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CONTROL Walking Study
Phase 1 trial testing practice of a complex walking task in Aging in 72 participants. Completed in 1 August 2024.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 72 |
| Start date | 1 August 2019 |
| Primary completion | 1 August 2024 |
| Estimated completion | 1 August 2024 |
| Sites | 1 location across United States |
VA Office of Research and Development — full company profile →
65 and older, any sex, with Aging. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in the fastest safe walking speed over a complex walking course
| Group | Value | 95% CI |
|---|---|---|
| Active tDCS | 0.033 | ± 0.097 |
| Sham tDCS | 0.041 | ± 0.104 |
Change in the volume of gray matter in the prefrontal cortex, as measured by MRI
| Group | Value | 95% CI |
|---|---|---|
| Active tDCS | -14.66 | ± 81.75 |
| Sham tDCS | -3.45 | ± 90.60 |
Resting-state functional MRI was used to measure the segregation of large-scale brain networks. Connectivity strength was quantified using Fisher z-transformed correlation coefficients, averaged across regions of interest within each network. Results are reported as mean z-scores for each group. Higher values reflect greater segregation (i.e., stronger within-network compared to between-network connectivity).
| Group | Value | 95% CI |
|---|---|---|
| Active tDCS | -.0017 | ± .0253 |
| Sham tDCS | -.0002 | ± .0215 |
Time frame: From enrollment until the end of follow-up, up to 8 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Active tDCS | Sham tDCS |
|---|---|---|---|
| Musculoskeletal injury (not serious) | Musculoskeletal and connective tissue disorders | — | — |
Data from ClinicalTrials.gov NCT03790657 adverse events section.
Older adults often experience substantial deficits in walking ability, especially for walking tasks that are more complex such as obstacle crossing. This is due in part to changes in the brain that make performance of physical and cognitive tasks more difficult. Rehabilitation can help to improve walking ability, but effective rehabilitation is time consuming and expensive. New approaches are needed to improve the efficiency of rehabilitation so that gains in walking ability are widely attainable. A promising strategy is to focus on enhancing motor learning, which is defined as improved ability to perform a motor task due to practice or experience. The investigators will investigate the use of non-invasive brain stimulation to increase motor learning and retention of the newly learned walking skills. The investigators will also use neuroimaging to assess brain characteristics that explain how motor learning works. The knowledge gained from this study is expected to contribute to better understanding of mechanistic targets and intervention approaches to improve rehabilitation of walking.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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