Trial Outcomes & Findings for Improving Locomotor Learning With Brain Stimulation (NCT NCT06414213)
NCT ID: NCT06414213
Last Updated: 2025-02-03
Results Overview
Functional near infrared spectroscopy (fNIRS) monitor (OctaMon by Artinis Medical Systems), changes in oxygenated hemoglobin concentration (O2Hb) relative to a baseline task
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
Baseline to 1 week follow up
Results posted on
2025-02-03
Participant Flow
Participant milestones
| Measure |
MI/Active tDCS
The participants received active tDCS current and participated in the Motor Imagery intervention.
Motor Imagery (MI): Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation.
Active tDCS: The participants received a 20-minute "active" session of tDCS at a 2-milliamp current.
|
MI/Sham tDCS
The participants received sham tDCS current and participated in the Motor Imagery intervention.
Motor Imagery (MI): Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation.
Sham tDCS: The participants received a 20-minute session of "sham" tDCS.
|
Control
The control group watched an unrelated (non stimulating) video for a duration equal to the MI groups' intervention tasks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
13
|
|
Overall Study
COMPLETED
|
12
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
Reasons for withdrawal
| Measure |
MI/Active tDCS
The participants received active tDCS current and participated in the Motor Imagery intervention.
Motor Imagery (MI): Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation.
Active tDCS: The participants received a 20-minute "active" session of tDCS at a 2-milliamp current.
|
MI/Sham tDCS
The participants received sham tDCS current and participated in the Motor Imagery intervention.
Motor Imagery (MI): Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation.
Sham tDCS: The participants received a 20-minute session of "sham" tDCS.
|
Control
The control group watched an unrelated (non stimulating) video for a duration equal to the MI groups' intervention tasks.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MI/Active tDCS
n=13 Participants
The participants received active tDCS current and participated in the Motor Imagery intervention.
Motor Imagery (MI): Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation.
Active tDCS: The participants received a 20-minute "active" session of tDCS at a 2-milliamp current.
|
MI/Sham tDCS
n=12 Participants
The participants received sham tDCS current and participated in the Motor Imagery intervention.
Motor Imagery (MI): Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation.
Sham tDCS: The participants received a 20-minute session of "sham" tDCS.
|
Control
n=13 Participants
The control group watched an unrelated (non stimulating) video for a duration equal to the MI groups' intervention tasks.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=38 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=13 Participants
|
12 Participants
n=12 Participants
|
13 Participants
n=13 Participants
|
38 Participants
n=38 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=38 Participants
|
|
Age, Continuous
|
22.42 years
STANDARD_DEVIATION 1.98 • n=13 Participants
|
22.36 years
STANDARD_DEVIATION 2.06 • n=12 Participants
|
24.1 years
STANDARD_DEVIATION 4.04 • n=13 Participants
|
22.96 years
STANDARD_DEVIATION 2.69 • n=38 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=13 Participants
|
11 Participants
n=12 Participants
|
10 Participants
n=13 Participants
|
32 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=13 Participants
|
1 Participants
n=12 Participants
|
3 Participants
n=13 Participants
|
6 Participants
n=38 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Baseline to 1 week follow upFunctional near infrared spectroscopy (fNIRS) monitor (OctaMon by Artinis Medical Systems), changes in oxygenated hemoglobin concentration (O2Hb) relative to a baseline task
Outcome measures
| Measure |
MI/Active tDCS
n=12 Participants
The participants received active tDCS current and participated in the Motor Imagery intervention.
Motor Imagery (MI): Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation.
Active tDCS: The participants received a 20-minute "active" session of tDCS at a 2-milliamp current.
|
MI/Sham tDCS
n=11 Participants
The participants received sham tDCS current and participated in the Motor Imagery intervention.
Motor Imagery (MI): Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation.
Sham tDCS: The participants received a 20-minute session of "sham" tDCS.
|
Control
n=10 Participants
The control group watched an unrelated (non stimulating) video for a duration equal to the MI groups' intervention tasks.
|
|---|---|---|---|
|
Prefrontal Cortical Activity
Baseline (Pre-Intervention)
|
0.04 μM
Standard Deviation 0.47
|
0.11 μM
Standard Deviation 0.68
|
0.58 μM
Standard Deviation 0.50
|
|
Prefrontal Cortical Activity
20 minutes post Baseline (Post-Intervention)
|
-0.62 μM
Standard Deviation 0.70
|
-0.19 μM
Standard Deviation 0.91
|
0.20 μM
Standard Deviation 0.81
|
|
Prefrontal Cortical Activity
1 Week Follow up
|
-0.61 μM
Standard Deviation 0.51
|
0.24 μM
Standard Deviation 1.11
|
0.12 μM
Standard Deviation 0.64
|
PRIMARY outcome
Timeframe: Baseline to 1 week follow upnumber of sessions attended
Outcome measures
| Measure |
MI/Active tDCS
n=13 Participants
The participants received active tDCS current and participated in the Motor Imagery intervention.
Motor Imagery (MI): Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation.
Active tDCS: The participants received a 20-minute "active" session of tDCS at a 2-milliamp current.
|
MI/Sham tDCS
n=12 Participants
The participants received sham tDCS current and participated in the Motor Imagery intervention.
Motor Imagery (MI): Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation.
