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Non-invasive Brain Stimulation
rTMS for Depression
N/A
Recruiting
Led By Nolan Williams, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or Female, between the ages of 22 and 65 at the time of screening
Male or Female, between the ages of 22 and 65 at the time of screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline (pre-intervention), during the intervention and immediately after the intervention.
Awards & highlights
Study Summary
This trial looks at whether a new kind of brain stimulation called "aiTBS" can help people with borderline personality disorder who also have depression.
Who is the study for?
Adults aged 22-65 with Borderline Personality Disorder and a current depressive episode, who are in good health, TMS naive, agree to lifestyle guidelines, use effective contraception if applicable, can understand English for assessments/interventions. Excludes pregnant individuals or those with mania/psychosis, substance abuse issues, certain medical conditions like metal implants incompatible with MRI or history of seizures.Check my eligibility
What is being tested?
The trial tests an accelerated form of theta-burst stimulation (aiTBS) on the brain's left dorsolateral prefrontal cortex and dorsomedial prefrontal cortex versus sham stimulation. It aims to assess aiTBS's effectiveness in alleviating depression symptoms in participants with BPD during a depressive episode.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, headache, lightheadedness, temporary hearing changes due to the noise of the machine. Rarely there could be seizure risk or more severe headaches.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 22 and 65 years old.
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I am between 22 and 65 years old.
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I have been diagnosed with MDD, BAPD II, or unspecified depressive disorder and Borderline Personality Disorder.
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I have never undergone TMS therapy.
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I have never undergone TMS therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline (pre-intervention), during the intervention and immediately after the intervention.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline (pre-intervention), during the intervention and immediately after the intervention.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mental Depression
Secondary outcome measures
Change in the clinician rated Montgomery-Asberg Depression Rating Scale (MADRS-C) in active DMPFC vs. sham aiTBS.
Feasibility of aiTBS in individuals with BPD and comorbid MDD or BAD II in a current MDE as defined by recruitment rate
Feasibility of aiTBS in individuals with BPD and comorbid MDD or BAD II in a current MDE as defined by retention rates
+1 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: Left Dorsolateral Prefrontal Cortex (L-DLPFC)Active Control1 Intervention
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC)
Group II: Dorsomedial Prefrontal Cortex (DMPFC)Active Control1 Intervention
The accelerated theta burst stimulation protocol will be applied to the dorsomedial prefrontal cortex (DMPFC)
Group III: Sham stimulationPlacebo Group1 Intervention
Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC) region
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,401 Previous Clinical Trials
17,341,824 Total Patients Enrolled
2 Trials studying Borderline Personality Disorder
63 Patients Enrolled for Borderline Personality Disorder
Nolan Williams, MDPrincipal InvestigatorStanford University
17 Previous Clinical Trials
1,247 Total Patients Enrolled
David Spiegel, MDPrincipal InvestigatorStanford University
10 Previous Clinical Trials
1,692 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My treatment's intensity is more than 65% of the maximum level.I am between 22 and 65 years old.I have a hormone disorder that hasn't been treated enough.I have used ketamine or had ECT for depression recently.I am currently experiencing mania or psychosis.I have access to psychiatric care before and after the study.I have been diagnosed with depression and borderline personality disorder.I can get rTMS treatment after the study ends.You have been diagnosed with autism or a developmental disability that affects your thinking and learning abilities.I have access to psychiatric care before and after the study.I am between 22 and 65 years old.I have been diagnosed with MDD, BAPD II, or unspecified depressive disorder and Borderline Personality Disorder.I have a history of serious brain or nerve conditions.I've had more than 8 ECT sessions without improvement.I have been diagnosed with obsessive-compulsive disorder.I have never undergone TMS therapy.I can get rTMS treatment after the study ends.I do not have metal implants in my head, a history of seizures, or known brain lesions.You agree to follow certain lifestyle guidelines for the entire study period.You currently have a serious problem with drugs or alcohol, or are experiencing withdrawal symptoms.I have never undergone TMS therapy.I have been diagnosed with Bipolar I Disorder or a primary psychotic disorder.You have been diagnosed with significant anxiety disorder, personality disorder, or long-lasting sadness (dysthymia).I sleep at least 5 hours each night.
Research Study Groups:
This trial has the following groups:- Group 1: Left Dorsolateral Prefrontal Cortex (L-DLPFC)
- Group 2: Dorsomedial Prefrontal Cortex (DMPFC)
- Group 3: Sham stimulation
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.
Borderline Personality Disorder Patient Testimony for trial: Trial Name: NCT04870255 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people have volunteered to partake in this experiment?
"Affirmative. Data available on clinicaltrials.gov implies that this trial, which was initially announced on July 20th 2021, is still accepting applicants. Only 45 participants are needed from 1 medical centre."
Answered by AI
Who is eligible to be a participant in this trial?
"This analysis is in search of 45 people aged 22 - 65, with a diagnosis of Involutional Psychosis. In addition to this qualification, participants must additionally fulfill the following prerequisites: Diagnosed Major Depressive Disorder (MDD), Bipolar Affective Disorder II (BAPD II) or unspecified depression disorder AND Borderline personality disorder accompanied by current Mood Depressive Episode (MDE). It is vital that these individuals have access to clinical rTMS post-trial and are committed to maintaining lifestyle considerations throughout duration of study period. Furthermore they should possess HAMD-17 and MADRS scores ≥20 at screening visit 1"
Answered by AI
What aims does this trial seek to accomplish?
"This medical trial intends to evaluate the effectiveness of aiTBS in treating BPD and comorbid MDD or BAD II within an acute MDE by assessing change in MADRS-C scores over two time points. Secondary outcomes include determining recruitment rate, retention rate (>80%) and measuring changes from baseline with the 10 item MADRS-C questionnaire (scores range 0 - 60)."
Answered by AI
Is this research endeavor open to senior citizens of advanced age?
"According to the qualifications for this trial, suitable participants must be aged between 22 and 65 years. There are 329 medical trials available for those under 18 and 1,124 studies targeting adults over 65."
Answered by AI
Are there opportunities to participate in this experiment presently?
"Clinicaltrials.gov data suggests that this medical trial, which was originally posted on July 20th 2021, is currently recruiting participants. The latest update to the listing was published on October 4th 2021."
Answered by AI
Who else is applying?
What state do they live in?
Alberta
California
Ontario
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0
3+
What site did they apply to?
Stanford Hospital
Why did patients apply to this trial?
I'm just not as happy as I used to be before my serious spinal cord injury.
PatientReceived 1 prior treatment
I believe that there is a strong need for more research in this subject. I am a medical doctor,.
PatientReceived 1 prior treatment
I have extremely treatment resistant depression, nothing has worked at all for me and experience way too many side effects. The borderline aspect of it keeps it so I just feel this cyclical sinking every time something doesn't work. Would love to see what other treatments besides psychiatric medication is out there.
PatientReceived no prior treatments
I've been contending with BPD for all my life, and every moment of every day is an exercise in learning how to mediate my emotions and learning to distinguish the disorder from me, which is a pointless exercise to a certain degree. I have been on and off psychotherapy and antidepressants and nothing has really worked so far. Being part of a novel clinical therapeutic trial would not only give me a shot at learning and being able to live with this disorder better but it would do the same for people with BPD the world over.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
Would you guys be able to contact me if any additional information is needed?
PatientReceived no prior treatments
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