Trial Outcomes & Findings for Neuroimaging in Patients Undergoing TMS for Depression (NCT NCT02974296)

Last Updated: 2020-10-23

Results Overview

Change from Baseline in Resting MRI Correlation Coefficients Between Left Dorsolateral Prefrontal Cortex and Subgenual Anterior Cingulate Change in Resting MRI is defined as post-pre

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

Week 1 prior to first TMS treatment and week 36 after completion of TMS treatments

Results posted on

2020-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	New Target TMS new target transcranial magnetic stimulation guided by MRI transcranial magnetic stimulation: non invasive brain stimulation approach	Standard TMS standard transcranial magnetic stimulation transcranial magnetic stimulation: non invasive brain stimulation approach
Overall Study STARTED	10	23
Overall Study COMPLETED	10	22
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neuroimaging in Patients Undergoing TMS for Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	New Target TMS n=10 Participants new target transcranial magnetic stimulation guided by MRI transcranial magnetic stimulation: non invasive brain stimulation approach	Standard TMS n=22 Participants standard transcranial magnetic stimulation transcranial magnetic stimulation: non invasive brain stimulation approach	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=99 Participants	22 Participants n=107 Participants	32 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	37.70 years STANDARD_DEVIATION 16.028 • n=99 Participants	41.50 years STANDARD_DEVIATION 15.152 • n=107 Participants	40.21 years STANDARD_DEVIATION 15.275 • n=206 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	12 Participants n=107 Participants	15 Participants n=206 Participants
Sex: Female, Male Male	7 Participants n=99 Participants	10 Participants n=107 Participants	17 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=99 Participants	21 Participants n=107 Participants	30 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	10 participants n=99 Participants	22 participants n=107 Participants	32 participants n=206 Participants

PRIMARY outcome

Timeframe: Week 1 prior to first TMS treatment and week 36 after completion of TMS treatments

Change from Baseline in Resting MRI Correlation Coefficients Between Left Dorsolateral Prefrontal Cortex and Subgenual Anterior Cingulate Change in Resting MRI is defined as post-pre

Outcome measures

Outcome measures
Measure	New Target TMS n=10 Participants new target transcranial magnetic stimulation guided by MRI transcranial magnetic stimulation: non invasive brain stimulation approach	Standard TMS n=22 Participants standard transcranial magnetic stimulation transcranial magnetic stimulation: non invasive brain stimulation approach
Change in Functional Connectivity Measured by Resting MRI	0.103399365 correlation coefficients Standard Deviation 0.161565183	-0.7637409 correlation coefficients Standard Deviation 0.106948404

SECONDARY outcome

Timeframe: Week 1 prior to first TMS treatment and week 36 after completion of TMS treatments

Patients will be classified as responders to TMS with at least 50% decrease in HDRS scores from baseline. Patients will be classified as non-responders to TMS with less than 50% decrease in HDRS scores from baseline. Change in HDRS-17 scores is defined as: \[pre-post)/pre\]x100 HDRS-17 scores range: 0-61 Levels of depression based on HDRS-17 scores: Not depressed: 0-7 Mild (subthreshold): 8-13 Moderate (mild): 14-18 Severe (moderate): 19-22 Very severe (severe): \>23

Outcome measures

Outcome measures
Measure	New Target TMS n=10 Participants new target transcranial magnetic stimulation guided by MRI transcranial magnetic stimulation: non invasive brain stimulation approach	Standard TMS n=22 Participants standard transcranial magnetic stimulation transcranial magnetic stimulation: non invasive brain stimulation approach
Change in Depressive Symptoms Measured by the Hamilton Depression Rating Scale (17-item HDRS)	64.9440 percentage change in HDRS scores Standard Deviation 15.16426	27.7345 percentage change in HDRS scores Standard Deviation 27.48549

Adverse Events

New Target TMS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard TMS

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

DR. Marta Moreno-Ortega

Columbia University

Phone: 9142187311

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place