AgingNCT05475236

Neural Underpinnings of Turning

A study testing Experimental: Locomotor Learning in people with Aging, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Aging
What is being tested?: Experimental: Locomotor Learning
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 28 Feb 2023to 28 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

age 65 years or older
preferred 10m walking speed < 1.1 m/s
self-report of "some difficulty with walking tasks, such as becoming tired when walking a quarter mile, or when climbing two flights of stairs, or when performing household chores."
Willingness to be randomized to either study group and to participate in all aspects of study assessment and intervention

Who cannot join

Diagnosed neurological disorder or injury of the central nervous system, or observation of symptoms consistent with such a condition (Alzheimer's, Parkinson's, stroke, etc.)
Contraindications to non-invasive brain stimulation (e.g., metal in head, wound on scalp)
Contraindications to magnetic resonance imaging (e.g., metal in body, claustrophobia, etc).
Use of medications affecting the central nervous system
severe arthritis, such as awaiting joint replacement
severe obesity (body mass index > 35)

Show all 17Show fewer

current cardiovascular, lung or renal disease; diabetes; terminal illness
myocardial infarction or major heart surgery in the previous year
cancer treatment in the past year, except for nonmelanoma skin cancers and cancers having an excellent prognosis (e.g., early stage breast or prostate cancer)
current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
uncontrolled hypertension at rest (systolic > 180 mmHg and/or diastolic > 100 mmHg)
bone fracture or joint replacement in the previous six months
current participation in physical therapy for lower extremity function or cardiopulmonary rehabilitation
current enrollment in any clinical trial
difficulty communicating with study personnel, and/or non-English speaking
planning to relocate out of the area during the study period
clinical judgment of investigative team regarding safety or non-compliance

Trial locations and contacts

1 site in 1 country.

United States1 site

North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135

Other trials in United States

About this study

Official title: Brain Networks of Turning Performance With Aging and Stroke

Older adults and stroke survivors often have difficulty performing complex walking tasks, due in part to changes in the brain. One task often overlooked is turning, which can lead to injury when performed poorly. The investigators will use non-invasive brain stimulation to assess brain activity and relate those observations to turning performance in older adults and stroke survivors.

Read the detailed description

This study is associated with an ongoing Clinical Trial (NCT03790657) called the CONTROL Walking Study, which combines locomotor learning and a form of non-invasive electrical brain stimulation call transcranial direct current stimulation (tDCS). The CONTROL Walking Study, randomly places participants into one of two experimental groups (transcranial direct current stimulation or sham stimulation). Following group placement participants complete a 2 week long walking and turning locomotor learning intervention while receiving a group dependent the form of tDCS or sham stimulation.

In leveraging the CONTROL Walking Study infrastructure to further examine the neural control of turning while walking, which is often impaired for older adults and people who have had a stroke. This study will assess neurophysiological brain function using transcranial magnetic stimulation (TMS) which is a form of non-invasive brain stimulation as well as assessing multiple forms of turning performance in older adults. Transcranial magnetic stimulation (TMS) will be used to assess cortical inhibitory neurophysiological function in motor networks of the brain. Importantly, recent work demonstrates significant associations between brain excitatory/inhibitory function and turning performance in older adults, although these results remain largely preliminary.

Therefore, the objective of this proposal is to further elucidate associations between neurophysiological function (measured with TMS) and 360 degree and 180 degree turning performance. The investigators will address the following specific aims:

Specific Aim 1 will test the hypothesis that greater cortical inhibition will be associated with shorter turn duration for 360 degree turns and 180 degree turns.

Specific Aim 2 will test the hypothesis that participants with greater baseline cortical inhibition will demonstrate larger 360 degree and 180 degree turning performance gains (i.e., shorter turn durations).

This new knowledge will provide additional information as to the neural mechanisms associated with turning performance in older adults. Moreover, these results could reveal mechanistic targets for future interventions to enhance turning performance learning and retention.

Conditions: Aging
Being tested: Experimental: Locomotor Learning
Keywords: Aging, Walking, Brain, Transcranial Magnetic Stimulation, Turning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental: Locomotor LearningBehavioural
Participants will undergo four sessions of locomotor and turn learning. Locomotor learning will involve practicing walking over different terrains (i.e., soft and firm mats) and obstacles at different walking speeds (slow or fast) and turning practice at each end of the walking course. The full cohort will undergo either transcranial direct current stimulation or sham stimulation.

Study groups in NCT05475236
Study group	Role	What they receive
Sham Stimulation	Sham comparator	Participants will undergo 30 seconds of 2 mA electrical current to the head through saline soaked electrodes. Receives: Behavioral: Experimental: Locomotor Learning
Transcranial Direct Current Simulation	Experimental	Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes. Receives: Behavioral: Experimental: Locomotor Learning

What is being measured

The primary outcome is the main question the study is designed to answer.

