Trial Outcomes & Findings for TMS and Exposure Therapy (NCT NCT04019054)
NCT ID: NCT04019054
Last Updated: 2021-04-01
Results Overview
The difference between the number of steps completed during the pre- and post-treatment behavioral approach tests.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
baseline and 1 week after treatment
Results posted on
2021-04-01
Participant Flow
Recruitment from 8/2019 to 3/2020. Study ended early due to COVID restrictions, as well as personnel and equipment limitations.
Participant milestones
| Measure |
Active iTBS, Ventromedial Prefrontal Cortex (vmPFC)
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vmPFC, as determined by position Fpz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), Ventromedial Prefrontal Cortex (vmPFC): iTBS delivered to vmPFC for active treatment of spider phobia.
|
Control iTBS, Vertex
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vertex, as determined by position Cz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), vertex: iTBS delivered to vertex for placebo treatment of spider phobia.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Active iTBS, Ventromedial Prefrontal Cortex (vmPFC)
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vmPFC, as determined by position Fpz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), Ventromedial Prefrontal Cortex (vmPFC): iTBS delivered to vmPFC for active treatment of spider phobia.
|
Control iTBS, Vertex
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vertex, as determined by position Cz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), vertex: iTBS delivered to vertex for placebo treatment of spider phobia.
|
|---|---|---|
|
Overall Study
Inadvertent Enrollment, discovered to meet exclusion criteria after enrollment
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Active iTBS, Ventromedial Prefrontal Cortex (vmPFC)
n=8 Participants
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vmPFC, as determined by position Fpz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), Ventromedial Prefrontal Cortex (vmPFC): iTBS delivered to vmPFC for active treatment of spider phobia.
|
Control iTBS, Vertex
n=9 Participants
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vertex, as determined by position Cz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), vertex: iTBS delivered to vertex for placebo treatment of spider phobia.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21 years
STANDARD_DEVIATION 2.3 • n=8 Participants
|
21 years
STANDARD_DEVIATION 3.8 • n=9 Participants
|
21 years
STANDARD_DEVIATION 3.1 • n=17 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=8 Participants
|
4 Participants
n=9 Participants
|
11 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=8 Participants
|
5 Participants
n=9 Participants
|
6 Participants
n=17 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
8 Participants
n=8 Participants
|
9 Participants
n=9 Participants
|
17 Participants
n=17 Participants
|
|
Patient Health Questionnaire (PHQ-9) score
|
2.11 units on a scale
STANDARD_DEVIATION 1.67 • n=8 Participants
|
1.91 units on a scale
STANDARD_DEVIATION 1.70 • n=9 Participants
|
2.00 units on a scale
STANDARD_DEVIATION 1.62 • n=17 Participants
|
|
Generalized Anxiety Disorder 7 (GAD7) questionnaire
|
3.22 units on a scale
STANDARD_DEVIATION 2.83 • n=8 Participants
|
2.55 units on a scale
STANDARD_DEVIATION 2.02 • n=9 Participants
|
2.85 units on a scale
STANDARD_DEVIATION 2.35 • n=17 Participants
|
PRIMARY outcome
Timeframe: baseline and 1 week after treatmentThe difference between the number of steps completed during the pre- and post-treatment behavioral approach tests.
Outcome measures
| Measure |
Active iTBS, Ventromedial Prefrontal Cortex (vmPFC)
n=8 Participants
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vmPFC, as determined by position Fpz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), Ventromedial Prefrontal Cortex (vmPFC): iTBS delivered to vmPFC for active treatment of spider phobia.
|
Control iTBS, Vertex
n=9 Participants
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vertex, as determined by position Cz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), vertex: iTBS delivered to vertex for placebo treatment of spider phobia.
|
|---|---|---|
|
Behavioral Approach Test, Change in Steps Completed
|
0 Steps
Standard Error 0.19
|
0.78 Steps
Standard Error 0.33
|
PRIMARY outcome
Timeframe: baseline and 1 weekChanges in scores on questionnaires regarding distress around spiders (Klorman spider phobia questionnaire). Scored on a scale of 0-31, with higher numbers associated with greater subjective fear of spiders. No subscales reported
Outcome measures
| Measure |
Active iTBS, Ventromedial Prefrontal Cortex (vmPFC)
n=8 Participants
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vmPFC, as determined by position Fpz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), Ventromedial Prefrontal Cortex (vmPFC): iTBS delivered to vmPFC for active treatment of spider phobia.
|
Control iTBS, Vertex
n=9 Participants
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vertex, as determined by position Cz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), vertex: iTBS delivered to vertex for placebo treatment of spider phobia.
|
|---|---|---|
|
Change in Subjective Distress, Klorman Spider Phobia Questionnaire
|
4.25 score on a scale
Standard Error 0.73
|
4.56 score on a scale
Standard Error 0.66
|
PRIMARY outcome
Timeframe: baseline and 1 weekChanges in scores on questionnaires regarding distress around spiders (Syzmanski Fear of Spiders Questionnaire). 18 items each scored on a scale of 1-7 (total score ranging 18-126), with higher numbers associated with greater subjective fear of spiders. No subscales reported
Outcome measures
| Measure |
Active iTBS, Ventromedial Prefrontal Cortex (vmPFC)
n=8 Participants
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vmPFC, as determined by position Fpz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), Ventromedial Prefrontal Cortex (vmPFC): iTBS delivered to vmPFC for active treatment of spider phobia.
|
Control iTBS, Vertex
n=9 Participants
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vertex, as determined by position Cz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), vertex: iTBS delivered to vertex for placebo treatment of spider phobia.
|
|---|---|---|
|
Change in Subjective Distress, Syzmanski Fear of Spiders Questionnaire
|
22.75 score on a scale
Standard Error 3.92
|
16.67 score on a scale
Standard Error 1.65
|
SECONDARY outcome
Timeframe: baseline and 1 week after treatmentPopulation: One subject within the active group was noted to have corrupted skin conductance data during analysis of post-treatment data and thus that subject's physiologic data was unable to be used for SCL analysis.Per Behavioral Approach Test (BAT) protocol, the test was ended when subjects were unable to complete a step. The number analyzed at each step reflects the number of subjects who completed that step in that group both before and after treatment.
The difference between the change in skin conductance measured during each step of the pre- and post-treatment behavioral approach tests (BATs). Differences were only compared in steps that subjects completed during both pre- and post-treatment BATs.
Outcome measures
| Measure |
Active iTBS, Ventromedial Prefrontal Cortex (vmPFC)
n=7 Participants
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vmPFC, as determined by position Fpz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), Ventromedial Prefrontal Cortex (vmPFC): iTBS delivered to vmPFC for active treatment of spider phobia.
|
Control iTBS, Vertex
n=9 Participants
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vertex, as determined by position Cz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), vertex: iTBS delivered to vertex for placebo treatment of spider phobia.
|
|---|---|---|
|
Behavioral Approach Test, Change in Skin Conductance
Step 1
|
.27 micro-siemens
Standard Error 1.67
|
4.75 micro-siemens
Standard Error 2.48
|
|
Behavioral Approach Test, Change in Skin Conductance
Step 2
|
-0.36 micro-siemens
Standard Error 1.20
|
4.79 micro-siemens
Standard Error 2.30
|
|
Behavioral Approach Test, Change in Skin Conductance
Step 3
|
-0.11 micro-siemens
Standard Error 1.17
|
4.70 micro-siemens
Standard Error 2.56
|
|
Behavioral Approach Test, Change in Skin Conductance
Step 4
|
-0.51 micro-siemens
Standard Error 1.43
|
4.65 micro-siemens
Standard Error 2.54
|
|
Behavioral Approach Test, Change in Skin Conductance
Step 5
|
-0.16 micro-siemens
Standard Error 1.67
|
5.50 micro-siemens
Standard Error 3.19
|
|
Behavioral Approach Test, Change in Skin Conductance
Step 6
|
-0.59 micro-siemens
Standard Error 1.64
|
0.74 micro-siemens
Standard Error 0.91
|
|
Behavioral Approach Test, Change in Skin Conductance
Step 7
|
-1.65 micro-siemens
Standard Error 1.90
|
2.61 micro-siemens
Standard Error 1.30
|
|
Behavioral Approach Test, Change in Skin Conductance
Step 8
|
-1.87 micro-siemens
Standard Error 1.03
|
-0.27 micro-siemens
Standard Error NA
Single data point, no standard error available
|
|
Behavioral Approach Test, Change in Skin Conductance
Step 9
|
-0.9 micro-siemens
Standard Error NA
Single data point, no standard error available
|
—
|
SECONDARY outcome
Timeframe: baseline and 1 week, difference reportedPopulation: Per Behavioral Approach Test (BAT) protocol, the test was ended when subjects were unable to complete a step. The number analyzed at each step reflects the number of subjects who completed that step in that group both before and after treatment, and compares the subject's data from before to after treatment.
