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Non-invasive Brain Stimulation
Continuous Theta Burst Stimulation (cTBS) for Bipolar Disorder
N/A
Waitlist Available
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15-30 minutes
Awards & highlights
No Placebo-Only Group
Summary
This trial uses a special type of brain stimulation guided by brain activity measurements to help adults with bipolar disorder. The goal is to balance brain activity by calming overactive areas and stimulating underactive areas, which may help manage mood and behavior.
Eligible Conditions
- Bipolar Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15-30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15-30 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Brain Activity (Beta Power) in Left dlPFC
Brain Activity (Beta Power) in Left vLPFC
Brain Activity (Beta Power) in Right dlPFC
+4 moreSecondary study objectives
Brain Activity (Beta Power) in Other RNet and CEN Regions
Functional Connectivity Among Other RNet and CEN Regions
Immediate Choices Made on the Delay Discounting Task
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Experimental Treatment
Group I: right dlPFC iTBS/left Som cTBS/Left vLPFC cTBSExperimental Treatment2 Interventions
A random number sequence will be generated for randomization of the 3 EEG/TBS session order to which each participant is assigned:
right dlPFC iTBS (iTBS applied to the right dorsolateral prefrontal cortex) left Som cTBS (cTBS applied to the left somatosensory cortex) left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)
Group II: right dlPFC iTBS/Left vLPFC cTBS/left Som cTBSExperimental Treatment2 Interventions
A random number sequence will be generated for randomization of the 3 EEG/TBS session order to which each participant is assigned:
right dlPFC iTBS (iTBS applied to the right dorsolateral prefrontal cortex) left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex) left Som cTBS (cTBS applied to the left somatosensory cortex)
Group III: left Som cTBS/right dlPFC iTBS/Left vLPFC cTBSExperimental Treatment2 Interventions
A random number sequence will be generated for randomization of the 3 EEG/TBS session order to which each participant is assigned:
left Som cTBS (cTBS applied to the left somatosensory cortex) right dlPFC iTBS (iTBS applied to the right dorsolateral prefrontal cortex) left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)
Group IV: left Som cTBS/Left vLPFC cTBS/right dlPFC iTBSExperimental Treatment2 Interventions
A random number sequence will be generated for randomization of the 3 EEG/TBS session order to which each participant is assigned:
left Som cTBS (cTBS applied to the left somatosensory cortex) left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex) right dlPFC iTBS (iTBS applied to the right dorsolateral prefrontal cortex)
Group V: Left vLPFC cTBS/right dlPFC iTBS/left Som cTBSExperimental Treatment2 Interventions
A random number sequence will be generated for randomization of the 3 EEG/TBS session order to which each participant is assigned:
left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex) right dlPFC iTBS (iTBS applied to the right dorsolateral prefrontal cortex) left Som cTBS (cTBS applied to the left somatosensory cortex)
Group VI: Left vLPFC cTBS/left Som cTBS/right dlPFC iTBSExperimental Treatment2 Interventions
A random number sequence will be generated for randomization of the 3 EEG/TBS session order to which each participant is assigned:
left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex) left Som cTBS (cTBS applied to the left somatosensory cortex) right dlPFC iTBS (iTBS applied to the right dorsolateral prefrontal cortex)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous Theta Burst Stimulation (cTBS)
2020
N/A
~70
Intermittent Theta Burst Stimulation (iTBS)
2022
N/A
~20
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Who is running the clinical trial?
Mary Phillips, MD MD (Cantab)Lead Sponsor
3 Previous Clinical Trials
170 Total Patients Enrolled
1 Trials studying Bipolar Disorder
134 Patients Enrolled for Bipolar Disorder
Milken InstituteOTHER
7 Previous Clinical Trials
261 Total Patients Enrolled
6 Trials studying Bipolar Disorder
255 Patients Enrolled for Bipolar Disorder
Fabio Ferrarelli, MD, PhDPrincipal InvestigatorUniversity of Pittsburgh
3 Previous Clinical Trials
214 Total Patients Enrolled
1 Trials studying Bipolar Disorder
134 Patients Enrolled for Bipolar Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of head injury, neurological conditions like autism, or other medical conditions that require ongoing treatment.You have taken certain medications in the past month that can increase the risk of seizures.You have been diagnosed with bipolar disorder and are currently experiencing symptoms of depression or are in a state of partial remission or euthymia, which means your symptoms are not fully resolved for at least 2 months.You or someone in your family has a history of epilepsy.You regularly drink excessive amounts of alcohol in a short period of time.Your estimated IQ score before any medical condition is less than 85.You have been diagnosed with bipolar disorder and are currently experiencing a depressive episode.You have a mental condition called psychosis.You are taking medications for mental health that are not on the approved list.Your score on the YMRS (a mood rating scale) is 38 or higher during any study visit.You do not have any mental health conditions that cause hallucinations or delusions.You are not taking medication for anxiety, bipolar disorder, or other mood disorders such as antipsychotics, lithium, or certain antidepressants.You should not have consumed large amounts of alcohol (binge drinking) in the week before the study, or more than 3 drinks per day for 3 days before the study. You should also not have consumed alcohol within 12 hours before any study visits. However, it's okay to use substances like nicotine, caffeine, and cannabis, as long as it's not at levels that would be considered problematic.Your depression score is 18 or higher during any study visit.You have been diagnosed with bipolar disorder but are currently not experiencing a manic or hypomanic episode. You have been stable for at least two months.
Research Study Groups:
This trial has the following groups:- Group 1: Left vLPFC cTBS/right dlPFC iTBS/left Som cTBS
- Group 2: right dlPFC iTBS/Left vLPFC cTBS/left Som cTBS
- Group 3: left Som cTBS/right dlPFC iTBS/Left vLPFC cTBS
- Group 4: Left vLPFC cTBS/left Som cTBS/right dlPFC iTBS
- Group 5: left Som cTBS/Left vLPFC cTBS/right dlPFC iTBS
- Group 6: right dlPFC iTBS/left Som cTBS/Left vLPFC cTBS
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.
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