Trial Outcomes & Findings for Investigating Transcranial Ultrasound as a Potential Intervention for Depression (NCT NCT02685488)
NCT ID: NCT02685488
Last Updated: 2018-01-08
Results Overview
The Beck Depression Inventory-II (BDI-II) is one of the most widely used self-report measures for assessing depression. It includes 21 self-report items. Scores range from 0 to 63, and higher scores indicate higher levels of depressive symptoms. In this study, the BDI-II was used to monitor depressive symptoms each day. The outcome is the change in BDI-II score as measured by BDI-II on Day 5 minus BDI-II on Day 1.
COMPLETED
NA
26 participants
Once on day 1 & day 5
2018-01-08
Participant Flow
Participant milestones
| Measure |
Transcranial Ultrasound
Active stimulation with the transcranial ultrasound at 500 kHz with a duty cycle of 0.24 and pulse repetition frequency of 40 Hz.
Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz.
|
Transcranial Ultrasound Sham
Stimulation with the transcranial ultrasound will be on "sham" mode. Unknown to both participants and experimenters, the ultrasound will not stimulate.
Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
14
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Transcranial Ultrasound
Active stimulation with the transcranial ultrasound at 500 kHz with a duty cycle of 0.24 and pulse repetition frequency of 40 Hz.
Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz.
|
Transcranial Ultrasound Sham
Stimulation with the transcranial ultrasound will be on "sham" mode. Unknown to both participants and experimenters, the ultrasound will not stimulate.
Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Investigating Transcranial Ultrasound as a Potential Intervention for Depression
Baseline characteristics by cohort
| Measure |
Transcranial Ultrasound
n=12 Participants
Active stimulation with the transcranial ultrasound at 500 kHz with a duty cycle of 0.24 and pulse repetition frequency of 40 Hz.
Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz.
|
Transcranial Ultrasound Sham
n=14 Participants
Stimulation with the transcranial ultrasound will be on "sham" mode. Unknown to both participants and experimenters, the ultrasound will not stimulate.
Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz.
|
Total
n=26 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
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 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
|
18.58 years
STANDARD_DEVIATION .669 • n=5 Participants
|
19.14 years
STANDARD_DEVIATION 1.292 • n=7 Participants
|
18.88 years
STANDARD_DEVIATION 1.071 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 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
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Beck Depression Inventory II
|
17.33 units on a scale
STANDARD_DEVIATION 4.207 • n=5 Participants
|
16.57 units on a scale
STANDARD_DEVIATION 5.36 • n=7 Participants
|
16.92 units on a scale
STANDARD_DEVIATION 4.783 • n=5 Participants
|
|
Penn State Worry Questionnaire
|
57.75 units on a scale
STANDARD_DEVIATION 9.555 • n=5 Participants
|
50.71 units on a scale
STANDARD_DEVIATION 10.709 • n=7 Participants
|
53.96 units on a scale
STANDARD_DEVIATION 10.611 • n=5 Participants
|
|
Ruminative Responses Scale
|
49.92 units on a scale
STANDARD_DEVIATION 8.764 • n=5 Participants
|
43.29 units on a scale
STANDARD_DEVIATION 9.980 • n=7 Participants
|
46.35 units on a scale
STANDARD_DEVIATION 9.847 • n=5 Participants
|
|
Overall Anxiety Severity and Impairment Scale
|
5.75 units on a scale
STANDARD_DEVIATION 3.415 • n=5 Participants
|
5.79 units on a scale
STANDARD_DEVIATION 2.392 • n=7 Participants
|
5.77 units on a scale
STANDARD_DEVIATION 2.847 • n=5 Participants
|
PRIMARY outcome
Timeframe: Once on day 1 & day 5The Beck Depression Inventory-II (BDI-II) is one of the most widely used self-report measures for assessing depression. It includes 21 self-report items. Scores range from 0 to 63, and higher scores indicate higher levels of depressive symptoms. In this study, the BDI-II was used to monitor depressive symptoms each day. The outcome is the change in BDI-II score as measured by BDI-II on Day 5 minus BDI-II on Day 1.
Outcome measures
| Measure |
Transcranial Ultrasound
n=12 Participants
Active stimulation with the transcranial ultrasound at 500 kHz with a duty cycle of 0.24 and pulse repetition frequency of 40 Hz.
Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz.
|
Transcranial Ultrasound Sham
n=12 Participants
Stimulation with the transcranial ultrasound will be on "sham" mode. Unknown to both participants and experimenters, the ultrasound will not stimulate.
Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz.
|
|---|---|---|
|
Depressive Symptoms Assessed With the Beck Depression Inventory-II
|
-4.42 units on a scale
Standard Deviation 4.621
|
-.650 units on a scale
Standard Deviation 4.249
|
SECONDARY outcome
Timeframe: Once on day 1 & 5The Ruminative Responses scale (RRS) consists of 22 statements. It measures rumination, past-focused repetitive thinking that causes and maintains depression. Participants are asked to rate on a scale of 1 (almost never) to 4 (almost always) how much they think about various things (e.g. "think about how alone you feel" and "think about all your shortcomings, failings, faults, mistakes"). Scores range from 22 to 88 with higher scores indicating more rumination. The RRS was used in this study to measure symptoms of rumination on the first and fifth day of this study. The outcome is the difference from Day 5 to Day 1.
