Study Summary
This trial will study the effects of transcranial brain stimulation on brain activity and emotions in adults with and without bipolar disorder, in order to better understand the predisposing brain mechanisms of bipolar disorder.
Eligible Conditions
- Bipolar Disorder
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
19 Primary · 16 Secondary · Reporting Duration: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Left amygdala activity
Left orbitofrontal cortex activity
Left ventral lateral prefrontal cortex-wholebrain functional connectivity
Left ventral striatum activity
Left ventrolateral prefrontal cortex activity
Left ventrolateral prefrontal cortex-left amygdala resting state functional connectivity
Left ventrolateral prefrontal cortex-left orbitofrontal cortex resting state functional connectivity
Left ventrolateral prefrontal cortex-left ventral striatum resting state functional connectivity
Left ventrolateral prefrontal cortex-midline dorsal anterior cingulate cortex resting state functional connectivity
Left ventrolateral prefrontal cortex-midline rostral anterior cingulate cortex resting state functional connectivity
Left ventrolateral prefrontal cortex-right amygdala resting state functional connectivity
Left ventrolateral prefrontal cortex-right orbitofrontal cortex resting state functional connectivity
Left ventrolateral prefrontal cortex-right ventral striatum resting state functional connectivity
Left ventrolateral prefrontal cortex-right ventrolateral prefrontal cortex resting state functional connectivity
Left ventrolateral prefrontal cortex-wholebrain resting state functional connectivity
Midline dorsal anterior cingulate cortex activity
Midline rostral anterior cingulate cortex activity
Prediction error-related left ventral striatum activity
Prediction error-related left ventral striatum-wholebrain functional connectivity
Prediction error-related right ventral striatum activity
Prediction error-related right ventral striatum-wholebrain functional connectivity
Reward expectancy-related left amygdala activity
Reward expectancy-related left orbitofrontal cortex activity
Reward expectancy-related left ventral striatum activity
Reward expectancy-related left ventrolateral prefrontal cortex activity
Reward expectancy-related left ventrolateral prefrontal cortex wholebrain functional connectivity
Reward expectancy-related left ventrolateral prefrontal cortex-left amygdala functional connectivity
Reward expectancy-related left ventrolateral prefrontal cortex-left orbitofrontal cortex functional connectivity
Reward expectancy-related left ventrolateral prefrontal cortex-left ventral striatum functional connectivity
Reward expectancy-related left ventrolateral prefrontal cortex-midline dorsal anterior cingulate cortex functional connectivity
Reward expectancy-related left ventrolateral prefrontal cortex-midline rostral anterior cingulate cortex functional connectivity
Reward expectancy-related left ventrolateral prefrontal cortex-right amygdala functional connectivity
Reward expectancy-related left ventrolateral prefrontal cortex-right orbitofrontal cortex functional connectivity
Reward expectancy-related left ventrolateral prefrontal cortex-right ventral striatum functional connectivity
Reward expectancy-related left ventrolateral prefrontal cortex-right ventrolateral prefrontal cortex functional connectivity
Reward expectancy-related midline dorsal anterior cingulate cortex activity
Reward expectancy-related midline rostral anterior cingulate cortex (rACC) activity
Reward expectancy-related right amygdala activity
Orbitofrontal cortex
Reward expectancy-related right ventral striatum activity
Reward expectancy-related right ventrolateral prefrontal cortex activity
Right amygdala activity
Right orbitofrontal cortex activity
Right ventral striatum activity
Right ventrolateral prefrontal cortex activity
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
6 Treatment Groups
Left ventrolateral prefrontal cortex (vlPFC)/Left SS/Left vlPFC sham
1 of 6
Left vlPFC/Left vlPFC sham/Left SS
1 of 6
Left SS/Left vlPFC sham/Left vlPFC
1 of 6
Left SS/Left vlPFC/Left vlPFC sham
1 of 6
Left vlPFC sham/Left SS/Left vlPFC
1 of 6
Left vlPFC sham/Left vlPFC/Left SS
1 of 6
Experimental Treatment
134 Total Participants · 6 Treatment Groups
Primary Treatment: Continuous Theta Burst Stimulation (cTBS) · No Placebo Group · N/A
Left ventrolateral prefrontal cortex (vlPFC)/Left SS/Left vlPFC shamExperimental Group · 2 Interventions: Sham Continuous Theta Burst Stimulation (Sham cTBS), Continuous Theta Burst Stimulation (cTBS) · Intervention Types: Device, Device
Left vlPFC/Left vlPFC sham/Left SSExperimental Group · 2 Interventions: Sham Continuous Theta Burst Stimulation (Sham cTBS), Continuous Theta Burst Stimulation (cTBS) · Intervention Types: Device, Device
Left SS/Left vlPFC sham/Left vlPFCExperimental Group · 2 Interventions: Sham Continuous Theta Burst Stimulation (Sham cTBS), Continuous Theta Burst Stimulation (cTBS) · Intervention Types: Device, Device
Left SS/Left vlPFC/Left vlPFC shamExperimental Group · 2 Interventions: Sham Continuous Theta Burst Stimulation (Sham cTBS), Continuous Theta Burst Stimulation (cTBS) · Intervention Types: Device, Device
Left vlPFC sham/Left SS/Left vlPFCExperimental Group · 2 Interventions: Sham Continuous Theta Burst Stimulation (Sham cTBS), Continuous Theta Burst Stimulation (cTBS) · Intervention Types: Device, Device
Left vlPFC sham/Left vlPFC/Left SSExperimental Group · 2 Interventions: Sham Continuous Theta Burst Stimulation (Sham cTBS), Continuous Theta Burst Stimulation (cTBS) · Intervention Types: Device, Device
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change in magnitude immediately before and immediately after each ctbs condition at scan visits (30-60 mins)
Who is running the clinical trial?
