Acute Stroke Clinical Trial
Official title:
Transcranial Direct Current Stimulation (tDCS) in Acute Stroke Patients
Very early after the onset of the focal perfusion deficit, excitotoxic mechanisms can
lethally damage neurons and glia. Excitotoxicity triggers a number of events that can further
contribute to tissue death. Such events include peri-infarct depolarizations (PID) and
cortical spreading depolarization (CSD) within the peri-infarct zone or ischaemic penumbra.
Noninvasive brain stimulation techniques such as transcranial direct current stimulation
(tDCS) are emerging as promising tools, owing to their effects on modulating cortical
activity. Experimental studies have indicated that cathodic polarization of the cortical
surface blocks initiation of CSD. Moreover, it has been recently demonstrated in murine
stroke models that cathodal tDCS exerts a measurable neuroprotective effect in the acute
phase of stroke, decreasing the number of spreading depolarizations and reducing the infarct
volume by 20 to 30%.
The investigators propose here a pilot study, in acute middle cerebral artery stroke
patients, with a double blind randomization: cathodal tDCS versus sham tDCS. The duration of
this study will be two years. Fifty acute middle cerebral artery stroke patients will be
included. The tDCS will begin within 4.5 hours of symptom onset. The main criteria of
evaluation will be the extent of diffusion-weighted imaging (DWI) infarct volume between
imaging on admission and 24 hours later. The investigators propose the hypothesis that in
acute stroke patients, cathodal tDCS could be an adjuvant approach to recanalizing therapies.
In a murine model, it has been demonstrated that a cathodic polarization of cortical surface
with intensities of 30 µA and higher blocked the spreading depression completely. There is no
study demonstrating this in stroke patients. tDCS is a powerful tool to modulate the
excitability of motor areas. Cathodal tDCS induces a decrease of 30-50% of motor evoked
potentials amplitudes. In another study, cathodal stimulation compared with sham induced a
prolonged decrease of tactile discrimination, while sham stimulation did not. In our study,
cathodal stimulation will be delivered over lateral motor area (C3 or C4, 10-20 system) using
an intensity of 2 mA, in order to assess if an inhibition, a hyperpolarization of the middle
cerebral artery stroke ischemic penumbra could be obtained.
tDCS is characterized by an excellent safety profile. tDCS studies in patients were performed
with intensities comprised between 1 and 2 mA. Safety for these intensities has been
demonstrated. Minor tDCS adverse effects in healthy humans and patients with varying
neurological disorders were reported. These tDCS studies were performed for a wide range of
neurological and psychiatric conditions including pain, depression, Parkinson disease and
stroke rehabilitation. Mild tingling sensation, moderate fatigue, itching sensation under the
stimulating electrodes, headache were described. Tinnitus was also reported.
In human studies, durations of tDCS stimulation are generally comprised between 3 and 40
minutes, in iterative sessions. In our study, tDCS will be begun less than 4h30 after the
beginning of symptoms. Studies with murine stroke models demonstrated that cathodal tDCS
starting 45 minutes after middle cerebral artery occlusion and lasting 6 hours had a
neuroprotective effect reducing the infarct volume by 30% (20% in the group 4 hours of
duration, compared to sham). Based on these data, in our study, tDCS will be delivered 20
minutes per hour, during 6 hours. Usual neurovascular cares (IV thrombolysis, thrombectomy if
indicated) will be unchanged.
Some simulation studies have demonstrated that approximately half of the current injected
during tDCS is shunted through the scalp. Using stimulating currents of 2 mA, the magnitude
of the current density in relevant regions of the brain is of the order of 0.1 A/m2,
corresponding to an electric field of 0.22 V/m. Induced skin burns are rare. Skin burns are
preceded by a painful sensation. Saline-soaked sponges placed under the electrodes have to
remain moist in order to avoid these burns. In our study, patients will be questioned about
the tolerance of tDCS stimulation each hour. Impedance values of the tDCS electrodes will be
checked each hour.
A cephalic electrode montage has been chosen. A setup with M1 placement of the target
electrode (C3 or C4, 10-20 system) and an extra-cephalic placement of the return electrode
(shoulder) leads to a twofold to threefold higher electric field in the brainstem as compared
to the more commonly used cephalic setup with the target electrode over M1, and the return
electrode over the contralateral fronto-polar area (FP2 or FP1, 10-20 system). Reported
cerebral autoregulation changes may have been mediated via stimulation of brainstem autonomic
centers. The use of a cephalic return electrode montage is thus recommended. Accordingly to
these recommendations, in our study, the two electrodes are in a cephalic position: C3 or C4
and FP2 or FP1 (10-20 system).
The main objective of our study is to assess if cathodic tDCS over M1 (C3 or C4) in acute
stroke patients allow to preserve the penumbra and to reduce the infarct volume (MRI day 1
versus admission MRI).
Secondary objectives are:
1. to determine if tDCS improve clinical outcome at 7 days after stroke using the National
Institute of Health Stroke Scale (NIHSS)
2. to determine if tDCS improve clinical outcome at 3 months after stroke using the Rankin
scale
3. To assess tDCS side effects
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