Trial Outcomes & Findings for Mechanisms of Non-Invasive Neuromodulation Interventions: Influence on Human Neurochemistry and Functional Connectivity (NCT NCT02677740)
NCT ID: NCT02677740
Last Updated: 2019-11-18
Results Overview
GABA concentration is quantified with MRS at 7 Tesla. Percent change of GABA concentration is calculated from baseline (i.e., pre-rTMS).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
Baseline/Pre-rTMS and 30 min after rTMS
Results posted on
2019-11-18
Participant Flow
Participant milestones
| Measure |
Inhibitory rTMS (1 Hz)
Subjects are exposed to a 20-min inhibitory rTMS intervention that transiently suppresses the excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.
Inhibitory rTMS (1 Hz): Participants receive rTMS at a rate of 1 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% resting motor threshold (RMT) for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the
|
Excitatory rTMS (5 Hz)
Subjects are exposed to a 20-min excitatory rTMS intervention that transiently increases the net excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.
Excitatory rTMS (5 Hz): Participants receive rTMS at a rate of 5 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% RMT for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the excitatory rTMS interv
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
1
|
|
Overall Study
COMPLETED
|
7
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mechanisms of Non-Invasive Neuromodulation Interventions: Influence on Human Neurochemistry and Functional Connectivity
Baseline characteristics by cohort
| Measure |
Inhibitory rTMS (1 Hz)
n=7 Participants
Subjects are exposed to a 20-min inhibitory rTMS intervention that transiently suppresses the excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.
Inhibitory rTMS (1 Hz): Participants receive rTMS at a rate of 1 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% resting motor threshold (RMT) for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the
|
Excitatory rTMS (5 Hz)
n=1 Participants
Subjects are exposed to a 20-min excitatory rTMS intervention that transiently increases the net excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.
Excitatory rTMS (5 Hz): Participants receive rTMS at a rate of 5 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% RMT for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the excitatory rTMS interv
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
28 years
STANDARD_DEVIATION 7 • n=93 Participants
|
22 years
STANDARD_DEVIATION NA • n=4 Participants
|
27 years
STANDARD_DEVIATION 7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=93 Participants
|
1 participants
n=4 Participants
|
8 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline/Pre-rTMS and 30 min after rTMSGABA concentration is quantified with MRS at 7 Tesla. Percent change of GABA concentration is calculated from baseline (i.e., pre-rTMS).
Outcome measures
| Measure |
Inhibitory rTMS (1 Hz)
n=7 Participants
Subjects are exposed to a 20-min inhibitory rTMS intervention that transiently suppresses the excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.
Inhibitory rTMS (1 Hz): Participants receive rTMS at a rate of 1 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% resting motor threshold (RMT) for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the
|
Excitatory rTMS (5 Hz)
n=1 Participants
Subjects are exposed to a 20-min excitatory rTMS intervention that transiently increases the net excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.
Excitatory rTMS (5 Hz): Participants receive rTMS at a rate of 5 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% RMT for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the excitatory rTMS interv
|
|---|---|---|
|
Percent Change of GABA Concentration in a Voxel Encompassing the Left Motor Cortex, Measured at 30 Min After rTMS
|
8 percent change
Standard Deviation 9
|
-27 percent change
Standard Deviation NA
There is only one participant in this arm, therefore, the standard deviation cannot be calculated.
|
PRIMARY outcome
Timeframe: Baseline/Pre-rTMS and 60 min after rTMSGABA concentration is quantified with MRS at 7 Tesla. Percent change of GABA concentration is calculated from baseline (i.e., pre-rTMS).
Outcome measures
| Measure |
Inhibitory rTMS (1 Hz)
n=7 Participants
Subjects are exposed to a 20-min inhibitory rTMS intervention that transiently suppresses the excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.
Inhibitory rTMS (1 Hz): Participants receive rTMS at a rate of 1 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% resting motor threshold (RMT) for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the
|
Excitatory rTMS (5 Hz)
n=1 Participants
Subjects are exposed to a 20-min excitatory rTMS intervention that transiently increases the net excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.
Excitatory rTMS (5 Hz): Participants receive rTMS at a rate of 5 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% RMT for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the excitatory rTMS interv
|
|---|---|---|
|
Percent Change of GABA Concentration in a Voxel Encompassing the Right Motor Cortex, Measured at 60 Min After rTMS
|
-6 percent change
Standard Deviation 6
|
4 percent change
Standard Deviation NA
There is only one participant in this arm, therefore, the standard deviation cannot be calculated.
|
PRIMARY outcome
Timeframe: Baseline/Pre-rTMS and 80 min after rTMSFunctional connectivity is measured with MRI at 7 Tesla as a dimensionless fractional amplitude of low-frequency fluctuations (fALFF). This is an index which reflects the intensity of spontaneous regional brain activity. It is calculated as the ratio of power spectra of low frequency (0.01-0.08 Hz) to that of the entire frequency range. Percent change of functional connectivity is calculated from baseline (i.e., pre-rTMS).
