GRAViceptive NEGlect Treatment in Acute Stroke Using Targeted Cranial ELECTrotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-03

Study Completion Date

2026-01-15

Brief Summary

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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.

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Detailed Description

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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

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Statistician

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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 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.

Group Type SHAM_COMPARATOR

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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No