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Non-invasive Brain Stimulation
TMS for Suicide
N/A
Recruiting
Led By Joan Camprodon, MD/PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through treatment completion, average of 3 days
Summary
This trial is investigating whether a specific kind of brain stimulation can reduce suicide risk in people with major depressive disorder or borderline personality disorder.
Who is the study for?
This trial is for adults aged 18-60 with major depressive disorder (MDD) or borderline personality disorder (BPD), who are experiencing suicidal thoughts and behaviors. Participants must own a smartphone and be able to use it during their inpatient stay. Those with metal implants, history of seizures, recent substance abuse, or certain psychopathologies like psychosis are not eligible.
What is being tested?
The study tests intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) on the inferior parietal lobule to see if it lowers suicide risk in patients with MDD or BPD. It compares active iTBS-TMS treatment against a sham (placebo-like) procedure.
What are the potential side effects?
Possible side effects include discomfort at the stimulation site, headache, lightheadedness, tingling or spasms of facial muscles. Rarely, there's a risk of seizure but this is minimized by adhering to safety protocols.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through treatment completion, average of 3 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through treatment completion, average of 3 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in Functional Connectivity of Key Nodes
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: MDE and Active iTBS-TMSExperimental Treatment1 Intervention
This group will consist of patients diagnosed with MDE that are receiving active iTBS-TMS.
Group II: BPD and Active iTBS-TMSExperimental Treatment1 Intervention
This group will consist of patients diagnosed with BPD that are receiving active iTBS-TMS.
Group III: MDE and Sham iTBS-TMSPlacebo Group1 Intervention
This group will consist of patients diagnosed with MDE that are receiving sham iTBS-TMS.
Group IV: BPD and Sham iTBS-TMSPlacebo Group1 Intervention
This group will consist of patients diagnosed with BPD that are receiving sham iTBS-TMS.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,015 Previous Clinical Trials
13,309,280 Total Patients Enrolled
18 Trials studying Suicide
5,182 Patients Enrolled for Suicide
Joan Camprodon, MD/PhDPrincipal Investigator6177265348
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have metal in your body that can be affected by magnets or have had an injury to your eyes from metal.My doctor has just given me permission to use my smart phone during my inpatient stayYou have a mental health condition, such as a manic episode or psychosis, that may not be suitable for the treatment being studied.You own a smartphone, such as an Android or an Apple device.You have expressed thoughts of hurting or killing yourself.You have a history of seizures.You have a medical device implanted in your body such as a pacemaker, medication pump, or stimulator.You have a recent history of substance abuse or addiction.You had a head injury that caused long-term unconsciousness or ongoing problems with your nervous system.People aged 18 to 60 years old.You have been diagnosed with bipolar disorder (BPD) or major depressive disorder (MDD).
Research Study Groups:
This trial has the following groups:- Group 1: MDE and Sham iTBS-TMS
- Group 2: BPD and Sham iTBS-TMS
- Group 3: MDE and Active iTBS-TMS
- Group 4: BPD and Active iTBS-TMS
Awards:
This trial has 0 awards, including: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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