Trial Outcomes & Findings for Neural Facilitation of Movements in People With SCI (NCT NCT05354206)
NCT ID: NCT05354206
Last Updated: 2024-11-22
Results Overview
This primary outcome is a measure of changes in corticospinal tract excitability as quantified by changes in the amplitude size of motor evoked potentials. Data for this arm were not collected due to early study termination.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
30 minutes before and 30 minutes into intervention
Results posted on
2024-11-22
Participant Flow
Participants enrolled from flyers and word of mouth at Washington University in St. Louis. The first participant was enrolled on 06/23/2022, the last participant was enrolled on 03/06/2023.
Recruitment was only perform for the second arm of the study: evaluating reticulospinal tract contributions during different types of movements. Participants performed range-of-motion and precision-control tasks in randomized order during the same session. As this study was terminated early based on change in funding, no participants were assigned to the "Evaluation of Motor Evoked Potentials" arm, and no data could be provided for this outcome measure.
Participant milestones
| Measure |
Reaction Time Evaluation During Non-invasive Spinal Cord Stimulation and Leg Movements
This arm will receive a loud auditory stimuli to evaluate the excitability of the reticulospinal tract during non-invasive spinal cord stimulation
Electrophysiology assessment - reticulospinal tract contribution during hip range of motion task Electrophysiology assessment - reticulospinal tract contribution during hip precision control task
Electrophysiology assessment - reticulospinal tract contribution during plantarflexion range of motion task Electrophysiology assessment - reticulospinal tract contribution during plantarflexion precision control task
Electrophysiology assessment - reticulospinal tract contribution during dorsiflexion range of motion task Electrophysiology assessment - reticulospinal tract contribution during dorsiflexion precision control task
|
Evaluation of Motor Evoked Potentials During Non-invasive Spinal Cord Stimulation and Leg Movements
This arm will receive the transcranial magnetic stimulation to evaluate the excitability of the corticospinal tract during non-invasive spinal cord stimulation
Electrophysiology assessment - reticulospinal tract contribution during hip range of motion task Electrophysiology assessment - reticulospinal tract contribution during hip precision control task
Electrophysiology assessment - reticulospinal tract contribution during plantarflexion range of motion task Electrophysiology assessment - reticulospinal tract contribution during plantarflexion precision control task
Electrophysiology assessment - reticulospinal tract contribution during dorsiflexion range of motion task Electrophysiology assessment - reticulospinal tract contribution during dorsiflexion precision control task
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
0
|
|
Overall Study
Withdrawals
|
1
|
0
|
|
Overall Study
Exclusions
|
3
|
0
|
|
Overall Study
COMPLETED
|
19
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Reaction Time Evaluation During Non-invasive Spinal Cord Stimulation and Leg Movements
This arm will receive a loud auditory stimuli to evaluate the excitability of the reticulospinal tract during non-invasive spinal cord stimulation
Electrophysiology assessment - reticulospinal tract contribution during hip range of motion task Electrophysiology assessment - reticulospinal tract contribution during hip precision control task
Electrophysiology assessment - reticulospinal tract contribution during plantarflexion range of motion task Electrophysiology assessment - reticulospinal tract contribution during plantarflexion precision control task
Electrophysiology assessment - reticulospinal tract contribution during dorsiflexion range of motion task Electrophysiology assessment - reticulospinal tract contribution during dorsiflexion precision control task
|
Evaluation of Motor Evoked Potentials During Non-invasive Spinal Cord Stimulation and Leg Movements
This arm will receive the transcranial magnetic stimulation to evaluate the excitability of the corticospinal tract during non-invasive spinal cord stimulation
Electrophysiology assessment - reticulospinal tract contribution during hip range of motion task Electrophysiology assessment - reticulospinal tract contribution during hip precision control task
Electrophysiology assessment - reticulospinal tract contribution during plantarflexion range of motion task Electrophysiology assessment - reticulospinal tract contribution during plantarflexion precision control task
Electrophysiology assessment - reticulospinal tract contribution during dorsiflexion range of motion task Electrophysiology assessment - reticulospinal tract contribution during dorsiflexion precision control task
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Neural Facilitation of Movements in People With SCI
Baseline characteristics by cohort
| Measure |
Reaction Time Evaluation During Non-invasive Spinal Cord Stimulation and Leg Movements
n=20 Participants
This arm will receive the loud auditory stimuli to evaluate the excitability of the reticulospinal tract first then the arm will receive the transcranial magnetic stimulation to excite the corticospinal tract second
Electrophysiology assessment - reticulospinal tract: Kinematics and reticular spinal motor excitability
Training with some stimulation: Motor task combined with real or sham stimulation
|
Evaluation of Motor Evoked Potentials During Non-invasive Spinal Cord Stimulation and Leg Movements
Evaluation of motor evoked potentials during non-invasive spinal cord stimulation and leg movements
This arm will receive the transcranial magnetic stimulation to evaluate the excitability of the corticospinal tract first then the arm will receive the loud auditory stimuli to evaluate the excitability of the reticulospinal track second.
