Trial Outcomes & Findings for Mini Theta Burst TMS in MDD Patients (NCT NCT04014959)

Last Updated: 2024-04-02

Results Overview

Change in subgenual anterior cingulate evoked response (fMRI BOLD) at all four timepoints across the two TMS/fMRI scan sessions: pre-intervention and preceding a single round of iTBS in the scanner (pre-tx, pre-iTBS); pre-intervention, following single iTBS in the scanner (pre-tx, post-iTBS); post intervention, preceding iTBS in the scanner (post-tx, pre-iTBS); and post-intervention, post-iTBS in the scanner (post-tx, post-iTBS). Greater negative change is associated with more clinical improvement.

Recruitment status

COMPLETED

Study phase

Target enrollment

41 participants

Primary outcome timeframe

5 days

Results posted on

2024-04-02

Participant Flow

Of the 86 subjects screened for the study, 41 were enrolled and 45 did not start study procedures (32 screen failed, 9 withdrew from participation, and 4 lost to follow-up).

Participant milestones

Participant milestones
Measure	All Participants All participants follow the same procedures. TMS/ fMRI Stimulation: The study uses a modified repetitive TMS stimulation protocol. Participants receive active TMS on five separate days: a baseline TMS/ fMRI scan, three "mini TMS" sessions, and a final TMS/ fMRI scan. Again, this level of stimulation is considered to be sub-threshold for that of a TMS treatment protocol.
Baseline MRI and Assessments STARTED	41
Baseline MRI and Assessments COMPLETED	39
Baseline MRI and Assessments NOT COMPLETED	2
Targeting TMS Scan STARTED	39
Targeting TMS Scan COMPLETED	38
Targeting TMS Scan NOT COMPLETED	1
TMS + fMRI Scan #1 STARTED	38
TMS + fMRI Scan #1 COMPLETED	38
TMS + fMRI Scan #1 NOT COMPLETED	0
Mini TMS Sessions (3 Visits) STARTED	38
Mini TMS Sessions (3 Visits) COMPLETED	37
Mini TMS Sessions (3 Visits) NOT COMPLETED	1
TMS + fMRI Scan #2 STARTED	37
TMS + fMRI Scan #2 COMPLETED	37
TMS + fMRI Scan #2 NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants All participants follow the same procedures. TMS/ fMRI Stimulation: The study uses a modified repetitive TMS stimulation protocol. Participants receive active TMS on five separate days: a baseline TMS/ fMRI scan, three "mini TMS" sessions, and a final TMS/ fMRI scan. Again, this level of stimulation is considered to be sub-threshold for that of a TMS treatment protocol.
Baseline MRI and Assessments Physician Decision	2
Targeting TMS Scan Lost to Follow-up	1
Mini TMS Sessions (3 Visits) Withdrawal by Subject	1

Baseline Characteristics

Only analyzed participants who completed all study procedures.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=41 Participants All participants follow the same procedures. TMS/ fMRI Stimulation: The study uses a modified repetitive TMS stimulation protocol. Participants receive active TMS on five separate days: a baseline TMS/ fMRI scan, three "mini TMS" sessions, and a final TMS/ fMRI scan. Again, this level of stimulation is considered to be sub-threshold for that of a TMS treatment protocol.
Age, Continuous	28.9 years STANDARD_DEVIATION 9.9 • n=41 Participants
Sex/Gender, Customized Gender Now · Male	18 Participants n=41 Participants
Sex/Gender, Customized Gender Now · Female	23 Participants n=41 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=41 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=41 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants
Race (NIH/OMB) Asian	4 Participants n=41 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants
Race (NIH/OMB) Black or African American	8 Participants n=41 Participants
Race (NIH/OMB) White	23 Participants n=41 Participants
Race (NIH/OMB) More than one race	4 Participants n=41 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=41 Participants
Snaith-Hamilton Pleasure Scale	5.84 units on a scale STANDARD_DEVIATION 3.48 • n=37 Participants • Only analyzed participants who completed all study procedures.

PRIMARY outcome

Timeframe: 5 days

Population: Of the 37 participants who completed all study procedures, the data from 36 participants was analyzed. Data one subject was not usable.

