:

1. Have a confirmed clinical diagnosis of a haemorrhagic or an ischaemic stroke confirmed clinically or by CT, PET or MRI Scan
2. Experienced a single (first) stroke or multiple strokes
3. In the acute, sub-acute or chronic phase of their recovery (the first three to seven days are referred to as the acute phase. The first two weeks to six months are defined as the sub-acute phase, and the chronic phase begins after three or six months (Teismann et al. 2011, Duncan et al. 2003a)
4. Have had a subcortical or cortical stroke
5. Be over the age of 18 years
6. Have any level of upper limb impairment

Exclusion Criteria:

1. A history of epilepsy (TMS studies) due to the fact that TMS could cause an epileptic fit
2. Impaired gross cognitive function; score of less than 24 of the Mini-Mental State Examination (Folstein et al. 1975)
3. Any metal implants in the head including cochlear implants
4. Any another neurological condition apart from stroke
5. Are currently participants in another intervention study using TMS/tDCS

Primary outcomes:
measure: Report change in upper limb function from baseline to 8 weeks and 3 months after treatment
timeFrame: Will be used, exactly before commencing training programme (day 1), at the end of the 8 week training programme and at 3 months follow-up
Secondary outcomes:
measure: Report change in cortical excitability from baseline to 8 weeks and 3 months after treatment
timeFrame: Will be used, exactly before commencing training programme (day 1), at the end of the 8 week training programme and at 3 months follow-up
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Faculty of Health Sciences, University of Southampton
Study officials:
References: