Neural Control of Gait & Navigation in ADRD

NCT06501820 | Enrolling By Invitation DMC FDA Device

• 2 other identifiers: IRB202400767R01AG089050
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

aging; subjective cognitive decline; vestibular; mobility

Outcome Measures

Primary Outcomes (1)

• Vestibular network segregation score, measured with functional MRI

  Independence of brain network functioning

  Pre-intervention, within 1 week post-intervention

Secondary Outcomes (2)

• Gait variability, measured with an inertial measurement unit on the sacrum

  Intervention is applied while participants are walking

• Path integration error, measured in degrees

  Intervention is applied while this task is performed

Study Arms (2)

Sham stimulation

SHAM COMPARATOR

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

Device: Transcranial direct current stimulation

Active stimulation

EXPERIMENTAL

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

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulation DEVICE

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

Active stimulation; Sham stimulation

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• 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\[120\] .

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Rachael Seidler

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sham transcranial magnetic stimulation is extremely effective. It involves current ramp up and down, resulting in potential tingling of the scalp similar to active stimulation. The investigator will also be blinded; they will enter a code into the stimulation box that results in either active or sham stimulation.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two group, repeated measures, double blind active or sham stimulation

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 15, 2024
• Study Start: November 13, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Following completion of the study and publication of results, the data will be available indefinitely.
• Access Criteria: Data will be accessible

Locations

US (1)