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Comparing Transcranial Direct Current Stimulation Montages in Stroke

Comparing Different Transcranial Direct Current Stimulation Montages in Acute Stroke Patients: a Randomized, Triple-blinded, Sham-controlled Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04340973
Enrollment
40
Registered
2020-04-10
Start date
2020-05-07
Completion date
2020-07-01
Last updated
2020-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Stroke

Keywords

tDCS, Acute Stroke, WMFT, SWMT, Fugl Meyer

Brief summary

40 acute subjects will be split into 5 groups. Each group will receive one of the following tDCS montages : anodal, bilateral, cathodal, extracephalic or placebo. Subjects will receive, in addition to conventional rehabilitation, 2mA for 20 mins of their attributed tDCS, 5 times a week. Evaluations will take place before the first stimulation period (48h post stroke), after 1, 2, 3 and 4 weeks. Evaluations consist of the Wolf Motor Function Test, the Fugl Meyer, and the Semmes Weinstein Monofilament Test

Detailed description

40 acute subjects will be randomized and split into 5 groups. Each group will receive one of the following tDCS montages : Anodal : Anode placer over the affected primary motor cortex, cathode over contralateral supra orbital area Bilateral : Anode placer over the affected primary motor cortex, cathode over unaffected motor cortex Cathodal : Cathode placer over the unaffected primary motor cortex, anode over contralateral supra orbital area Extracephalic : Anode placer over the affected primary motor cortex, cathode over right shoulder Placebo : anode montage but current is ramped up over 15 secondes, then ramped down. Subjects will receive, in addition to conventional rehabilitation (±1.5h/weekday), 2mA for 20 mins of their attributed tDCS, 5 times a week. Evaluations will take place before the first stimulation period (48h post stroke), after 1, 2, 3 and 4 weeks. Evaluations consist of the Wolf Motor Function Test, the Fugl Meyer, and the Semmes Weinstein Monofilament Test All researchers, therapists, data analysis and patients are blinded by a code system implemented in the tDCS machine

Interventions

DEVICETranscranial Direct Current Stimulation

Subjects received a micro-current through their scalp to induce cortical and subcortical changes

Sponsors

University of Liege
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Everyone is blinded, codes are selected by a third party not involved in any step of the study

Intervention model description

5 groups, each group receives one of four treatments or the sham treatment. Double-blinded, sham controlled study

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* First Ever Stroke * Motor or sensory deficit * Understands and follows orders * Signed inform consent

Exclusion criteria

* One Yes on the medium and high risk sections of the TSST (Bornheim et al.,2019)

Design outcomes

Primary

MeasureTime frameDescription
Change in Wolf Motor Function TestPre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4Functional upper limb test, filmed and scored subjectively
Change in Fugl Meyer Motor AssessmentPre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4Functional upper limb, lower limb and sensory test
Change in Semmes Weinstein Monofilament TestPre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 411 Point Sensory test

Countries

Belgium

Contacts

Primary ContactStephen Bornheim, Msc
stephen.bornheim@uliege.be003243662193

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026