Safety and Feasibility of DBS for Bipolar Depression
Deep Brain Stimulation for Bipolar Depression: Assessing the Safety and Use of Intracranial Neurophenotyping of State Switches
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 22 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
Not stated in the study description — ask the study team about visits and procedures.
- 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 deep brain stimulation (DBS), which uses electrical signals in the brain, for adults with Bipolar I depression that has not improved with treatment. Researchers will track brain signals to see if DBS can help depression safely without causing mania, a period of very high mood or energy.
This study addresses a critical unmet need in the treatment of bipolar disorder by investigating whether Subcallosal Cingulate (SCC) Deep Brain Stimulation (DBS) can safely and effectively treat treatment-resistant bipolar depression without inducing manic switches. The researchers propose to accomplish this by incorporating monitoring of the SCC local field potentials (LFP) for depression tracking and amygdala LFP monitoring for mania prediction while treating Bipolar I patients with SCC DBS Stimulation. This approach could establish a new paradigm for personalized neuromodulation therapy that uses real-time neural monitoring to optimize outcomes while minimizing risks. By incorporating bilateral, dual-site LFP monitoring from both the SCC and amygdala, this research will allow the researchers to assess the therapeutic efficacy of continuous SCC-DBS and develop novel safety biomarkers that could transform the clinical management of DBS therapy in psychiatry. The findings will have immediate implications for clinical practice and will advance the study team's fundamental understanding of the neural circuits underlying mood regulation and dysregulation in bipolar disorder.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 22–70, speak English, and able to give written consent.
- Have Bipolar I disorder confirmed by a study interview and a current period of major depression lasting at least 12 months.
- Mania has been under control for at least 1 year. Depression scores must be 20 or higher and mania scores below 12 at screening and the starting visit.
- At least 4 full treatment trials have not helped the current depression. These must include 2 antidepressant medicines from different drug groups.
- Take at least 1 mood-stabilizing medicine, with medicines unchanged for at least 4 weeks before the starting visit. Agree to stay on current anti-mania medicines.
- Be cleared for brain surgery and have a psychiatrist willing to work with the study team.
- Be able to live in the New York City area for the first 6 months or travel to the study site each month.
- Provide at least 2 emergency contacts who are age 22 or older and live reasonably nearby.
Who can't join
- Current mania or hypomania (a milder high mood), or 4 or more mood episodes in the past year. Suicidal thoughts with intent or a plan, or a suicide attempt in the past 6 months.
- Current psychosis, such as seeing things that are not there; a history of a psychotic disorder; or psychosis during depression. Past psychosis only during bipolar mania is not excluded by the history rule.
- Moderate or severe substance use disorder in the past 6 months, or a substance use disorder without at least 12 months of remission.
- Dementia or thinking problems that prevent participation; borderline or severe personality disorder that would disrupt participation; or a current main diagnosis of OCD, an eating disorder, or PTSD.
- A past vagus nerve stimulation (VNS) or DBS implant; use of another study drug or device; or a condition that makes MRI, anesthesia, brain surgery, or safe placement of brain wires unsuitable.
- Active infection, a weak immune system, an unstable medical illness, body mass index (BMI) over 35, or CRP (a blood marker of inflammation) over 3. Also, bleeding problems or blood thinners that cannot be safely stopped.
- Pregnant, planning pregnancy during the study, or able to become pregnant but unwilling to use effective birth control.
- Prisoners or people living in institutions. People unable to make consent decisions are excluded unless they gave consent before losing that ability. Employees, VIPs, celebrities, and public figures are excluded unless they gave consent before that status was known.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Age 22-70 years * Ability to provide written informed consent * Primary diagnosis of Bipolar I Disorder confirmed by SCID-5 * Current major depressive episode (MDE) of at least 12 months duration * Stable control of mania for a minimum of 1 year * Agreement to remain on current anti-mania medication regimen * Hamilton Depression Rating Scale-17 (HDRS-17) score ≥20 at screening and baseline * Young Mania Rating Scale (YMRS) score \<12 at screening and baseline * Treatment-resistant depression: failure to respond to at least 4 adequate trials of antidepressant treatment in the current episode. Antidepressant treatments include: Medications (Must include 2 antidepressant medications from different pharmacological classes), Psychotherapy, ECT, repetitive transcranial magnetic stimulation (rTMS), IV ketamine or intra-nasal esketamine. * All patients must be receiving at least one mood stabilizing medication at entry into the trial. Medication regimen must be stable for a minimum of 4 weeks before the baseline visit. * Able to provide informed consent * English-speaking * Deemed suitable surgical candidate by neurosurgical evaluation * Under care of treating psychiatrist willing to collaborate with study team * Able to reside in New York Metropolitan area during first 6 months or willing/able to travel monthly to study site * Provision of at least two emergency contacts age ≥22 residing within reasonable proximity Exclusion Criteria * Current manic or hypomanic episode (YMRS ≥12) * Rapid cycling pattern (≥4 mood episodes in the past 12 months) * Active suicidal ideation with intent or plan * Suicide attempt within six months prior to baseline * Current psychotic symptoms * Primary diagnosis of schizophrenia, schizoaffective disorder, or other psychotic disorder * History (current and/or lifetime) of one or more schizophrenia-spectrum or other psychotic disorders including: schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, and major depressive disorder with psychosis (unipolar or bipolar), and/or psychotic depression (unipolar or bipolar) (does not include psychosis occurring in the context of a manic episode of a subject with bipolar disorder) * Substance use disorder (moderate or severe) within 6 months * Presence of any type of dementia / Major Neurocognitive Disorder / significant cognitive impairment interfering with study participation * Subject has had a prior VNS Therapy or deep brain stimulation (DBS) implant * Subject has a diagnosis of Substance Use Disorder as defined by the DSM-V without sustained remission (12 months or longer) * History of borderline or severe personality disorder, as determined by clinical judgment, which would significantly interfere with a subject's participation in the study * Active primary diagnosis of one or more of the following disorders: obsessive-compulsive disorder, eating disorder, or post-traumatic stress disorder * Cognitive or psychiatric deficit (e.g., amnesia, delirium) that in the investigator's judgment would interfere with the subject's ability to accurately complete study assessments * Current or lifetime history of psychotic features in any major depressive episode (MDE) * Treatment with another investigational device or investigational drugs * Contraindications to MRI (metallic implants, claustrophobia unmanageable with anxiolytics) * Contraindications to general anesthesia or neurosurgery * Significant structural brain abnormalities precluding safe electrode placement * Active infection or immunocompromised state * Active unstable medial condition (diabetes, heart disease, hypertension, cancer, endocrine) * BMI \>35; and/or CRP \>3 * Coagulopathy or anticoagulation that cannot be safely interrupted * Pregnancy or planning pregnancy during study period * Women of childbearing potential unwilling to use effective contraception * Prisoners or institutionalized individuals * Decisionally impaired individuals (unless previously consented when capacitated) * Special status patients (employees, VIPs, celebrities, public figures) unless consented before special status known
Study sites (1)
NY
- Center for Advanced Circuit Therapeutics, Clinical Neurosciences Center, Mount Sinai West · New York, NY 10019More trials in New York