StrokeNCT05479006
Determine the Effect of Targeted High-definition Transcranial Direct Current Stimulation (tDCS) on Reducing Post-stroke Upper Limb Motor Impairments
A study testing Transcranial direct current stimulation (high- definition) in people with Stroke, run by Carle Foundation Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Transcranial direct current stimulation (high- definition)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 1 Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Paresis confined to one side, with substantial motor impairment of the paretic upper limb
- Capacity to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Carle Foundation Hospital
Urbana, Illinois, 61801
Carly Skadden, MPH, 217-326-0102 ext. 1, carly.skadden@carle.com
Sanjiv Jain, MD, 217-383-3800, sanjiv.jain@carle.com
About this study
Official title: Determine the Effect of Targeted High-definition tDCS on Reducing Post-stroke Upper Limb Motor Impairments
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.
Read the detailed description
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
- Stroke
- Being tested
- Transcranial direct current stimulation (high- definition)
- Keywords
- Stroke, Non-invasive Brain Stimulation, Movement Impairment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (high- definition)Device
20 minutes, 2 mA stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Anodal stimulation | Active comparator | Anodal stimulation targets the primary motor cortex (arm area) in the lesioned hemisphere, sham on the contralesional hemisphere. Receives: Device: Transcranial direct current stimulation (high- definition) |
| Cathodal stimulation | Active comparator | Cathodal stimulation targets the dorsal premotor cortex (arm area) in the contralesional hemisphere, sham on the lesioned hemisphere. Receives: Device: Transcranial direct current stimulation (high- definition) |
| Bilateral Stimulation | Active comparator | 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. Receives: Device: Transcranial direct current stimulation (high- definition) |
| Sham stimulation | Sham comparator | Sham stimulation to both hemisphere of the brain Receives: Device: Transcranial direct current stimulation (high- definition) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
This is a neurophysiological measure that determines the use of the contralesional cortico-reticulospinal tract.
Measured: Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention
Secondary outcomes (2)
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
Measured: Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention
Change in Fugl-Meyer Upper Extremity assessment
This reflects the overall motor impairment level.
Measured: Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start30 Sep 2022
- Primary completion30 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carle Foundation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479006
- Sponsor's protocol ID
- 14906
- Status last verified
- Oct 2026
- First submitted
- 26 Jul 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are committed to enhancing the value of research and furthering the advancement of public knowledge. We recognize that the public dissemination of our scientific results can facilitate the creation of collaborative efforts with domestic and international collaborators. Furthermore, we recognize that the proposed project may result in novel ideas for new methods, technologies, and data that could benefit the entire research community. Therefore, final research data will be shared openly and timely in accordance with the most recent NIH guidelines (http://grants.nih.gov/grants/policy/data\_sharing/) while being mindful that the confidentiality and privacy of participants in research must be protected at all times.
Publications
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.
PubMed 40518976Yang, Y., Sidorov, E., & Dewald, J. P. (2021). Targeted tDCS reduces the expression of the upper limb flexion synergy in chronic hemiparetic stroke. Archives of Physical Medicine and Rehabilitation, 102(10), e10.
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.
PubMed 38195605Williamson 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.
PubMed 37900725