Sham tDCS: The participants received a 20-minute session of "sham" tDCS.
|
Control
n=13 Participants
The control group watched an unrelated (non stimulating) video for a duration equal to the MI groups' intervention tasks.
|
|---|---|---|---|
|
Adherence to Interventions
|
1.92 Numbers of session completed
Standard Deviation 0.27
|
1.91 Numbers of session completed
Standard Deviation 0.28
|
1.77 Numbers of session completed
Standard Deviation .43
|
PRIMARY outcome
Timeframe: Baseline to 1 week follow upnumber of participants completing intervention and follow-up assessment
Outcome measures
| Measure |
MI/Active tDCS
n=13 Participants
The participants received active tDCS current and participated in the Motor Imagery intervention.
Motor Imagery (MI): Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation.
Active tDCS: The participants received a 20-minute "active" session of tDCS at a 2-milliamp current.
|
MI/Sham tDCS
n=12 Participants
The participants received sham tDCS current and participated in the Motor Imagery intervention.
Motor Imagery (MI): Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation.
Sham tDCS: The participants received a 20-minute session of "sham" tDCS.
|
Control
n=13 Participants
The control group watched an unrelated (non stimulating) video for a duration equal to the MI groups' intervention tasks.
|
|---|---|---|---|
|
Retention of Participants
|
12 Participants
|
11 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Baseline to 1 week follow upNumber of unexpected and/or serious adverse events
Outcome measures
| Measure |
MI/Active tDCS
n=12 Participants
The participants received active tDCS current and participated in the Motor Imagery intervention.
Motor Imagery (MI): Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation.
Active tDCS: The participants received a 20-minute "active" session of tDCS at a 2-milliamp current.
|
MI/Sham tDCS
n=11 Participants
The participants received sham tDCS current and participated in the Motor Imagery intervention.
Motor Imagery (MI): Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation.
Sham tDCS: The participants received a 20-minute session of "sham" tDCS.
|
Control
n=10 Participants
The control group watched an unrelated (non stimulating) video for a duration equal to the MI groups' intervention tasks.
|
|---|---|---|---|
|
Adverse Events in Each Study Arm
|
0 number of adverse events
|
0 number of adverse events
|
0 number of adverse events
|
PRIMARY outcome
Timeframe: Baseline to 1 week follow upRecorded time to complete the obstacle course
Outcome measures
| Measure |
MI/Active tDCS
n=12 Participants
The participants received active tDCS current and participated in the Motor Imagery intervention.
Motor Imagery (MI): Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation.
Active tDCS: The participants received a 20-minute "active" session of tDCS at a 2-milliamp current.
|
MI/Sham tDCS
n=11 Participants
The participants received sham tDCS current and participated in the Motor Imagery intervention.
Motor Imagery (MI): Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation.
Sham tDCS: The participants received a 20-minute session of "sham" tDCS.
|
Control
n=10 Participants
The control group watched an unrelated (non stimulating) video for a duration equal to the MI groups' intervention tasks.
|
|---|---|---|---|
|
Time to Completion
1 Week Follow up
|
39.1 seconds
Standard Deviation 3.98
|
45.43 seconds
Standard Deviation 3.8
|
36.1 seconds
Standard Deviation 8.3
|
|
Time to Completion
Baseline/Pre
|
46.60 seconds
Standard Deviation 7.8
|
47.64 seconds
Standard Deviation 6.42
|
39.27 seconds
Standard Deviation 8.1
|
|
Time to Completion
Post-Test
|
40.72 seconds
Standard Deviation 3.45
|
47.21 seconds
Standard Deviation 4.3
|
37.2 seconds
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Baseline to 1 week follow upPopulation: The motor imagery/active tDCS and motor imagery/sham tDCS groups participated in the KVIQ-10 assessments, receiving motor imagery and active or sham transcranial direct current stimulation, respectively. These assessments evaluated their kinesthetic and visual imagery abilities, in order to compare their relative capabilities. The control group did not participate in the KVIQ-10 because they did not engage in motor imagery training, making the administration of the KVIQ-10 irrelevant for them.
The Kinesthetic and Visual Imagery Questionnaire (KVIQ-10) measures the ability to imagine movements. This test evaluates the subject's ability to see (visual imagery) and feel (kinesthetic imagery) movements. The KVIQ-10 total score ranges from 10 to 50 (visual and kinesthetic subscale scores each range from 5 to 25).The KVIQ consists of 10 items, (5 movements for each scale), each item being a separate movement followed by rating the ease or difficulty of generating those self-images on a 5-point Likert scale (where 1 = no image or sensation and 5 = Image as clear as seeing or as intense as executing the action). Higher scores reflect higher imagery abilities.
Outcome measures
| Measure |
MI/Active tDCS
n=12 Participants
The participants received active tDCS current and participated in the Motor Imagery intervention.
Motor Imagery (MI): Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation.
Active tDCS: The participants received a 20-minute "active" session of tDCS at a 2-milliamp current.
|
MI/Sham tDCS
n=11 Participants
The participants received sham tDCS current and participated in the Motor Imagery intervention.
Motor Imagery (MI): Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation.
Sham tDCS: The participants received a 20-minute session of "sham" tDCS.
|
Control
The control group watched an unrelated (non stimulating) video for a duration equal to the MI groups' intervention tasks.
|
|---|---|---|---|
|
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
External Imagery
|
21.3 score on a scale
Standard Deviation 4.1
|
22.7 score on a scale
Standard Deviation 3.0
|
—
|
|
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Kinesthetic Imagery
|
22.9 score on a scale
Standard Deviation 4.7
|
21.7 score on a scale
Standard Deviation 4.5
|
—
|
Adverse Events
MI/Active tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MI/Sham tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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