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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

64 participants

Primary outcome timeframe

Pre-test (baseline), Post-test (training usually lasts for 3 hours), Retention Test (30 mins following training)

Results posted on

2024-08-28

Participant Flow

Participant milestones

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

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

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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

TMS Over Primary Motor Cortex (M1)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

TMS Over Premotor Cortex (PMC)

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

Michael Borich, DPT, PhD

Emory University

Phone: 404-712-0612

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place