StrokeE-brainNCT05329818
Clinical, Electrophysiological and E-field Modelling Evidence of High Density Transcranial Direct Current Stimulation in Motor Stroke
A study testing high definition transcranial direct current stimulation in people with Stroke, run by Xavier Corominas at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- high definition transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2021to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University Hospital Joan XXIII
Tarragona, Catalonia, 43007
Maria Teresa Colomina Fosch, MD, PhD, +34977558153, mariateresa.colomina@urv.cat
Xavier Corominas, MsC
About this study
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.
Read the detailed description
Stroke cause direct network dysfunctions correlating with the underlying behavioral deficits In that context, characterize and boost neuronal reshaping towards a favorable state for recovery has become a distinguished therapeutic approach. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation able to locally modulate neuronal activity and modify neural arquitecture.
In such scenario, the investigators develop in this protocol a new tDCS multitarget fronto-cerebellar tDCS approach, exploring the benefits of boosting motor dysfunctions by means of a dual site-approach, up-regulating dlPFC and CB activity. The investigators here design a pilot experimental clinical trial exploring the accumulative clinical potential for motor skill \& learning recovery and EEG effects of a high-density bifocal transcranial direct current stimulation protocol (HD-tDCS).
The investigators hypothesize that the tDCS protocol will promote direct functional motor reorganization helping relearning motor process, will boost the activity of prefrontal settled systems correcting attentional deficits and increasing strength connectivity with premotor systems, and will normalize large-scale abnormalities increasing interhemispheric functional connectivity (i.e., functional integration), decreasing interhemispheric asymmetry (i.e., functional segregation) and restoring transcallosal balance, impacting positively either in motor and cognitive recovery. All in all, this study will be the first exploring the simultaneous modulation of two different targets in stroke population corresponding to different networks looking for a summative/synergistic effects helping motor and cognitive functions recovery.
- Conditions
- Stroke
- Being tested
- high definition transcranial direct current stimulation
- Keywords
- Stroke, Neuromodulation, Transcranial direct current stimulation, Non-invasive brain stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high definition transcranial direct current stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Prefrontal stimulation. | Experimental | Participants receive anodal tDCS on the ipsilesional dlPFC for 5days/week for 2 weeks. Receives: Device: high definition transcranial direct current stimulation |
| Cerebellar stimulation. | Experimental | Participants receive anodal tDCS on the contralesional cerebellum for 5days/week for 2 weeks. min of HD-tDCS with 2.0mA. Receives: Device: high definition transcranial direct current stimulation |
| Fronto-cerebellar stimulation. | Experimental | Participants receive simultaneous anodal tDCS on the ipsilesional dlPFC and in contralesional cerebellum for 5days/week for 2 weeks. Receives: Device: high definition transcranial direct current stimulation |
| Sham stimulation. | Sham comparator | Participants receive sham tDCS for 5days/week for 2 weeks. Receives: Device: high definition transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The visuo-motor task is a computer task classically used to explore the human motor underpinnings of error control, skill learning, acquisition and/or adaptation. In the task, participants are instructed to control a cursor displayed in the computer's screen be means of a joystick handled with the impaired limb. A series of consecutive trials exploring motor adaptation to external perturbations are conducted. In order to quantify the motor performance adaptation from the visuo-motor task, the mean angular trajectory error ("MeanSumErr"; cm) at peak tangential velocity (PV),will be the selected output to represent subjects performance, where lower punctuations will correspond to better motor adaptation.
Measured: 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.
The AX-CPT is a computer paradigm classically used to explore sustained attention and cognitive control where its performance can be correlated with the impairment level in neurological conditions. In the AX-CPT participants are required to be aware to a serial continuous presentation of letters giving a target response. Participants are instructed to provide a correct response each time the cue-probe letter combination A + X is presented. Otherwise, participants are instructed to provide an alternative response when any other cue-probe letter combination is presented (e.g., A + S, etc.).In order to quantify attention performance from the AX-CPT task, the total number of errors will be the outcome used to represent sustained attention impairment.
Measured: 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.
The Montreal cognitive assessment (MoCA) is a quantitative screening tool used to explore stroke related cognitive deficits. The MoCA test is composed by a series of questions and tasks specifically designed to assess visuospatial functions, executive functions, working memory and short-term memory, attention, concentration, language and orientation. In order to quantify global pre-to-post intervention change in the cognitive impairment, the total summed punctuations will be used.
Measured: 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.
The NIHSS is a quantitative scale of stroke related neurologic deficits widely used to characterize baseline impairment in clinical trials. The NIHSS scale is a neurologic examination exploring consciousness level, visual field, language, hemineglect, hemiplegia, movement disorders and sensory domains. In order to represent global stroke severity impairment, the total summed punctuations will be used.
Measured: 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.
The letter cancelation test quantifies the presence of visual neglect scanning deficits. The bells cancelation test quantifies visual neglect deficits in the extra personal space. The line bisection test quantifies spatial neglect deficits.In order to quantify visual deficits from the letter cancelation test, bells cancelation test, and line bisection test, the total number of marked letters, the total number of marked bells and the deviation percentage of the patient's mark from the actual center of the line will be the outcomes used to represent the test performance. Each outcome will be reported and analyzed by isolate.
