An interventional study of Experimental: Locomotor Learning in Aging, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Basic science
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.
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.
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Exclusion Criteria:
Participants will undergo 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.
Behavioral: Experimental: Locomotor Learning
Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.
Behavioral: Experimental: Locomotor Learning
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.
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).
Time frame: 30 minutes, Measured at Baseline
360 Degree Turn Duration From Baseline
Change in 360 degree turn duration during a 360 degree turn test
Time frame: 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.
Time frame: 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.
Time frame: 20 minutes, Measured at Baseline
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.
Time frame: Baseline
| Milestone | Sham Stimulation | Transcranial Direct Current Simulation |
|---|---|---|
| Started | 11 | 5 |
| Completed | 11 | 4 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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).
| milliseconds (ms) | Sham Stimulation | Transcranial Direct Current Simulation |
|---|---|---|
| Duration of Cortical Silent Period (CSP) (ms) | 104.34 ± 34.93 | 99.71 ± 40.45 |
Change in 360 degree turn duration during a 360 degree turn test
| Seconds (s) | Sham Stimulation | Transcranial Direct Current Simulation |
|---|---|---|
| 360 Degree Turn Duration From Baseline | 0.306 (-0.1 to 0.98) | .367 (0.24 to 0.43) |
Change in 180 degree turn duration as measured during a 2 minute walking task where participants walk back and forth down a corridor.
| Seconds (s) | Sham Stimulation | Transcranial Direct Current Simulation |
|---|---|---|
| 180 Degree Turn Duration From Baseline | 0.11 (-0.725 to 0.94) | 0.22 (0.04 to 0.49) |
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.
| % Maximal Stimulator Output (%MSO) | Sham Stimulation | Transcranial Direct Current Simulation |
|---|---|---|
| Resting Motor Threshold (Percent of Machine Output) | 56.13 (47.5 to 63.5) | 68.25 (59 to 72) |
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.
| score on a scale | Sham Stimulation | Transcranial Direct Current Simulation |
|---|---|---|
| Katz Independence Questionnaire | 6 (6 to 6) | 6 (6 to 6) |
Collected over 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).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sham Stimulation | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Transcranial Direct Current Simulation | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | Sham Stimulation | Transcranial Direct Current Simulation | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 11 | 5 | 16 |
| Age, Continuous(years) | Sham Stimulation | Transcranial Direct Current Simulation | Total |
|---|---|---|---|
| Mean | 70 (66 to 76) | 72 (65 to 80) | 71.4 (65 to 80) |
| Sex: Female, Male(Participants) | Sham Stimulation | Transcranial Direct Current Simulation | Total |
|---|---|---|---|
| Female | 6 | 2 | 8 |
| Male | 5 | 3 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Sham Stimulation | Transcranial Direct Current Simulation | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 10 | 4 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Sham Stimulation | Transcranial Direct Current Simulation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 11 | 5 | 16 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Sham Stimulation | Transcranial Direct Current Simulation | Total |
|---|---|---|---|
| United States | 11 | 5 | 16 |
| Height(Meters (m)) | Sham Stimulation | Transcranial Direct Current Simulation | Total |
|---|---|---|---|
| Mean | 1.71 (1.55 to 1.93) | 1.73 (1.63 to 2.00) | 1.73 (1.55 to 2.00) |
| Weight(Kilograms (kg)) | Sham Stimulation | Transcranial Direct Current Simulation | Total |
|---|---|---|---|
| Mean | 83.38 (54.43 to 140.16) | 74.84 (54.43 to 93.89) | 80.71 (54.43 to 140.16) |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Icf
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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