Outcome measures
| Measure |
Transcranial Ultrasound
n=12 Participants
Active stimulation with the transcranial ultrasound at 500 kHz with a duty cycle of 0.24 and pulse repetition frequency of 40 Hz.
Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz.
|
Transcranial Ultrasound Sham
n=12 Participants
Stimulation with the transcranial ultrasound will be on "sham" mode. Unknown to both participants and experimenters, the ultrasound will not stimulate.
Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz.
|
|---|---|---|
|
Rumination Symptoms Assessed With the Ruminative Responses Scale
|
-1.83 units on a scale
Standard Deviation 5.670
|
-2.10 units on a scale
Standard Deviation 6.045
|
SECONDARY outcome
Timeframe: Once on day 1 & day 5The PSWQ assesses trait worry, a key component of Generalized Anxiety Disorder. Participants rate themselves on a scale of 1 ("not at all typical of me") to 5 ("very typical of me") for sixteen different statements. Scores range from 16-80, and higher scores reflect higher levels of worry. This scale has been widely used to assess worry and will allow for assessment of worry in the present study (Brown et al., 1992). The PSWQ was used to monitor symptoms of worry on first and fifth day of this study. The outcome measure is difference from Day 5 to Day 1.
Outcome measures
| Measure |
Transcranial Ultrasound
n=12 Participants
Active stimulation with the transcranial ultrasound at 500 kHz with a duty cycle of 0.24 and pulse repetition frequency of 40 Hz.
Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz.
|
Transcranial Ultrasound Sham
n=12 Participants
Stimulation with the transcranial ultrasound will be on "sham" mode. Unknown to both participants and experimenters, the ultrasound will not stimulate.
Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz.
|
|---|---|---|
|
Worry Symptoms Assessed With the Penn State Worry Questionnaire
|
-1.83 units on a scale
Standard Deviation 7.732
|
3.30 units on a scale
Standard Deviation 5.677
|
SECONDARY outcome
Timeframe: Once on day 1 & day 5The Overall Anxiety Severity and Impairment Scale (OASIS) assesses severity of anxiety symptoms across anxiety disorders and with subsyndromal symptoms. Participants rate five items on a scale from 0 (indicating no anxiety or impairment) to 4 (indicating severe or extreme anxiety or impairment). Scores range from 0 to 20, with higher scores indicating more severe anxiety and impairment from anxiety (Norman et al., 2006). The OASIS was used to monitor overall severity of anxiety on each day of the study. The outcome measure is difference from Day 5 to Day 1.
Outcome measures
| Measure |
Transcranial Ultrasound
n=12 Participants
Active stimulation with the transcranial ultrasound at 500 kHz with a duty cycle of 0.24 and pulse repetition frequency of 40 Hz.
Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz.
|
Transcranial Ultrasound Sham
n=12 Participants
Stimulation with the transcranial ultrasound will be on "sham" mode. Unknown to both participants and experimenters, the ultrasound will not stimulate.
Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz.
|
|---|---|---|
|
Anxiety Symptoms Assessed With the Overall Anxiety Severity and Impairment Scale
|
-1.33 units on a scale
Standard Deviation 1.723
|
-2.50 units on a scale
Standard Deviation 3.240
|
POST_HOC outcome
Timeframe: Assessed before Stim/Sham and 10 minutes after every day for five days; scores represent change from after to before stim/sham averaged across all five daysThe Visual Analog Mood Scale (VAMS) asks patients to rate how much they are experiencing eight mood categories on a scale of 0-100. Global Affect and Global Vigor are subscales. The Global Vigor scale includes a number of items related to anxiety (calm, tense) as well as fatigue (alert, weary). Based on decreases that were seen in global vigor, we create a sum variable of only calm \& tense items on the VAMS to examine whether state anxiety decreased. Scores range from 0-20, with higher scores indicating more anxiety. This sum variable served as a post-hoc measures of anxiety each day of the study before stimulation/sham, 10 minutes after stimulation/sham, and 30 minutes after stimulation/sham. Outcome is the difference between measure taken 10 minutes after Stim/Sham and measure taken before Stim/Sham. This measure was taken each of the five days and outcome represents the average over all five days from after to before Stim/Sham.
Outcome measures
| Measure |
Transcranial Ultrasound
n=12 Participants
Active stimulation with the transcranial ultrasound at 500 kHz with a duty cycle of 0.24 and pulse repetition frequency of 40 Hz.
Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz.
|
Transcranial Ultrasound Sham
n=12 Participants
Stimulation with the transcranial ultrasound will be on "sham" mode. Unknown to both participants and experimenters, the ultrasound will not stimulate.
Transcranial Ultrasound: Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz.
|
|---|---|---|
|
State Anxiety Assessed With Two Items From the Visual Analogue Mood Scale
|
-11.9833 units on a scale
Standard Deviation 27.24018
|
-.6082 units on a scale
Standard Deviation 33.90624
|
Adverse Events
Transcranial Ultrasound
Transcranial Ultrasound Sham
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