NCT Number: NCT05479006
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Not applicable
Urbana, Illinois, 61801, United States
Location status: Recruiting
Carly Skadden, MPH
CONTACT
217-326-0102 ext. 1
Sanjiv Jain, MD
CONTACT
Sanjiv Jain, MD
SUB_INVESTIGATOR
Yuan Yang, PhD, MS
PRINCIPAL_INVESTIGATOR
This sham-controlled cross-over study design will include four visits: 1) anodal stimulation targeting the ipsilesional hemisphere, 2) cathodal one at the contralesional hemisphere, 3) bilateral stimulation with anodal on the ipsilesional hemisphere and cathodal on the contralesional hemisphere and 4) a sham stimulation visit. The sequence of the stimulations will be randomized and double-blinded (assessor and participants). After each intervention, there will be at least 2 weeks wash-out period before participants receive the next intervention and assessments. Each visit will last up to 3 hours including the preparation time and breaks.
We will use neuro-navigation high-definition tDCS (NNG HD-tDCS) to target specific brain regions in a more precise way than before. A subject-specific head model will be built to evaluate the effect of lesion size and location on the electrical field of tDCS. The MR images (if available, otherwise CT images) will be used to build this subject-specific head model. The stimulation electrode montage and inter-electrode distance will be carefully examined by computer simulation to determine the optimal setup and dosage for NNG HD-tDCS.
The patient time commitment in this study is approximately 10 weeks where subjects have 4 x 1-day intervention and measurements, with 2 weeks washout the period in between.
The total number of potential enrolled subjects in this pilot study is 30.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
20 minutes, 2 mA stimulation.
Time frame: Baseline (initial visit), before (within 30 min range) and immediately after (within 30 min range) the intervention
This is a neurophysiological measure that determines the use of the ipsilesional corticospinal tract.
Time frame: Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention
This is a neurophysiological measure that determines the use of the contralesional cortico-reticulospinal tract.
Time frame: Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention
This clinical measure is mainly related to the upper limb muscle synergies
Time frame: Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention
This reflects the overall motor impairment level.
Time frame: Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention
This indicates the expression of muscle tone or spasticity
Contact information is provided by the study sponsor or research team.
Sanjiv Jain, MD
CONTACT
Yuan Yang, PhD
CONTACT
Carle Foundation Hospital
Other
Determine the Effect of Targeted High-definition tDCS on Reducing Post-stroke Upper Limb Motor Impairments
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