Phase 1
N=72
CONTROL Walking Study
Aging
Bottom Line
View on ClinicalTrials.gov: NCT03790657 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Walking Speed Change From Baseline — 0.033; 0.041 meters per second
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- practice of a complex walking task (Behavioral); Active transcranial direct current stimulation (Active tDCS) (Device); Sham transcranial direct current stimulation (Sham tDCS) (Device)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Walking Speed Change From Baseline |
0.033; 0.041 | — |
| SECONDARY Prefrontal Cortex Gray Matter Volume Change From Baseline |
-14.66; -3.45 | — |
| SECONDARY Brain Resting State Network Segregation (Z-transformed Correlation Coefficient) |
-.0017; -.0002 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- age 65 years or older
- preferred 10m walking speed 35)
- 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
Data sourced from ClinicalTrials.gov (NCT03790657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.