Clinical, Electrophysiological and E-field Modelling Evidence of High Density Transcranial Direct Current Stimulation in Motor Stroke
NCT ID: NCT05329818
Last Updated: 2022-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-06-15
2023-06-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transcranial Versus Suboccipital Direct Current Stimulation
NCT04117256
Effect of Repeated tDCS Sessions on Cognitive Improvement in Patients With Disorders of Consciousness
NCT02394691
Effects of Different Intensities of Bilateral-transcranial Direct Current Stimulation in Healthy Individuals
NCT05929014
Comparing Transcranial Direct Current Stimulation Montages in Stroke
NCT04340973
Developing an EEG Probe for Studying and Modulating Cognitive Control
NCT05612659
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prefrontal stimulation.
Participants receive anodal tDCS on the ipsilesional dlPFC for 5days/week for 2 weeks.
high definition transcranial direct current stimulation
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.
Cerebellar stimulation.
Participants receive anodal tDCS on the contralesional cerebellum for 5days/week for 2 weeks. min of HD-tDCS with 2.0mA.
high definition transcranial direct current stimulation
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.
Fronto-cerebellar stimulation.
Participants receive simultaneous anodal tDCS on the ipsilesional dlPFC and in contralesional cerebellum for 5days/week for 2 weeks.
high definition transcranial direct current stimulation
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.
Sham stimulation.
Participants receive sham tDCS for 5days/week for 2 weeks.
high definition transcranial direct current stimulation
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
high definition transcranial direct current stimulation
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* tDCS contraindications as defined by the international safety guidelines
* Large aphasic, psychiatric and cognitive deficits limiting patient's comprehension
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Xavier Corominas
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xavier Corominas
Principal investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Joan XXIII
Tarragona, Catalonia, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
077/2021
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.