NCT06747676

GRAViceptive NEGlect Treatment in Acute Stroke Using Targeted Cranial ELECTrotherapy

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-03
• Primary completion: 2026-01-15
• Completion: 2026-01-15
• First posted: 2024-12-24
• Last updated: 2025-02-03

Locations

2 sites across 1 country: Brazil

Regulatory

• FDA-regulated device study