Vestibular brain stimulation to improve gait and navigation in older adults with subjective cognitive decline
Official title: Neural Control of Gait & Navigation in ADRD, Aim 3 Clinical Trial
Run by University of Florida · NCT06501820 · Data updated 2026-11-12
Researchers will test whether bilaterally stimulating vestibular cortex with tDCS while walking and doing tasks can improve brain network segregation and walking/navigation in older adults who report cognitive decline.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years to 89 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Status | Recruiting |
| Started | November 13, 2025 |
| Main results expected | May 1, 2029 |
| Study ends | May 1, 2030 |
| Registry record updated | July 31, 2026 |
| Trial ID | NCT06501820 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Community-dwelling adults aged 65-89 with subjective cognitive decline and no dementia, who can walk unassisted for at least ten minutes and pass safety screening.
✕Probably not a fit
Individuals without subjective cognitive decline or those with established dementia or significant cognitive impairment may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study tests whether bilateral vestibular cortex tDCS can alter brain networks related to vestibular and motor control in older adults with subjective cognitive decline. Participants will perform a walking plus spatial navigation task, receive either active or sham tDCS for 20 minutes over three sessions, and undergo pre- and post-treatment MRI (structural and resting-state) to measure changes in network segregation. Primary outcomes include gait metrics and navigation error, along with brain connectivity between vestibular-motor and vestibular-hippocampal networks. The trial uses neuro-navigated stimulation targeting OP2 regions with 2 mA current, and randomization is double-blind. Enrollment aims for 60 participants, split evenly between active and sham groups.
Why it matters
Potential benefit: If successful, this approach could identify a noninvasive way to enhance gait stability and spatial navigation in aging populations at risk for mobility and cognitive decline.
How similar studies have gone: Prior work suggests vestibular stimulation can modulate related brain networks, but applying targeted neuro-navigated tDCS to gait and navigation in SCD is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Community dwelling men and women 18-35 years old or 65-89 years old * Ability to walk unassisted for ten minutes * Willingness to undergo all testing procedures * English speaking Additional Inclusion Criteria for those with SCD * Subjective report of cognitive complaints with scores \>16 on the Cognitive Change Index (CCI-20), a validated scale of subjective cognitive decline (Saykin et al., 2013). This scale consists of 20 items that are rated on 5 point Likert scale, where 1= "Normal: No change compared to 5 years ago", 3= "Mild Problem: Some change compared to 5 years ago) and 5="Severe Problem: Much worse compared to 5 years ago".) * No evidence of dementia or mild cognitive impairment based on cognitive screening (i.e., Montreal Cognitive Assessment (MoCA) score within normal limits for age, education and sex using the NACC Uniform Data Set (UDS) norms (Weintraub et al., 2018)\[119\] * No psychometric evidence of cognitive impairment based on performance on the Neuropsychological Battery from the NACC Unified Data Set, version 3\[119\]. The battery includes measures of attention, recent memory, language, visuospatial, and executive function. Norms are available for over 3600 older adults \[119\]. Scores on these measures cannot be lower than 1.0 SD (16th %ile) below normative values based on age, education, and gender. * Reading at \> 8th grade level based on the reading subtest of the Wide Range Achievement Test- IV. * Global Clinic Dementia Rating (CDR) score must be 0 \[156\] * Family history of dementia/probable Alzheimer's disease in first degree relative (parents, children, siblings) * Normal functional behavior in terms of daily activities, based on the Functional Activities Scale\[122\] * In line with recommendations of SCD task force (Molienueva et al., 2017)\[116\] an informant must be available for two reasons: a) to provide information about the participant's complaints using the informant version of the CCI-20, and b) to corroborate normal IADL's on the Functional Activity Questionnaire\[120\] . Exclusion Criteria: * Significant medical event requiring hospitalization in the past 6 months that has the potential to contaminate data being collected (fracture, hospitalization etc.) * Severe visual impairment or corrected visual acuity less than 20/40, which would preclude completion of the assessments * Inability to undergo brain imaging due to claustrophobia or implants such as pacemakers, heart valves, brain aneurysm clips, orthodontics, non-removable body jewelry, or shrapnel containing ferromagnetic metal * tDCS ineligibility for Aim 3 (history of epilepsy, medications that alter cortical excitability, etc.) * History of stroke * Any history of clinically diagnosed traumatic brain injury resulting in \> 1 minute loss of consciousness * Any major ADL disability (unable to feed, dress, bath, use the toilet, or transfer) * Report of lower extremity pain due to osteoarthritis that significantly limits mobility * Diagnosis or treatment for rheumatoid arthritis * Known neuromuscular disorder or overt neurological disease (e.g. Multiple Sclerosis, Rhabdomyolysis, Myasthenia Gravis, Ataxia, Apraxia, post-polio syndrome, mitochondrial myopathy, Parkinson's Disease, ALS etc.) * Unable to communicate because of severe hearing loss or speech disorder * Planned surgical procedure or hospitalization in the next 12 months (joint replacement, coronary artery bypass graft, etc.) * Severe pulmonary disease, requiring the use of supplemental oxygen * Terminal illness, as determined by a physician * Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, recent history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina * Is planning to move out of the area during the follow up period * Use of walker or wheel chair * Failure to provide informed consent
Where it's running
-
University of Florida
Gainesville, Florida, United States Recruiting
Study contacts
- Principal investigator: Rachael Seidler — University of Florida
- Study coordinator: Rachael Seidler
- Email: rachaelseidler@ufl.edu
- Phone: (734) 834-0385
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.