Trial Outcomes & Findings for Investigation of Brain Network Dynamics in Depression (NCT NCT01931995)
NCT ID: NCT01931995
Last Updated: 2021-07-07
Results Overview
The primary outcome measure is the relative change in functional connectivity in prefrontal corticolimbic brain networks resulting from TMS stimulation of two nodes in the dorsolateral prefrontal cortex: one which is positively correlated to the subgenual cingulate and one which is negatively correlated to this area. Functional connectivity is a measure of correlation strength which biologically reflects correlations between low-frequency oscillations in the fMRI blood oxygenation level dependent signal. As a correlation, this ranges from -1 to 1. This is then Fisher transformed from an r value to a z value (range -2 to -2).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Assessed immediately following each intervention
Results posted on
2021-07-07
Participant Flow
45 subjects were recruited between February 2013 and June 2016. All subjects were recruited in Boston, Massachusetts.
45 subjects were enrolled and 37 subjects completed all three sessions. No randomization was done.
Participant milestones
| Measure |
TMS to Positively Correlated DLPFC
Subjects first received High frequency TMS to a target region of dorsolateral prefrontal cortex which is positively correlated with the subgenual cingulate cortex
TMS positively correlated DLPFC: TMS, or transcranial magnetic stimulation, is a technique that is employed to non-invasively activate or suppress targeted regions of the cerebral cortex. One TMS system has been FDA approved to treat certain medically refractory forms of depression.
Following this, there was a washout period of at least 6 days, after which they received TMS to negatively correlated DLPFC.
|
TMS to Negatively Correlated DLPFC
Subjects first received high frequency TMS to a target region of dorsolateral prefrontal cortex which is negatively correlated with the subgenual cingulate cortex
TMS to negatively correlated DLPFC: TMS, or transcranial magnetic stimulation, is a way of non-invasively activating or suppressing targeted regions of the cerebral cortex. One TMS system has been FDA approved to treat certain medically refractory forms of depression.
After a washout period of at least 6 days they received stimulation with the other treatment (TMS to positively correlated DLPFC).
|
|---|---|---|
|
First Intervention (1 Day)
STARTED
|
23
|
22
|
|
First Intervention (1 Day)
COMPLETED
|
19
|
18
|
|
First Intervention (1 Day)
NOT COMPLETED
|
4
|
4
|
|
Washout (at Least 6 Days)
STARTED
|
19
|
18
|
|
Washout (at Least 6 Days)
COMPLETED
|
19
|
18
|
|
Washout (at Least 6 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Day)
STARTED
|
18
|
19
|
|
Second Intervention (1 Day)
COMPLETED
|
18
|
19
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
TMS to Positively Correlated DLPFC
Subjects first received High frequency TMS to a target region of dorsolateral prefrontal cortex which is positively correlated with the subgenual cingulate cortex
TMS positively correlated DLPFC: TMS, or transcranial magnetic stimulation, is a technique that is employed to non-invasively activate or suppress targeted regions of the cerebral cortex. One TMS system has been FDA approved to treat certain medically refractory forms of depression.
Following this, there was a washout period of at least 6 days, after which they received TMS to negatively correlated DLPFC.
|
TMS to Negatively Correlated DLPFC
Subjects first received high frequency TMS to a target region of dorsolateral prefrontal cortex which is negatively correlated with the subgenual cingulate cortex
TMS to negatively correlated DLPFC: TMS, or transcranial magnetic stimulation, is a way of non-invasively activating or suppressing targeted regions of the cerebral cortex. One TMS system has been FDA approved to treat certain medically refractory forms of depression.
