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Brain Stimulation
Theta Burst Stimulation for Bipolar Disorder
N/A
Recruiting
Led By Fabio Ferrarelli, MD, PhD
Research Sponsored by Mary Phillips, MD MD (Cantab)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No family history of BD
Not in a current depressive episode
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in magnitude immediately before and immediately after each ctbs condition at scan visits (30-60 mins)
Awards & highlights
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.
Who is the study for?
This trial is for adults aged 18-35 with Bipolar Disorder I/II in remission or mild-moderate hypomania. They must score low on depression and mania scales, can be unmedicated or on certain stable medications (excluding antidepressant monotherapy), and have no severe psychiatric disorders, substance abuse issues, head injuries, neurological diseases, or family history of epilepsy.Check my eligibility
What is being tested?
The study tests the effects of Theta Burst Stimulation (TBS) on brain activity and emotions in people with Bipolar Disorder. It compares Continuous TBS (cTBS), which is an active treatment, to a sham version that mimics the procedure without real stimulation to see if cTBS reduces symptoms like negative emotions.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of TBS may include headache, scalp discomfort at the stimulation site during treatment sessions, lightheadedness immediately following treatment sessions, and rare risk of seizure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My family does not have a history of bipolar disorder.
Select...
I am not currently experiencing a depressive episode.
Select...
I am between 18 and 35 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in magnitude immediately before and immediately after each ctbs condition at scan visits (30-60 mins)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in magnitude immediately before and immediately after each ctbs condition at scan visits (30-60 mins)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reward expectancy-related left amygdala activity
Reward expectancy-related left orbitofrontal cortex activity
Reward expectancy-related left ventral striatum activity
+16 moreSecondary outcome measures
Left amygdala activity
Left orbitofrontal cortex activity
Left ventral lateral prefrontal cortex-wholebrain functional connectivity
+13 moreOther outcome measures
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
+7 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Left vlPFC/Left vlPFC sham/Left SSExperimental Treatment2 Interventions
A random number sequence will be generated for randomization of the 3 cTBS scan session order to which each participant is assigned:
left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)
left SS cTBS (cTBS applied to the left somatosensory area)
left vlPFC sham TBS (go through the motions of applying cTBS to the left ventrolateral prefrontal cortex but very low current is administered so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells) Participants will know that one session will be a sham, but they will be blinded to which session is the sham.
Group II: Left vlPFC sham/Left vlPFC/Left SSExperimental Treatment2 Interventions
A random number sequence will be generated for randomization of the 3 cTBS scan session order to which each participant is assigned:
left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)
left SS cTBS (cTBS applied to the left somatosensory area)
left vlPFC sham TBS (go through the motions of applying cTBS to the left ventrolateral prefrontal cortex but very low current is administered so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells) Participants will know that one session will be a sham, but they will be blinded to which session is the sham.
Group III: Left vlPFC sham/Left SS/Left vlPFCExperimental Treatment2 Interventions
A random number sequence will be generated for randomization of the 3 cTBS scan session order to which each participant is assigned:
left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)
left SS cTBS (cTBS applied to the left somatosensory area)
left vlPFC sham TBS (go through the motions of applying cTBS to the left ventrolateral prefrontal cortex but very low current is administered so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells) Participants will know that one session will be a sham, but they will be blinded to which session is the sham.
Group IV: Left ventrolateral prefrontal cortex (vlPFC)/Left SS/Left vlPFC shamExperimental Treatment2 Interventions
A random number sequence will be generated for randomization of the 3 cTBS scan session order to which each participant is assigned:
left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)
left SS cTBS (cTBS applied to the left somatosensory area)
left vlPFC sham TBS (go through the motions of applying cTBS to the left ventrolateral prefrontal cortex but very low current is administered so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells) Participants will know that one session will be a sham, but they will be blinded to which session is the sham.
