Trial Outcomes & Findings for Frontal and Parietal Contributions to Proprioception and Motor Skill Learning (NCT NCT05739994)
NCT ID: NCT05739994
Last Updated: 2025-12-05
Results Overview
Assessed by measuring movement accuracy on a maze-tracing task. Accuracy is defined by percent of movement path that falls within the maze. Participants traced the maze 10 times at 3 different speed ranges. Overall performance accuracy was taken as the mean accuracy across the three speed ranges. A change in mean accuracy reflects learning.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
118 participants
Primary outcome timeframe
Assessed 4 times during the 2-hour main session: Pre-cTBS ("Pre"), immediately post-cTBS ("Post1"), after 40 trials of maze-tracing practice ("Post2"), and after 80 trials of maze-tracing practice ("Post 3").
Results posted on
2025-12-05
Participant Flow
Participants were recruited with flyers posted in the community. They were asked to complete an electronic screening form to determine basic eligibility and, if they appeared eligible, the experimenter scheduled the familiarization session.
During the familiarization session, after giving informed consent, participants experienced the transcranial magnetic stimulation (TMS) used in the main experiment. This was to make sure they were not bothered by the sensations before random group assignment. Of the 118 who enrolled, 25 found the TMS uncomfortable and were excluded. A further 6 withdrew due to scheduling conflicts, leaving 87 who received a group assignment.
Participant milestones
| Measure |
Dorsolateral Prefrontal Cortex (DLPFC)
Theta burst transcranial magnetic stimulation (cTBS) will be applied over dorsolateral prefrontal cortex (DLPFC).
Theta burst transcranial magnetic stimulation: Continuous theta burst TMS (cTBS) will be delivered to a location on the head. cTBS consists of 600 low-intensity TMS pulses delivered over 40 seconds in a pattern of 50 Hz triplets delivered at 5 Hz.
|
Supramarginal Gyrus (SMG)
Theta burst transcranial magnetic stimulation (cTBS) will be applied over the supramarginal gyrus (SMG).
Theta burst transcranial magnetic stimulation: Continuous theta burst TMS (cTBS) will be delivered to a location on the head. cTBS consists of 600 low-intensity TMS pulses delivered over 40 seconds in a pattern of 50 Hz triplets delivered at 5 Hz.
|
Sham Control Group
Sham theta burst transcranial magnetic stimulation (cTBS) will be applied over the vertex.
Sham theta burst transcranial magnetic stimulation: Continuous theta burst TMS (cTBS) will be delivered near the head, while an unplugged TMS coil is held at the vertex. No current will be induced in the head with this procedure.
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
30
|
|
Overall Study
COMPLETED
|
27
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
4
|
Reasons for withdrawal
| Measure |
Dorsolateral Prefrontal Cortex (DLPFC)
Theta burst transcranial magnetic stimulation (cTBS) will be applied over dorsolateral prefrontal cortex (DLPFC).
Theta burst transcranial magnetic stimulation: Continuous theta burst TMS (cTBS) will be delivered to a location on the head. cTBS consists of 600 low-intensity TMS pulses delivered over 40 seconds in a pattern of 50 Hz triplets delivered at 5 Hz.
|
Supramarginal Gyrus (SMG)
Theta burst transcranial magnetic stimulation (cTBS) will be applied over the supramarginal gyrus (SMG).
Theta burst transcranial magnetic stimulation: Continuous theta burst TMS (cTBS) will be delivered to a location on the head. cTBS consists of 600 low-intensity TMS pulses delivered over 40 seconds in a pattern of 50 Hz triplets delivered at 5 Hz.
|
Sham Control Group
Sham theta burst transcranial magnetic stimulation (cTBS) will be applied over the vertex.
Sham theta burst transcranial magnetic stimulation: Continuous theta burst TMS (cTBS) will be delivered near the head, while an unplugged TMS coil is held at the vertex. No current will be induced in the head with this procedure.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
4
|
Baseline Characteristics
Frontal and Parietal Contributions to Proprioception and Motor Skill Learning
Baseline characteristics by cohort
| Measure |
Dorsolateral Prefrontal Cortex (DLPFC)
n=27 Participants
Theta burst transcranial magnetic stimulation (cTBS) will be applied over dorsolateral prefrontal cortex (DLPFC).
Theta burst transcranial magnetic stimulation: Continuous theta burst TMS (cTBS) will be delivered to a location on the head. cTBS consists of 600 low-intensity TMS pulses delivered over 40 seconds in a pattern of 50 Hz triplets delivered at 5 Hz.
|
Supramarginal Gyrus (SMG)
n=26 Participants
Theta burst transcranial magnetic stimulation (cTBS) will be applied over the supramarginal gyrus (SMG).
Theta burst transcranial magnetic stimulation: Continuous theta burst TMS (cTBS) will be delivered to a location on the head. cTBS consists of 600 low-intensity TMS pulses delivered over 40 seconds in a pattern of 50 Hz triplets delivered at 5 Hz.
|
Sham Control Group
n=26 Participants
Sham theta burst transcranial magnetic stimulation (cTBS) will be applied over the vertex.
Sham theta burst transcranial magnetic stimulation: Continuous theta burst TMS (cTBS) will be delivered near the head, while an unplugged TMS coil is held at the vertex. No current will be induced in the head with this procedure.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
25.2 years
STANDARD_DEVIATION 7.0 • n=37 Participants
|
22.5 years
STANDARD_DEVIATION 3.6 • n=37 Participants
|
23.1 years
STANDARD_DEVIATION 4.2 • n=74 Participants
|
23.6 years
STANDARD_DEVIATION 5.3 • n=267 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=37 Participants
|
16 Participants
n=37 Participants
|
12 Participants
n=74 Participants
|
42 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=37 Participants
|
10 Participants
n=37 Participants
|
14 Participants
n=74 Participants
|
37 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=37 Participants
|
7 Participants
n=37 Participants
|
4 Participants
n=74 Participants
|
14 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=37 Participants
|
19 Participants
n=37 Participants
|
22 Participants
n=74 Participants
|
65 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=37 Participants
|
12 Participants
n=37 Participants
|
11 Participants
n=74 Participants
|
32 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
2 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=37 Participants
|
11 Participants
n=37 Participants
|
12 Participants
n=74 Participants
|
37 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=37 Participants
|
2 Participants
n=37 Participants
|
3 Participants
n=74 Participants
|
8 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=37 Participants
|
26 participants
n=37 Participants
|
26 participants
n=74 Participants
|
79 participants
n=267 Participants
|
|
Edinburgh handedness inventory
|
89.2 units on a scale
STANDARD_DEVIATION 10.7 • n=37 Participants
|
85.2 units on a scale
STANDARD_DEVIATION 16.5 • n=37 Participants
|
78.4 units on a scale
STANDARD_DEVIATION 18.9 • n=74 Participants
|
84.3 units on a scale
STANDARD_DEVIATION 16.1 • n=267 Participants
|
|
Resting Motor Threshold (RMT)
|
49.3 Percent of max stimulator output (%MSO)
STANDARD_DEVIATION 9.7 • n=37 Participants
|
50.7 Percent of max stimulator output (%MSO)
STANDARD_DEVIATION 8.6 • n=37 Participants
|
50.3 Percent of max stimulator output (%MSO)
STANDARD_DEVIATION 8.0 • n=74 Participants
|
50.1 Percent of max stimulator output (%MSO)
STANDARD_DEVIATION 8.7 • n=267 Participants
|
PRIMARY outcome
Timeframe: Assessed 4 times during the 2-hour main session: Pre-cTBS ("Pre"), immediately post-cTBS ("Post1"), after 40 trials of maze-tracing practice ("Post2"), and after 80 trials of maze-tracing practice ("Post 3").Assessed by measuring movement accuracy on a maze-tracing task. Accuracy is defined by percent of movement path that falls within the maze. Participants traced the maze 10 times at 3 different speed ranges. Overall performance accuracy was taken as the mean accuracy across the three speed ranges. A change in mean accuracy reflects learning.
Outcome measures
| Measure |
Dorsolateral Prefrontal Cortex (DLPFC)
n=27 Participants
Theta burst transcranial magnetic stimulation (cTBS) will be applied over dorsolateral prefrontal cortex (DLPFC).
Theta burst transcranial magnetic stimulation: Continuous theta burst TMS (cTBS) will be delivered to a location on the head. cTBS consists of 600 low-intensity TMS pulses delivered over 40 seconds in a pattern of 50 Hz triplets delivered at 5 Hz.
|
Supramarginal Gyrus (SMG)
n=26 Participants
Theta burst transcranial magnetic stimulation (cTBS) will be applied over the supramarginal gyrus (SMG).
Theta burst transcranial magnetic stimulation: Continuous theta burst TMS (cTBS) will be delivered to a location on the head. cTBS consists of 600 low-intensity TMS pulses delivered over 40 seconds in a pattern of 50 Hz triplets delivered at 5 Hz.
|
Sham Control Group
n=26 Participants
Sham theta burst transcranial magnetic stimulation (cTBS) will be applied over the vertex.
Sham theta burst transcranial magnetic stimulation: Continuous theta burst TMS (cTBS) will be delivered near the head, while an unplugged TMS coil is held at the vertex. No current will be induced in the head with this procedure.
|
|---|---|---|---|
|
Motor Skill
Pre timepoint
|
66.6 Accuracy (%)
Standard Deviation 9.3
|
59.4 Accuracy (%)
Standard Deviation 8.9
|
59.9 Accuracy (%)
Standard Deviation 10.6
|
|
Motor Skill
Post 1 timepoint
|
64.9 Accuracy (%)
Standard Deviation 10.5
|
58.5 Accuracy (%)
Standard Deviation 9.7
|
63.5 Accuracy (%)
Standard Deviation 9.1
|
|
Motor Skill
Post 3 timepoint
|
68.2 Accuracy (%)
Standard Deviation 11.6
|
62.1 Accuracy (%)
Standard Deviation 10
|
66.3 Accuracy (%)
Standard Deviation 11.3
|
|
Motor Skill
Post 2 timepoint
|
69.4 Accuracy (%)
Standard Deviation 8.6
|
61.8 Accuracy (%)
Standard Deviation 8.7
|
65.4 Accuracy (%)
Standard Deviation 10.9
|
PRIMARY outcome
Timeframe: Assessed at 2 timepoints during the 2-hour main session: pre-cTBS ("Pre") and post-cTBS ("Post").Two-alternative forced choice task where the robot moves the participant's hand in two different positions, and the participant reports whether second position was closer or further than first position. This data is fitted with a logistic regression relating the distance between the two positions and the likelihood that participant reports "further". The outcome measure is the distance at which the participant is equally likely to say "closer" or "further"; this is defined as the point of subjective equality, which indexes proprioceptive accuracy. If the number is small (close to zero), it means the person has high proprioceptive accuracy. If the number is large, it means the person is less accurate.
