Overseen byKristen Ellard, PhD
Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Massachusetts General Hospital
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?The investigators are conducting this research study to better understand how individuals with bipolar disorder regulate their emotions, and if transcranial magnetic stimulation (TMS) can help improve emotion regulation for individuals with bipolar mood disorders.
Do I need to stop my current medications to join the trial?The trial does not specify if you need to stop your current medications. However, your medication must be stable for at least 3 months before joining.
Is TMS a promising treatment for bipolar disorder?Yes, TMS is a promising treatment for bipolar disorder. Studies show that it can help reduce symptoms of bipolar depression, especially when other treatments don't work. It's a non-invasive method that uses magnetic fields to stimulate the brain, and it has shown positive results in improving mood and maintaining these improvements over time.24789
What data supports the idea that Transcranial Magnetic Stimulation for Bipolar Disorder is an effective treatment?The available research shows that Transcranial Magnetic Stimulation (TMS) can be effective for treating bipolar disorder. One study found that patients with bipolar depression responded to TMS in a similar way to those with unipolar depression, which is a more common form of depression. This suggests that TMS can help improve symptoms in people with bipolar disorder. Another study indicated that TMS might be particularly good at reducing paranoia, a symptom sometimes seen in bipolar disorder. However, it's important to note that while there is some evidence supporting TMS for bipolar disorder, the overall strength of this evidence is not as strong as it is for unipolar depression.345710
What safety data exists for TMS in treating bipolar disorder?The pilot study titled 'Left prefrontal transcranial magnetic stimulation (TMS) treatment of depression in bipolar affective disorder' specifically addresses the safety of TMS in treating bipolar disorder. It was designed to determine the acute safety and feasibility of using TMS for depressive symptoms in bipolar affective disorder. This suggests that some safety data exists, particularly focusing on the acute phase of treatment.13467
Eligibility Criteria
This trial is for adults aged 18-55 with bipolar mood disorders who struggle to regulate their emotions. Healthy individuals without psychiatric conditions, as confirmed by an interview, and who score below 80 on the Emotion Regulation Scale can also participate.Inclusion Criteria
I am between 18 and 55 years old.
Treatment Details
The study is testing whether Transcranial Magnetic Stimulation (TMS), a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain, can improve emotion regulation in people with bipolar disorder.
2Treatment groups
Experimental Treatment
Active Control
Group I: Bipolar GroupExperimental Treatment1 Intervention
This group consists of individuals with a diagnosis of bipolar disorder who have been randomized to receive high-dose TMS (i.e., 1800 pulses) and sham TMS.
Group II: Healthy ControlActive Control1 Intervention
This group consists of individuals with no psychiatric diagnosis.
TMS is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Transcranial Magnetic Stimulation for:
- Depression
- Anxiety disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
🇪🇺 Approved in European Union as Transcranial Magnetic Stimulation for:
- Depression
- Anxiety disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
🇨🇦 Approved in Canada as Transcranial Magnetic Stimulation for:
- Depression
- Anxiety disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
Find a clinic near you
Research locations nearbySelect from list below to view details:
Martinos Center for Biomedical ImagingCharlestown, MA
Loading ...
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
References
Left prefrontal transcranial magnetic stimulation (TMS) treatment of depression in bipolar affective disorder: a pilot study of acute safety and efficacy. [2019]Repetitive transcranial magnetic stimulation (rTMS) has been shown to improve depressive symptoms. We designed and carried out the following left prefrontal rTMS study to determine the safety, feasibility, and potential efficacy of using TMS to treat the depressive symptoms of bipolar affective disorder (BPAD).
Augmentative transcranial magnetic stimulation (TMS) combined with brain navigation in drug-resistant rapid cycling bipolar depression: a case report of acute and maintenance efficacy. [2009]The efficacy of transcranial magnetic stimulation (TMS) has been poorly investigated in the acute and maintenance treatment of bipolar depression. The present case supports the efficacy of low-frequency repetitive TMS (rTMS) of the right dorsolateral pre-frontal cortex (RDLPFC) combined to brain navigation in a drug-resistant, bipolar depressed subject with rapid cycling. While continuing the pharmacological treatment at stable doses, the patient was stimulated for 3 weeks at 1 Hz, 110% of motor threshold, 300 stimuli/day showing a significant improvement on the Hamilton Depression Rating Scale (HDRS(21)), the Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression, improvement scale (CGI-I) total scores. On completion of the 3-week rTMS, the patient was treated with periodic maintenance sessions of rTMS at the same parameters of acute phase for an additional 6 months, at the end of which the therapeutic gains were maintained according to rating scales scores. Larger controlled trials assessing the acute and maintenance efficacy of rTMS in bipolar depression are needed.
