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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
Chief complaint of suicidal thoughts and behaviors
Diagnosed with BPD or MDD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through treatment completion, average of 3 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have expressed thoughts of hurting or killing yourself.
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You have been diagnosed with bipolar disorder (BPD) or major depressive disorder (MDD).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through treatment completion, average of 3 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and through treatment completion, average of 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
2,924 Previous Clinical Trials
13,193,343 Total Patients Enrolled
17 Trials studying Suicide
5,073 Patients Enrolled for Suicide
Joan Camprodon, MD/PhDPrincipal Investigator6177265348

Media Library

Intermittent Theta Burst Transcranial Magnetic Stimulation (Active) (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04130958 — N/A
Suicide Research Study Groups: MDE and Active iTBS-TMS, MDE and Sham iTBS-TMS, BPD and Sham iTBS-TMS, BPD and Active iTBS-TMS
Suicide Clinical Trial 2023: Intermittent Theta Burst Transcranial Magnetic Stimulation (Active) Highlights & Side Effects. Trial Name: NCT04130958 — N/A
Intermittent Theta Burst Transcranial Magnetic Stimulation (Active) (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04130958 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still room in this clinical trial to enroll participants?

"The latest data on clinicaltrials.gov indicates that this study, which was originally announced on June 1st 2022, is actively seeking participants. The information has been amended as recently as October 3rd 2022."

Answered by AI

Does the protocol of this trial encompass participants aged 85 or older?

"As detailed in the enrollment conditions, only individuals between 18 and 60 years old may be eligible to join this clinical trial."

Answered by AI

Who meets the criteria to be involved in this medical experiment?

"This ongoing trial seeks to enrol 80 individuals with borderline personality disorder, aged between 18 and 60. The criteria for inclusion are: a valid age range of 18-60 years old, ownership of a modern smartphone (e.g., Apple or Android), and the willingness to use said device during any inpatient stays."

Answered by AI

How many individuals have registered to take part in this clinical trial?

"Affirmative. Clinicaltrials.gov indicates that this scientific research, which was initially posted on June 1st 2022, is currently recruiting volunteers. Approximately 80 people must be enrolled from a single medical facility."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
Ontario
California
How old are they?
18 - 65
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
3+

Why did patients apply to this trial?

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Massachusetts General Hospital: < 48 hours
~53 spots leftby Jan 2025