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Investigating Transcranial Ultrasound as a Potential Intervention for Depression

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ClinicalTrials.gov Identifier: NCT02685488
Recruitment Status : Completed
First Posted : February 18, 2016
Results First Posted : January 8, 2018
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
John Allen, University of Arizona

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Depression
Anxiety Disorders
Interventions Device: Transcranial Ultrasound Power
Device: Transcranial Ultrasound Sham
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Transcranial Ultrasound Transcranial Ultrasound Sham
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 12 14
Completed 12 13
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title Transcranial Ultrasound Transcranial Ultrasound Sham Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 12 14 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 14 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
14
 100.0%
26
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 14 participants 26 participants
18.58  (.669) 19.14  (1.292) 18.88  (1.071)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 14 participants 26 participants
Female
8
  66.7%
10
  71.4%
18
  69.2%
Male
4
  33.3%
4
  28.6%
8
  30.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 14 participants 26 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  16.7%
2
  14.3%
4
  15.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
3
  21.4%
3
  11.5%
White
8
  66.7%
7
  50.0%
15
  57.7%
More than one race
1
   8.3%
0
   0.0%
1
   3.8%
Unknown or Not Reported
1
   8.3%
2
  14.3%
3
  11.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 14 participants 26 participants
12 14 26
Beck Depression Inventory II   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 12 participants 14 participants 26 participants
17.33  (4.207) 16.57  (5.36) 16.92  (4.783)
[1]
Measure Description: 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.
Penn State Worry Questionnaire   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 12 participants 14 participants 26 participants
57.75  (9.555) 50.71  (10.709) 53.96  (10.611)
[1]
Measure Description: The 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).
Ruminative Responses Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 12 participants 14 participants 26 participants
49.92  (8.764) 43.29  (9.980) 46.35  (9.847)
[1]
Measure Description: The 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.
Overall Anxiety Severity and Impairment Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 12 participants 14 participants 26 participants
5.75  (3.415) 5.79  (2.392) 5.77  (2.847)
[1]
Measure Description: The 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).
1.Primary Outcome
Title Depressive Symptoms Assessed With the Beck Depression Inventory-II
Hide Description 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.
Time Frame Once on day 1 & day 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transcranial Ultrasound Transcranial Ultrasound Sham
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.42  (4.621) -.650  (4.249)
2.Secondary Outcome
Title Rumination Symptoms Assessed With the Ruminative Responses Scale
Hide Description The 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.
Time Frame Once on day 1 & 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transcranial Ultrasound Transcranial Ultrasound Sham
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.83  (5.670) -2.10  (6.045)
3.Secondary Outcome
Title Worry Symptoms Assessed With the Penn State Worry Questionnaire
Hide Description The 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.
Time Frame Once on day 1 & day 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transcranial Ultrasound Transcranial Ultrasound Sham
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.83  (7.732) 3.30  (5.677)
4.Secondary Outcome
Title Anxiety Symptoms Assessed With the Overall Anxiety Severity and Impairment Scale
Hide Description The 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.
Time Frame Once on day 1 & day 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transcranial Ultrasound Transcranial Ultrasound Sham
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.33  (1.723) -2.50  (3.240)
5.Post-Hoc Outcome
Title State Anxiety Assessed With Two Items From the Visual Analogue Mood Scale
Hide Description The 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.
Time Frame 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 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transcranial Ultrasound Transcranial Ultrasound Sham
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
-11.9833  (27.24018) -.6082  (33.90624)
Time Frame Participants were monitored for the length of time during which they participated in the study. For most participants, they were monitored from Day 1 of participation to Day 5 of participation (Day 1 to Day 5 occurred within 7 days). However, participants had an option to continue the study up to 10 days if they felt it was helpful for their depression. As such, participants could be monitored for up to 10 days of participation (within 14 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transcranial Ultrasound Transcranial Ultrasound Sham
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Transcranial Ultrasound Transcranial Ultrasound Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/14 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Transcranial Ultrasound Transcranial Ultrasound Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Transcranial Ultrasound Transcranial Ultrasound Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/14 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. John J.B. Allen
Organization: University of Arizona
Phone: (520) 621-7448
Responsible Party: John Allen, University of Arizona
ClinicalTrials.gov Identifier: NCT02685488     History of Changes
Other Study ID Numbers: RSRCH--‐703FY'15
First Submitted: February 14, 2016
First Posted: February 18, 2016
Results First Submitted: October 30, 2017
Results First Posted: January 8, 2018
Last Update Posted: January 8, 2018