Trial Outcomes & Findings for CONTROL Walking Study (NCT NCT03790657)
NCT ID: NCT03790657
Last Updated: 2025-09-22
Results Overview
Change in the fastest safe walking speed over a complex walking course
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
72 participants
Primary outcome timeframe
Measured at follow up visit (approximately three weeks after baseline)
Results posted on
2025-09-22
Participant Flow
Participants were screened to ensure they met all inclusion/exclusion criteria, did not have major disease or injury affecting brain function or walking function, were medically stable, and could safely participate in the study protocol.
Participant milestones
| Measure |
Active tDCS
20 minutes of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task
|
Sham tDCS
30 seconds of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
38
|
|
Overall Study
COMPLETED
|
32
|
36
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Active tDCS
20 minutes of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task
|
Sham tDCS
30 seconds of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
These numbers are those who passed the onsite screening visit.
Baseline characteristics by cohort
| Measure |
Active tDCS
n=32 Participants
20 minutes of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task
|
Sham tDCS
n=36 Participants
30 seconds of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.97 years
STANDARD_DEVIATION 5.65 • n=5 Participants • These numbers are those who passed the onsite screening visit.
|
75.83 years
STANDARD_DEVIATION 8.06 • n=7 Participants • These numbers are those who passed the onsite screening visit.
|
74.49 years
STANDARD_DEVIATION 7.03 • n=5 Participants • These numbers are those who passed the onsite screening visit.
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
17 Participants
n=7 Participants • These numbers are those who passed the onsite screening visit.
|
25 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
19 Participants
n=7 Participants • These numbers are those who passed the onsite screening visit.
|
43 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
1 Participants
n=7 Participants • These numbers are those who passed the onsite screening visit.
|
1 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
0 Participants
n=7 Participants • These numbers are those who passed the onsite screening visit.
|
1 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
0 Participants
n=7 Participants • These numbers are those who passed the onsite screening visit.
|
0 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
2 Participants
n=7 Participants • These numbers are those who passed the onsite screening visit.
|
3 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
33 Participants
n=7 Participants • These numbers are those who passed the onsite screening visit.
|
63 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
0 Participants
n=7 Participants • These numbers are those who passed the onsite screening visit.
|
0 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
0 Participants
n=7 Participants • These numbers are those who passed the onsite screening visit.
|
0 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
2 Participants
n=7 Participants • These numbers are those who passed the onsite screening visit.
|
4 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
34 Participants
n=7 Participants • These numbers are those who passed the onsite screening visit.
|
64 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
0 Participants
n=7 Participants • These numbers are those who passed the onsite screening visit.
|
0 Participants
n=5 Participants • These numbers are those who passed the onsite screening visit.
|
|
Walking speed
|
1.25 meters per second
STANDARD_DEVIATION 0.23 • n=5 Participants • These numbers are those who passed the onsite screening visit.
|
1.19 meters per second
STANDARD_DEVIATION 0.19 • n=7 Participants • These numbers are those who passed the onsite screening visit.
|
1.22 meters per second
STANDARD_DEVIATION 0.21 • n=5 Participants • These numbers are those who passed the onsite screening visit.
|
|
Montreal Cognitive Assessment
|
26.41 units on a scale
STANDARD_DEVIATION 1.88 • n=5 Participants • These numbers are those who passed the onsite screening visit.
|
26.58 units on a scale
STANDARD_DEVIATION 2.6 • n=7 Participants • These numbers are those who passed the onsite screening visit.
|
26.5 units on a scale
STANDARD_DEVIATION 2.29 • n=5 Participants • These numbers are those who passed the onsite screening visit.
|
PRIMARY outcome
Timeframe: Measured at follow up visit (approximately three weeks after baseline)Change in the fastest safe walking speed over a complex walking course
Outcome measures
| Measure |
Active tDCS
n=32 Participants
20 minutes of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task
|
Sham tDCS
n=36 Participants
30 seconds of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task
|
|---|---|---|
|
Walking Speed Change From Baseline
|
0.033 meters per second
Standard Deviation 0.097
|
0.041 meters per second
Standard Deviation 0.104
|
SECONDARY outcome
Timeframe: Measured at follow up visit (approximately three weeks after baseline)Population: Some participants did not complete the MRI assessment at baseline or at follow-up due to technical or logistical difficulties.
Change in the volume of gray matter in the prefrontal cortex, as measured by MRI
Outcome measures
| Measure |
Active tDCS
n=31 Participants
20 minutes of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task
|
Sham tDCS
n=32 Participants
30 seconds of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task
|
|---|---|---|
|
Prefrontal Cortex Gray Matter Volume Change From Baseline
|
-14.66 cubic millimeters
Standard Deviation 81.75
|
-3.45 cubic millimeters
Standard Deviation 90.60
|
SECONDARY outcome
Timeframe: Measured at follow up visit (approximately three weeks after baseline)Population: A total of 65 participants underwent MRI imaging, of which only 50 participants were included. Eight participants were missing either baseline or post-assessment scan. Four participants did not complete all necessary scanning sequences.
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).
Outcome measures
| Measure |
Active tDCS
n=25 Participants
20 minutes of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task
|
Sham tDCS
n=25 Participants
30 seconds of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task
|
|---|---|---|
|
Brain Resting State Network Segregation (Z-transformed Correlation Coefficient)
|
-.0017 z-transformed correlation coefficient
Standard Deviation .0253
|
-.0002 z-transformed correlation coefficient
Standard Deviation .0215
|
Adverse Events
Active tDCS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham tDCS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active tDCS
n=32 participants at risk
20 minutes of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task
|
Sham tDCS
n=36 participants at risk
30 seconds of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal injury (not serious)
|
3.1%
1/32 • From enrollment until the end of follow-up, up to 8 weeks
|
2.8%
1/36 • From enrollment until the end of follow-up, up to 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place