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Theta Burst Stimulation in Young Adults With Depression

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ClinicalTrials.gov Identifier: NCT03737032
Recruitment Status : Not yet recruiting
First Posted : November 9, 2018
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Erika Forbes, University of Pittsburgh

Brief Summary:
For the proposed 2-year study, the investigators will conduct a within-subject, counterbalanced investigation using functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS) to examine the acute effects of theta-burst stimulation (TBS) on function in dorsomedial prefrontal cortex (dmPFC) in 35 young adults with depression (18-25 years, 50% female).

Condition or disease Intervention/treatment Phase
Depression Device: Intermittent Theta Burst Stimulation Device: Continuous Theta Burst Stimulation Device: Sham Theta Burst Stimulation Not Applicable

Detailed Description:
Each participant will undergo 3 sessions of TMS, one each of continuous and intermittent TBS--with the goal of decreasing or increasing dmPFC responding, respectively--and one of sham TBS. Session order will be counterbalanced, with a double-blind approach to condition. Brain function, behavior, and mood will be assessed before and after each TBS session. Broadly, the investigators predict that inhibitory TBS to the dmPFC will enhance neural, behavioral, and subjective aspects of reward function by reducing dmPFC function and dmPFC connectivity with the ventral striatum (VS).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: All participants will receive intermittent Theta Burst Stimulation (TBS), continuous TBS, and sham TBS mimicking stimulation, in randomized, double-blind order across three sessions.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The content of each TBS condition will be unknown to participants and to the research staff member conducting assessment of change neural, behavioral, and subjective response with TBS.
Primary Purpose: Basic Science
Official Title: Theta Burst Stimulation in Young Adults With Depression
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intermittent, Continuous, Sham Order
3 sessions of theta burst stimulation administered in the following order: 1) Intermittent theta burst stimulation, 2) Continuous theta burst stimulation, 3) Sham theta burst stimulation.
Device: Intermittent Theta Burst Stimulation
Theta Burst Stimulation, a form of Transcranial Magnetic Stimulation, will be applied to the dorsomedial prefrontal cortex. will include 600 pulses delivered in brief bursts of three pulses with a frequency of 50 Hz, at an intensity of 110% of resting motor threshold, and administered every 200 ms (5 Hz). Bursts will be delivered without interruption for a total duration of 40 seconds.

Device: Continuous Theta Burst Stimulation
Theta Burst Stimulation, a form of Transcranial Magnetic Stimulation, will be applied to the dorsomedial prefrontal cortex. will include 600 pulses delivered in brief bursts of three pulses with a frequency of 50 Hz, at an intensity of 110% of resting motor threshold, and administered every 200 ms (5 Hz). Bursts will be delivered during 2 second periods (10 bursts/period) interleaved with 8-second stimulation-free intervals, for a total duration of 190 seconds.

Device: Sham Theta Burst Stimulation
For the sham of theta burst stimulation, the device providing Theta Burst Stimulation can be placed in the same position and turned on, creating a similar experience for the participant, without providing any neural stimulation. Sham TBS will be delivered with a Cool-B65 Active/Placebo Coil, which includes a sham setting, and MagLink research software.

Experimental: Intermittent, Sham, Continuous Order
3 sessions of theta burst stimulation administered in the following order: 1) Intermittent theta burst stimulation, 2) Sham theta burst stimulation, 3) Continuous theta burst stimulation.
Device: Intermittent Theta Burst Stimulation
Theta Burst Stimulation, a form of Transcranial Magnetic Stimulation, will be applied to the dorsomedial prefrontal cortex. will include 600 pulses delivered in brief bursts of three pulses with a frequency of 50 Hz, at an intensity of 110% of resting motor threshold, and administered every 200 ms (5 Hz). Bursts will be delivered without interruption for a total duration of 40 seconds.

Device: Continuous Theta Burst Stimulation
Theta Burst Stimulation, a form of Transcranial Magnetic Stimulation, will be applied to the dorsomedial prefrontal cortex. will include 600 pulses delivered in brief bursts of three pulses with a frequency of 50 Hz, at an intensity of 110% of resting motor threshold, and administered every 200 ms (5 Hz). Bursts will be delivered during 2 second periods (10 bursts/period) interleaved with 8-second stimulation-free intervals, for a total duration of 190 seconds.

Device: Sham Theta Burst Stimulation
For the sham of theta burst stimulation, the device providing Theta Burst Stimulation can be placed in the same position and turned on, creating a similar experience for the participant, without providing any neural stimulation. Sham TBS will be delivered with a Cool-B65 Active/Placebo Coil, which includes a sham setting, and MagLink research software.

