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TRANScranial direct current stimulation
current
for Post-stroke mOtor Recovery
– a phase II sTudy(TRANSPORT2)
Wayne Feng MD MS
Medical University of South Carolina
&
Gottfried Schlaug MD PhD
Beth Israel Deaconess Medical Center
Non-Invasive Brain Stimulation
Schlaug, Expert review Medical Device, 2008 Feng, tDCS in stroke recovery, 2010
Current Status of tDCS in Stroke Motor Recovery
100+ studies, more human trials than animal studies
14 double-blind sham-controlled studies with ≥5 tDCS
sessions in motor recovery
– 6 studies with anodal stimulation on affected
hemisphere
– 5 studies with cathodal stimulation on unaffected
hemisphere
– 1 study with cathodal stimulation on the affected
hemisphere
– 5 studies with bihemispheric stimulation
– 3 studies compared ipsilesional anodal and
contralateral cathodal stimulation
3
Challenges & Opportunities
Dosage/Current
Montage
Acute vs. chronic
Outcome
measure(s)
Peripheral Rehab
Therapy
Patient selection
4
Derived Stimulation Parameters
– Current (mA)
– Current Density (A/m2) =
Current ÷ pad Size
– Charge (C) = Current × Duration
– Charge Density (C/m2) =
Current Density × Duration
– Total Charge (C) = Charge × Sessions
– Total Charge Density (C/m2) =
Charge Density × Sessions
Described Stimulation Parameters
– Current (mA) [1-2mA]
– Pad Size (cm2) [3*5; 5*5; 5*7]
– Duration (min) [10 -40]
– Number of Sessions [5-30]
5
Define Dosage in tDCS
6
Dose of tDCS Emerges as an Important Brain Modulator
Safety and Tolerability of High Dose
tDCS Has been Assessed
1mA >> 2mA >> 2.5mA >> 3.0mA>> 3.5mA>>4.0mA
*Funded by NIH: P20 GM109040
Electrode Montage –
Bihemispheric is better
8
Acute vs. Chronic Stroke Phase
9
Selection of Outcome Measures
10
CIMT as Adjunct Rehab TherapyMean difference = ( tDCS + RT) – (Sham stimulation + RT)
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Effective
Standardized
Quantifiable
EXCITE trial was the first NIH sponsored stroke rehab trial and completed in 2005
Feng et al., Annals of Neurology 78; 860-870, 2015
Corticospinal Tract Lesion Load: An Imaging
Biomarker for Stroke Motor Outcomes
Study Design
13
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Inclusion Criteria
Each subject must meet all of the following criteria to
participate in this study:– 21-80 years old of any race; and
– First-ever unihemispheric ischemic stroke that occurred at least 3
months ago; and
– Unilateral limb weakness with Fugl-Meyer Upper Extremity score of ≤ 56
(out of 66) to avoid ceiling effect; and
– At least 10 degrees of wrist dorsiflexion or 20 degrees of elbow
flexion/extension (this matches the EXCITE trial inclusion criteria); and
– An absolute difference of FM-UE scores between two baseline
assessments that is ≤ 4 points indicating patient has a stable motor
impairment;
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Exclusion CriteriaSubjects who meet any of the following criteria will be excluded from
the study
Primary intracerebral hematoma, subarachnoid hemorrhage or bi-hemispheric ischemic
strokes; or
Taking drugs, at the time of study, including but not limited to carbamazepine, flunarizine,
sulpiride, rivastigmine, dextromethorpan; or
Other co-existent neuromuscular disorders affecting upper extremity motor function; or
Other neurological disorders(eg. severe dementia or parkinson disease) pre- or post-stroke
affecting subject’s ability to pariticipate in the study; or
History of medically uncontrolled depression or other psychiatric disorder despite
medications either before or after stroke that may subject’s ability to participate in the study;
or
Uncontrolled hypertension despite medical treatment(s) at the time of enrollment, defined as
SBP≥185mmHg or DBP≥110mmHg; or
Presence of any MRI/tDCS/TMS risk factors: a) an electrically, magnetically or mechanically
activated metal or nonmetal implants including cardiac pacemaker, intracerebral vascular
clips or any other electrically sensitive support system; b) non-fixed metal in any part of the
body, including a previous metallic injury to eye; c) pregnancy (effects of tDCS on the fetus
are unknown); d) history of seizure disorder or post-stroke seizure; e) preexisting scalp
lesion, bone defect or hemicraniectomy.
16
Hypothetic Scenarios
17
Acknowledgement
Stroke recovery working group
NDMC
NCC
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