Trial Outcomes & Findings for Neural Underpinnings of Turning (NCT NCT05475236)
NCT ID: NCT05475236
Last Updated: 2025-06-11
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
30 minutes, Measured at Baseline
Results posted on
2025-06-11
Participant Flow
Participant milestones
| Measure |
Sham Stimulation
Participants will undergo 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.
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.
|
Transcranial Direct Current Simulation
Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
5
|
|
Overall Study
COMPLETED
|
11
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Sham Stimulation
Participants will undergo 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.
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.
|
Transcranial Direct Current Simulation
Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Neural Underpinnings of Turning
Baseline characteristics by cohort
| Measure |
Sham Stimulation
n=11 Participants
Participants will undergo 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.
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.
|
Transcranial Direct Current Simulation
n=5 Participants
Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.
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.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
70 years
n=5 Participants
|
72 years
n=7 Participants
|
71.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Height
|
1.71 Meters (m)
n=5 Participants
|
1.73 Meters (m)
n=7 Participants
|
1.73 Meters (m)
n=5 Participants
|
|
Weight
|
83.38 Kilograms (kg)
n=5 Participants
|
74.84 Kilograms (kg)
n=7 Participants
|
80.71 Kilograms (kg)
n=5 Participants
|
|
BMI
|
27.90 weight (kg) / [height (m)]2
n=5 Participants
|
24.74 weight (kg) / [height (m)]2
n=7 Participants
|
26.91 weight (kg) / [height (m)]2
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutes, Measured at BaselinePopulation: 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.
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).
Outcome measures
| Measure |
Sham Stimulation
n=3 Participants
Participants will undergo 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.
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.
|
Transcranial Direct Current Simulation
n=4 Participants
Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.
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)
|
104.34 milliseconds (ms)
Standard Deviation 34.93
|
99.71 milliseconds (ms)
Standard Deviation 40.45
|
PRIMARY outcome
Timeframe: Measured at follow up visit (approximately three weeks after baseline)Population: 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.
Change in 360 degree turn duration during a 360 degree turn test
Outcome measures
| Measure |
Sham Stimulation
n=10 Participants
Participants will undergo 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.
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.
|
Transcranial Direct Current Simulation
n=3 Participants
Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.
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.
|
|---|---|---|
|
360 Degree Turn Duration From Baseline
|
0.306 Seconds (s)
Interval -0.1 to 0.98
|
.367 Seconds (s)
Interval 0.24 to 0.43
|
PRIMARY outcome
Timeframe: Measured at follow up visit (approximately three weeks after baseline)Population: One participant from both groups had data collection errors, one additional participant from the active tDCS group withdrew from the study.
Change in 180 degree turn duration as measured during a 2 minute walking task where participants walk back and forth down a corridor.
Outcome measures
| Measure |
Sham Stimulation
n=10 Participants
Participants will undergo 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.
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.
|
Transcranial Direct Current Simulation
n=3 Participants
Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.
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.
|
|---|---|---|
|
180 Degree Turn Duration From Baseline
|
0.11 Seconds (s)
Interval -0.725 to 0.94
|
0.22 Seconds (s)
Interval 0.04 to 0.49
|
PRIMARY outcome
Timeframe: 20 minutes, Measured at BaselinePopulation: 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.
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.
Outcome measures
| Measure |
Sham Stimulation
n=3 Participants
Participants will undergo 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.
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.
|
Transcranial Direct Current Simulation
n=4 Participants
Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.
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.
|
|---|---|---|
|
Resting Motor Threshold (Percent of Machine Output)
|
56.13 % Maximal Stimulator Output (%MSO)
Interval 47.5 to 63.5
|
68.25 % Maximal Stimulator Output (%MSO)
Interval 59.0 to 72.0
|
SECONDARY outcome
Timeframe: Baseline6-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.
Outcome measures
| Measure |
Sham Stimulation
n=11 Participants
Participants will undergo 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.
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.
|
Transcranial Direct Current Simulation
n=5 Participants
Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.
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.
|
|---|---|---|
|
Katz Independence Questionnaire
|
6 score on a scale
Interval 6.0 to 6.0
|
6 score on a scale
Interval 6.0 to 6.0
|
Adverse Events
Sham Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Transcranial Direct Current Simulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place