Outcome measures

Outcome measures
Measure	All Enrolled Participants n=36 Participants All participants follow the same procedures. TMS/ fMRI Stimulation: The study uses a modified repetitive TMS stimulation protocol. Participants receive active TMS on five separate days: a baseline TMS/ fMRI scan, three "mini TMS" sessions, and a final TMS/ fMRI scan.
Changes in Evoked Functional Brain Activity Pre/Post Short iTBS Stimulation Before and After the 3-Day TMS Intervention Regimen Post-tx/Pre-iTBS	-0.2640429 % BOLD signal change Interval -0.44510461 to -0.08298111
Changes in Evoked Functional Brain Activity Pre/Post Short iTBS Stimulation Before and After the 3-Day TMS Intervention Regimen Pre-tx/Pre-iTBS	-0.2684097 % BOLD signal change Interval -0.3902711 to -0.1465483
Changes in Evoked Functional Brain Activity Pre/Post Short iTBS Stimulation Before and After the 3-Day TMS Intervention Regimen Pre-tx/Post-iTBS	-0.1897918 % BOLD signal change Interval -0.31831449 to -0.06126901
Changes in Evoked Functional Brain Activity Pre/Post Short iTBS Stimulation Before and After the 3-Day TMS Intervention Regimen Post-tx/Post-iTBS	-0.4190647 % BOLD signal change Interval -0.5876522 to -0.2504772

SECONDARY outcome

Timeframe: Up to one week

Population: Of the 37 participants who completed all study procedures, the data of one subject was unusable. Therefore, the data of 36 participants was used for analysis.

The Depression, Anxiety, and Stress Scale (DASS-21) is a self-report tool with 21 items, assessing depression, anxiety, and stress levels. The scale scores range from 0 to 63, with higher scores indicating more severe or frequent emotional symptoms. The change in DASS-21 score will be evaluated pre and post the 3-day TMS Intervention Regimen.

Outcome measures

Outcome measures
Measure	All Enrolled Participants n=36 Participants All participants follow the same procedures. TMS/ fMRI Stimulation: The study uses a modified repetitive TMS stimulation protocol. Participants receive active TMS on five separate days: a baseline TMS/ fMRI scan, three "mini TMS" sessions, and a final TMS/ fMRI scan.
Change in Depression, Anxiety and Stress Scale (DASS-21) Score Pre/Post the 3-Day TMS Intervention Regimen Pre 3-day TMS intervention	26.78 score on a scale Standard Error 1.566064
Change in Depression, Anxiety and Stress Scale (DASS-21) Score Pre/Post the 3-Day TMS Intervention Regimen Post 3-day TMS intervention	17.61 score on a scale Standard Error 2.012374

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to one week

Population: Of the 37 participants who completed all study procedures, the data of one subject was unusable. Therefore, the data of 36 participants was used for analysis.

Change in subgenual anterior cingulate evoked response (fMRI BOLD) Before and After the 3-Day TMS Intervention Regimen Greater negative change is associated with more clinical improvement.

Outcome measures

Outcome measures
Measure	All Enrolled Participants n=36 Participants All participants follow the same procedures. TMS/ fMRI Stimulation: The study uses a modified repetitive TMS stimulation protocol. Participants receive active TMS on five separate days: a baseline TMS/ fMRI scan, three "mini TMS" sessions, and a final TMS/ fMRI scan.
Change in Evoked Functional Brain Activity Before and After the 3-Day TMS Intervention Regimen Pre 3-day TMS intervention	-0.19 % BOLD signal change Standard Error 0.063308
Change in Evoked Functional Brain Activity Before and After the 3-Day TMS Intervention Regimen Post 3-day TMS intervention	-0.42 % BOLD signal change Standard Error 0.083043

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Participants n=41 participants at risk All participants follow the same procedures. TMS/ fMRI Stimulation: The study uses a modified repetitive TMS stimulation protocol. Participants receive active TMS on five separate days: a baseline TMS/ fMRI scan, three "mini TMS" sessions, and a final TMS/ fMRI scan. Again, this level of stimulation is considered to be sub-threshold for that of a TMS treatment protocol.
Gastrointestinal disorders Vomiting during TMS/fMRI scan	2.4% 1/41 • Number of events 1 • Adverse event (AE) data was collected from study enrollment until study completion (Up to 3 weeks).
Psychiatric disorders Anxiety during TMS/fMRI scan	2.4% 1/41 • Number of events 1 • Adverse event (AE) data was collected from study enrollment until study completion (Up to 3 weeks).
Social circumstances Emotional Discomfort during assessment	2.4% 1/41 • Number of events 1 • Adverse event (AE) data was collected from study enrollment until study completion (Up to 3 weeks).
General disorders Faint	2.4% 1/41 • Number of events 1 • Adverse event (AE) data was collected from study enrollment until study completion (Up to 3 weeks).
Musculoskeletal and connective tissue disorders Cutis verticis gyrata (CVG)	2.4% 1/41 • Number of events 1 • Adverse event (AE) data was collected from study enrollment until study completion (Up to 3 weeks).

Additional Information

Dr. Desmond Oathes, Principal Investigator

University of Pennsylvania

Phone: 215-573-9390

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place