Trial Outcomes & Findings for Accelerated TMS to a Novel Brain Target in MDD and PTSD (NCT NCT03114891)
NCT ID: NCT03114891
Last Updated: 2023-05-06
Results Overview
We used the Montgomery-Asberg Depression Rating Scale (MADRS) to measure depression severity after TMS at fMRI-guided brain target vs standard brain target. The MADRS is clinician-rated and consists of 10 items; each item is rated on a 0-6 scale, resulting in a maximum total score of 60 points. Higher MADRS score indicates more severe depression. For this outcome, we calculated the change (percent decrease) from the participant's baseline MADRS score to their MADRS score after the first round of TMS (to either fMRI-guided brain target or standard brain target). If the outcome is positive, there was a reduction in the MADRS total score, or a reduction in the presence of depressive symptoms after TMS. If the change is negative, there was an increase in the MADRS total score, or an increase in the presence of depressive symptoms after TMS. Higher positive values means better outcome (or more symptom reduction).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Before and after the first round of two weeks of TMS treatment (two daily iTBS sessions over 10 consecutive weekdays)
Results posted on
2023-05-06
Participant Flow
Of the 87 subjects screened for the study, 37 did not start treatment (19 were deemed ineligible,15 withdrew, 3 lost to follow up) and 50 enrolled in the study (assigned to an intervention group).
Participant milestones
| Measure |
First Round: fMRI-guided Target/Video, Second Round: 6cm Target/Task
First round: This site of stimulation will be created from participants' individualized resting connectivity data. We will identify a cortical target in the left prefrontal cortex (LPFC) that influences the subgenual anterior cingulate cortex (sgACC). Two daily sessions (\~10min apart) of intermittent theta-burst stimulation will be administered to this fMRI-guided target for 10 consecutive weekdays. Between the two iTBS sessions, participants will watch a relaxing nature video.
Second round: After 3 weeks, participants will undergo another set of two daily iTBS sessions for 10 consecutive weekdays to their 'standard' target (6cm anterior of their hand knob). Between the two iTBS sessions, participants will complete a working memory task.
|
First Round: 6cm Target/Video, Second Round: fMRI-guided Target/Task
First round: This 'standard' target will be identified by measuring 6cm anterior of the hand knob. Two daily sessions (\~10min apart) of intermittent theta-burst stimulation will be administered to this to this target for 10 consecutive weekdays. Between the two iTBS sessions, participants will watch a relaxing nature video.
Second round: After 3 weeks, participants will undergo another set of two daily iTBS sessions for 10 consecutive weekdays to their fMRI-guided target (cortical target influencing sgACC). Between the two iTBS sessions, participants will complete a working memory task.
|
First Round: fMRI-guided Target/Task, Second Round: 6cm Target/Video
First round: This site of stimulation will be created from participants' individualized resting connectivity data. We will identify a cortical target in the left prefrontal cortex (LPFC) that influences the subgenual anterior cingulate cortex (sgACC). Two daily sessions (\~10min apart) of intermittent theta-burst stimulation will be administered to this fMRI-guided target for 10 consecutive weekdays. Between the two iTBS sessions, participants will complete a working memory task.
Second round: After 3 weeks, participants will undergo another set of two daily iTBS sessions for 10 consecutive weekdays to their 'standard' target (6cm anterior of their hand knob). Between the two iTBS sessions, participants will watch a relaxing nature video.
|
First Round: 6cm Target/Task, Second Round: fMRI-guided Target/Video
First round: This 'standard' target will be identified by measuring 6cm anterior of the hand knob. Two daily sessions (\~10min apart) of intermittent theta-burst stimulation will be administered to this to this target for 10 consecutive weekdays. Between the two iTBS sessions, participants will complete a working memory task.
Second round: After 3 weeks, participants will undergo another set of two daily iTBS sessions for 10 consecutive weekdays to their fMRI-guided target (cortical target influencing sgACC). Between the two iTBS sessions, participants will watch a relaxing nature video.
