NCT05479006 Determine the Effect of Targeted High-definition Transcranial Direct Current Stimulation (tDCS) on Reducing Post-stroke Upper Limb Motor Impairments
| NCT ID | NCT05479006 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Carle Foundation Hospital |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-09-30 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2022-09-30 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * Paresis confined to one side, with substantial motor impairment of the paretic upper limb * Capacity to provide informed consent Exclusion Criteria: * 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) * Using a pacemaker * Metal implants in the head * Known adverse reactions to TMS and tDCS * Pregnant
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05479006 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05479006 currently recruiting?
Yes, NCT05479006 is actively recruiting participants. Contact the research team at yuan.yang@carle.com for enrollment information.
Where is the NCT05479006 trial being conducted?
This trial is being conducted at Urbana, United States.
Who is sponsoring the NCT05479006 clinical trial?
NCT05479006 is sponsored by Carle Foundation Hospital. The trial plans to enroll 30 participants.
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