Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04051658 |
Other study ID # |
MU-CIRB 2018/238.0712 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 6, 2019 |
Est. completion date |
December 31, 2021 |
Study information
Verified date |
June 2022 |
Source |
Mahidol University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The aim of the present study is to evaluate the possible effect of using dual-tDCS applied
before conventional physical therapy on motor functions and hemodynamic response
Description:
It is generally accepted that transcranial direct current stimulation (tDCS) can induce
change in cortical excitability and thus modulate brain plasticity in the human brain. tDCS
has been used in neurorehabilitation to benefit ischemic stroke patients at different stages
of stroke especially during acute, subacute, and chronic phase with positive and safety
reports. After a unilateral stroke, the excitability of the affected hemisphere is decreased,
an increase in the excitability of the unaffected hemisphere and an abnormally high
interhemispheric inhibition (IHI) drive from the intact to lesioned hemisphere have been
reported.
These neuronal reorganizations and plasticity begin in the very early stages after stroke.
Prevent the abnormal IHI and thus increase the excitability of the affected hemisphere in the
early phase would be beneficial for stroke rehabilitation.
Based on the polarity-specific effects, anodal tDCS increases cortical excitability and
cathodal tDCS decreases cortical excitability. tDCS can be applied in two distinct montages:
monocephalic and bi-hemispheric/dual-tDCS (applying two electrodes over both cerebral
hemispheres at the same time). To induce post-stroke motor recovery, two different
monocephalic montages are typically used: i) to restore excitability in the ipsilesional
hemisphere: anode over the ipsilesional hemisphere and the cathode as the reference electrode
placed over the contra-orbital area ii) to down-regulate excitability of the contralesional
hemisphere and rebalance IHI: cathode over the contralesional hemisphere and the anode as the
reference electrode. Dual-tDCS can be also applied, permitting simultaneous coupling of
excitatory and inhibitory effects on both cortices. In the acute phase, there is few evidence
regarding the effect of tDCS on upper or lower limbs motor functions. However no evidence for
tDCS combined with training in the acute phase. Some previous studies reported a positive
effect on upper or lower limbs performance of tDCS with physical therapy in subacute to
chronic stroke. The immediate and long-term effectiveness of each tDCS montage (monocephalic
and bi-hemispheric/dual-tDCS) without physical rehabilitation in acute stroke also has been
reported. However, there is still unclear evidence regarding the best tDCS montage with
conventional physical therapy for stroke recovery, especially for the early phase The
mechanism underlying cortical excitability changes after tDCS is still elusive. However, one
possible mechanism indicating a change in cortical activity is the subsequent variation in
hemodynamic response. Since different montages of tDCS can induce different responses on
brain excitability. Different methods have been developed for cerebral hemodynamic
evaluations i.e. cerebral blood flow velocity (CBFV). Transcranial color-coded duplex
ultrasonography (TCCD) has been used to measure CBFV through the major intracranial vessels
through relatively thin bone windows. It is a non-invasive, relatively inexpensive, safe, and
portable allowing bedside monitoring of CBFV that is convenient in the intensive care
setting.
Five consecutive days for tDCS over the M1 appeared to be safe in acute stroke patient and
tDCS over the M1 have been reported to improve motor functions and balance performance.
Clinical outcomes that have been using in the clinical setting such as Fugl-Meyer Assessment
for motor functions, strength assessed by hand-held dynamometer, Time up and go for dynamic
balance and mobility, Five times sit to stand the test for dynamic balance and muscle
strength will be used as a secondary motor outcome.
The aim of the present study is to investigate hemodynamic response and motor performance
following difference montages of 5 tDCS sessions over the primary motor cortex (M1) applied
before conventional physical therapy, at immediate after of 5-sessions and then follow up at
1 month.