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New treatment option for Bipolar Disorder
Official title Intermittent Theta Burst Stimulation (iTBS) for Emotion Regulation in Bipolar Disorder
ClinicalTrials.gov ID: NCT06274567
What this study is testing
- What it's testing
- The objective of this study protocol is to test whether intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) can strengthen functional connectivity with a key region in emotion regulation (ER) neurocircuitry (anterior insula, AI) and improve performance on ER-related tasks in patients with bipolar disorder. Individual IPL sites for stimulation will be identified through baseline, pre-TMS functional magnetic resonance imaging (fMRI) scans.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 24 to 65
You may be able to join if
- Individuals of all genders
- ages 24-65
- Diagnostic Statistical Manual (DSM-5) defined diagnosis of bipolar I or II disorder (BD); assessed using the Mini-International Neuropsychiatric...
- Current depressive episode, assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) score ≥20,
- Ability to provide informed consent and verifiable contact information, including current psychiatric treatment provider
You likely can't join if
- current mania/hypomania assessed by the Young Mania Rating Scale (YMRS \> 12)
- rapid-cycling bipolar illness, defined as \>4 episodes per year, indicating increased risk of switch to mania
- current active suicidality (suicidal ideation with intent or plan), as assessed by a score \>4 on the MADRS item #10
- current substance use disorder for the past 6 months; substance use disorder in remission permitted
- history of psychosis
- dementia or other major neurological disorders, as assessed by a Mini-Mental State Exam (MMSE) score \<24 and Montreal Cognitive Assessment (MOCA)...
See the full eligibility criteria
- Individuals of all genders
- ages 24-65
- Diagnostic Statistical Manual (DSM-5) defined diagnosis of bipolar I or II disorder (BD); assessed using the Mini-International Neuropsychiatric Interview (M.I.N.I.) version 7.0.2.
- Current depressive episode, assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) score ≥20,
- Ability to provide informed consent and verifiable contact information, including current psychiatric treatment provider
- Stable medication regimen for at least one month, which must include a mood stabilizer
- current mania/hypomania assessed by the Young Mania Rating Scale (YMRS \> 12)
- rapid-cycling bipolar illness, defined as \>4 episodes per year, indicating increased risk of switch to mania
- current active suicidality (suicidal ideation with intent or plan), as assessed by a score \>4 on the MADRS item #10
- current substance use disorder for the past 6 months; substance use disorder in remission permitted
- history of psychosis
- dementia or other major neurological disorders, as assessed by a Mini-Mental State Exam (MMSE) score \<24 and Montreal Cognitive Assessment (MOCA) score \<26
- medical illness or non-psychiatric medical treatment that would likely interfere with study participation
- contraindications for magnetic resonance imaging (MRI) or transcranial magnetic stimulation (TMS), including the presence of metallic implants that would interfere with safety (i.e. cardiac pacemaker, metal plates...
- a clinical course of a neuromodulatory therapy (e.g. transcranial magnetic stimulation, transcranial direct current stimulation, electroconvulsive therapy) within the past 6 months
- current use of benzodiazepines, which can interfere with iTBS stimulation
- current pregnancy, to limit potential risks to an unborn child Other: Given that \>86% of BD patients experience lifetime comorbid anxiety, co-occurring anxiety disorders will be allowable for inclusion, thus providing...
The study team makes the final eligibility decision.
Where it's taking place
- Charlestown, Massachusetts, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 24 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlestown, Massachusetts, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.