About this trial
Significant motor impairments occur in 80% of individuals after moderate to severe stroke and impact the body side to the lesioned hemisphere. Typical motor impairments involve loss of dexterity with highly prevalent upper limb flexion synergy. Advances in treating flexion synergy impairments have been hampered by a lack of precision rehabilitation. Previous studies suggest and support the role of cortico-reticulospinal tract (CRST) hyperexcitability in post-stroke flexion synergy. CRST hyperexcitability is often caused by damage to the corticospinal tract (CST). We hypothesize that: 1) inhibiting the contralesional dorsal premotor cortex (cPMd) will directly reduce the CRST hyperexcitability and thus, reduce the expression of the flexion synergy; 2) facilitating the ipsilesional primary motor cortex (iM1) will improve the excitability of the damaged CST, therefore reducing the CRST hyperexcitability and the flexion synergy. we propose to use a novel targeted high-definition tDCS (THD-tDCS) to specifically modulate the targeted cortical regions for testing his hypothesis, via the following aims: Aim 1. Evaluate the effect of cathodal THD-tDCS over the cPMd on reducing the CRST hyperexcitability and the expression of flexion synergy. Aim 2. Evaluate the effect of anodal THD-tDCS over the iM1 on improving the excitability of the CST, and determine whether this, thus, also reduces the CRST hyperexcitability and the flexion synergy. Aim 3. Evaluate the confluence effect of bilateral THD-tDCS, i.e., simultaneous cathodal stimulation over the cPMd and anodal over the iM1.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Paresis confined to one side, with substantial motor impairment of the paretic upper limb
Capacity to provide informed consent
Disqualifiers
Muscle tone abnormalities and motor or sensory impairment in the non-paretic limb
Severe wasting or contracture or significant sensory deficits in the paretic upper limb
Severe cognitive or affective dysfunction that prevents normal communication and understanding of consent or instruction
Severe concurrent medical problems (e.g. cardiorespiratory impairment)
Trial design
Crossover
Treatments tested in this trial
Transcranial direct current stimulation (high- definition)
Device20 minutes, 2 mA stimulation.
Treatment groups
Trial outcomes
Primary outcomes
Change in Transcranial Magnetic Stimulation-Evoke Motor-evoked Potential 1: Ispilesional stimulation in the brain and contralateral response in the muscle
This is a neurophysiological measure that determines the use of the ipsilesional corticospinal tract.
Change in Transcranial Magnetic Stimulation-Evoke Motor-evoked Potential 2: Contralesional stimulation in the brain and ipsilateral response in the muscle
This is a neurophysiological measure that determines the use of the contralesional cortico-reticulospinal tract.
Secondary outcomes
Change in a subset of Fugl-Meyer Upper Extremity assessment which is mainly related to the muscle synergies
This clinical measure is mainly related to the upper limb muscle synergies
Change in Fugl-Meyer Upper Extremity assessment
This reflects the overall motor impairment level.
Other outcomes
Modified Ashworth Scale
This indicates the expression of muscle tone or spasticity
Sponsors and contacts
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Carle Foundation Hospital
Lead sponsor
American Heart Association
Collaborator