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

NCT ID: NCT05479006

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke

Keywords

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Stroke Non-invasive Brain Stimulation Movement Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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. After each intervention, there will be at least 2 weeks wash-out period before participants receive the next intervention and assessments.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The sequence of the stimulations will be randomized (generated in RedCap) and double-blinded (assessor and participants).

Study Groups

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Anodal stimulation

Anodal stimulation targets the primary motor cortex (arm area) in the lesioned hemisphere, sham on the contralesional hemisphere.

Group Type ACTIVE_COMPARATOR

Transcranial direct current stimulation (high- definition)

Intervention Type DEVICE

20 minutes, 2 mA stimulation.

Cathodal stimulation

Cathodal stimulation targets the dorsal premotor cortex (arm area) in the contralesional hemisphere, sham on the lesioned hemisphere.

Group Type ACTIVE_COMPARATOR

Transcranial direct current stimulation (high- definition)

Intervention Type DEVICE

20 minutes, 2 mA stimulation.

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.

Group Type ACTIVE_COMPARATOR

Transcranial direct current stimulation (high- definition)

Intervention Type DEVICE

20 minutes, 2 mA stimulation.

Sham stimulation

Sham stimulation to both hemisphere of the brain

Group Type SHAM_COMPARATOR

Transcranial direct current stimulation (high- definition)

Intervention Type DEVICE

20 minutes, 2 mA stimulation.

Interventions

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Transcranial direct current stimulation (high- definition)

20 minutes, 2 mA stimulation.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Carle Foundation Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Carle Foundation Hospital

Urbana, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Yuan Yang, PhD

Role: CONTACT

Phone: 217-244-5870

Email: [email protected]

Sanjiv Jain, MD

Role: CONTACT

Phone: 217-383-3800

Email: [email protected]

Facility Contacts

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Carly Skadden, MPH

Role: primary

Sanjiv Jain, MD

Role: backup

References

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Williamson JN, James SA, Mulyana B, Kim S, He D, Li S, Sidorov EV, Yang Y. Quantitative EEG Metrics for Determining HD-tDCS Induced Alteration of Brain Activity in Stroke Rehabilitation. Restor Neurol Neurosci. 2024 Nov;42(3-4):209-221. doi: 10.1177/09226028251347427. Epub 2025 Jun 16.

Reference Type BACKGROUND
PMID: 40518976 (View on PubMed)

McPherson JG, Stienen AH, Drogos JM, Dewald JP. Modification of Spastic Stretch Reflexes at the Elbow by Flexion Synergy Expression in Individuals With Chronic Hemiparetic Stroke. Arch Phys Med Rehabil. 2018 Mar;99(3):491-500. doi: 10.1016/j.apmr.2017.06.019. Epub 2017 Jul 24.

Reference Type BACKGROUND
PMID: 28751255 (View on PubMed)

Peng RH, He D, James SA, Williamson JN, Skadden C, Jain S, Hassaneen W, Miranpuri A, Kaur A, Sarol JN, Yang Y. Determining the effects of targeted high-definition transcranial direct current stimulation on reducing post-stroke upper limb motor impairments-a randomized cross-over study. Trials. 2024 Jan 9;25(1):34. doi: 10.1186/s13063-023-07886-w.

Reference Type BACKGROUND
PMID: 38195605 (View on PubMed)

Williamson JN, James SA, He D, Li S, Sidorov EV, Yang Y. High-definition transcranial direct current stimulation for upper extremity rehabilitation in moderate-to-severe ischemic stroke: a pilot study. Front Hum Neurosci. 2023 Oct 12;17:1286238. doi: 10.3389/fnhum.2023.1286238. eCollection 2023.

Reference Type BACKGROUND
PMID: 37900725 (View on PubMed)

Other Identifiers

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14906

Identifier Type: -

Identifier Source: org_study_id