AgingNCT06501820
Neural Control of Gait & Navigation in ADRD
A study testing Transcranial direct current stimulation in people with Aging, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2025to 1 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 89 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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]
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- 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] .
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hunter Stewart contact
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32611
Rachael Seidler, 734-834-0385, rachaelseidler@ufl.edu
About this study
Official title: Neural Control of Gait & Navigation in ADRD, Aim 3 Clinical Trial
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.
Read the detailed description
The investigators will conduct this experiment with individuals that have subjective cognitive decline. At pre- and post-test, they will receive structural MRI and resting state fMRI so that we can quantify brain vestibular-motor and vestibular-hippocampal network segregation. These will serve as the primary outcome metrics.
Participants will perform a walking + spatial navigation task. Their performance in the first 15 minutes will count as their pre-test behavioral score (gait speed, gait variability, navigation path integration task error). Participants will then receive either sham or active bilateral vestibular cortical tDCS. They will be randomly assigned into the active (n=30) or sham tDCS group (n=30) without their awareness. The active group will receive 20 minutes of 2mA tDCS bilaterally to the vestibular cortex (right parietal operculum 2 (OP2), MNI coordinates 50,-32,18; left OP2, MNI coordinates 38,-20,16); these regions have been identified through meta-analyses as being responsive to various types of vestibular stimulation. Electrodes will be placed using a Brainsight (Rogue Research, Montreal, QC, Canada) neuro-navigation system in which we will fit each participant's head to a standardized template space (MNI 152 template) from their MRIs (neuro-navigated stimulation). The anode electrode will be placed over the left vestibular cortex, whereas the cathode will be placed over the right. Stimulation at 2 mA has previously been shown to result in net excitation in both regions stimulated, as opposed to the traditional approach that increases excitability under the anode and inhibits excitability under the cathode. The sham tDCS group will receive stimulation for only 30 seconds during an active ramp up, and then immediate ramp down. This is to ensure that neither group is actively aware if they are receiving tDCS stimulation. The experimenter will also be blinded to whether a participant is receiving active or sham stimulation; they will enter a code into the stimulation box, making the protocol double blind. Participants will perform walking + spatial navigation on three days for 30 minutes per day (tDCS will be on for the first 20 minutes), under either active or sham stimulation. This protocol will be applied over three sessions, each separated by at least 24 hours and all three completed within 10 days.
The investigators will determine whether bilateral tDCS increases vestibular-motor and vestibular-hippocampal network segregation. They will examine behavioral task improvements as secondary outcomes. Using an ANOVA model, a total sample size of 60 (n=30 per group) results in 80% power to detect an effect size as small as Cohen f= 0.37 at significance level 0.05. Using a two-sided two-sample t-test with the same sample size, power and significance level (if the investigators were to analyze each variable separately), the minimum detectable effect size is 0.75 and for a nonparametric Wilcoxon-Mann-Whitney test, it becomes 0.76 under the same settings.
- Conditions
- Aging
- Being tested
- Transcranial direct current stimulation
- Keywords
- aging, subjective cognitive decline, vestibular, mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
2mA transcranial direct current stimulation, applied bilaterally on the scalp, over the brain vestibular cortex
| Study group | Role | What they receive |
|---|---|---|
| Sham stimulation | Sham comparator | The tDCS electrodes are applied and the current ramps up and then down, resulting in a very effective sham condition. Receives: Device: Transcranial direct current stimulation |
| Active stimulation | Experimental | Transcranial direct current stimulation, bilateral, 2 mA, applied to the vestibular cortex. Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vestibular network segregation score, measured with functional MRI
Independence of brain network functioning
Measured: Pre-intervention, within 1 week post-intervention
Secondary outcomes (2)
Gait variability, measured with an inertial measurement unit on the sacrum
Variability of walking
Measured: Intervention is applied while participants are walking
Path integration error, measured in degrees
Navigation task performance
Measured: Intervention is applied while this task is performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start13 Nov 2025
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group, repeated measures, double blind active or sham stimulation
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Rachael Seidler, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501820
- Sponsor's protocol ID
- IRB202400767
- Other IDs
- R01AG089050
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified brain and behavioral data will be shared via Open Science Framework and other databases.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Control of Gait & Navigation in ADRD, Aim 3 Clinical Trial
- ClinicalTrials.gov ID
- NCT06501820
- Acronym / sponsor ID
- IRB202400767
- Conditions
- Aging
- Keywords
- aging, subjective cognitive decline, vestibular, mobility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will conduct this experiment with individuals that have subjective cognitive decline. At pre- and post-test, they will receive structural MRI and resting state fMRI so that we can quantify brain vestibular-motor and vestibular-hippocampal network segregation. These will serve as the primary outcome metrics.
