Optimal Targeted High-definition Transcranial Direct Current Stimulation for Reducing Post-stroke Upper Limb Motor Impairments
26 maj 2026 uppdaterad av: Yuan Yang, Carle Foundation Hospital
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
16
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Sanjiv Jain, MD
- Telefonnummer: 217-383-3800
- E-post: sanjiv.jain@carle.com
Studera Kontakt Backup
- Namn: Yuan Yang, PhD, MS
- Telefonnummer: 217-244-5870
- E-post: yuan.yang@carle.com
Studieorter
-
-
Illinois
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Urbana, Illinois, Förenta staterna, 61801-3028
- Carle Foundation Hospital
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Huvudutredare:
- Yuan Yang, PhD, MS
-
Kontakt:
- Carly Skadden, MPH
- Telefonnummer: 1 217-326-0102
- E-post: carly.skadden@carle.com
-
Underutredare:
- Sanjiv Jain, MD
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Optimal targeted HD-tDCS + mCIMT
Optimal targeted HD-tDCS (high-definition transcranial direct current stimulation) during Constraint Induced Movement Therapy (mCIMT)
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High-definition transcranial direct stimulation with individualized, optimal parameters.
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.
|
|
Sham Comparator: Sham HD-tDCS + mCIMT
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)
|
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.
High-definition transcranial direct stimulation with zero stimulation intensity (placebo)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in the Fugl-Meyer Upper Extremity score from baseline
Tidsram: 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.
|
Right after the final intervention session
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in the Wolf Motor Function Test Time Score From Baseline
Tidsram: Right after the final intervention session
|
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.
|
Right after the final intervention session
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
31 mars 2027
Avslutad studie (Beräknad)
30 juni 2027
Studieregistreringsdatum
Först inskickad
14 maj 2026
Först inskickad som uppfyllde QC-kriterierna
14 maj 2026
Första postat (Faktisk)
20 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 maj 2026
Senast verifierad
1 april 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 26CNI4419
- 26BCDA1622682 (Annat bidrag/finansieringsnummer: American Heart Association)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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
Tidsram för IPD-delning
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
Kriterier för IPD Sharing Access
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
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
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Nej
Studerar en amerikansk FDA-reglerad produktprodukt
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