Trial Outcomes & Findings for Modulation of Cognitive Control Signals in Prefrontal Cortex by Rhythmic Transcranial Magnetic Stimulation (NCT NCT03828734)

Last Updated: 2020-11-19

Results Overview

Participants make a button press on a keyboard to indicate if the probed items are matched or non-matched to the items held in memory after a retrospective cue is presented. The investigators calculate the percent correct for non-match conditions, defined as the hit rate, and the percent incorrect for match conditions, defined as the false alarm rate. The number of remembered items, often referred to as working memory capacity, is calculated as the number of items to be remembered (2, 3, or 4) times the hit rate minus the false alarm rate, divided by one minus the false alarm rate. The range of values is 0 to 4 where larger values mean better performance. For TMS to frontal cortex, working memory capacity is reported when the participant was cued to the right. For TMS to parietal cortex, working memory capacity is reported when the participant was cued to the left.

Recruitment status

COMPLETED

Study phase

Target enrollment

58 participants

Primary outcome timeframe

1 week

Results posted on

2020-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	TMS to Frontal Cortex Followed by TMS to Parietal Cortex Participants will receive transcranial magnetic stimulation (TMS) while performing a cognitive control task. In the first stimulation session, the TMS coil will be placed over the frontal cortex on the scalp. In the second session, the TMS coil will be placed over the parietal cortex on the scalp. During every session, participants receive Alpha TMS, Theta TMS, and Arrhythmic TMS.	TMS to Parietal Cortex Followed by TMS to Frontal Cortex Participants will receive TMS while performing a cognitive control task. In their first stimulation session, the TMS coil will be placed over the parietal cortex on the scalp. In their second session, the TMS coil will be placed over the frontal cortex on the scalp. During every session, participants receive Alpha TMS, Theta TMS, and Arrhythmic TMS.
Baseline STARTED	32	26
Baseline COMPLETED	32	26
Baseline NOT COMPLETED	0	0
Pre-Randomization (1 Week) STARTED	32	26
Pre-Randomization (1 Week) COMPLETED	29	25
Pre-Randomization (1 Week) NOT COMPLETED	3	1
First Intervention STARTED	29	25
First Intervention COMPLETED	25	25
First Intervention NOT COMPLETED	4	0
First Washout (1 Week) STARTED	25	25
First Washout (1 Week) COMPLETED	25	24
First Washout (1 Week) NOT COMPLETED	0	1
Second Intervention STARTED	25	24
Second Intervention COMPLETED	25	24
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Modulation of Cognitive Control Signals in Prefrontal Cortex by Rhythmic Transcranial Magnetic Stimulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=58 Participants Participants will receive TMS while performing a cognitive control task. In one stimulation session, the TMS coil will be placed over the frontal cortex on the scalp. In another session, the TMS coil will be placed over the parietal cortex on the scalp. During every session, participants receive Alpha TMS, Theta TMS, and Arrhythmic TMS.
Age, Continuous	22.2 years STANDARD_DEVIATION 3.83 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	16 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	58 participants n=5 Participants
Number of Remembered Items	1.8039 number of remembered items STANDARD_DEVIATION 0.4988 • n=5 Participants
Response Time	0.8225 seconds STANDARD_DEVIATION 0.1605 • n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: 54 participants were randomized into the experiment arms. 5 participants did not complete both arms and are excluded from analysis. In addition, data from 2 participant was corrupted and 5 participants were excluded due to poor task performance. Analysis was run on 42 participants.

Outcome measures

Outcome measures
Measure	TMS to Frontal Cortex n=42 Participants Participants receive TMS to frontal cortex while performing a cognitive control task. During every session, participants receive Theta TMS, Alpha TMS, and Arrhythmic TMS.	TMS to Parietal Cortex n=42 Participants Participants receive TMS to parietal cortex while performing a cognitive control task. During every session, participants receive Theta TMS, Alpha TMS, and Arrhythmic TMS.
Number of Remembered Items Theta TMS	1.863 number of remembered items Standard Deviation 0.613	1.754 number of remembered items Standard Deviation 0.524
Number of Remembered Items Alpha TMS	1.796 number of remembered items Standard Deviation 0.495	1.797 number of remembered items Standard Deviation 0.572
Number of Remembered Items Arrhythmic TMS	1.803 number of remembered items Standard Deviation 0.381	1.864 number of remembered items Standard Deviation 0.469

PRIMARY outcome

Timeframe: 1 week

The electrical activity of the brain is recorded during performance of the task and brain stimulation. The investigators will perform Morlet wavelet convolution on the recorded electrical signal to calculate the amplitude of neural oscillations in the frequency bands: theta (4-7 hertz) and alpha (8-12 hertz). The amplitude of neural oscillations is reported during the second half of stimulation in the region that is being stimulated. The amplitude is normalized for each participant as the percent change from the amplitude during the baseline period (before the task begins). For TMS to frontal cortex the amplitude of theta oscillations are reported and for TMS to parietal cortex the amplitude of alpha oscillations are reported.