|
|---|---|---|---|---|
|
First Treatment Round
STARTED
|
12
|
14
|
11
|
13
|
|
First Treatment Round
COMPLETED
|
12
|
11
|
10
|
12
|
|
First Treatment Round
NOT COMPLETED
|
0
|
3
|
1
|
1
|
|
3 Week Break
STARTED
|
12
|
11
|
10
|
12
|
|
3 Week Break
COMPLETED
|
11
|
10
|
10
|
11
|
|
3 Week Break
NOT COMPLETED
|
1
|
1
|
0
|
1
|
|
Second Treatment Round
STARTED
|
11
|
10
|
10
|
11
|
|
Second Treatment Round
COMPLETED
|
9
|
10
|
10
|
11
|
|
Second Treatment Round
NOT COMPLETED
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
First Round: fMRI-guided Target/Video, Second Round: 6cm Target/Task
First round: This site of stimulation will be created from participants' individualized resting connectivity data. We will identify a cortical target in the left prefrontal cortex (LPFC) that influences the subgenual anterior cingulate cortex (sgACC). Two daily sessions (\~10min apart) of intermittent theta-burst stimulation will be administered to this fMRI-guided target for 10 consecutive weekdays. Between the two iTBS sessions, participants will watch a relaxing nature video.
Second round: After 3 weeks, participants will undergo another set of two daily iTBS sessions for 10 consecutive weekdays to their 'standard' target (6cm anterior of their hand knob). Between the two iTBS sessions, participants will complete a working memory task.
|
First Round: 6cm Target/Video, Second Round: fMRI-guided Target/Task
First round: This 'standard' target will be identified by measuring 6cm anterior of the hand knob. Two daily sessions (\~10min apart) of intermittent theta-burst stimulation will be administered to this to this target for 10 consecutive weekdays. Between the two iTBS sessions, participants will watch a relaxing nature video.
Second round: After 3 weeks, participants will undergo another set of two daily iTBS sessions for 10 consecutive weekdays to their fMRI-guided target (cortical target influencing sgACC). Between the two iTBS sessions, participants will complete a working memory task.
|
First Round: fMRI-guided Target/Task, Second Round: 6cm Target/Video
First round: This site of stimulation will be created from participants' individualized resting connectivity data. We will identify a cortical target in the left prefrontal cortex (LPFC) that influences the subgenual anterior cingulate cortex (sgACC). Two daily sessions (\~10min apart) of intermittent theta-burst stimulation will be administered to this fMRI-guided target for 10 consecutive weekdays. Between the two iTBS sessions, participants will complete a working memory task.
Second round: After 3 weeks, participants will undergo another set of two daily iTBS sessions for 10 consecutive weekdays to their 'standard' target (6cm anterior of their hand knob). Between the two iTBS sessions, participants will watch a relaxing nature video.
|
First Round: 6cm Target/Task, Second Round: fMRI-guided Target/Video
First round: This 'standard' target will be identified by measuring 6cm anterior of the hand knob. Two daily sessions (\~10min apart) of intermittent theta-burst stimulation will be administered to this to this target for 10 consecutive weekdays. Between the two iTBS sessions, participants will complete a working memory task.
Second round: After 3 weeks, participants will undergo another set of two daily iTBS sessions for 10 consecutive weekdays to their fMRI-guided target (cortical target influencing sgACC). Between the two iTBS sessions, participants will watch a relaxing nature video.
|
|---|---|---|---|---|
|
First Treatment Round
Lost to Follow-up
|
0
|
1
|
1
|
0
|
|
First Treatment Round
Withdrawal by Subject
|
0
|
2
|
0
|
1
|
|
3 Week Break
Lost to Follow-up
|
1
|
0
|
0
|
1
|
|
3 Week Break
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Second Treatment Round
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Second Treatment Round
Physician Decision
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Accelerated TMS to a Novel Brain Target in MDD and PTSD
Baseline characteristics by cohort
| Measure |
First Round: fMRI-guided Target/Video
n=12 Participants
First round: This site of stimulation will be created from participants' individualized resting connectivity data. We will identify a cortical target in the left prefrontal cortex (LPFC) that influences the subgenual anterior cingulate cortex (sgACC). Two daily sessions (\~10min apart) of intermittent theta-burst stimulation will be administered to this fMRI-guided target for 10 consecutive weekdays. Between the two iTBS sessions, participants will watch a relaxing nature video.
Second round: After 3 weeks, participants will undergo another set of two daily iTBS sessions for 10 consecutive weekdays to their 'standard' target (6cm anterior of their hand knob). Between the two iTBS sessions, participants will complete a working memory task.
|
First Round: 6cm Target/Video
n=14 Participants
First round: This 'standard' target will be identified by measuring 6cm anterior of the hand knob. Two daily sessions (\~10min apart) of intermittent theta-burst stimulation will be administered to this to this target for 10 consecutive weekdays. Between the two iTBS sessions, participants will watch a relaxing nature video.
