Determine the Effect of Targeted High-definition Transcranial Direct Current Stimulation (tDCS) on Reducing Post-stroke Upper Limb Motor Impairments

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorCarle Foundation Hospital

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Transcranial direct current stimulation (high- definition)

    Device

    20 minutes, 2 mA stimulation.

Treatment groups

30 Participants
are divided into 4 treatment groups
Group A: Anodal stimulationActive comparator 1 intervention
Group B: Cathodal stimulationActive comparator 1 intervention
Group C: Bilateral StimulationActive comparator 1 intervention
Group D: Sham stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (initial visit), before (within 30 min range) and immediately after (within 30 min range) the intervention
2

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.

Time frame
Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention

Secondary outcomes

1

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

Time frame
Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention
2

Change in Fugl-Meyer Upper Extremity assessment

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

Other outcomes

1

Modified Ashworth Scale

This indicates the expression of muscle tone or spasticity

Time frame
Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention

Sponsors and contacts

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Carle Foundation Hospital

Lead sponsor

American Heart Association

Collaborator