Clinical, Electrophysiological and E-field Modelling Evidence of High Density Transcranial Direct Current Stimulation in Motor Stroke
E-brain
1 other identifier
interventional
40
1 country
1
Brief Summary
The present study aims to investigate the therapeutic potential of a high definition transcranial direct current stimulation protocol, stimulating frontal and cerebellar areas boosting the cognitive and motor recovery of stroke population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Jun 2021
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2021
CompletedFirst Submitted
Initial submission to the registry
March 29, 2022
CompletedFirst Posted
Study publicly available on registry
April 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2023
CompletedApril 15, 2022
April 1, 2022
1.5 years
March 29, 2022
April 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pre-to-post intervention change on motor skills. To measure such domain, the Fugl-Meyer assessment (FMA) will be used.
The Fugl Meyer is a widely used scale to asses motor impairment on post-stroke patients and is considered one of the most comprehensive and reliable quantitative measures for motor hemiplegic dysfunctions 61. The FMA provides an incapacity index divided in five sub-scales encompassing the assessment of functional motricity, sensibility, balance, joint range and joint pain. Among the sub-sections of the scale, we will only use the functional motricity assessment to evaluate the motor domain, including the upper extremity (FMA-UE) and the lower extremity (FMA-LE). The FMA-UE and FMA-LE include a series of items measuring movement, coordination and reflexes.
Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.
Secondary Outcomes (7)
Pre-to-post intervention change on motor adaptation skills. To measure such domain, a computer-based visuo-motor task will be used.
Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.
Pre-to-post intervention change on cognitive abilities.To measure such domain. the AX-continuous performance task (AX-CPT) will be used.
Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.
Pre-to-post intervention change on cognitive abilities. To measure such domain the Montreal cognitive assessment (MoCA) will be used.
Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.
Pre-to-post intervention change on global stroke impairment. To measure such domain the National institutes of health stroke scale (NIHSS) will be used.
Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.
Pre-to-post intervention change on neglect impairment. To measure such domain, the letter cancelation test, the bell cancelation test and the line bisection test will be used.
Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.
- +2 more secondary outcomes
Study Arms (4)
Prefrontal stimulation.
EXPERIMENTALParticipants receive anodal tDCS on the ipsilesional dlPFC for 5days/week for 2 weeks.
Cerebellar stimulation.
EXPERIMENTALParticipants receive anodal tDCS on the contralesional cerebellum for 5days/week for 2 weeks. min of HD-tDCS with 2.0mA.
Fronto-cerebellar stimulation.
EXPERIMENTALParticipants receive simultaneous anodal tDCS on the ipsilesional dlPFC and in contralesional cerebellum for 5days/week for 2 weeks.
Sham stimulation.
SHAM COMPARATORParticipants receive sham tDCS for 5days/week for 2 weeks.
Interventions
Non-invasive brain stimulation neuromodulation using HD (3,14cm\^2) gel based round electrodes. Scalp electrode locations will be positioned based on a optimized biophysical solution targeting ipsilesional dlPFC and the contralesional anterior cerebellum. Patients in the prefrontal stimulation group will receive 20 min of HD-tDCS with 1.73mA. Patients in the cerebellar stimulation group will receive 20 min of HD-tDCS with 2.0mA. Patients in the prefrontal stimulation group will receive 20 min of HD-tDCS with 3.73 mA. Patients in the sham stimulation group will receive 20 min of sham HD-tDCS, with 30 seconds ramp-up and 30 seconds ramp-down.
Eligibility Criteria
You may qualify if:
- Received a diagnosis of supratentorial ischemic or hemorrhagic stroke confirmed by neuroimage (MRI, PET, CT, fMRI or DTI) in the middle cerebral artery territory or encompassing fronto-temporo-parietal hemorrhages
- Enrolled in a live rehabilitation program in the rehabilitation and physical medicine department
- Between 4 and 12 months after stroke episode
- Have signed the informed form
You may not qualify if:
- Medical instability with the presence of infections, assisted ventilation, epilepsy or recurrent seizures, untreated psychiatric disorders or an active treatment with sedative drugs
- tDCS contraindications as defined by the international safety guidelines
- Large aphasic, psychiatric and cognitive deficits limiting patient's comprehension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xavier Corominaslead
Study Sites (1)
University Hospital Joan XXIII
Tarragona, Catalonia, 43007, Spain
Related Publications (1)
Corominas-Teruel X, Bracco M, Fibla M, Segundo RMS, Villalobos-Llao M, Gallea C, Beranger B, Toba M, Valero-Cabre A, Colomina MT. High-density transcranial direct current stimulation to improve upper limb motor function following stroke: study protocol for a double-blind randomized clinical trial targeting prefrontal and/or cerebellar cognitive contributions to voluntary motion. Trials. 2023 Dec 4;24(1):783. doi: 10.1186/s13063-023-07680-8.
PMID: 38049806DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 29, 2022
First Posted
April 15, 2022
Study Start
June 15, 2021
Primary Completion
December 15, 2022
Study Completion
June 15, 2023
Last Updated
April 15, 2022
Record last verified: 2022-04