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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

GRAViceptive NEGlect Treatment in Acute Stroke Using Targeted Cranial ELECTrotherapy

Graviceptive Neglect After Stroke: Clinical, Neuroanatomical and Physiological Effects of Focal Neuromodulation

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

We aim to determine if targeted high-definition transcranial direct current stimulation (HD-tDCS) can safely correct errors in visual verticality perception in patients after stroke affecting either hemisphere.

Who May Be Eligible (Plain English)

Who May Qualify: - Supratentorial ischemic stroke diagnosed by neuroimaging and clinical analysis; - Clinically stable (stable vital signs for 24 hours; no chest pain in the last 24 hours; no significant arrhythmia; no evidence of deep vein thrombosis); - Normal or corrected-to-normal vision; - No previous experience with HD-tDCS; - Ability to provide willing to sign a consent form (patient or legal representative); - Ability to comply with the intervention and assessment schedule of the protocol. - Presence of visual verticality misperception. Who Should NOT Join This Trial: - Migraine; - Pregnancy; - Pacemakers; - Seizures; - Claustrophobia; - Transient ischemic attack; - Other neurological disorders; - Psychiatric disorders; - Sensitive scalp or prior brain surgery; - Diagnosis of severe carotid atherosclerotic disease (stenosis ≥ 70%); - Presence of metal implants, cardiac pacemakers, or claustrophobia; - Diagnosis of COVID-19 or other infectious disease that requires isolation; - Uncontrolled medical problems, such as terminal cancer or kidney disease. - Left-handed or mixed-handed individuals as determined using the Edinburgh Handedness Inventory (Appendix 10); - Peripheral vestibular deficits observed using neuro-otological screening tests when the participant's clinical condition allows (head shake test, head thrust test, Dix-Hallpike, and Pagnini-McClure); - Prior musculoskeletal disorders affecting alignment and postural balance (e.g., moderate to severe scoliosis; torticollis); - Cognitive dysfunction outside normal limits on the Mini-Mental State Examination (score below 23); - Global or Wernicke's aphasia; Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Supratentorial ischemic stroke diagnosed by neuroimaging and clinical analysis; * Clinically stable (stable vital signs for 24 hours; no chest pain in the last 24 hours; no significant arrhythmia; no evidence of deep vein thrombosis); * Normal or corrected-to-normal vision; * No previous experience with HD-tDCS; * Ability to provide informed consent (patient or legal representative); * Ability to comply with the intervention and assessment schedule of the protocol. * Presence of visual verticality misperception. Exclusion Criteria: * Migraine; * Pregnancy; * Pacemakers; * Seizures; * Claustrophobia; * Transient ischemic attack; * Other neurological disorders; * Psychiatric disorders; * Sensitive scalp or prior brain surgery; * Diagnosis of severe carotid atherosclerotic disease (stenosis ≥ 70%); * Presence of metal implants, cardiac pacemakers, or claustrophobia; * Diagnosis of COVID-19 or other infectious disease that requires isolation; * Uncontrolled medical problems, such as terminal cancer or kidney disease. * Left-handed or mixed-handed individuals as determined using the Edinburgh Handedness Inventory (Appendix 10); * Peripheral vestibular deficits observed using neuro-otological screening tests when the participant's clinical condition allows (head shake test, head thrust test, Dix-Hallpike, and Pagnini-McClure); * Prior musculoskeletal disorders affecting alignment and postural balance (e.g., moderate to severe scoliosis; torticollis); * Cognitive dysfunction outside normal limits on the Mini-Mental State Examination (score below 23); * Global or Wernicke's aphasia;

Treatments Being Tested

DEVICE

Active: High-Definition transcranial Direct Current Stimulation (HD-tDCS)

Active high-definition transcranial direct current stimulation (HD-tDCS) will be delivered by a low-intensity direct current stimulator (Soterix Medical) using a 3x1 ring configuration with a central cathode over the contralesional temporo-parietal junction. During the stimulation, participants will perform tasks to stimulate correct visual verticality perception. Six active HD-tDCS sessions of 2mA for 20 minutes HD-tDCS, 3 times daily for 2 days with session intervals greater than 3 hours.

DEVICE

Sham: High-Definition transcranial Direct Current Stimulation (HD-tDCS)

Six sessions (3 times daily for 2 days) of 2mA sham HD-tDCS cathode center over the contralesional TPJ for 20min. Direct current (DC) will be generated by a low-intensity direct current stimulator (Soterix Medical) and then split into the 3 high-density Ag/AgCl sintered ring electrodes. The sham stimulation condition will consist of the same positioning of the electrodes as the active condition, with a ramp-up to 2mA over 30 seconds and a subsequent ramp-down of 30 seconds.

Locations (2)

Ribeirão Preto Medical School, University of São Paulo
Ribeirão Preto, São Paulo, Brazil
University of São Paulo, Ribeirão Preto Medical School
Ribeirão Preto, São Paulo, Brazil