Outcome measures

Outcome measures
Measure	TMS to Frontal Cortex n=42 Participants Participants receive TMS to frontal cortex while performing a cognitive control task. During every session, participants receive Theta TMS, Alpha TMS, and Arrhythmic TMS.	TMS to Parietal Cortex n=42 Participants Participants receive TMS to parietal cortex while performing a cognitive control task. During every session, participants receive Theta TMS, Alpha TMS, and Arrhythmic TMS.
Amplitude of Neural Oscillations Theta TMS	1.443 microvolts Standard Deviation 1.227	-0.201 microvolts Standard Deviation 0.505
Amplitude of Neural Oscillations Alpha TMS	0.489 microvolts Standard Deviation 0.412	0.241 microvolts Standard Deviation 1.045
Amplitude of Neural Oscillations Arrhythmic TMS	0.944 microvolts Standard Deviation 0.705	-0.132 microvolts Standard Deviation 0.600

PRIMARY outcome

Timeframe: 1 week

Participants make a button press on a keyboard to indicate if the probe items are matched or non-matched to the items held in memory after a retrospective cue is presented. The investigators will calculate the response time of this choice as the difference between the time of the button press and presentation of the probe. For TMS to frontal cortex, response time is reported when the participant was cued to the right. For TMS to parietal cortex, response time is reported when the participant was cued to the left.

Outcome measures

Outcome measures
Measure	TMS to Frontal Cortex n=42 Participants Participants receive TMS to frontal cortex while performing a cognitive control task. During every session, participants receive Theta TMS, Alpha TMS, and Arrhythmic TMS.	TMS to Parietal Cortex n=42 Participants Participants receive TMS to parietal cortex while performing a cognitive control task. During every session, participants receive Theta TMS, Alpha TMS, and Arrhythmic TMS.
Response Time Theta TMS	0.728 seconds Standard Deviation 0.157	0.714 seconds Standard Deviation 0.154
Response Time Alpha TMS	0.711 seconds Standard Deviation 0.162	0.710 seconds Standard Deviation 0.162
Response Time Arrhythmic TMS	0.720 seconds Standard Deviation 0.155	0.717 seconds Standard Deviation 0.166

Adverse Events

TMS to Frontal Cortex

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

TMS to Parietal Cortex

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	TMS to Frontal Cortex n=53 participants at risk Participants receive TMS to frontal cortex while performing a cognitive control task. During every session, participants receive Theta TMS, Alpha TMS, and Arrhythmic TMS.	TMS to Parietal Cortex n=50 participants at risk Participants receive TMS to parietal cortex while performing a cognitive control task. During every session, participants receive Theta TMS, Alpha TMS, and Arrhythmic TMS.
Skin and subcutaneous tissue disorders Headache	20.8% 11/53 • Number of events 11 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.	22.0% 11/50 • Number of events 11 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.
Skin and subcutaneous tissue disorders Neck pain	1.9% 1/53 • Number of events 1 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.	2.0% 1/50 • Number of events 1 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.
Skin and subcutaneous tissue disorders Scalp pain	17.0% 9/53 • Number of events 9 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.	16.0% 8/50 • Number of events 8 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.
Skin and subcutaneous tissue disorders Tingling	5.7% 3/53 • Number of events 3 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.	4.0% 2/50 • Number of events 2 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.
Ear and labyrinth disorders Ringing or buzzing noise	0.00% 0/53 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.	0.00% 0/50 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.
Skin and subcutaneous tissue disorders Burning sensation	5.7% 3/53 • Number of events 3 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.	4.0% 2/50 • Number of events 2 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.
Skin and subcutaneous tissue disorders Local redness	3.8% 2/53 • Number of events 2 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.	4.0% 2/50 • Number of events 2 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.
General disorders Sleepiness	18.9% 10/53 • Number of events 10 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.	18.0% 9/50 • Number of events 9 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.
General disorders Trouble concentrating	20.8% 11/53 • Number of events 11 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.	12.0% 6/50 • Number of events 6 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.
General disorders Dizziness	3.8% 2/53 • Number of events 2 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.	0.00% 0/50 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.
General disorders Flickering lights	0.00% 0/53 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.	2.0% 1/50 • Number of events 1 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.
Skin and subcutaneous tissue disorders Itching	0.00% 0/53 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.	4.0% 2/50 • Number of events 2 • Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.

Additional Information

Justin Riddle, PhD

University of North Carolina at Chapel Hill

Phone: 919-966-4755

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place