Recruiting

tDCS

Sponsor:

Carle Foundation Hospital

Code:

NCT05479006

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcranial direct current stimulation (high- definition)

Study Details

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.

Conditions

Stroke

Study ID

NCT05479006

Start date

Sep 30, 2022

Status verified date

Dec, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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

Interventions

Transcranial direct current stimulation (high- definition)

20 minutes, 2 mA stimulation.

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 ]
  • Change in Transcranial Magnetic Stimulation-Evoke Motor-evoked Potential 2: Contralesional stimulation in the brain and ipsilateral response in the muscle [ Time Frame: Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention ]

Central Contacts and Locations

Central contacts

Locations

Carle Foundation Hospital

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Principal Investigator:

Yuan Yang, PhD, MS

More Information

Sponsor

Carle Foundation Hospital

Last update posted

Dec 19, 2025

Last verified

Dec, 2025

Keywords

  • Stroke
  • Non-invasive Brain Stimulation
  • Movement Impairment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carle Foundation Hospital on 2025-12-19.