Measured: 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 modualtion of resting-state and task-engaged power spectral frequency, functional connectivity and entropy. To measure such domains, a electroencephalography (EEG) analysis will be conducted.
EEG data will be used to capturethe neural response to different HD-tDCS stimulation among our intervented groups.Data will be analyzed exploring mean power spectrum variations, exploring interhemispheric asymmetry by means of the pairwise derived Brain Symmetry Index, exploring functional connectivity modulation by means of the imaginary part of coherency and deep matrix comparisons, and exploring the variations on signal's complexity by means of a modified multi-scale entropy method. Each analysis will be conducted and explored in isolate.
Measured: Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.
Correlations between the electric field impact and the changes in the behavioral outcomes (clinical outcomes and eeg response). To perform such correlations, individual simulated biophysical models of electric stimulation distribution will be conducted.
First, we will reconstruct T1-weighted MRI individual head models. Following simulations of the received stimualtion protocol will be conducted in every single subject to explore the real impact of the stimulation. Different components of the electric field will be extracted and correlated with the behavioral results.
Measured: MRI will be acquired 2 weeks before treatment onset or from the medical database.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start15 Jun 2021
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xavier Corominas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xavier Corominas, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329818
- Sponsor's protocol ID
- 077/2021
- Acronym
- E-brain
- Status last verified
- Apr 2022
- First submitted
- 29 Mar 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38049806
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Electrophysiological and E-field Modelling Evidence of High Density Transcranial Direct Current Stimulation in Motor Stroke
- ClinicalTrials.gov ID
- NCT05329818
- Acronym / sponsor ID
- E-brain / 077/2021
- Conditions
- Stroke
- Keywords
- Stroke, Neuromodulation, Transcranial direct current stimulation, Non-invasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xavier CorominasUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 15 Apr 2022 (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.
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.
Detailed description
Stroke cause direct network dysfunctions correlating with the underlying behavioral deficits In that context, characterize and boost neuronal reshaping towards a favorable state for recovery has become a distinguished therapeutic approach. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation able to locally modulate neuronal activity and modify neural arquitecture.
In such scenario, the investigators develop in this protocol a new tDCS multitarget fronto-cerebellar tDCS approach, exploring the benefits of boosting motor dysfunctions by means of a dual site-approach, up-regulating dlPFC and CB activity. The investigators here design a pilot experimental clinical trial exploring the accumulative clinical potential for motor skill \& learning recovery and EEG effects of a high-density bifocal transcranial direct current stimulation protocol (HD-tDCS).
The investigators hypothesize that the tDCS protocol will promote direct functional motor reorganization helping relearning motor process, will boost the activity of prefrontal settled systems correcting attentional deficits and increasing strength connectivity with premotor systems, and will normalize large-scale abnormalities increasing interhemispheric functional connectivity (i.e., functional integration), decreasing interhemispheric asymmetry (i.e., functional segregation) and restoring transcallosal balance, impacting positively either in motor and cognitive recovery. All in all, this study will be the first exploring the simultaneous modulation of two different targets in stroke population corresponding to different networks looking for a summative/synergistic effects helping motor and cognitive functions recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prefrontal stimulation. | Experimental | Device: high definition transcranial direct current stimulationParticipants receive anodal tDCS on the ipsilesional dlPFC for 5days/week for 2 weeks. |
| Cerebellar stimulation. | Experimental | Device: high definition transcranial direct current stimulationParticipants receive anodal tDCS on the contralesional cerebellum for 5days/week for 2 weeks. min of HD-tDCS with 2.0mA. |
| Fronto-cerebellar stimulation. | Experimental | Device: high definition transcranial direct current stimulationParticipants receive simultaneous anodal tDCS on the ipsilesional dlPFC and in contralesional cerebellum for 5days/week for 2 weeks. |
| Sham stimulation. | Sham comparator | Device: high definition transcranial direct current stimulationParticipants receive sham tDCS for 5days/week for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 current stimulationNon-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. | Device | Cerebellar stimulation., Fronto-cerebellar stimulation., Prefrontal stimulation., Sham stimulation. |
Primary outcome
Pre-to-post intervention change on motor skills. To measure such domain, the Fugl-Meyer assessment (FMA) will be used.
Time frame: Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.
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.
7 secondary outcomes
Pre-to-post intervention change on motor adaptation skills. To measure such domain, a computer-based visuo-motor task will be used.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 modualtion of resting-state and task-engaged power spectral frequency, functional connectivity and entropy. To measure such domains, a electroencephalography (EEG) analysis will be conducted.
Time frame: Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.
Correlations between the electric field impact and the changes in the behavioral outcomes (clinical outcomes and eeg response). To perform such correlations, individual simulated biophysical models of electric stimulation distribution will be conducted.
Time frame: MRI will be acquired 2 weeks before treatment onset or from the medical database.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Derived from this study: PubMed 38049806Corominas-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.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 current stimulation in people with Stroke, run by Xavier Corominas at 1 site in Spain.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Apr 2022. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Teresa Colomina Fosch, MD, PhD (+34977558153, mariateresa.colomina@urv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-to-post intervention change on motor skills. To measure such domain, the Fugl-Meyer assessment (FMA) will be used. (time frame: Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05329818, which also lists 1 linked publication.
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 15 Apr 2022.