Participants will perform a walking + spatial navigation task. Their performance in the first 15 minutes will count as their pre-test behavioral score (gait speed, gait variability, navigation path integration task error). Participants will then receive either sham or active bilateral vestibular cortical tDCS. They will be randomly assigned into the active (n=30) or sham tDCS group (n=30) without their awareness. The active group will receive 20 minutes of 2mA tDCS bilaterally to the vestibular cortex (right parietal operculum 2 (OP2), MNI coordinates 50,-32,18; left OP2, MNI coordinates 38,-20,16); these regions have been identified through meta-analyses as being responsive to various types of vestibular stimulation. Electrodes will be placed using a Brainsight (Rogue Research, Montreal, QC, Canada) neuro-navigation system in which we will fit each participant's head to a standardized template space (MNI 152 template) from their MRIs (neuro-navigated stimulation). The anode electrode will be placed over the left vestibular cortex, whereas the cathode will be placed over the right. Stimulation at 2 mA has previously been shown to result in net excitation in both regions stimulated, as opposed to the traditional approach that increases excitability under the anode and inhibits excitability under the cathode. The sham tDCS group will receive stimulation for only 30 seconds during an active ramp up, and then immediate ramp down. This is to ensure that neither group is actively aware if they are receiving tDCS stimulation. The experimenter will also be blinded to whether a participant is receiving active or sham stimulation; they will enter a code into the stimulation box, making the protocol double blind. Participants will perform walking + spatial navigation on three days for 30 minutes per day (tDCS will be on for the first 20 minutes), under either active or sham stimulation. This protocol will be applied over three sessions, each separated by at least 24 hours and all three completed within 10 days.
The investigators will determine whether bilateral tDCS increases vestibular-motor and vestibular-hippocampal network segregation. They will examine behavioral task improvements as secondary outcomes. Using an ANOVA model, a total sample size of 60 (n=30 per group) results in 80% power to detect an effect size as small as Cohen f= 0.37 at significance level 0.05. Using a two-sided two-sample t-test with the same sample size, power and significance level (if the investigators were to analyze each variable separately), the minimum detectable effect size is 0.75 and for a nonparametric Wilcoxon-Mann-Whitney test, it becomes 0.76 under the same settings.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two group, repeated measures, double blind active or sham stimulation
| Arm | Type | Receives |
|---|---|---|
| Sham stimulation | Sham comparator | Device: Transcranial direct current stimulationThe tDCS electrodes are applied and the current ramps up and then down, resulting in a very effective sham condition. |
| Active stimulation | Experimental | Device: Transcranial direct current stimulationTranscranial direct current stimulation, bilateral, 2 mA, applied to the vestibular cortex. |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- 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".)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulation2mA transcranial direct current stimulation, applied bilaterally on the scalp, over the brain vestibular cortex | Device | Active stimulation, Sham stimulation |
Primary outcome
Vestibular network segregation score, measured with functional MRI
Time frame: Pre-intervention, within 1 week post-intervention
Independence of brain network functioning
2 secondary outcomes
Gait variability, measured with an inertial measurement unit on the sacrum
Time frame: Intervention is applied while participants are walking
Path integration error, measured in degrees
Time frame: Intervention is applied while this task is performed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified brain and behavioral data will be shared via Open Science Framework and other databases.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hunter Stewart contact
Rachael Seidler principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Aging, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachael Seidler ((734) 834-0385, rachaelseidler@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vestibular network segregation score, measured with functional MRI (time frame: Pre-intervention, within 1 week post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.