After a washout period of at least 6 days they received stimulation with the other treatment (TMS to positively correlated DLPFC).
|
|---|---|---|
|
First Intervention (1 Day)
Withdrawal by Subject
|
2
|
2
|
|
First Intervention (1 Day)
Physician Decision
|
1
|
1
|
|
First Intervention (1 Day)
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Investigation of Brain Network Dynamics in Depression
Baseline characteristics by cohort
| Measure |
TMS to Positively Correlated DLPFC
n=19 Participants
High frequency TMS to a target region of dorsolateral prefrontal cortex which is positively correlated with the subgenual cingulate cortex
TMS positively correlated DLPFC: TMS, or transcranial magnetic stimulation, is a technique that is employed to non-invasively activate or suppress targeted regions of the cerebral cortex. One TMS system has been FDA approved to treat certain medically refractory forms of depression.
|
TMS to Negatively Correlated DLPFC
n=18 Participants
High frequency TMS to a target region of dorsolateral prefrontal cortex which is positively correlated with the subgenual cingulate cortex
TMS to negatively correlated DLPFC: TMS, or transcranial magnetic stimulation, is a way of non-invasively activating or suppressing targeted regions of the cerebral cortex. One TMS system has been FDA approved to treat certain medically refractory forms of depression.
|
Total
n=37 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
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
24.8 years
STANDARD_DEVIATION 4 • n=5 Participants
|
22.7 years
STANDARD_DEVIATION 4 • n=7 Participants
|
23.9 years
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
37 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed immediately following each interventionThe primary outcome measure is the relative change in functional connectivity in prefrontal corticolimbic brain networks resulting from TMS stimulation of two nodes in the dorsolateral prefrontal cortex: one which is positively correlated to the subgenual cingulate and one which is negatively correlated to this area. Functional connectivity is a measure of correlation strength which biologically reflects correlations between low-frequency oscillations in the fMRI blood oxygenation level dependent signal. As a correlation, this ranges from -1 to 1. This is then Fisher transformed from an r value to a z value (range -2 to -2).
Outcome measures
| Measure |
TMS to Positively Correlated DLPFC
n=37 Participants
High frequency TMS to a target region of dorsolateral prefrontal cortex which is positively correlated with the subgenual cingulate cortex
TMS positively correlated DLPFC: TMS, or transcranial magnetic stimulation, is a technique that is employed to non-invasively activate or suppress targeted regions of the cerebral cortex. One TMS system has been FDA approved to treat certain medically refractory forms of depression.
|
TMS to Negatively Correlated DLPFC
n=37 Participants
High frequency TMS to a target region of dorsolateral prefrontal cortex which is positively correlated with the subgenual cingulate cortex
TMS to negatively correlated DLPFC: TMS, or transcranial magnetic stimulation, is a way of non-invasively activating or suppressing targeted regions of the cerebral cortex. One TMS system has been FDA approved to treat certain medically refractory forms of depression.
|
|---|---|---|
|
Relative Changes in Corticolimbic Functional Connectivity as a Result of TMS
|
-0.11 Fisher transformed z values
Standard Deviation 0.14
|
-0.19 Fisher transformed z values
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Assessed immediately following each intervention.This outcome measure will employ FDG PET scanning to assess changes in local glucose metabolism resulting from TMS to two dorsolateral prefrontal stimulation targets. More specially, changes in glucose metabolism will be assessed at the stimulation targets, in the subgenual cingulate and in the amygdala. This is measured in whole brain normalized standardized uptake values (wbnSUV).
Outcome measures
| Measure |
TMS to Positively Correlated DLPFC
n=37 Participants
High frequency TMS to a target region of dorsolateral prefrontal cortex which is positively correlated with the subgenual cingulate cortex
TMS positively correlated DLPFC: TMS, or transcranial magnetic stimulation, is a technique that is employed to non-invasively activate or suppress targeted regions of the cerebral cortex. One TMS system has been FDA approved to treat certain medically refractory forms of depression.
|
TMS to Negatively Correlated DLPFC
n=37 Participants
High frequency TMS to a target region of dorsolateral prefrontal cortex which is positively correlated with the subgenual cingulate cortex
TMS to negatively correlated DLPFC: TMS, or transcranial magnetic stimulation, is a way of non-invasively activating or suppressing targeted regions of the cerebral cortex. One TMS system has been FDA approved to treat certain medically refractory forms of depression.
|
|---|---|---|
|
Changes in Local Glucose Metabolism at Corticolimbic Network Nodes
|
-0.06 whole brain normalized suv values
Standard Error 0.02
|
0.054 whole brain normalized suv values
Standard Error 0.02
|
Adverse Events
TMS to Positively Correlated DLPFC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TMS to Negatively Correlated DLPFC
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place