Treatment for balance and perception issues after stroke using brain stimulation

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

This study is testing a new brain stimulation treatment to see if it can help stroke patients improve their balance and perception of verticality.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Sao Paulo (Academic / other)
• Locations: 2 sites (Ribeirão Preto, São Paulo and 1 other locations)
• Trial ID: NCT06747676 on ClinicalTrials.gov

What this trial studies

This study investigates the use of high-definition transcranial direct current stimulation (HD-tDCS) to treat graviceptive neglect in stroke patients, a condition that affects their perception of verticality and balance. It employs a phase I/II randomized sham-controlled double-blind design, enrolling 28 participants who will receive either active or sham stimulation over six sessions. The study will also assess cerebrovascular responses and cortical activity through transcranial Doppler and EEG, while examining the relationship between verticality perception errors and brain damage in specific areas. Follow-up assessments will occur one month post-intervention to evaluate the effectiveness of the treatment.

Who should consider this trial

Good fit: Ideal candidates are individuals who have experienced a supratentorial ischemic stroke and exhibit visual verticality misperception.

Not a fit: Patients with conditions such as migraines, psychiatric disorders, or those with significant medical issues like severe carotid atherosclerosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve balance and perception of uprightness in stroke patients, enhancing their quality of life.

How similar studies have performed: While the approach of using HD-tDCS for this specific condition is novel, similar non-invasive brain stimulation techniques have shown promise in other neurological conditions.

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;

Where this trial is running

Ribeirão Preto, São Paulo and 1 other locations

• Ribeirão Preto Medical School, University of São Paulo — Ribeirão Preto, São Paulo, Brazil (Recruiting)
• University of São Paulo, Ribeirão Preto Medical School — Ribeirão Preto, São Paulo, Brazil (Not_yet_recruiting)

Study contacts

• Principal investigator: Taiza Edwards, PhD — Ribeirão Preto Medical School, University of São Paulo
• Study coordinator: Taiza G. S. Edwards, PhD

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