Investigating Transcranial Ultrasound as a Potential Intervention for Depression

NCT02685488 | Completed Results

• 1 other identifier: RSRCH---703FY'15
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

Depression is the leading cause of disability worldwide. Because a significant number of people with depression do not respond to medication or therapy, alternative treatment options are greatly needed. Recent research has focused on brain stimulation methods due to their therapeutic utility for treating depression. Yet, current brain stimulation methods have drawbacks, including invasive surgery and limited precision in targeting specific areas. A novel brain stimulation method, transcranial ultrasound (TUS), is noninvasive, has greater spatial precision than most existing methods, and is proven safe for humans. TUS has been found to increase positive mood in chronic pain patients. In a double blind study, TUS increased positive mood in over 140 healthy undergraduates at the University of Arizona. Despite evidence that TUS can increase positive mood in humans, it has yet to be investigated whether TUS can increase positive mood in humans who are experiencing chronic low mood or depression. The present study will, for the first time, examine whether TUS can improve depressive symptoms. Twenty to thirty participants with mild to moderate depressive symptoms (Beck Depression Inventory Score between 10 and 25) will be randomly assigned to a TUS sham or TUS activation condition. In the TUS activation condition, TUS will be used to stimulate the right fronto-temporal area, which has previously been shown to increase positive mood. Participants in the TUS sham condition will not receive any brain stimulation. Participants will attend five sessions within seven days or ten sessions within fourteen days. At each session, in addition to brain stimulation, self-reported mood and depressive symptoms will be recorded. Furthermore, the investigators will use electroencephalogram (EEG) to record changes in brain electrical signals during TUS stimulation. Based on prior research, the investigators predict that mood will increase and depressive symptoms will decrease with TUS stimulation.

Conditions

Depression; Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

• Depressive Symptoms Assessed With the Beck Depression Inventory-II

  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.

  Once on day 1 & day 5

Secondary Outcomes (3)

• Rumination Symptoms Assessed With the Ruminative Responses Scale

  Once on day 1 & 5

• Worry Symptoms Assessed With the Penn State Worry Questionnaire

  Once on day 1 & day 5

• Anxiety Symptoms Assessed With the Overall Anxiety Severity and Impairment Scale

  Once on day 1 & day 5

Study Arms (2)

Transcranial Ultrasound Power

ACTIVE COMPARATOR

Transcranial Ultrasound Power

Device: Transcranial Ultrasound Power

Transcranial Ultrasound Sham

SHAM COMPARATOR

Transcranial Ultrasound Sham. Unknown to both participants and experimenters, the ultrasound will not stimulate.

Device: Transcranial Ultrasound Sham

Interventions

Transcranial Ultrasound Power DEVICE

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 Power

Transcranial Ultrasound Sham DEVICE

Transcranial ultrasound will be used without power for a "sham" condition.

Transcranial Ultrasound Sham

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Beck Depression Inventory score between 10 and 25

You may not qualify if:

• left-handedness
• prior serious head-related injury
• any medical condition that would impact EEG profiles
• chronic migraines or other severe headaches
• pregnancy
• lack of proficiency in English
• lack of secure housing
• current confounding treatment (including any psychotropic medication or psychotherapy)
• current active suicidal potential necessitating immediate treatment, as such participants will be referred for immediate treatment.

Sponsors & Collaborators

• University of Arizona: lead

Related Publications (6)

• Hameroff S, Trakas M, Duffield C, Annabi E, Gerace MB, Boyle P, Lucas A, Amos Q, Buadu A, Badal JJ. Transcranial ultrasound (TUS) effects on mental states: a pilot study. Brain Stimul. 2013 May;6(3):409-15. doi: 10.1016/j.brs.2012.05.002. Epub 2012 May 29.

  PMID: 22664271 BACKGROUND

• Tufail Y, Yoshihiro A, Pati S, Li MM, Tyler WJ. Ultrasonic neuromodulation by brain stimulation with transcranial ultrasound. Nat Protoc. 2011 Sep 1;6(9):1453-70. doi: 10.1038/nprot.2011.371.

  PMID: 21886108 BACKGROUND

• Fava M. Diagnosis and definition of treatment-resistant depression. Biol Psychiatry. 2003 Apr 15;53(8):649-59. doi: 10.1016/s0006-3223(03)00231-2.

  PMID: 12706951 BACKGROUND

• Gavrilov LR, Tsirulnikov EM, Davies IA. Application of focused ultrasound for the stimulation of neural structures. Ultrasound Med Biol. 1996;22(2):179-92. doi: 10.1016/0301-5629(96)83782-3.

  PMID: 8735528 BACKGROUND

• Bystritsky A, Korb AS, Douglas PK, Cohen MS, Melega WP, Mulgaonkar AP, DeSalles A, Min BK, Yoo SS. A review of low-intensity focused ultrasound pulsation. Brain Stimul. 2011 Jul;4(3):125-36. doi: 10.1016/j.brs.2011.03.007. Epub 2011 Apr 1.

  PMID: 21777872 BACKGROUND

• ter Haar G. Therapeutic applications of ultrasound. Prog Biophys Mol Biol. 2007 Jan-Apr;93(1-3):111-29. doi: 10.1016/j.pbiomolbio.2006.07.005. Epub 2006 Aug 4.

  PMID: 16930682 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Results Point of Contact

• Title: Dr. John J.B. Allen
• Organization: University of Arizona

john.jb.allen@arizona.edu

(520) 621-7448

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Study Record Dates

• First Submitted: February 14, 2016
• First Posted: February 18, 2016
• Study Start: October 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: January 8, 2018
• Results First Posted: January 8, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share