StrokePhase 1/2GravNegElectNCT06747676
GRAViceptive NEGlect Treatment in Acute Stroke Using Targeted Cranial ELECTrotherapy
A Phase 1/2 study testing Active: High-Definition transcranial Direct Current Stimulation (HD-tDCS) in people with Stroke, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Active: High-Definition transcranial Direct Current Stimulation (HD-tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesBrazil
- Study dates
- 3 Jan 2025to 15 Jan 2028
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Migraine;
- Pregnancy;
- Pacemakers;
- Seizures;
- Claustrophobia;
- Transient ischemic attack;
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- 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;
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Ribeirão Preto Medical School, University of São Paulo
Ribeirão Preto, São Paulo, 14015160
University of São Paulo, Ribeirão Preto Medical School
Ribeirão Preto, São Paulo, 14049-900
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Active: High-Definition transcranial Direct Current Stimulation (HD-tDCS), Sham: High-Definition transcranial Direct Current Stimulation (HD-tDCS)
- Keywords
- Stroke, Graviceptive Neglect, Verticality Perception, Non-invasive Brain Stimulation, Neuroimaging, Electroencephalography, Transcranial doppler, HD-tDCS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active: High-Definition transcranial Direct Current Stimulation (HD-tDCS)Device
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: High-Definition transcranial Direct Current Stimulation (HD-tDCS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Active HD-tDCS | Experimental | 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. Receives: Device: Active: High-Definition transcranial Direct Current Stimulation (HD-tDCS) |
| Sham HD-tDCS | Sham comparator | 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. Receives: Device: Sham: High-Definition transcranial Direct Current Stimulation (HD-tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Verticality Perception (VV; visual graviceptive neglect)
Change in VV: assessment using the bucket method.
Measured: From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).
Secondary outcomes (9)
Visual Verticality Perception (VV; visual graviceptive neglect)
Change in VV: assessment using the bucket method.
Measured: From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).
Ocular torsion
Change in ocular torsion: assessment using fundus photography (Phelcom; Eyer 1 device)
Measured: From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).
Ocular torsion
Change in ocular torsion: assessment using fundus photography (Phelcom; Eyer 1 device)
Measured: From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).
Electroencephalography
Electroencephalography measurements focusing on resting state networks related to visual verticality perception.
Measured: From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).
Electroencephalography
Electroencephalography measurements focusing on resting state networks related to visual verticality perception.
Measured: From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).
Cerebrovascular reactivity
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.
Measured: From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).
Cerebrovascular reactivity
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.
Measured: From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).
Spatial neglect
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.
Measured: From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).
Spatial neglect
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.
Measured: From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start3 Jan 2025
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Jan 2028 (estimated)
Why it stopped: The study has been temporarily suspended due to a low recruitment rate and funding restrictions. Additional funding support is actively being pursued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase I/II randomized sham-controlled double-blind parallel clinical trial design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson University, Fundação de Amparo à Pesquisa do Estado de São Paulo, Viasonix, Phelcom, FBX Medical
- Responsible party
- Principal investigator, Taiza G. S. Edwards, PhD, University of Sao Paulo
- Investigators
- Taiza Edwards, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747676
- Sponsor's protocol ID
- 74877723.4.0000.5440
- Other IDs
- 2023/03252-2, 2023
- Acronym
- GravNegElect
- Status last verified
- Jul 2026
- First submitted
- 18 Dec 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graviceptive Neglect After Stroke: Clinical, Neuroanatomical and Physiological Effects of Focal Neuromodulation
- ClinicalTrials.gov ID
- NCT06747676
- Acronym / sponsor ID
- GravNegElect / 74877723.4.0000.5440
- Conditions
- Stroke
- Keywords
- Stroke, Graviceptive Neglect, Verticality Perception, Non-invasive Brain Stimulation, Neuroimaging, Electroencephalography, Transcranial doppler, HD-tDCS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study has been temporarily suspended due to a low recruitment rate and funding restrictions. Additional funding support is actively being pursued.
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Thomas Jefferson University, Fundação de Amparo à Pesquisa do Estado de São Paulo, Viasonix, Phelcom, FBX Medical
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 24 Dec 2024 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase I/II randomized sham-controlled double-blind parallel clinical trial design
| Arm | Type | Receives |
|---|---|---|
| Active HD-tDCS | Experimental | Device: Active: High-Definition transcranial Direct Current Stimulation (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. |
| Sham HD-tDCS | Sham comparator | Device: Sham: High-Definition transcranial Direct Current Stimulation (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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (18 listed)
- Migraine;
- Pregnancy;
- Pacemakers;
- Seizures;
- Claustrophobia;
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 |
|---|---|---|
| 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 | Active HD-tDCS |
| 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. | Device | Sham HD-tDCS |
Primary outcome
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.
9 secondary outcomes
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).
Ocular torsion
Time frame: 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).
Electroencephalography
Time frame: 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).
Cerebrovascular reactivity
Time frame: 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).
Spatial neglect
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- 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.
Taiza Edwards, PhD principal investigator
University of Sao Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Active: High-Definition transcranial Direct Current Stimulation (HD-tDCS) in people with Stroke, run by University of Sao Paulo at 2 sites in Brazil.
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 7 inclusion and 18 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: paused, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2026.