GRAViceptive NEGlect Treatment in Acute Stroke Using Targeted Cranial ELECTrotherapy

NCT06747676 | Recruiting Phase 1 FDA Device

• 2 other identifiers: 74877723.4.0000.54402023/03252-2
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Stroke

Keywords

Stroke; Graviceptive Neglect; Verticality Perception; Non-invasive Brain Stimulation; Neuroimaging; Electroencephalography; Transcranial doppler; HD-tDCS

Outcome Measures

Primary Outcomes (1)

• Visual Verticality Perception (VV; visual graviceptive neglect)

  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 Outcomes (9)

• Visual Verticality Perception (VV; visual graviceptive neglect)

  From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).

• Ocular torsion

  From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).

• Ocular torsion

  From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).

• Electroencephalography

  From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).

• Electroencephalography

  From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).

Other Outcomes (1)

• Brain magnetic resonance imaging (MRI)

  Up to 15 days post stroke.

Study Arms (2)

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.

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.

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

Interventions

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.

Active HD-tDCS

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.

Sham HD-tDCS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• University of Sao Paulo: lead
• Thomas Jefferson University: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Viasonix: collaborator
• Phelcom: collaborator
• FBX Medical: collaborator

Study Sites (2)

Ribeirão Preto Medical School, University of São Paulo

Ribeirão Preto, São Paulo, 14015160, Brazil

RECRUITING

University of São Paulo, Ribeirão Preto Medical School

Ribeirão Preto, São Paulo, 14049-900, Brazil

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Taiza Edwards, PhD

  Ribeirão Preto Medical School, University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taiza G. S. Edwards, PhD

CONTACT

+55-16-33153379; taiza@fmrp.usp.br

Lizanilda Albuquerque, BSc

CONTACT

+55-16-36021202; lizanilda@usp.br

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Phase I/II randomized sham-controlled double-blind parallel clinical trial design

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: January 3, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

BR (2)