Clinical trial NCT06747676: GRAViceptive NEGlect Treatment in Acute Stroke Using Targeted Cranial ELECTrotherapy
Official title: Graviceptive Neglect After Stroke: Clinical, Neuroanatomical and Physiological Effects of Focal Neuromodulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Stroke
Keywords: Stroke
Graviceptive Neglect
Verticality Perception
Non-invasive Brain Stimulation
Neuroimaging
Electroencephalography
Transcranial doppler
HD-tDCS
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Thomas Jefferson University
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Viasonix
name: Phelcom
name: FBX Medical
First posted: 2024-12-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase I/II randomized sham-controlled double-blind parallel clinical trial design
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Visual Verticality Perception (VV; visual graviceptive neglect)
timeFrame: From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).
Secondary outcomes:
measure: Visual Verticality Perception (VV; visual graviceptive neglect)
timeFrame: From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).
measure: Ocular torsion
timeFrame: From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).
measure: Ocular torsion
timeFrame: From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).
measure: Electroencephalography
timeFrame: From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).
measure: Electroencephalography
timeFrame: From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).
measure: Cerebrovascular reactivity
timeFrame: From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).
measure: Cerebrovascular reactivity
timeFrame: From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).
measure: Spatial neglect
timeFrame: From baseline (before the first session) to 1 day post-intervention protocol (after six HDtDCS sessions).
measure: Spatial neglect
timeFrame: From baseline (before the first session) to 30±5 days post-intervention protocol (after six HDtDCS sessions).
Other outcomes:
measure: Brain magnetic resonance imaging (MRI)
timeFrame: Up to 15 days post stroke.
Locations:
city: Ribeirão Preto
country: Brazil
facility: Ribeirão Preto Medical School, University of São Paulo
state: SP
city: Ribeirão Preto
country: Brazil
facility: University of São Paulo, Ribeirão Preto Medical School
state: SP
Study officials:
affiliation: Ribeirão Preto Medical School, University of São Paulo
name: Taiza Edwards, PhD
role: PRINCIPAL_INVESTIGATOR
References: