Trial Outcomes & Findings for Cortical Contributions to Motor Sequence Learning (NCT NCT04138953)
NCT ID: NCT04138953
Last Updated: 2024-08-28
Results Overview
The SRTT involves pressing a key that corresponds to a target square presented on a monitor. Sequenced skill (SS) is calculated by subtracting the response time of sequenced key presses from random key presses within and across a test block. An increase in SS value indicates an increase in sequenced skill and is a preferable result.
COMPLETED
NA
64 participants
Pre-test (baseline), Post-test (training usually lasts for 3 hours), Retention Test (30 mins following training)
2024-08-28
Participant Flow
Participant milestones
| Measure |
Sham TMS
Sham brain stimulation
|
TMS Over Primary Motor Cortex (M1)
Noninvasive brain stimulation in the motor cortex
Transcranial Magnetic Stimulation (TMS): Transcranial magnetic stimulation, also known as repetitive transcranial magnetic stimulation, is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction.
It will be used to create a 'virtual lesion,' disrupting neural activity in a specific brain region to identify whether it is causally involved in a specific behavioral process.
|
TMS Over Premotor Cortex (PMC)
Noninvasive brain stimulation in the premotor cortex
Transcranial Magnetic Stimulation (TMS): Transcranial magnetic stimulation, also known as repetitive transcranial magnetic stimulation, is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction.
It will be used to create a 'virtual lesion,' disrupting neural activity in a specific brain region to identify whether it is causally involved in a specific behavioral process.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
24
|
|
Overall Study
COMPLETED
|
20
|
20
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cortical Contributions to Motor Sequence Learning
Baseline characteristics by cohort
| Measure |
Sham TMS
n=20 Participants
Sham brain stimulation
|
TMS Over Primary Motor Cortex (M1)
n=20 Participants
Noninvasive brain stimulation in the motor cortex
Transcranial Magnetic Stimulation (TMS): Transcranial magnetic stimulation, also known as repetitive transcranial magnetic stimulation, is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction.
It will be used to create a 'virtual lesion,' disrupting neural activity in a specific brain region to identify whether it is causally involved in a specific behavioral process.
|
TMS Over Premotor Cortex (PMC)
n=24 Participants
Noninvasive brain stimulation in the premotor cortex
Transcranial Magnetic Stimulation (TMS): Transcranial magnetic stimulation, also known as repetitive transcranial magnetic stimulation, is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction.
It will be used to create a 'virtual lesion,' disrupting neural activity in a specific brain region to identify whether it is causally involved in a specific behavioral process.
|
Total
n=64 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multi racial
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-test (baseline), Post-test (training usually lasts for 3 hours), Retention Test (30 mins following training)Population: The population in this analysis includes participants who completed the indicated study visit and had usable data. Five participants in the PMC group are not included due to technical issues; for 2 participants the stimulation target could not be confirmed during data analysis and 3 participants had different timing values than other members of their cohort. Of participants with usable pre- and post- test data, 11 from the M1 group and 12 from the PMC group completed the retention test.
The SRTT involves pressing a key that corresponds to a target square presented on a monitor. Sequenced skill (SS) is calculated by subtracting the response time of sequenced key presses from random key presses within and across a test block. An increase in SS value indicates an increase in sequenced skill and is a preferable result.
Outcome measures
| Measure |
Sham TMS
n=20 Participants
Sham brain stimulation
|
TMS Over Primary Motor Cortex (M1)
n=20 Participants
Noninvasive brain stimulation in the motor cortex
Transcranial Magnetic Stimulation (TMS): Transcranial magnetic stimulation, also known as repetitive transcranial magnetic stimulation, is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction. It will be used to create a 'virtual lesion,' disrupting neural activity in a specific brain region to identify whether it is causally involved in a specific behavioral process.
|
TMS Over Premotor Cortex (PMC)
n=19 Participants
Noninvasive brain stimulation in the premotor cortex
Transcranial Magnetic Stimulation (TMS): Transcranial magnetic stimulation, also known as repetitive transcranial magnetic stimulation, is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction. It will be used to create a 'virtual lesion,' disrupting neural activity in a specific brain region to identify whether it is causally involved in a specific behavioral process.
|
|---|---|---|---|
|
Serial Reaction Time Task (SRTT) Performance
SS Pre-test
|
31 milliseconds (ms)
Standard Deviation 38
|
35 milliseconds (ms)
Standard Deviation 19
|
38 milliseconds (ms)
Standard Deviation 24
|
|
Serial Reaction Time Task (SRTT) Performance
SS Post-test
|
24 milliseconds (ms)
Standard Deviation 21
|
30 milliseconds (ms)
Standard Deviation 22
|
17 milliseconds (ms)
Standard Deviation 23
|
|
Serial Reaction Time Task (SRTT) Performance
SS Retention Testing
|
31 milliseconds (ms)
Standard Deviation 25
|
40 milliseconds (ms)
Standard Deviation 23
|
29 milliseconds (ms)
Standard Deviation 11
|
SECONDARY outcome
Timeframe: Pre-test (baseline), Post-test (training usually lasts for 3 hours)Population: The population in this analysis includes participants who completed the indicated study visit and had usable data. Five participants in the premotor cortex (PMC) group are not included due to technical issues; for two participants the stimulation target could not be confirmed during data analysis and three participants had different timing values than other members of their cohort.
Evaluate the effect of sequence learning on motor cortical excitability. Cortical excitability will be indexed by peak-to-peak amplitudes of transcranial magnetic stimulation (TMS)-evoked electromyographic responses in the hand contralateral to the motor cortex targeted by TMS quantified before and after training. An increase in MEPs indicates neural plasticity due to increases in skill.
Outcome measures
| Measure |
Sham TMS
n=20 Participants
Sham brain stimulation
|
TMS Over Primary Motor Cortex (M1)
n=20 Participants
Noninvasive brain stimulation in the motor cortex
Transcranial Magnetic Stimulation (TMS): Transcranial magnetic stimulation, also known as repetitive transcranial magnetic stimulation, is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction. It will be used to create a 'virtual lesion,' disrupting neural activity in a specific brain region to identify whether it is causally involved in a specific behavioral process.
|
TMS Over Premotor Cortex (PMC)
n=19 Participants
Noninvasive brain stimulation in the premotor cortex
Transcranial Magnetic Stimulation (TMS): Transcranial magnetic stimulation, also known as repetitive transcranial magnetic stimulation, is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction. It will be used to create a 'virtual lesion,' disrupting neural activity in a specific brain region to identify whether it is causally involved in a specific behavioral process.
|
|---|---|---|---|
|
Cortical Excitability Measured by Motor Evoked Potentials (MEPs)
MEP Amplitude Pre-test
|
1.03 millivolts (mV)
Standard Deviation 0.97
|
1.29 millivolts (mV)
Standard Deviation 1.22
|
0.45 millivolts (mV)
Standard Deviation 0.37
|
|
Cortical Excitability Measured by Motor Evoked Potentials (MEPs)
MEP Amplitude Post-test
|
1.15 millivolts (mV)
Standard Deviation 1.03
|
1.37 millivolts (mV)
Standard Deviation 1.24
|
0.51 millivolts (mV)
Standard Deviation 0.53
|
Adverse Events
Sham TMS
TMS Over Primary Motor Cortex (M1)
TMS Over Premotor Cortex (PMC)
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