Outcome measures
| Measure |
Inhibitory rTMS (1 Hz)
n=7 Participants
Subjects are exposed to a 20-min inhibitory rTMS intervention that transiently suppresses the excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.
Inhibitory rTMS (1 Hz): Participants receive rTMS at a rate of 1 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% resting motor threshold (RMT) for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the
|
Excitatory rTMS (5 Hz)
n=1 Participants
Subjects are exposed to a 20-min excitatory rTMS intervention that transiently increases the net excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.
Excitatory rTMS (5 Hz): Participants receive rTMS at a rate of 5 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% RMT for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the excitatory rTMS interv
|
|---|---|---|
|
Percent Change of Functional Connectivity in Left Motor Cortex, Where Functional Connectivity is Measured as a Dimensionless Fractional Amplitude of Low-frequency Fluctuations (fALFF), at 80 Min After rTMS
|
-2 percent change
Standard Deviation 11
|
9 percent change
Standard Deviation NA
There is only one participant in this arm, therefore, the standard deviation cannot be calculated.
|
PRIMARY outcome
Timeframe: Baseline/Pre-rTMS and 80 min after rTMSFunctional connectivity is measured with MRI at 7 Tesla as a dimensionless fractional amplitude of low-frequency fluctuations (fALFF). This is an index which reflects the intensity of spontaneous regional brain activity. It is calculated as the ratio of power spectra of low frequency (0.01-0.08 Hz) to that of the entire frequency range. Percent change of functional connectivity is calculated from baseline (i.e., pre-rTMS).
Outcome measures
| Measure |
Inhibitory rTMS (1 Hz)
n=7 Participants
Subjects are exposed to a 20-min inhibitory rTMS intervention that transiently suppresses the excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.
Inhibitory rTMS (1 Hz): Participants receive rTMS at a rate of 1 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% resting motor threshold (RMT) for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the
|
Excitatory rTMS (5 Hz)
n=1 Participants
Subjects are exposed to a 20-min excitatory rTMS intervention that transiently increases the net excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.
Excitatory rTMS (5 Hz): Participants receive rTMS at a rate of 5 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% RMT for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the excitatory rTMS interv
|
|---|---|---|
|
Percent Change of Functional Connectivity in Right Motor Cortex, Where Functional Connectivity is Measured as a Dimensionless Fractional Amplitude of Low-frequency Fluctuations (fALFF), at 80 Min After rTMS
|
-1 percent change
Standard Deviation 10
|
17 percent change
Standard Deviation NA
There is only one participant in this arm, therefore, the standard deviation cannot be calculated.
|
Adverse Events
Inhibitory rTMS (1 Hz)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Excitatory rTMS (5 Hz)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Inhibitory rTMS (1 Hz)
n=7 participants at risk
Subjects are exposed to a 20-min inhibitory rTMS intervention that transiently suppresses the excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.
Inhibitory rTMS (1 Hz): Participants receive rTMS at a rate of 1 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% resting motor threshold (RMT) for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the
|
Excitatory rTMS (5 Hz)
n=1 participants at risk
Subjects are exposed to a 20-min excitatory rTMS intervention that transiently increases the net excitability of cortical structures beneath the site of stimulation. Subjects undergo MRI and MRS both before and right after the rTMS intervention. One week before the MRI/MRS acquisitions, neurophysiological parameters are also measured before and right after the rTMS intervention.
Excitatory rTMS (5 Hz): Participants receive rTMS at a rate of 5 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% RMT for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the excitatory rTMS interv
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|---|---|---|
|
General disorders
Sleepiness
|
42.9%
3/7 • Number of events 3 • approximately 4 hours
|
100.0%
1/1 • Number of events 1 • approximately 4 hours
|
|
General disorders
Warmth
|
14.3%
1/7 • Number of events 1 • approximately 4 hours
|
0.00%
0/1 • approximately 4 hours
|
|
General disorders
Metallic Taste
|
14.3%
1/7 • Number of events 1 • approximately 4 hours
|
100.0%
1/1 • Number of events 1 • approximately 4 hours
|
|
Psychiatric disorders
Anxiety/Worry/Nervousness
|
28.6%
2/7 • Number of events 2 • approximately 4 hours
|
0.00%
0/1 • approximately 4 hours
|
|
General disorders
Headache
|
14.3%
1/7 • Number of events 1 • approximately 4 hours
|
0.00%
0/1 • approximately 4 hours
|
|
General disorders
Tooth Pain
|
14.3%
1/7 • Number of events 1 • approximately 4 hours
|
0.00%
0/1 • approximately 4 hours
|
|
General disorders
Shoulder Pain
|
14.3%
1/7 • Number of events 1 • approximately 4 hours
|
0.00%
0/1 • approximately 4 hours
|
Additional Information
Silvia Mangia, Associate Professor
University of Minnesota
Phone: 6126254920
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place