Experimental: Continuous, Intermittent, Sham Order
3 sessions of theta burst stimulation administered in the following order: 1) Continuous theta burst stimulation, 2) Intermittent theta burst stimulation, 3) Sham theta burst stimulation.
Device: Intermittent Theta Burst Stimulation
Theta Burst Stimulation, a form of Transcranial Magnetic Stimulation, will be applied to the dorsomedial prefrontal cortex. will include 600 pulses delivered in brief bursts of three pulses with a frequency of 50 Hz, at an intensity of 110% of resting motor threshold, and administered every 200 ms (5 Hz). Bursts will be delivered without interruption for a total duration of 40 seconds.

Device: Continuous Theta Burst Stimulation
Theta Burst Stimulation, a form of Transcranial Magnetic Stimulation, will be applied to the dorsomedial prefrontal cortex. will include 600 pulses delivered in brief bursts of three pulses with a frequency of 50 Hz, at an intensity of 110% of resting motor threshold, and administered every 200 ms (5 Hz). Bursts will be delivered during 2 second periods (10 bursts/period) interleaved with 8-second stimulation-free intervals, for a total duration of 190 seconds.

Device: Sham Theta Burst Stimulation
For the sham of theta burst stimulation, the device providing Theta Burst Stimulation can be placed in the same position and turned on, creating a similar experience for the participant, without providing any neural stimulation. Sham TBS will be delivered with a Cool-B65 Active/Placebo Coil, which includes a sham setting, and MagLink research software.

Experimental: Continuous, Sham, Intermittent Order
3 sessions of theta burst stimulation administered in the following order: 1) Continuous theta burst stimulation, 2) Sham theta burst stimulation, 3) Intermittent theta burst stimulation.
Device: Intermittent Theta Burst Stimulation
Theta Burst Stimulation, a form of Transcranial Magnetic Stimulation, will be applied to the dorsomedial prefrontal cortex. will include 600 pulses delivered in brief bursts of three pulses with a frequency of 50 Hz, at an intensity of 110% of resting motor threshold, and administered every 200 ms (5 Hz). Bursts will be delivered without interruption for a total duration of 40 seconds.

Device: Continuous Theta Burst Stimulation
Theta Burst Stimulation, a form of Transcranial Magnetic Stimulation, will be applied to the dorsomedial prefrontal cortex. will include 600 pulses delivered in brief bursts of three pulses with a frequency of 50 Hz, at an intensity of 110% of resting motor threshold, and administered every 200 ms (5 Hz). Bursts will be delivered during 2 second periods (10 bursts/period) interleaved with 8-second stimulation-free intervals, for a total duration of 190 seconds.

Device: Sham Theta Burst Stimulation
For the sham of theta burst stimulation, the device providing Theta Burst Stimulation can be placed in the same position and turned on, creating a similar experience for the participant, without providing any neural stimulation. Sham TBS will be delivered with a Cool-B65 Active/Placebo Coil, which includes a sham setting, and MagLink research software.

Experimental: Sham, Intermittent, Continuous Order
3 sessions of theta burst stimulation administered in the following order: 1) Sham theta burst stimulation, 2) Intermittent theta burst stimulation, 3) Continuous theta burst stimulation.
Device: Intermittent Theta Burst Stimulation
Theta Burst Stimulation, a form of Transcranial Magnetic Stimulation, will be applied to the dorsomedial prefrontal cortex. will include 600 pulses delivered in brief bursts of three pulses with a frequency of 50 Hz, at an intensity of 110% of resting motor threshold, and administered every 200 ms (5 Hz). Bursts will be delivered without interruption for a total duration of 40 seconds.

Device: Continuous Theta Burst Stimulation
Theta Burst Stimulation, a form of Transcranial Magnetic Stimulation, will be applied to the dorsomedial prefrontal cortex. will include 600 pulses delivered in brief bursts of three pulses with a frequency of 50 Hz, at an intensity of 110% of resting motor threshold, and administered every 200 ms (5 Hz). Bursts will be delivered during 2 second periods (10 bursts/period) interleaved with 8-second stimulation-free intervals, for a total duration of 190 seconds.

Device: Sham Theta Burst Stimulation
For the sham of theta burst stimulation, the device providing Theta Burst Stimulation can be placed in the same position and turned on, creating a similar experience for the participant, without providing any neural stimulation. Sham TBS will be delivered with a Cool-B65 Active/Placebo Coil, which includes a sham setting, and MagLink research software.