Electrophysiology assessment - corticospinal tract: Kinematics and cortical spinal motor excitability
Training with some stimulation: Motor task combined with real or sham stimulation
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
25.8 years
STANDARD_DEVIATION 8.67 • n=39 Participants
|
—
|
25.8 years
STANDARD_DEVIATION 8.67 • n=35 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
—
|
6 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=39 Participants
|
—
|
14 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
—
|
2 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=39 Participants
|
—
|
18 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=39 Participants
|
—
|
9 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=39 Participants
|
—
|
11 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=39 Participants
|
—
|
20 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 30 minutes before and 30 minutes into interventionThis primary outcome is a measure of changes in corticospinal tract excitability as quantified by changes in the amplitude size of motor evoked potentials. Data for this arm were not collected due to early study termination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: During intervention, *1 Day*.Population: The average across all participants is reported.
This primary outcome measures changes in reticulospinal tract excitability (RST) during training as quantified by changes in reaction time after a startling auditory stimulus. RST contrubution was evaluated for dorsiflexion, plantarflexion, hip flexion movements during precision and range of motion control tasks under three conditions: with transcutaneous spinal cord stimulation or without stimulation. All conditions/evaluations were performed in the same session. 30 repetitions were performed per condition during a single session and averaged for each participant. RST is a ratio calculated by = (visual - startle)/(visual - auditory), where: visual represents the reaction time to a visual cue, auditory represents the reaction time to an auditory cue, startle represents the reaction time to a startling cue. A RST ratio value greater than 1 would indicate a significant contribution of the reticulospinal tract for a given task. A value equal or lower than 1 would suggest
Outcome measures
| Measure |
Reaction Time Evaluation During Non-invasive Spinal Cord Stimulation and Leg Movements
n=16 Participants
This arm will receive the loud auditory stimuli to evaluate the excitability of the reticulospinal tract first then the arm will receive the transcranial magnetic stimulation to excite the corticospinal tract second
Electrophysiology assessment - reticulospinal tract: Kinematics and reticular spinal motor excitability
Training with some stimulation: Motor task combined with real or sham stimulation
|
|---|---|
|
Reticulospinal Tract Excitability During Different Types of Movements
RST: Hip flexion - range of motion - No stimulation
|
1.405 arbitrary units
Standard Error 0.285
|
|
Reticulospinal Tract Excitability During Different Types of Movements
RST: Hip flexion - precision control - No stimulation
|
1.480 arbitrary units
Standard Error 0.325
|
|
Reticulospinal Tract Excitability During Different Types of Movements
RST: Plantar flexion - range of motion - No stimulation
|
1.443 arbitrary units
Standard Error 0.325
|
|
Reticulospinal Tract Excitability During Different Types of Movements
RST: Plantar flexion - precision control - No stimulation
|
1.455 arbitrary units
Standard Error 0.258
|
|
Reticulospinal Tract Excitability During Different Types of Movements
RST: Dorsiflexion - range of motion - No stimulation
|
1.544 arbitrary units
Standard Error 0.578
|
|
Reticulospinal Tract Excitability During Different Types of Movements
RST: Dorsiflexion - precision control - No stimulation
|
1.364 arbitrary units
Standard Error 0.377
|
|
Reticulospinal Tract Excitability During Different Types of Movements
RST: Hip flexion - range of motion - stimulation
|
1.497 arbitrary units
Standard Error 0.569
|
|
Reticulospinal Tract Excitability During Different Types of Movements
RST: Hip flexion - precision control - stimulation
|
1.689 arbitrary units
Standard Error 0.667
|
|
Reticulospinal Tract Excitability During Different Types of Movements
RST: Plantar flexion - range of motion - stimulation
|
1.465 arbitrary units
Standard Error 0.667
|
|
Reticulospinal Tract Excitability During Different Types of Movements
RST: Plantar flexion - precision control - stimulation
|
1.376 arbitrary units
Standard Error 0.285
|
|
Reticulospinal Tract Excitability During Different Types of Movements
RST: Dorsiflexion - range of motion - stimulation
|
1.363 arbitrary units
Standard Error 0.225
|
|
Reticulospinal Tract Excitability During Different Types of Movements
RST: Dorsiflexion - precision control - stimulation
|
1.294 arbitrary units
Standard Error 0.189
|
Adverse Events
Reaction Time Evaluation During Non-invasive Spinal Cord Stimulation and Leg Movements
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Evaluation of Motor Evoked Potentials During Non-invasive Spinal Cord Stimulation and Leg Movements
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