Second round: After 3 weeks, participants will undergo another set of two daily iTBS sessions for 10 consecutive weekdays to their fMRI-guided target (cortical target influencing sgACC). Between the two iTBS sessions, participants will complete a working memory task.
|
First Round: fMRI-guided Target/Task
n=11 Participants
First round: This site of stimulation will be created from participants' individualized resting connectivity data. We will identify a cortical target in the left prefrontal cortex (LPFC) that influences the subgenual anterior cingulate cortex (sgACC). Two daily sessions (\~10min apart) of intermittent theta-burst stimulation will be administered to this fMRI-guided target for 10 consecutive weekdays. Between the two iTBS sessions, participants will complete a working memory task.
Second round: After 3 weeks, participants will undergo another set of two daily iTBS sessions for 10 consecutive weekdays to their 'standard' target (6cm anterior of their hand knob). Between the two iTBS sessions, participants will watch a relaxing nature video.
|
First Round: 6cm Target/Task
n=13 Participants
First round: This 'standard' target will be identified by measuring 6cm anterior of the hand knob. Two daily sessions (\~10min apart) of intermittent theta-burst stimulation will be administered to this to this target for 10 consecutive weekdays. Between the two iTBS sessions, participants will complete a working memory task.
Second round: After 3 weeks, participants will undergo another set of two daily iTBS sessions for 10 consecutive weekdays to their fMRI-guided target (cortical target influencing sgACC). Between the two iTBS sessions, participants will watch a relaxing nature video.
|
Total
n=50 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
35.25 years
STANDARD_DEVIATION 13.79 • n=5 Participants
|
36.42 years
STANDARD_DEVIATION 12.06 • n=7 Participants
|
29.27 years
STANDARD_DEVIATION 8.45 • n=5 Participants
|
36 years
STANDARD_DEVIATION 10.56 • n=4 Participants
|
34.46 years
STANDARD_DEVIATION 11.45 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
PHQ-9
|
15.08 units on a scale
STANDARD_DEVIATION 5.21 • n=5 Participants
|
15.43 units on a scale
STANDARD_DEVIATION 4.69 • n=7 Participants
|
16 units on a scale
STANDARD_DEVIATION 4.77 • n=5 Participants
|
17.85 units on a scale
STANDARD_DEVIATION 3.21 • n=4 Participants
|
16.10 units on a scale
STANDARD_DEVIATION 4.51 • n=21 Participants
|
PRIMARY outcome
Timeframe: Before and after the first round of two weeks of TMS treatment (two daily iTBS sessions over 10 consecutive weekdays)We used the Montgomery-Asberg Depression Rating Scale (MADRS) to measure depression severity after TMS at fMRI-guided brain target vs standard brain target. The MADRS is clinician-rated and consists of 10 items; each item is rated on a 0-6 scale, resulting in a maximum total score of 60 points. Higher MADRS score indicates more severe depression. For this outcome, we calculated the change (percent decrease) from the participant's baseline MADRS score to their MADRS score after the first round of TMS (to either fMRI-guided brain target or standard brain target). If the outcome is positive, there was a reduction in the MADRS total score, or a reduction in the presence of depressive symptoms after TMS. If the change is negative, there was an increase in the MADRS total score, or an increase in the presence of depressive symptoms after TMS. Higher positive values means better outcome (or more symptom reduction).
Outcome measures
| Measure |
First Round: fMRI-guided Target/Video, Second Round: 6cm Target/Task
n=12 Participants
First round: This site of stimulation will be created from participants' individualized resting connectivity data. We will identify a cortical target in the left prefrontal cortex (LPFC) that influences the subgenual anterior cingulate cortex (sgACC). Two daily sessions (\~10min apart) of intermittent theta-burst stimulation will be administered to this fMRI-guided target for 10 consecutive weekdays. Between the two iTBS sessions, participants will watch a relaxing nature video.
Second round: After 3 weeks, participants will undergo another set of two daily iTBS sessions for 10 consecutive weekdays to their 'standard' target (6cm anterior of their hand knob). Between the two iTBS sessions, participants will complete a working memory task.
|
First Round: 6cm Target/Video, Second Round: fMRI-guided Target/Task
n=11 Participants
First round: This 'standard' target will be identified by measuring 6cm anterior of the hand knob. Two daily sessions (\~10min apart) of intermittent theta-burst stimulation will be administered to this to this target for 10 consecutive weekdays. Between the two iTBS sessions, participants will watch a relaxing nature video.