Outcome measures
| Measure |
Dorsolateral Prefrontal Cortex (DLPFC)
n=27 Participants
Theta burst transcranial magnetic stimulation (cTBS) will be applied over dorsolateral prefrontal cortex (DLPFC).
Theta burst transcranial magnetic stimulation: Continuous theta burst TMS (cTBS) will be delivered to a location on the head. cTBS consists of 600 low-intensity TMS pulses delivered over 40 seconds in a pattern of 50 Hz triplets delivered at 5 Hz.
|
Supramarginal Gyrus (SMG)
n=26 Participants
Theta burst transcranial magnetic stimulation (cTBS) will be applied over the supramarginal gyrus (SMG).
Theta burst transcranial magnetic stimulation: Continuous theta burst TMS (cTBS) will be delivered to a location on the head. cTBS consists of 600 low-intensity TMS pulses delivered over 40 seconds in a pattern of 50 Hz triplets delivered at 5 Hz.
|
Sham Control Group
n=26 Participants
Sham theta burst transcranial magnetic stimulation (cTBS) will be applied over the vertex.
Sham theta burst transcranial magnetic stimulation: Continuous theta burst TMS (cTBS) will be delivered near the head, while an unplugged TMS coil is held at the vertex. No current will be induced in the head with this procedure.
|
|---|---|---|---|
|
Proprioception
Pre timepoint
|
0.9 mm
Standard Deviation 0.62
|
0.79 mm
Standard Deviation 0.72
|
0.73 mm
Standard Deviation 0.56
|
|
Proprioception
Post timepoint
|
1.2 mm
Standard Deviation 1.14
|
0.8 mm
Standard Deviation 0.55
|
0.75 mm
Standard Deviation 0.79
|
Adverse Events
Dorsolateral Prefrontal Cortex (DLPFC)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Supramarginal Gyrus (SMG)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Sham Control Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dorsolateral Prefrontal Cortex (DLPFC)
n=28 participants at risk
Theta burst transcranial magnetic stimulation (cTBS) will be applied over dorsolateral prefrontal cortex (DLPFC).
Theta burst transcranial magnetic stimulation: Continuous theta burst TMS (cTBS) will be delivered to a location on the head. cTBS consists of 600 low-intensity TMS pulses delivered over 40 seconds in a pattern of 50 Hz triplets delivered at 5 Hz.
|
Supramarginal Gyrus (SMG)
n=28 participants at risk
Theta burst transcranial magnetic stimulation (cTBS) will be applied over the supramarginal gyrus (SMG).
Theta burst transcranial magnetic stimulation: Continuous theta burst TMS (cTBS) will be delivered to a location on the head. cTBS consists of 600 low-intensity TMS pulses delivered over 40 seconds in a pattern of 50 Hz triplets delivered at 5 Hz.
|
Sham Control Group
n=30 participants at risk
Sham theta burst transcranial magnetic stimulation (cTBS) will be applied over the vertex.
Sham theta burst transcranial magnetic stimulation: Continuous theta burst TMS (cTBS) will be delivered near the head, while an unplugged TMS coil is held at the vertex. No current will be induced in the head with this procedure.
|
|---|---|---|---|
|
General disorders
Discomfort from TMS
|
14.3%
4/28 • Number of events 4 • Adverse events were monitored during each study visit: the familiarization session (about 1 hour), the MRI (about 30 minutes), and the main session (about 2 hours).
|
25.0%
7/28 • Number of events 7 • Adverse events were monitored during each study visit: the familiarization session (about 1 hour), the MRI (about 30 minutes), and the main session (about 2 hours).
|
16.7%
5/30 • Number of events 5 • Adverse events were monitored during each study visit: the familiarization session (about 1 hour), the MRI (about 30 minutes), and the main session (about 2 hours).
|
|
Nervous system disorders
Headache
|
3.6%
1/28 • Number of events 1 • Adverse events were monitored during each study visit: the familiarization session (about 1 hour), the MRI (about 30 minutes), and the main session (about 2 hours).
|
0.00%
0/28 • Adverse events were monitored during each study visit: the familiarization session (about 1 hour), the MRI (about 30 minutes), and the main session (about 2 hours).
|
3.3%
1/30 • Number of events 1 • Adverse events were monitored during each study visit: the familiarization session (about 1 hour), the MRI (about 30 minutes), and the main session (about 2 hours).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place