Duration of Cortical Silent Period (CSP) (ms)
Cortical Silent Period (CSP) is a single-pulse TMS measure of GABA-mediated cortical inhibition, in which stimulation is applied to the motor cortex while participants are activating a target muscle (here, the tibialis anterior muscle), resulting in a brief reduction in muscle activity. CSP is measured as the time during which the muscle activity is less than the pre-simulation muscle activity level until the return of voluntary muscle activity. CSP is measured in milliseconds (ms).
Measured: 30 minutes, Measured at Baseline
360 Degree Turn Duration From Baseline
Change in 360 degree turn duration during a 360 degree turn test
Measured: Measured at follow up visit (approximately three weeks after baseline)
180 Degree Turn Duration From Baseline
Change in 180 degree turn duration as measured during a 2 minute walking task where participants walk back and forth down a corridor.
Measured: Measured at follow up visit (approximately three weeks after baseline)
Resting Motor Threshold (Percent of Machine Output)
Resting motor threshold (rMT) is obtained by single-pulse TMS and assesses voltage-gated sodium-channel-mediated cortical excitability. rMT is the minimum intensity (% machine output) of stimulation needed to repeatedly evoke a motor evoked potential (MEP) of at least 50 microvolts in over 50% of trials. It is reported as a percentage of total machine output.
Measured: 20 minutes, Measured at Baseline

Secondary outcomes (1)

Katz Independence Questionnaire
6-item participant reported questionnaire assessing level of independence [bathing, dressing, toileting, transferring, continence, feeding]. Total scores range: 0-6, the higher the score, the more independent.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 202328 Jun 2024

First posted26 Jul 2022
Study start28 Feb 2023
Primary completion28 Jun 2024
Study completion28 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AgingStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe 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: Participants will randomized to either receive transcranial direct current stimulation (tDCS) or sham
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05475236
Sponsor's protocol ID: N3954-M
Other IDs: 1IK1RX003954-01A1
Status last verified: Jun 2025
First submitted: 15 Jul 2022
Last updated: 11 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: A limited dataset will be created and shared pursuant to a Data Use Agreement appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity

All Aging trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brain Networks of Turning Performance With Aging and Stroke
ClinicalTrials.gov ID: NCT05475236
Acronym / sponsor ID: N3954-M
Conditions: Aging
Keywords: Aging, Walking, Brain, Transcranial Magnetic Stimulation, Turning
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 28 Feb 2023 (actual)
Primary completion: 28 Jun 2024 (actual)
Study completion: 28 Jun 2024 (actual)
First posted: 26 Jul 2022 (actual)
Results: Posted 11 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Specific Aim 1 will test the hypothesis that greater cortical inhibition will be associated with shorter turn duration for 360 degree turns and 180 degree turns.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Participants will randomized to either receive transcranial direct current stimulation (tDCS) or sham

Arm	Type	Receives
Sham Stimulation	Sham comparator	Behavioral: Experimental: Locomotor LearningParticipants will undergo 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.
Transcranial Direct Current Simulation	Experimental	Behavioral: Experimental: Locomotor LearningParticipants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

age 65 years or older
preferred 10m walking speed < 1.1 m/s
self-report of "some difficulty with walking tasks, such as becoming tired when walking a quarter mile, or when climbing two flights of stairs, or when performing household chores."
Willingness to be randomized to either study group and to participate in all aspects of study assessment and intervention

Key exclusion criteria (17 listed)

Diagnosed neurological disorder or injury of the central nervous system, or observation of symptoms consistent with such a condition (Alzheimer's, Parkinson's, stroke, etc.)
Contraindications to non-invasive brain stimulation (e.g., metal in head, wound on scalp)
Contraindications to magnetic resonance imaging (e.g., metal in body, claustrophobia, etc).
Use of medications affecting the central nervous system
severe arthritis, such as awaiting joint replacement

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
Experimental: Locomotor LearningParticipants will undergo four sessions of locomotor and turn learning. Locomotor learning will involve practicing walking over different terrains (i.e., soft and firm mats) and obstacles at different walking speeds (slow or fast) and turning practice at each end of the walking course. The full cohort will undergo either transcranial direct current stimulation or sham stimulation.	Behavioural	Sham Stimulation, Transcranial Direct Current Simulation

