GRAViceptive NEGlect Treatment in Acute Stroke Using Targeted Cranial ELECTrotherapy

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

Interventions

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.

Sponsors & Collaborators

• Thomas Jefferson University

  collaborator OTHER

• Fundação de Amparo à Pesquisa do Estado de São Paulo

  collaborator OTHER_GOV

• Viasonix

  collaborator UNKNOWN

• Phelcom

  collaborator UNKNOWN

• FBX Medical

  collaborator UNKNOWN

• University of Sao Paulo

  lead OTHER

Principal Investigators

• Taiza Edwards, PhD · Ribeirão Preto Medical School, University of São Paulo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-03

Primary Completion

2026-01-15

Completion

2026-01-15

FDA Device

Yes

Countries

• Brazil

Study Locations