Second round: After 3 weeks, participants will undergo another set of two daily iTBS sessions for 10 consecutive weekdays to their fMRI-guided target (cortical target influencing sgACC). Between the two iTBS sessions, participants will complete a working memory task.
|
First Round: fMRI-guided Target/Task, Second Round: 6cm Target/Video
n=10 Participants
First round: This site of stimulation will be created from participants' individualized resting connectivity data. We will identify a cortical target in the left prefrontal cortex (LPFC) that influences the subgenual anterior cingulate cortex (sgACC). Two daily sessions (\~10min apart) of intermittent theta-burst stimulation will be administered to this fMRI-guided target for 10 consecutive weekdays. Between the two iTBS sessions, participants will complete a working memory task.
Second round: After 3 weeks, participants will undergo another set of two daily iTBS sessions for 10 consecutive weekdays to their 'standard' target (6cm anterior of their hand knob). Between the two iTBS sessions, participants will watch a relaxing nature video.
|
First Round: 6cm Target/Task, Second Round: fMRI-guided Target/Task
n=12 Participants
First round: This 'standard' target will be identified by measuring 6cm anterior of the hand knob. Two daily sessions (\~10min apart) of intermittent theta-burst stimulation will be administered to this to this target for 10 consecutive weekdays. Between the two iTBS sessions, participants will complete a working memory task.
Second round: After 3 weeks, participants will undergo another set of two daily iTBS sessions for 10 consecutive weekdays to their fMRI-guided target (cortical target influencing sgACC). Between the two iTBS sessions, participants will watch a relaxing nature video.
|
|---|---|---|---|---|
|
Percent Change in Depression Severity of TMS at fMRI-guided Brain Target vs Standard Brain Target
|
49.11 percentage of change
Standard Deviation 25.42
|
24.94 percentage of change
Standard Deviation 37.97
|
36.47 percentage of change
Standard Deviation 33.91
|
42.56 percentage of change
Standard Deviation 30.75
|
Adverse Events
fMRI-guided Target/Video
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
6cm Target/Video
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
fMRI-guided Target/Task
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
6cm Target/Task
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
fMRI-guided Target/Video
n=23 participants at risk
Two daily rounds (\~10min apart) of intermittent theta-burst stimulation to the fMRI-guided target for 10 consecutive weekdays. Between the two rounds of TMS, participants watched a relaxing nature video.
|
6cm Target/Video
n=24 participants at risk
Two daily rounds (\~10min apart) of intermittent theta-burst stimulation to the 'standard' or 6cm target for 10 consecutive weekdays. Between the two rounds of TMS, participants watched a relaxing nature video.
|
fMRI-guided Target/Task
n=21 participants at risk
Two daily rounds (\~10min apart) of intermittent theta-burst stimulation to the fMRI-guided target for 10 consecutive weekdays. Between the two iTBS sessions, participants will complete a working memory task.
|
6cm Target/Task
n=24 participants at risk
Two daily rounds (\~10min apart) of intermittent theta-burst stimulation to the 'standard' or 6cm target for 10 consecutive weekdays. Between the two iTBS sessions, participants will complete a working memory task.
|
|---|---|---|---|---|
|
General disorders
Headache
|
0.00%
0/23 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
16.7%
4/24 • Number of events 13 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
9.5%
2/21 • Number of events 3 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
0.00%
0/24 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
|
Musculoskeletal and connective tissue disorders
Scalp muscle/Facial muscle pain
|
0.00%
0/23 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
4.2%
1/24 • Number of events 1 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
4.8%
1/21 • Number of events 1 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
0.00%
0/24 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
|
Musculoskeletal and connective tissue disorders
Jaw pain
|
0.00%
0/23 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
4.2%
1/24 • Number of events 1 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
4.8%
1/21 • Number of events 2 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
0.00%
0/24 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/23 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
4.2%
1/24 • Number of events 1 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
0.00%
0/21 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
0.00%
0/24 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
|
Nervous system disorders
Dizziness and disorientation
|
0.00%
0/23 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
0.00%
0/24 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
4.8%
1/21 • Number of events 1 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
0.00%
0/24 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
|
Psychiatric disorders
Worsening of symptoms
|
0.00%
0/23 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
8.3%
2/24 • Number of events 3 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
0.00%
0/21 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
0.00%
0/24 • Up to 2 weeks for each intervention
Safety population included all participants who received at the one round of TMS intervention. Our adverse event definition includes all the specifications of the clinicaltrials.gov definition, but it also includes 'any symptom, sign, illness or experience that the Principal Investigator determines as significantly worse during course of the study'. Thus, our definition considers non-medical occurrences as AEs.
|
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