Primary outcome

Duration of Cortical Silent Period (CSP) (ms)
Time frame: 30 minutes, Measured at Baseline
Cortical Silent Period (CSP) is a single-pulse TMS measure of GABA-mediated cortical inhibition, in which stimulation is applied to the motor cortex while participants are activating a target muscle (here, the tibialis anterior muscle), resulting in a brief reduction in muscle activity. CSP is measured as the time during which the muscle activity is less than the pre-simulation muscle activity level until the return of voluntary muscle activity. CSP is measured in milliseconds (ms).
360 Degree Turn Duration From Baseline
Time frame: Measured at follow up visit (approximately three weeks after baseline)
Change in 360 degree turn duration during a 360 degree turn test
180 Degree Turn Duration From Baseline
Time frame: Measured at follow up visit (approximately three weeks after baseline)
Change in 180 degree turn duration as measured during a 2 minute walking task where participants walk back and forth down a corridor.
Resting Motor Threshold (Percent of Machine Output)
Time frame: 20 minutes, Measured at Baseline
Resting motor threshold (rMT) is obtained by single-pulse TMS and assesses voltage-gated sodium-channel-mediated cortical excitability. rMT is the minimum intensity (% machine output) of stimulation needed to repeatedly evoke a motor evoked potential (MEP) of at least 50 microvolts in over 50% of trials. It is reported as a percentage of total machine output.

1 secondary outcome

Katz Independence Questionnaire
Time frame: Baseline

Results and safety

Results posted to the registry on 11 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sham Stimulation	11	11
Transcranial Direct Current Simulation	5	4

Primary outcome: Duration of Cortical Silent Period (CSP) (ms)

Time frame: 30 minutes, Measured at Baseline. Mean (Standard Deviation). Unit: milliseconds (ms)

Measure	Sham Stimulation n = 3	Transcranial Direct Current Simulation n = 4
Value	104.34 (34.93)	99.71 (40.45)

Population analysed: Cortical silent period (CSP) data could not be collected from eight participants in the sham group and four participants in the active tDCS group. In these cases, a reliable cortical stimulation site (i.e., motor hotspot) and consistent motor evoked potential (MEP) responses could not be identified, which are required to determine the resting motor threshold necessary for CSP assessment.

Primary outcome: 360 Degree Turn Duration From Baseline

Time frame: Measured at follow up visit (approximately three weeks after baseline). Mean (Full Range). Unit: Seconds (s)

Measure	Sham Stimulation n = 10	Transcranial Direct Current Simulation n = 3
Value	0.306 (-0.1 to 0.98)	.367 (0.24 to 0.43)

Population analysed: There was a data collection error for one participant in the sham group. There was one data collection error and one participant withdrawal in the tDCS group.

Primary outcome: 180 Degree Turn Duration From Baseline

Time frame: Measured at follow up visit (approximately three weeks after baseline). Mean (Full Range). Unit: Seconds (s)

Measure	Sham Stimulation n = 10	Transcranial Direct Current Simulation n = 3
Value	0.11 (-0.725 to 0.94)	0.22 (0.04 to 0.49)

Population analysed: One participant from both groups had data collection errors, one additional participant from the active tDCS group withdrew from the study.

Primary outcome: Resting Motor Threshold (Percent of Machine Output)

Time frame: 20 minutes, Measured at Baseline. Mean (Full Range). Unit: % Maximal Stimulator Output (%MSO)

Measure	Sham Stimulation n = 3	Transcranial Direct Current Simulation n = 4
Value	56.13 (47.5 to 63.5)	68.25 (59 to 72)

Population analysed: Reliable cortical stimulation site (i.e., motor hotspot) and consistent motor evoked potential (MEP) responses could not be identified, which are required to determine the resting motor threshold.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were monitored from the baseline visit through the follow-up visit, approximately 3 weeks later (i.e., a monitoring period of about 3 weeks per participant).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sham Stimulation	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Transcranial Direct Current Simulation	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Limitations and caveats (from the sponsor): Technical challenges during TMS data collection led to incomplete or unreliable neurophysiological data for several participants, limiting the interpretability of outcomes. Additionally, the overall sample size was small, which constrains the generalizability of the findings. The TMS component of the protocol required an FDA risk determination, which delayed the initiation of data collection and further contributed to the limited number of participants available for analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. A limited dataset will be created and shared pursuant to a Data Use Agreement appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.

Related trials for Aging

RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity

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. This study is not recruiting at the moment.

Clayton W Swanson, PhD principal investigator

North Florida/South Georgia Veterans Health System, Gainesville, FL

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: Locomotor Learning in people with Aging, run by VA Office of Research and Development 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 4 inclusion and 17 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: finished, as of the sponsor's last update on 11 Jun 2025. 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?

Yes. Results are posted in the registry (first posted 11 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Cortical Silent Period (CSP) (ms) (time frame: 30 minutes, Measured at Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05475236.

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 11 Jun 2025.