Changes in subjective pre-step anticipatory distress (reported 0-100) reported prior to each step during the behavioral approach test. Positive score indicates corresponding reduction in distress from pre- to post-treatment.
Outcome measures
| Measure |
Active iTBS, Ventromedial Prefrontal Cortex (vmPFC)
n=8 Participants
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vmPFC, as determined by position Fpz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), Ventromedial Prefrontal Cortex (vmPFC): iTBS delivered to vmPFC for active treatment of spider phobia.
|
Control iTBS, Vertex
n=9 Participants
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vertex, as determined by position Cz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), vertex: iTBS delivered to vertex for placebo treatment of spider phobia.
|
|---|---|---|
|
Change in Subjective Anticipatory Distress, Behavioral Approach Test
Step 1
|
0.57 score on a scale
Standard Error 7.47
|
26.89 score on a scale
Standard Error 9.01
|
|
Change in Subjective Anticipatory Distress, Behavioral Approach Test
Step 2
|
4.86 score on a scale
Standard Error 14.43
|
35.56 score on a scale
Standard Error 7.42
|
|
Change in Subjective Anticipatory Distress, Behavioral Approach Test
Step 3
|
11.86 score on a scale
Standard Error 12.09
|
39.44 score on a scale
Standard Error 6.64
|
|
Change in Subjective Anticipatory Distress, Behavioral Approach Test
Step 4
|
17.57 score on a scale
Standard Error 11.27
|
41.25 score on a scale
Standard Error 6.60
|
|
Change in Subjective Anticipatory Distress, Behavioral Approach Test
Step 5
|
12.33 score on a scale
Standard Error 7.92
|
45.83 score on a scale
Standard Error 6.76
|
|
Change in Subjective Anticipatory Distress, Behavioral Approach Test
Step 6
|
16.0 score on a scale
Standard Error 7.97
|
42.0 score on a scale
Standard Error 11.58
|
|
Change in Subjective Anticipatory Distress, Behavioral Approach Test
Step 7
|
16.25 score on a scale
Standard Error 7.42
|
48.3 score on a scale
Standard Error 12.02
|
|
Change in Subjective Anticipatory Distress, Behavioral Approach Test
Step 8
|
17.5 score on a scale
Standard Error 2.50
|
10.0 score on a scale
Standard Error NA
Single data point, no standard error available
|
|
Change in Subjective Anticipatory Distress, Behavioral Approach Test
Step 9
|
10.0 score on a scale
Standard Error NA
Single data point, no standard error available
|
—
|
SECONDARY outcome
Timeframe: Average tolerated intensity during TMS treatment sessions (days 1, 2, and 3 of treatment)The TMS treatment intensity tolerated by subjects in each group, averaged over the 3-day course of treatment for each subject. Ranges from 80-100% and is defined in reference to the subject's motor threshold.
Outcome measures
| Measure |
Active iTBS, Ventromedial Prefrontal Cortex (vmPFC)
n=8 Participants
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vmPFC, as determined by position Fpz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), Ventromedial Prefrontal Cortex (vmPFC): iTBS delivered to vmPFC for active treatment of spider phobia.
|
Control iTBS, Vertex
n=9 Participants
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vertex, as determined by position Cz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), vertex: iTBS delivered to vertex for placebo treatment of spider phobia.
|
|---|---|---|
|
Average Treatment Intensity Tolerated
|
90.8 percentage of motor threshold
Standard Error 2.87
|
98.8 percentage of motor threshold
Standard Error 0.85
|
SECONDARY outcome
Timeframe: baseline and 1 week, change in scores from pre to post reportedPopulation: Per Behavioral Approach Test (BAT) protocol, the test was ended when subjects were unable to complete a step. The number analyzed at each step reflects the number of subjects who completed that step in that group both before and after treatment, and compares the subject's data from before to after treatment.
Changes in subjective post-step maximum distress (reported 0-100) reported immediately following each step during the behavioral approach test. Positive change in score represents a corresponding reduction in relative distress.
