Recruiting

tDCS

Sponsor:

University of Florida

Code:

NCT06501820

Conditions

Aging

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Interventions

Transcranial direct current stimulation

Study Details

Brief summary:

Brain network segregation, or independent functioning, declines with age and is associated with slower walking speed. Here, the investigators will determine the extent to which brain vestibular network segregation can be altered with bilateral vestibular cortical transcranial direct current stimulation (tDCS) in older adults with subjective cognitive decline. Participants will be randomly assigned to an active or sham stimulation condition. They will receive three, 20-minute sessions of tDCS while they are walking and performing cognitive tasks. MRI of the brain will be acquired before and after these three sessions.

Conditions

Aging

Study ID

NCT06501820

Start date

Nov 13, 2025

Status verified date

Jul, 2026

Completion date

May 1, 2030

Anticipated

Primary completion date

May 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

sham comparator: Sham stimulation

The tDCS electrodes are applied and the current ramps up and then down, resulting in a very effective sham condition.

experimental: Active stimulation

Transcranial direct current stimulation, bilateral, 2 mA, applied to the vestibular cortex.

Interventions

Transcranial direct current stimulation

2mA transcranial direct current stimulation, applied bilaterally on the scalp, over the brain vestibular cortex

Primary outcome measure

  • Vestibular network segregation score, measured with functional MRI [ Time Frame: Pre-intervention, within 1 week post-intervention ]

Central Contacts and Locations

Central contacts

Rachael Seidler

(734) 834-0385rachaelseidler@ufl.edu

Hunter Stewart

hunter.stewart@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Rachael Seidler

734-834-0385rachaelseidler@ufl.edu

More Information

Sponsor

University of Florida

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • aging
  • subjective cognitive decline
  • vestibular
  • mobility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-07-31.