Group V: Left SS/Left vlPFC/Left vlPFC shamExperimental Treatment2 Interventions
A random number sequence will be generated for randomization of the 3 cTBS scan session order to which each participant is assigned:
left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)
left SS cTBS (cTBS applied to the left somatosensory area)
left vlPFC sham TBS (go through the motions of applying cTBS to the left ventrolateral prefrontal cortex but very low current is administered so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells) Participants will know that one session will be a sham, but they will be blinded to which session is the sham.
Group VI: Left SS/Left vlPFC sham/Left vlPFCExperimental Treatment2 Interventions
A random number sequence will be generated for randomization of the 3 cTBS scan session order to which each participant is assigned:
left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)
left SS cTBS (cTBS applied to the left somatosensory area)
left vlPFC sham TBS (go through the motions of applying cTBS to the left ventrolateral prefrontal cortex but very low current is administered so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells) Participants will know that one session will be a sham, but they will be blinded to which session is the sham.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous Theta Burst Stimulation (cTBS)
2020
N/A
~90
Find a Location
Who is running the clinical trial?
Mary Phillips, MD MD (Cantab)Lead Sponsor
2 Previous Clinical Trials
31 Total Patients Enrolled
1 Trials studying Bipolar Disorder
26 Patients Enrolled for Bipolar Disorder
National Institute of Mental Health (NIMH)NIH
2,785 Previous Clinical Trials
2,689,622 Total Patients Enrolled
145 Trials studying Bipolar Disorder
63,451 Patients Enrolled for Bipolar Disorder
Fabio Ferrarelli, MD, PhDPrincipal InvestigatorUniversity of Pittsburgh
3 Previous Clinical Trials
106 Total Patients Enrolled
1 Trials studying Bipolar Disorder
26 Patients Enrolled for Bipolar Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are left-handed or use both hands interchangeably.You have been diagnosed with bipolar disorder.You do not have a condition that causes hallucinations or delusions.You have a score of less than 15 on the Young Mania Rating Scale, which measures symptoms of mania.My family does not have a history of bipolar disorder.I am not currently experiencing a depressive episode.I am either younger than 18 or older than 35.I am currently experiencing a depressive episode.My diagnosis is not bipolar I or II disorder.I haven't had heavy drinking sessions or consumed more than 3 alcohol units daily before the scan.I am between 18 and 35 years old.You have a history of alcohol or drug addiction, except for cannabis. However, recent and ongoing use of cannabis will not be allowed. We will conduct urine and saliva tests to ensure you are not currently using drugs or intoxicated with alcohol during the study.You have been diagnosed with bipolar disorder.I have a family history of bipolar disorder.I am not taking SNRI antidepressants or bupropion.I haven't used any substances that could cause seizures in the last month.I have Bipolar Disorder I or II and have been stable or only mildly affected for over 2 months.I am taking medication for bipolar disorder, not just an antidepressant alone.Your depression symptoms are severe, with a score of 18 or higher on the HRSD scale.You do not have a current or past history of bipolar disorder or other serious mental health conditions, except for anxiety or mild mood disorders.You have a mental health condition called psychosis.I am not taking any psychotropic medications not allowed in the study.You have had or currently have any mental health condition, except for anxiety or certain mood disorders.I have a history of head injury, neurological issues, autism, or other systemic medical diseases.Your estimated IQ score, before any illness or condition, is less than 85.You cannot have Bipolar Disorder.I have been diagnosed with depression and scored 8 or higher on a depression scale.You have family members who have had epilepsy in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Left SS/Left vlPFC sham/Left vlPFC
- Group 2: Left SS/Left vlPFC/Left vlPFC sham
- Group 3: Left vlPFC sham/Left vlPFC/Left SS
- Group 4: Left vlPFC/Left vlPFC sham/Left SS
- Group 5: Left vlPFC sham/Left SS/Left vlPFC
- Group 6: Left ventrolateral prefrontal cortex (vlPFC)/Left SS/Left vlPFC sham
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Does the eligibility criteria for this research study encompass minors?
"The stipulated age range for this trial is 18 to 35 years old."
Answered by AI
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."
Answered by AI
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