Outcome measures
| Measure |
Active iTBS, Ventromedial Prefrontal Cortex (vmPFC)
n=8 Participants
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vmPFC, as determined by position Fpz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), Ventromedial Prefrontal Cortex (vmPFC): iTBS delivered to vmPFC for active treatment of spider phobia.
|
Control iTBS, Vertex
n=9 Participants
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vertex, as determined by position Cz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), vertex: iTBS delivered to vertex for placebo treatment of spider phobia.
|
|---|---|---|
|
Change in Subjective Maximum Distress, Behavioral Approach Test
Step 7
|
4.0 score on a scale
Standard Error 9.63
|
41.67 score on a scale
Standard Error 16.41
|
|
Change in Subjective Maximum Distress, Behavioral Approach Test
Step 1
|
-5.14 score on a scale
Standard Error 6.02
|
18.33 score on a scale
Standard Error 7.78
|
|
Change in Subjective Maximum Distress, Behavioral Approach Test
Step 2
|
10.43 score on a scale
Standard Error 11.31
|
32.78 score on a scale
Standard Error 8.58
|
|
Change in Subjective Maximum Distress, Behavioral Approach Test
Step 3
|
10.43 score on a scale
Standard Error 13.04
|
38.33 score on a scale
Standard Error 6.92
|
|
Change in Subjective Maximum Distress, Behavioral Approach Test
Step 4
|
13.83 score on a scale
Standard Error 14.93
|
28.13 score on a scale
Standard Error 9.86
|
|
Change in Subjective Maximum Distress, Behavioral Approach Test
Step 5
|
19.50 score on a scale
Standard Error 5.29
|
40.83 score on a scale
Standard Error 10.12
|
|
Change in Subjective Maximum Distress, Behavioral Approach Test
Step 6
|
10.0 score on a scale
Standard Error 13.87
|
36.0 score on a scale
Standard Error 15.44
|
|
Change in Subjective Maximum Distress, Behavioral Approach Test
Step 8
|
5.0 score on a scale
Standard Error 5.0
|
25.0 score on a scale
Standard Error NA
Single data point, no standard error available
|
|
Change in Subjective Maximum Distress, Behavioral Approach Test
Step 9
|
10.0 score on a scale
Standard Error NA
Single data point, no standard error available
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 2, and 3 (after each TMS treatment)The average post-treatment pain score as defined by the short-form 15-item McGill pain scale (scored from 0 to 45, with a higher score indicating a greater degree of pain, and a lower score indicating less pain). Each individual subject's average score was calculated by averaging his/her respective scores collected after each of the three TMS sessions. Each group's average score was calculated by averaging the average pain scores of each subject.
Outcome measures
| Measure |
Active iTBS, Ventromedial Prefrontal Cortex (vmPFC)
n=8 Participants
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vmPFC, as determined by position Fpz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), Ventromedial Prefrontal Cortex (vmPFC): iTBS delivered to vmPFC for active treatment of spider phobia.
|
Control iTBS, Vertex
n=9 Participants
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vertex, as determined by position Cz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), vertex: iTBS delivered to vertex for placebo treatment of spider phobia.
|
|---|---|---|
|
Pain Score
|
3.33 score on a scale
Standard Error 1.47
|
1.67 score on a scale
Standard Error 0.64
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately following repeat behavioral approach testing (i.e. the very last activity of the final/4th/followup visit).After completion of all other study-related activities and questionnaires (i.e. after completing post-treatment SPQ, FOS, and BAT during the followup visit), subjects were asked to guess to which group they had been assigned after completing the study and before being unblinded by the PI. Raters were also asked to guess to which group each subject had been assigned. Chi-squared analyses were performed for both subjects and raters for each group to validate blinding.
Outcome measures
| Measure |
Active iTBS, Ventromedial Prefrontal Cortex (vmPFC)
n=8 Participants
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vmPFC, as determined by position Fpz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), Ventromedial Prefrontal Cortex (vmPFC): iTBS delivered to vmPFC for active treatment of spider phobia.
|
Control iTBS, Vertex
n=9 Participants
Stimulation intensity of 100% of the individual resting motor threshold in bursts of three pulses at a frequency of 50 Hz every 200 ms on top of a 5Hz carrier wave. Pulse delivery is over 2 s and repeated every 10 s, 20 times in succession, for a total of 600 pulses delivered in 3.33 minutes.
Delivered over vertex, as determined by position Cz of the international 10-20 EEG electrode system.
Intermittent Theta Burst Stimulation (iTBS), vertex: iTBS delivered to vertex for placebo treatment of spider phobia.
|
|---|---|---|
|
Group Assignment Conjecture
Number of correct subject guesses
|
5 guesses
|
4 guesses
|
|
Group Assignment Conjecture
Number of correct rater guesses
|
4 guesses
|
5 guesses
|
Adverse Events
Active iTBS, Ventromedial Prefrontal Cortex (vmPFC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control iTBS, Vertex
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