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

Part of paid clinical trials in Urbana, Illinois.

Sponsor
Carle Foundation Hospital
Study ID
NCT05479006
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial direct current stimulation (high- definition) — DEVICE
    20 minutes, 2 mA stimulation.

Study Details

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.

Key Dates

Start date
Sep 30, 2022
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Anodal stimulation
    Anodal stimulation targets the primary motor cortex (arm area) in the lesioned hemisphere, sham on the contralesional hemisphere.
  • Active Comparator: Cathodal stimulation
    Cathodal stimulation targets the dorsal premotor cortex (arm area) in the contralesional hemisphere, sham on the lesioned hemisphere.
  • Active Comparator: Bilateral Stimulation
    Anodal stimulation targets the primary motor cortex (arm area) in the lesioned hemisphere and cathodal stimulation targets the dorsal premotor cortex (arm area) in the contralesional hemisphere at the same time.
  • Sham Comparator: Sham stimulation
    Sham stimulation to both hemisphere of the brain

Primary Outcome Measure

Change in Transcranial Magnetic Stimulation-Evoke Motor-evoked Potential 1: Ispilesional stimulation in the brain and contralateral response in the muscle [ Time Frame: Baseline (initial visit), before (within 30 min range) and immediately after (within 30 min range) the intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Carle Foundation HospitalUrbanaIllinois61801
Carly Skadden, MPH
[email protected]
217-326-0102
Sanjiv Jain, MD
[email protected]
217-383-3800
Sanjiv Jain, MD (SUB_INVESTIGATOR)
Yuan Yang, PhD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Urbana, IL

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Carle Foundation Hospital· Urbana, IL

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