Neuromodulation of Mood Switch Circuitry in Bipolar Disorder
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 70 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Before treatment, investigators will use brain scans (MRI) to create a personalized map of each participant's brain activity."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests targeted brain stimulation for adults with bipolar disorder and at least moderate depression. The treatment, called rTMS, uses magnetic pulses at the scalp to stimulate the brain. Each person will have brain scans to choose a treatment target and receive both real and sham (placebo) treatment to compare effects on mood.
This study is exploring a new approach to treating depression in people with bipolar disorder (BD). Investigators are testing whether a non-invasive form of brain stimulation can help us understand depressed-to-euthymic mood shifts and their related brain circuits in BD. Investigators in this study will use a technique called repetitive transcranial magnetic stimulation, or rTMS. It uses non-invasive magnetic pulses delivered to the scalp to stimulate specific areas of the brain. rTMS is already used to treat depression, and investigators are now studying whether it can be made even more effective for people with bipolar disorder by precisely targeting an individualized brain region for each participant. Participants in this study will receive two courses of rTMS, one active and one placebo (called "sham"), in a randomized order so investigators can directly compare the effects. Before treatment, investigators will use brain scans (MRI) to create a personalized map of each participant's brain activity. This lets investigators identify the exact stimulation target most likely to influence the brain circuits involved in BD mood shifts. Investigators will track mood symptoms closely throughout the study to measure what changes. Investigators believe that depression in BD is partly driven by disrupted communication between two brain regions involved in processing what feels important or rewarding. Investigators want to find out whether rTMS can restore that communication and whether doing so leads to measurable improvements in depression.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18–70 years old. People of all genders may join.
- Have bipolar disorder and at least moderate depression.
- Sign a consent form and agree to follow study steps and stay in the study for its full length.
- Take no bipolar disorder medicine, or have taken the same dose for at least 1 month before screening. Plan to keep that medicine status during the study.
- Have access to mental health care before, during, and after the study.
- If female and able to become pregnant, use highly effective birth control for at least 1 month before screening and throughout the study.
- Know enough English to complete tests and follow study instructions.
Who can't join
- Be at immediate risk of suicide.
- Have a main mental health diagnosis other than bipolar disorder, or another mental health condition that could affect safety or study results.
- Have a history of seizures, a condition or medicine that raises seizure risk, or a serious brain or nerve disorder.
- Have had a serious alcohol or drug use disorder in the past 6 months.
- Have a serious heart condition or uncontrolled high blood pressure.
- Have something that makes MRI brain scans unsafe, such as certain metal objects or implants, or permanent makeup.
- Be pregnant, breastfeeding, or planning pregnancy during the study.
- Have abnormal blood tests for body salts, thyroid, or liver function, or another condition the study team believes could prevent safe completion.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Adults of all genders aged 18-70 at the time of screening. 3. Diagnosis of Bipolar Disorder (by DSM-V criteria) 4. Depressive symptoms of at least moderate severity (GRID HDRS-17 score \>= 14 or as determined by expert clinician). 5. Not currently taking medications for BD OR on a stable dose of medication for at least 1 month prior to screening and plans to remain off medications OR on this stable dose for the duration of participation. 6. Access to psychiatric care before, during, and after completion of the study. 7. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation. 8. Proficiency in English sufficient to complete assessments and follow study procedure instructions. 9. Stated willingness to comply with all study procedures and availability for the duration of the study. Exclusion Criteria: 1. Imminent risk of suicide. 2. Presence of a primary DSM-5 diagnosis other than bipolar disorder (BD-I or BD-II), or a current comorbid psychiatric disorder that, in the opinion of the investigators, would confound outcome assessment or interfere with safe participation. 3. History of seizures or any condition / concurrent medication that could notably lower seizure threshold. 4. Met criteria for any significant substance use disorder (by DSM-V criteria) in the 6 months prior to screening. 5. History or presence of significant neurological disorder (e.g., traumatic brain injury, stroke, Parkinson's disease or other movement disorder, epilepsy). 6. History or presence of significant heart condition (e.g., recent myocardial infarction, congestive heart failure \> stage 2, angina pectoris, bradycardia or tachycardia at the baseline assessment, uncontrolled hypertension). 7. MRI contraindication, including presence of foreign metal bodies or implants, implanted or conductive objects in or near the head (e.g., stents, deep brain stimulators, vagus nerve stimulators, aneurysm coils, ocular implants, cochlear implants), permanent make-up. 8. Individuals who are nursing, pregnant, or contemplating pregnancy within the length of study participation. 9. Abnormal bloodwork for electrolytes, thyroid, or liver function. 10. History or presence of any disorder or medical condition that, in the opinion of the study team, may compromise, interfere, or limit the individual's ability to complete the intervention or study procedures.
Study sites (1)
NY
- Weill Cornell Medicine · New York, NY 10065Research Coordinator, Interventional Psychiatry Program · Study contact · 646-962-2900 · tmsinfo@med.cornell.eduImmanuel Elbau, MD, PhD · Principal investigatorMore trials in New York