Long-term efficacy after acute augmentative repetitive transcranial magnetic stimulation in bipolar depression: a 1-year follow-up study. [2022]: The efficacy of repetitive transcranial magnetic stimulation (rTMS) has been poorly investigated in the long-term. The present follow-up study was aimed to assess the long-term efficacy and the discontinuation effects of rTMS in a sample of depressed bipolar patients.
rTMS in resistant mixed states: an exploratory study. [2018]Repetitive transcranial magnetic stimulation (rTMS) has shown efficacy in resistant unipolar depression, but its efficacy in bipolar disorders has not yet been extensively investigated. Mixed episodes are reported in up to 40% of acute bipolar admissions and are associated with severe psychopathology, comorbidity, high risk of suicide and poor treatment response. Right low-frequency rTMS (LF-rTMS) as an augmentation treatment might be effective for mixed states.
A negative double-blind controlled trial of sequential bilateral rTMS in the treatment of bipolar depression. [2019]To explore the therapeutic benefit of sequential bilateral repetitive transcranial magnetic stimulation (rTMS) in the treatment of bipolar depression.
Do bipolar disorder soft signs impact outcomes following Transcranial Magnetic Stimulation (TMS) therapy for depression? [2020]Transcranial Magnetic Stimulation (TMS) is not currently FDA approved for depressed patients with bipolar disorder (BD), but many unipolar depressed patients presenting for TMS have soft signs of bipolarity. It is not known whether or not these soft signs portend differential outcomes.
The efficacy of repetitive transcranial magnetic stimulation (rTMS) for bipolar depression: A systematic review and meta-analysis. [2021]Repetitive transcranial magnetic stimulation (rTMS) has established efficacy in the treatment of unipolar depression and a growing evidence base in the treatment of bipolar depression. The objective of this study was to provide an estimate of the efficacy of rTMS in bipolar depression as an up to date synthesis of this literature is lacking.
Repetitive Transcranial Magnetic Stimulation in the Treatment of Bipolar Disorder. [2023]Bipolar disorder (BD) is a debilitating mood disorder marked by manic, hypomanic and/or mixed or depressive episodes. It affects approximately 1-2% of the population and is linked to high rates of suicide, functional impairment and poorer quality of life. Presently, treatment options for BD are limited. There is a strong evidence base for pharmacological (e.g., lithium) and psychological (e.g., psychoeducation) treatments; however, both of these pose challenges for treatment outcomes (e.g., non-response, side-effects, limited access). Repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, is a recommended treatment for unipolar depression, but it is unclear whether rTMS is an effective, safe and well tolerated treatment in people with BD. This article reviews the extant literature on the use of rTMS to treat BD across different mood states. We found 34 studies in total (N = 611 patients), with most assessing bipolar depression (n = 26), versus bipolar mania (n = 5), mixed state bipolar (n = 2) or those not in a current affective episode (n = 1). Across all studies, there appears to be a detectable signal of efficacy for rTMS treatment, as most studies report that rTMS treatment reduced bipolar symptoms. Importantly, within the randomised controlled trial (RCT) study designs, most reported that rTMS was not superior to sham in the treatment of bipolar depression. However, these RCTs are based on small samples (NBD ⩽ 52). Reported side effects of rTMS in BD include headache, dizziness and sleep problems. Ten studies (N = 14 patients) reported cases of affective switching; however, no clear pattern of potential risk factors for affective switching emerged. Future adequately powered, sham-controlled trials are needed to establish the ideal rTMS treatment parameters to help better determine the efficacy of rTMS for the treatment of BD.
Repetitive transcranial magnetic stimulation (rTMS) in bipolar disorder: A systematic review. [2023]Repetitive transcranial magnetic stimulation (rTMS) is commonly used in unipolar depression; yet, its evidence in bipolar disorder (BD) is limited. We sought to review the evidence on the use of rTMS across the different stages of BD.
Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Bipolar Disorder in Comparison to the Treatment of Unipolar Depression in a Naturalistic Setting. [2022]Repetitive transcranial magnetic stimulation (rTMS) is effective in the treatment of depression. However, for the subset of patients with bipolar disorder, less data is available and overall strength of evidence is weaker than for its use in unipolar depression. A cohort of 505 patients (of which 46 had a diagnosis of bipolar disorder) with depression who were treated with rTMS were analyzed retrospectively with regards to their response to several weeks of treatment. Hamilton Depression Rating Scale (HDRS) was assessed as main outcome. Unipolar and bipolar patients with depression did not differ significantly in baseline demographic variables or severity of depression. Both groups did not differ significantly in their response to treatment as indicated by absolute and relative changes in the HDRS and response and remission rates. On HDRS subitem-analysis, bipolar patients showed superior amelioration of the symptom "paranoid symptoms" in a statistically significant manner. In conclusion, depressed patients with a diagnosis of bipolar disorder benefit from rTMS in a similar fashion as patients with unipolar depression in a naturalistic setting. rTMS might be more effective in reducing paranoia in bipolar than in unipolar patients.