GRAViceptive NEGlect Treatment in Acute Stroke Using Targeted Cranial ELECTrotherapy (GravNegElect)

July 8, 2026 updated by: Taiza G. S. Edwards, PhD, University of Sao Paulo

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study explores a new approach to treat graviceptive neglect, a condition that affects balance and perception of uprightness, using a non-invasive brain stimulation technique called HD-tDCS (high-definition transcranial direct current stimulation). Using a phase I/II randomized sham-controlled double-blind parallel clinical trial design, we aim to analyze if HD-tDCS can safely help correct abnormal visual verticality perception in 28 people after stroke. We will also investigate the effects of our protocol on cerebrovascular response using transcranial Doppler and cortical activity using EEG. Neuroanatomical characteristics will be analyzed to establish the relationship between verticality perception error and the extent of temporo-parietal junction (TPJ) damage and, more broadly, the putative VV structural brain Network (VVN). Each participant will receive six HD-tDCS sessions of 2mA for 20 minutes in a central cathode montage applied over the contralesional TPJ. Patients will be randomized into two groups, with 50% receiving active stimulation and 50% receiving sham stimulation. The sham stimulation condition will consist of the same electrode placement, with a 2mA ramp-up over 30 seconds, followed by a 30-second ramp-down. Both groups will undergo 6 sessions, three times a day, for 2 days. The follow-up assessment will be performed 1 month after stimulation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Taiza G. S. Edwards, PhD
  • Phone Number: +55-16-33153379
  • Email: taiza@fmrp.usp.br

Study Contact Backup

  • Name: Lizanilda Albuquerque, BSc
  • Phone Number: +55-16-36021202
  • Email: lizanilda@usp.br

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14049-900
        • University of São Paulo, Ribeirão Preto Medical School
      • Ribeirão Preto, São Paulo, Brazil, 14015160
        • Ribeirão Preto Medical School, University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active HD-tDCS
Participants will receive six sessions of 2mA active HD-tDCS cathode center over the contralesional TPJ for 20 minutes, 3 times daily for 2 days with session intervals greater than 3 hours.
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.
Sham Comparator: Sham HD-tDCS
Participants will receive six sessions of 2mA sham HD-tDCS cathode center over the contralesional TPJ for 20 minutes, 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Verticality Perception (VV; visual graviceptive neglect)
Time Frame: From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).
Change in VV: assessment using the bucket method.
From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Verticality Perception (VV; visual graviceptive neglect)
Time Frame: From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).
Change in VV: assessment using the bucket method.
From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).
Ocular torsion
Time Frame: From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).
Change in ocular torsion: assessment using fundus photography (Phelcom; Eyer 1 device)
From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).
Ocular torsion
Time Frame: From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).
Change in ocular torsion: assessment using fundus photography (Phelcom; Eyer 1 device)
From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).
Electroencephalography
Time Frame: From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).
Electroencephalography measurements focusing on resting state networks related to visual verticality perception.
From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).
Electroencephalography
Time Frame: From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).
Electroencephalography measurements focusing on resting state networks related to visual verticality perception.
From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).
Cerebrovascular reactivity
Time Frame: From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).
Transcranial Doppler Ultrasonography (TCD; Viasonix Dolphin/XF Robot) will be employed to measure cerebral blood flow velocity in the middle cerebral arteries while the participant performs the breath-holding maneuver.
From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).
Cerebrovascular reactivity
Time Frame: From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).
Transcranial Doppler Ultrasonography (TCD; Viasonix Dolphin/XF Robot) will be employed to measure cerebral blood flow velocity in the middle cerebral arteries while the participant performs the breath-holding maneuver.
From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).
Spatial neglect
Time Frame: From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).
Spatial neglect will be assessed using the conventional Behavior Inattention Test (BIT), which consists of 6 items: 1) line crossing; 2) letter cancellation; 3) star cancellation; 4) figure and shape copying; 5) line bisection; and 6) representational drawing.
From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).
Spatial neglect
Time Frame: From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).
Spatial neglect will be assessed using the conventional Behavior Inattention Test (BIT), which consists of 6 items: 1) line crossing; 2) letter cancellation; 3) star cancellation; 4) figure and shape copying; 5) line bisection; and 6) representational drawing.
From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brain magnetic resonance imaging (MRI)
Time Frame: Up to 15 days post stroke.
The structural integrity of the visual verticality network will be evaluated using diffusion MRI.
Up to 15 days post stroke.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundação de Amparo à Pesquisa do Estado de São Paulo
Thomas Jefferson University
Viasonix
Phelcom
FBX Medical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Taiza Edwards, PhD, Ribeirão Preto Medical School, University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 74877723.4.0000.5440
  • 2023/03252-2 (Other Grant/Funding Number: The São Paulo Research Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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