Theta Burst Stimulation in Young Adults With Depression

Sponsor
Erika Forbes (Other)
Overall Status
Recruiting
CT.gov ID
NCT03737032
Collaborator
National Institute of Mental Health (NIMH) (NIH)
36
Enrollment
1
Location
6
Arms
30
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Device: Intermittent Theta Burst Stimulation
  • Device: Continuous Theta Burst Stimulation
  • Device: Sham Theta Burst Stimulation
N/A

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).

Study Design

Study Type:
Interventional
Anticipated 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.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
Actual Study Start Date :
Jan 31, 2020
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. fMRI-assessed brain function in the dorsomedial prefrontal cortex [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1The University of Pittsburgh, Department of PsychiatryPittsburghPennsylvaniaUnited States15213

Sponsors and Collaborators

  • Erika Forbes
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Erika E Forbes, Ph.D., The University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Erika Forbes, Professor of Psychiatry, Psychology, Pediatrics, & Clinical and Translational Science, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT03737032
Other Study ID Numbers:
  • PRO18040159
  • R21MH117400
First Posted:
Nov 9, 2018
Last Update Posted:
Oct 6, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2021