Experimental: Sham, Continuous, Intermittent Order
3 sessions of theta burst stimulation administered in the following order: 1) Sham theta burst stimulation, 2) Continuous theta burst stimulation, 3) Intermittent theta burst stimulation.
Device: Intermittent Theta Burst Stimulation
Theta Burst Stimulation, a form of Transcranial Magnetic Stimulation, will be applied to the dorsomedial prefrontal cortex. will include 600 pulses delivered in brief bursts of three pulses with a frequency of 50 Hz, at an intensity of 110% of resting motor threshold, and administered every 200 ms (5 Hz). Bursts will be delivered without interruption for a total duration of 40 seconds.

Device: Continuous Theta Burst Stimulation
Theta Burst Stimulation, a form of Transcranial Magnetic Stimulation, will be applied to the dorsomedial prefrontal cortex. will include 600 pulses delivered in brief bursts of three pulses with a frequency of 50 Hz, at an intensity of 110% of resting motor threshold, and administered every 200 ms (5 Hz). Bursts will be delivered during 2 second periods (10 bursts/period) interleaved with 8-second stimulation-free intervals, for a total duration of 190 seconds.

Device: Sham Theta Burst Stimulation
For the sham of theta burst stimulation, the device providing Theta Burst Stimulation can be placed in the same position and turned on, creating a similar experience for the participant, without providing any neural stimulation. Sham TBS will be delivered with a Cool-B65 Active/Placebo Coil, which includes a sham setting, and MagLink research software.




Primary Outcome Measures :
  1. fMRI-assessed brain function in the dorsomedial prefrontal cortex [ Time Frame: before and after TBS is administered (1 hour) ]
    Change in functional magnetic resonance imaging (fMRI)-assessed blood oxygen-level-dependent (BOLD) response to monetary reward in the dorsomedial prefrontal cortex (dmPFC), the site to which TBS will be administered. Change will be computed as the difference before/after each TBS session, for a total of 3 sessions.


Secondary Outcome Measures :
  1. fMRI-assessed dmPFC-VS functional connectivity [ Time Frame: before and after TBS is administered (1 hour) ]
    Change in fMRI-assessed functional connectivity in response to monetary reward between the dmPFC and the ventral striatum. Change will be computed as the difference before/after each TBS session, for a total of 3 sessions.

  2. Hedonic capacity [ Time Frame: before and after TBS is administered (1 hour) ]
    Change in self-reported hedonic capacity measured with the Snaith Hamilton Pleasure Scale (14 item measure, with each item rated 1-4 and higher scores indicating greater experience of pleasure; yielding a total score between 14 and 56). Change will be computed as the difference before/after each TBS session, for a total of 3 sessions.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• DSM-5 Diagnosis of Major Depressive Disorder, Persistent Depressive Disorder (Dysthymia), Other Specified Depressive Disorder, or Other Unspecified Depressive Disorder

Exclusion Criteria:

  • Bipolar disorder, substance dependence, or lifetime history of psychosis
  • Neurological disorder (e.g., seizure disorder)
  • Pregnant
  • MRI contradictions: claustrophobia, permanent orthodontic devices, metal implants or other forms of metal in the body that cannot be removed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03737032


Contacts
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Contact: Erika E Forbes, Ph.D. 412-383-5438 forbese@upmc.edu
Contact: Melissa M Nance, B.A. 412-624-4140 nancem@upmc.edu

Locations
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United States, Pennsylvania
The University of Pittsburgh, Department of Psychiatry Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Erika E Forbes, Ph.D.    412-383-5438    forbese@upmc.edu   
Contact: Fabio Ferrarelli, MD, Ph.D.    (412) 864-1668    ferrarellif@upmc.edu   
Principal Investigator: Erika E Forbes, Ph.D.         
Sponsors and Collaborators
Erika Forbes
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Erika E Forbes, Ph.D. The University of Pittsburgh

Publications:

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Responsible Party: Erika Forbes, Professor of Psychiatry, Psychology, Pediatrics, & Clinical and Translational Science, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03737032     History of Changes
Other Study ID Numbers: PRO18040159
R21MH117400 ( U.S. NIH Grant/Contract )
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share all individual participant data (IPD) that underlie results in publications that report findings related to tests of our major hypotheses.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will become available after results of planned tests are published or 5 years after completion of data collection, whichever occurs first. Data will remain available for 5 years.
Access Criteria: We will create procedures for other researchers to request data and will maintain quality assurance of data requests and data sharing. Researchers who share data will be affiliated and in good standing with academic institutions, will have current certification of training in responsible conduct of research, and will complete data requests describing the purpose of the project, the data requested, and the data analysis plan. Requests will be reviewed by the Principal Investigator and, if needed, other members of the research team. Criteria for sharing data will include characteristics described above, as well as scientific merit of the proposed use of data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders