Hemiparetic StrokeNCT07599774
Optimal Targeted High-definition Transcranial Direct Current Stimulation for Reducing Post-stroke Upper Limb Motor Impairments
A study testing High-definition transcranial direct stimulation: optimal and Modified constraint-induced movement therapy in people with Hemiparetic Stroke, run by Carle Foundation Hospital at 1 site in United States.
Trial summary
Non-invasive, non-pharmaceutical technologies that augment routine clinical practice for brain diseases and manage chronic symptoms have advanced rapidly over the past two decades. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemiparetic Stroke
- What is being tested?
- High-definition transcranial direct stimulation: optimal and Modified constraint-induced movement therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18 years or older
- Must have had a stroke that resulted in paresis confined to one side. The use of a wheelchair or other assisting devices are not exclusionary.
- Must have substantial motor impairment of the paretic upper limb
- Absence of severe wasting or contracture or significant sensory deficits in the paretic upper limb
- Absence of severe concurrent medical problems (e.g. cardiorespiratory impairment)
- Fugl-Meyer Upper Extremity Score of 8-50 based on assessment performed during the baseline visit.
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- Must have had either MRI or CT of the brain performed at Carle as part of their stroke care. Imaging may have been performed either during the diagnostic work-up for stroke or as follow-up after diagnosis. The most recent images from either MRI or CT will be collected for this study.
- Capacity to provide informed consent and participate in English (Since this study is a clinical trial and the team is yet to provide the translation service at this stage, the study is restricted to those who can consent and participate in English only).
- Must be willing and able to perform study procedures
Who cannot join
- Self-reported sensitive skin or adhesive allergy as assessed by the tDCS Safety Screening Questionnaire
- Has a cardiac pacemaker, defibrillator or an implantable cardiac resynchronization therapy device
- Has metal implants in the head and/or brain
- Presence of muscle tone abnormalities and motor or sensory impairment in the non-paretic limb
- Presence of severe muscle wasting or contracture or significant sensory deficits in the paretic upper limb
- Currently pregnant or planning to become pregnant during the study period
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- History of epilepsy, febrile convulsion, recurrent fainting spells or unexplained recurring headaches
- Current use of illicit/recreational drugs
- Currently undergoing anti-malarial treatment. (Note: participants can be considered for study participation after ant-malarial treatment has been discontinued)
- Has known adverse reaction to TMS or tDCS
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
Carle Foundation Hospital
Urbana, Illinois, 61801-3028
Carly Skadden, MPH, 217-326-0102 ext. 1, carly.skadden@carle.com
Yuan Yang, PhD, MS
About this study
Official title: Optimal Targeted High-definition tDCS for Reducing Post-stroke Upper Limb Motor Impairments
Non-invasive, non-pharmaceutical technologies that augment routine clinical practice for brain diseases and manage chronic symptoms have advanced rapidly over the past two decades. Among these, non-invasive brain stimulation such as transcranial direct current stimulation (tDCS) promotes neuroplasticity in injured brains, with fewer side effects and risks than invasive, implanted approaches such as deep-brain stimulation. Stimulating the brain can improve its function and help with recovery after a stroke. It has been a challenge to do this non-invasively. This is because the brain is reshaped after a stroke, and thus, it is difficult to find the right places to stimulate from the outside. In previous research, investigators found that optimal type and target of tDCS varied among subjects. The goal of this pilot trial is to test the feasibility of combining individually optimized, targeted high-definition tDCS (THD-tDCS) with rehabilitation therapy. Investigators will include 16 chronic stroke subjects with their optimal stimulation setup, obtained from their previous research. The participants will be computer-randomized into two equal-sized groups to receive either optimal THD-tDCS or sham stimulation, together with rehabilitation therapy (modified constraint-induced movement therapy, mCIMT) for five sessions over two weeks. Outcome measures will be collected at the baseline and right after the final intervention session. The primary outcome measure will be the change in the FM-UE score from baseline to immediately post the final intervention to assess the immediate effect of the intervention on upper extremity motor impairment. The secondary outcome measure will be the Wolf Motor Function Test time score to evaluate the immediate effect on functional motor performance.
- Conditions
- Hemiparetic Stroke
- Being tested
- High-definition transcranial direct stimulation: sham, High-definition transcranial direct stimulation: optimal, Modified constraint-induced movement therapy
- Keywords
- Upper limb, Stroke rehabilitation, Individualized intervention, High-definition transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-definition transcranial direct stimulation: shamDevice
High-definition transcranial direct stimulation with zero stimulation intensity (placebo)
High-definition transcranial direct stimulation: optimalDevice
High-definition transcranial direct stimulation with individualized, optimal parameters.
Modified constraint-induced movement therapyBehavioural
Modified Constraint-Induced Movement Therapy (mCIMT) is an evidence-based neurorehabilitation approach that improves upper limb function after stroke or brain injury by restricting the unaffected limb while intensively training the affected limb.
| Study group | Role | What they receive |
|---|---|---|
| Optimal targeted HD-tDCS + mCIMT | Active comparator | Optimal targeted HD-tDCS (high-definition transcranial direct current stimulation) during Constraint Induced Movement Therapy (mCIMT) Receives: Device: High-definition transcranial direct stimulation: optimal; Behavioral: Modified constraint-induced movement therapy |
| Sham HD-tDCS + mCIMT | Sham comparator | Sham HD-tDCS (high-definition transcranial direct current stimulation) administers no dose or zero milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT) Receives: Device: High-definition transcranial direct stimulation: sham; Behavioral: Modified constraint-induced movement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Fugl-Meyer Upper Extremity score from baseline
Fugl-Meyer Upper Extremity (FM-UE) is a measure of motor impairment (0 to 66 points, with higher points indicating less impairment). FM-UE scale consists of a 33-item assessment which provides a global assessment of upper extremity motor impairment. A rater provides an ordinal rating (2=near normal ability/response, 1=partial ability, 0=unable to perform/no response) for each item.
Measured: Right after the final intervention session
Secondary outcomes (1)
Change in the Wolf Motor Function Test Time Score From Baseline
Wolf Motor Function (WMFT) Test is a measure of functional motor activity that quantifies upper extremity motor ability through timed and functional tasks. The WMFT Time Score the median of 15 timed arm movements and hand dexterity tasks, each to be completed up to 120s. If a task could not be completed in 120s, a score of 121s was assigned. Higher score indicates a worse motor function.
Measured: Right after the final intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start15 Nov 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiparetic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carle Foundation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Yuan Yang, Carle Foundation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599774
- Sponsor's protocol ID
- 26CNI4419
- Other IDs
- 26BCDA1622682
- Status last verified
- Apr 2026
- First submitted
- 14 May 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I will follow American Heart Association Open Science Policy to share IPD: https://professional.heart.org/en/research-programs/awardee-resources/open-science-policy-statements-for-aha-funded-research
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Targeted High-definition tDCS for Reducing Post-stroke Upper Limb Motor Impairments
- ClinicalTrials.gov ID
- NCT07599774
- Acronym / sponsor ID
- 26CNI4419
- Conditions
- Hemiparetic Stroke
- Keywords
- Upper limb, Stroke rehabilitation, Individualized intervention, High-definition transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Carle Foundation HospitalUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-invasive, non-pharmaceutical technologies that augment routine clinical practice for brain diseases and manage chronic symptoms have advanced rapidly over the past two decades. Among these, non-invasive brain stimulation such as transcranial direct current stimulation (tDCS) promotes neuroplasticity in injured brains, with fewer side effects and risks than invasive, implanted approaches such as deep-brain stimulation. Stimulating the brain can improve its function and help with recovery after a stroke. It has been a challenge to do this non-invasively. This is because the brain is reshaped after a stroke, and thus, it is difficult to find the right places to stimulate from the outside. In previous research, investigators found that optimal type and target of tDCS varied among subjects. The goal of this pilot trial is to test the feasibility of combining individually optimized, targeted high-definition tDCS (THD-tDCS) with rehabilitation therapy. Investigators will include 16 chronic stroke subjects with their optimal stimulation setup, obtained from their previous research. The participants will be computer-randomized into two equal-sized groups to receive either optimal THD-tDCS or sham stimulation, together with rehabilitation therapy (modified constraint-induced movement therapy, mCIMT) for five sessions over two weeks. Outcome measures will be collected at the baseline and right after the final intervention session. The primary outcome measure will be the change in the FM-UE score from baseline to immediately post the final intervention to assess the immediate effect of the intervention on upper extremity motor impairment. The secondary outcome measure will be the Wolf Motor Function Test time score to evaluate the immediate effect on functional motor performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimal targeted HD-tDCS + mCIMT | Active comparator | Device: High-definition transcranial direct stimulation: optimal, Behavioral: Modified constraint-induced movement therapyOptimal targeted HD-tDCS (high-definition transcranial direct current stimulation) during Constraint Induced Movement Therapy (mCIMT) |
| Sham HD-tDCS + mCIMT | Sham comparator | Device: High-definition transcranial direct stimulation: sham, Behavioral: Modified constraint-induced movement therapySham HD-tDCS (high-definition transcranial direct current stimulation) administers no dose or zero milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must be 18 years or older
- Must have had a stroke that resulted in paresis confined to one side. The use of a wheelchair or other assisting devices are not exclusionary.
- Must have substantial motor impairment of the paretic upper limb
- Absence of severe wasting or contracture or significant sensory deficits in the paretic upper limb
- Absence of severe concurrent medical problems (e.g. cardiorespiratory impairment)
Key exclusion criteria (10 listed)
- Self-reported sensitive skin or adhesive allergy as assessed by the tDCS Safety Screening Questionnaire
- Has a cardiac pacemaker, defibrillator or an implantable cardiac resynchronization therapy device
- Has metal implants in the head and/or brain
- Presence of muscle tone abnormalities and motor or sensory impairment in the non-paretic limb
- Presence of severe muscle wasting or contracture or significant sensory deficits in the paretic upper limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-definition transcranial direct stimulation: shamHigh-definition transcranial direct stimulation with zero stimulation intensity (placebo) | Device | Sham HD-tDCS + mCIMT |
| High-definition transcranial direct stimulation: optimalHigh-definition transcranial direct stimulation with individualized, optimal parameters. | Device | Optimal targeted HD-tDCS + mCIMT |
| Modified constraint-induced movement therapyModified Constraint-Induced Movement Therapy (mCIMT) is an evidence-based neurorehabilitation approach that improves upper limb function after stroke or brain injury by restricting the unaffected limb while intensively training the affected limb. | Behavioural | Optimal targeted HD-tDCS + mCIMT, Sham HD-tDCS + mCIMT |
Primary outcome
Change in the Fugl-Meyer Upper Extremity score from baseline
Time frame: Right after the final intervention session
Fugl-Meyer Upper Extremity (FM-UE) is a measure of motor impairment (0 to 66 points, with higher points indicating less impairment). FM-UE scale consists of a 33-item assessment which provides a global assessment of upper extremity motor impairment. A rater provides an ordinal rating (2=near normal ability/response, 1=partial ability, 0=unable to perform/no response) for each item.
1 secondary outcome
Change in the Wolf Motor Function Test Time Score From Baseline
Time frame: Right after the final intervention session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Yes. I will follow American Heart Association Open Science Policy to share IPD: https://professional.heart.org/en/research-programs/awardee-resources/open-science-policy-statements-for-aha-funded-research
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-definition transcranial direct stimulation: optimal and Modified constraint-induced movement therapy in people with Hemiparetic Stroke, run by Carle Foundation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan Yang, PhD, MS (217-244-5870, yuan.yang@carle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Fugl-Meyer Upper Extremity score from baseline (time frame: Right after the final intervention session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.