Mary Phillips, MD MD (Cantab)Lead Sponsor
2 Previous Clinical Trials
68 Total Patients Enrolled
1 Trials studying Bipolar Disorder
63 Patients Enrolled for Bipolar Disorder
National Institute of Mental Health (NIMH)NIH
2,616 Previous Clinical Trials
1,982,793 Total Patients Enrolled
142 Trials studying Bipolar Disorder
63,248 Patients Enrolled for Bipolar Disorder
Mary Phillips, MD, MD4.563 ReviewsPrincipal Investigator - University of Pittsburgh
Gwinnett Medical Center, Northside Hospital
Medical School - Rutgers, The State University of New Jersey, Doctor of Medicine
Newark Beth Israel Medical Center, Residency in Obstetrics and Gynecology
1 Previous Clinical Trials
5 Total Patients Enrolled
5Patient Review
Dr. Hayles-Patterson was excellent. She was very informative and made me feel relaxed. She talked to me like a friend, which I appreciate. I'm glad I selected her as my OBGYN.
Fabio Ferrarelli, MD, PhDPrincipal InvestigatorUniversity of Pittsburgh
3 Previous Clinical Trials
143 Total Patients Enrolled
1 Trials studying Bipolar Disorder
63 Patients Enrolled for Bipolar Disorder
Eligibility Criteria
Age 18 - 35 · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:This applies to everyone who wants to participate in the study.
You are taking a combination of anxiety, antipsychotic, mood stabilizing, or sleep medications (except for antidepressant alone) for more than 2 months.
You do not have Bipolar Disorder.
You are not currently experiencing depression.
You have bipolar disorder.
If you have bipolar disorder, you must not be currently experiencing severe symptoms and should have been stable for at least 2 months.
You do not have a severe mental illness called psychosis.
Frequently Asked Questions
What criteria must be met to qualify for participation in this clinical research?
"This clinical trial is seeking 134 participants who suffer from manic disorder, and meet the age requirement of 18 to 35." - Anonymous Online Contributor
Unverified Answer
How many participants have been enlisted for this experiment thus far?
"That is correct. Clinicaltrials.gov data affirms that the medical trial, which was initially publicized on April 6th 2021, is presently recruiting patients. Approximately 134 volunteers need to be enlisted from 1 location." - Anonymous Online Contributor
Unverified Answer
What is the primary purpose of this research project?
"The main outcome of this trial, which will be assessed within a 30 to 60 minute timeframe before and after cTBS conditions, is the degree of reward expectancy-related activity in midline dorsal anterior cingulate cortex. Secondary outcomes include: left ventrolateral prefrontal cortex wholebrain functional connectivity when completing the reward task; pre/post contrast differences in left orbitofrontal cortex BOLD signal between possible win vs neutral control scenarios; and corresponding right orbitofrontal cortex changes." - Anonymous Online Contributor
Unverified Answer
Does the eligibility criteria for this research study encompass minors?
"The stipulated age range for this trial is 18 to 35 years old." - Anonymous Online Contributor
Unverified Answer
Is enrollment for this clinical research program open at present?
"Indeed, the details of this study found on clinicaltrials.gov indicate that enrollment is still open. The trial was initially posted on April 6th 2021 and has been modified as recently as October 31st 2022 with 134 participants needed from 1 site." - Anonymous Online Contributor
Unverified Answer