Optimal Targeted High-definition Transcranial Direct Current Stimulation for Reducing Post-stroke Upper Limb Motor Impairments

NCT07599774 | Not Yet Recruiting

• 2 other identifiers: 26CNI441926BCDA1622682
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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 our previous research, we 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. We will include 16 chronic stroke subjects with their optimal stimulation setup, obtained from our 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

Keywords

Upper limb; Stroke rehabilitation; Individualized intervention; High-definition transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Right after the final intervention session

Secondary Outcomes (1)

• Change in the Wolf Motor Function Test Time Score From Baseline

  Right after the final intervention session

Study Arms (2)

Optimal targeted HD-tDCS + mCIMT

ACTIVE COMPARATOR

Optimal targeted HD-tDCS (high-definition transcranial direct current stimulation) during Constraint Induced Movement Therapy (mCIMT)

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)

Device: High-definition transcranial direct stimulation: sham; Behavioral: Modified constraint-induced movement therapy

Interventions

High-definition transcranial direct stimulation: sham DEVICE

High-definition transcranial direct stimulation with zero stimulation intensity (placebo)

Sham HD-tDCS + mCIMT

High-definition transcranial direct stimulation: optimal DEVICE

High-definition transcranial direct stimulation with individualized, optimal parameters.

Optimal targeted HD-tDCS + mCIMT

Modified constraint-induced movement therapy BEHAVIORAL

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.

Optimal targeted HD-tDCS + mCIMT; Sham HD-tDCS + mCIMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 18 years or older
• 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.
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Carle Foundation Hospital: lead
• American Heart Association: collaborator

Study Sites (1)

Carle Foundation Hospital

Urbana, Illinois, 61801-3028, United States

Location

Central Study Contacts

Yuan Yang, PhD, MS

CONTACT

217-244-5870; yuan.yang@carle.com

Sanjiv Jain, MD

CONTACT

217-383-3800; sanjiv.jain@carle.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Please refer to https://professional.heart.org/en/research-programs/awardee-resources/open-science-policy-statements-for-aha-funded-research for detailed information in term of time-frame of sharing such data
• Access Criteria: Please refer to https://professional.heart.org/en/research-programs/awardee-resources/open-science-policy-statements-for-aha-funded-research for detailed information in term of access criteria

Locations

US (1)