Epub 2018 Apr 3. The main eligibility criterion was the presence of a depressive episode of at least moderate intensity, corresponding to a Hamilton Depression Rating Scale (17-items; HDRS-17)>17 (Hamilton, 1960). Deep TMS with the H1 coil is FDA approved for the treatment of depression in patients who have not improved by using any number of medications. We enrolled 50 adults aging from 18 to 65 years old diagnosed with bipolar disorder types I or II in an acute depressive episode. Cognitive functioning and deep transcranial magnetic stimulation (DTMS) in major psychiatric disorders: A systematic review. Improving the antidepressant efficacy of transcranial magnetic stimulation: maximizing the number of stimulations and treatment location in treatment-resistant depression. Depress Anxiety 28: 973–980. Google Scholar. While there is a growing anecdotal database supporting its use in bipolar depression … Patients who presented two consecutive missing visits were considered washouts. Moreover, there are limited first-line therapies for treating bipolar depression (BD), treatment-resistance being two times higher compared to unipolar depression (Li et al, 2012; Tondo et al, 2014). Epub 2018 Feb 15. World J Biol Psychiatry 11: 81–109. The coil is situated inside a helmet to achieve effective cooling during stimulation. Bipolar depression (BD) is a highly prevalent condition with limited therapeutic options. Epub 2015 Dec 22. Bipolar depression (BD) is a … 2019 Dec 10;19(1):319. doi: 10.1186/s12883-019-1531-z. Two small randomized controlled … We estimated that the effects of active vs sham dTMS would be similar than in findings from that preliminary study that compared the efficacy of the H1 vs H1L coil groups. These observations might explain why benzodiazepine users in our study presented a worse clinical outcome regardless of allocation group. Cognitive outcomes of TMS treatment in bipolar depression: Safety data from a randomized controlled trial. Clinical efficacy and safety of repetitive transcranial magnetic stimulation in acute bipolar depression. Unable to load your collection due to an error, Unable to load your delegates due to an error. Missing visits were replaced at the end of the acute stimulation phase; therefore, all patients received 20 dTMS sessions. After that, pairwise comparisons were performed at each time point (contrast command in Stata). Therefore, our results should be interpreted as preliminary and hypothesis-driven for future, pivotal trials. Finally, dTMS was similarly effective for both bipolar I and bipolar II patients. The groups were similar in all main clinical and demographic characteristics at baseline. During this period, dTMS efficacy progressively decreased over time, with superiority at week 6, but not at week 8. Maintenance deep transcranial magnetic stimulation sessions are associated with reduced depressive relapses in patients with unipolar or bipolar depression. All patients presented treatment-resistant depression (TRD). Similarly it has been suggested that rTMS may be effective against depressive symptoms in mixed states, with fewer evidence regarding … 8600 Rockville Pike Article  Moreover, the results of this meta-analysis were not available when our study was designed. For the independent variables, we compared 1 predictor variable at a time and group. Hamilton M (1960). Relationship between placebo response rate and clinical trial outcome in bipolar depression. MTs were reassessed at the first day of treatment and then every week. They were used as a clinical safety parameter, to exclude possible decompensated clinical conditions that could cause or worsen secondary depressive symptoms and to perform differential diagnoses. Scalp pain rates were higher in the active (20%) vs sham (0%) groups (p=0.05). Association between antidepressant resistance in unipolar depression and subsequent bipolar disorder: cohort study. Notwithstanding, the technique has been under constant development to increase its efficacy. Analyses were performed in Stata 14 (Statacorp, College Station, TX, USA). This effect was also not important enough to harm blinding, as patients and raters did not guess the allocation group beyond chance. Another study using rTMS in BD also observed that more rTMS sessions in the acute treatment phase were associated with lower relapse rates (Cohen et al, 2010). Out of 50 patients, 43 finished the trial. Are there subtypes of bipolar depression? Myczkowski ML, Fernandes A, Moreno M, Valiengo L, Lafer B, Moreno RA, Padberg F, Gattaz W, Brunoni AR. Pacchiarotti I, Bond DJ, Baldessarini RJ, Nolen WA, Grunze H, Licht RW et al (2013). Sienaert P, Lambrichts L, Dols A, De Fruyt J (2013). Recruitment strategies included referrals from physicians, patients from academic mood disorders clinics and advertisement through social media and local newspapers. Tavares, D., Myczkowski, M., Alberto, R. et al. To obtain Grunze H, Vieta E, Goodwin GM, Bowden C, Licht RW, Moller HJ et al (2010). If you have experienced worsening bipolar depression symptoms on account of medication, or are simply looking for an alternative solution to help manage your symptoms, deep transcranial magnetic stimulation … Methods: Fourty-three patients were … The TMS sessions were delivered using the Brainsway dTMS system with the H1-coil investigational device (Brainsway Ltd, Jerusalem, Israel). A sham coil is also included in the same helmet. Clinical predictors associated with duration of repetitive transcranial magnetic stimulation treatment for remission in bipolar depression: a naturalistic study. Evidence highlights that TMS can reduce the symptoms of depression. Options for pharmacological treatment of refractory bipolar depression. World Psychiatry 15: 85–86. The effects were most evident immediately after the end of the acute treatment phase (20 dTMS sessions), and progressively faded away during the 4-week follow-up, which suggests that extended dTMS treatment might be necessary after the acute phase for an enduring response. Deep transcranial magnetic stimulation (dTMS), a non-invasive procedure that uses magnetic fields to stimulate brain cells, may be useful when added to medication to treat bipolar … Also, this meta-analysis suggested that low-frequency rTMS over the right DLPFC might be more effective than high-frequency over the left DLPFC. These pulses are delivered through a magnetic coil … PubMed  Prevention and treatment information (HHS). Bipol Disord 15: 61–69. Clipboard, Search History, and several other advanced features are temporarily unavailable. Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders. There were also a few patients (<10%) on aripiprazole, topiramate, olanzapine, risperidone, asenapine, carbamazepine, or ziprasidone. Curr Psychiatry Rep 16: 431. There was a trend for greater response rates in the active (48%) vs sham (24%) groups (OR=2.92, 95% CI 0.87–9.78, p=0.08) at week 4. Finally, we employed no neuronavigated methods for target localization. CAS  Yatham LN, Kennedy SH, Parikh SV, Schaffer A, Beaulieu S, Alda M et al (2013). Levkovitz Y, Isserles M, Padberg F, Lisanby SH, Bystritsky A, Xia G et al (2015). Our primary hypothesis was that the interaction of time with group would be significant, with active dTMS being superior to sham at week 4. Internet Explorer). It is the safest treatment with the least side effects for … Tijdschr Psychiatr 56: 533–538. The assessment of anxiety states by rating. The frequency of bipolar disorder types I and type II was 50% for each group. The International Society for Bipolar Disorders (ISBD) task force report on antidepressant use in bipolar disorders. In the last 3 years, ZJD received research and equipment in-kind support for an investigator-initiated study through Brainsway Inc and Magventure Inc. ZJD has also served on the advisory board for Sunovion, Hoffmann-La Roche Limited and Merck and received speaker support from Eli Lilly. Bipol Disord 15: 1–44. the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Can J Psychiatry 61: 561–575. Regarding dTMS, although case series suggest it might be effective in BD treatment (Harel et al, 2011; Rapinesi et al, 2015), no results from randomized clinical trials have been reported so far. The World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for the biological treatment of bipolar disorders: update 2010 on the treatment of acute bipolar depression. We conducted a randomized sham-controlled trial to evaluate the efficacy and safety of dTMS in treatment-resistant BD patients. Even though the use of this drug class in BD remains controversial (Pacchiarotti et al, 2013; Yatham et al, 2013), in most real-life clinical setting these drugs are often used. However, this approach was associated with lower dTMS efficacy in the pivotal dTMS depression trial (Levkovitz et al, 2015), possibly because sessions at intensities <120%MT are less effective (Levkovitz et al, 2009). Epub 2020 Jan 17. 2019 Jul;17(3):232-237. doi: 10.1176/appi.focus.20190009. In fact, 86% of our sample was composed of patients using at least one treatment considered as a first-line therapy according to CANMAT guidelines (Yatham et al, 2013) at trial onset, with 50% of BD patients using lithium in clinically effective doses. Transcranial magnetic stimulation (TMS) is a neuromodulation technique in the treatment of depression. Participants and personnel were therefore fully blinded to allocation group status. No TEMS episodes were observed. Scalp pain was the only adverse event more prevalent in active compared to sham dTMS. Transcranial Magnetic Stimulation (TMS) is an increasingly accepted neurostimulation- based treatment for major depressive disorder. Before the screening interview, potential participants had their MT (the lowest stimulation intensity necessary to evoke a motor potential with at least 50 μV amplitude in 50% of attempts) assessed to determine eligibility. To verify blinding integrity, we asked, at week 8, for patients and raters to guess whether the allocation group was active on a 0–100 scale; guessing scores were compared using a t-test. Researchers found that TMS was more effective than sham TMS … We also performed per protocol (PP) analyses. Fitzgerald PB, Hoy KE, Elliot D, McQueen S, Wambeek LE, Daskalakis ZJ (2016). In fact, our dTMS response rate (48%) was similar than the rTMS response rate for BD (44.3%) according to a recent meta-analysis (McGirr et al, 2016)—possibly, the lack of a significant finding for response in our study occurred due to an underpowered analysis owing to a low sample size. A secretary not directly participating in the research was responsible for handling the numbered cards to the staff before each session. J Neurol Neurosurg Psychiatry 23: 56–62. The doctor performing the treatment will determine the amount of magnetic energy needed during the first treatment session. The primary outcome was changes in the 17-item Hamilton Depression Rating Scale (HDRS-17) from baseline to endpoint (week 4). Our study lasted 8 weeks, with a 4-week follow-up period after the acute treatment phase, when patients received no extra stimulation sessions. J Affect Disord. However, we opted for stimulating the left DLPFC as low-frequency dTMS over the right DLPFC was not investigated for unipolar depression yet. Selingardi PML, de Lima Rodrigues AL, da Silva VA, Fernandes DTRM, Rosí J Jr, Marcolin MA, Yeng LT, Brunoni AR, Teixeira MJ, Galhardoni R, de Andrade DC. You are using a browser version with limited support for CSS. Iovieno N, Nierenberg AA, Parkin SR, Hyung Kim DJ, Walker RS, Fava M et al (2016). FOIA Transcranial Magnetic Stimulation. Deep (H1-coil) transcranial magnetic stimulation (dTMS) is a novel TMS modality with established efficacy for unipolar depression. Although hypomania and mania episodes characterize the disorder, depressive episodes in fact exceed them in duration and frequency (Holtzman et al, 2015; Perich et al, 2016; Zimmerman, 2016). Bipolar disorder is a prevalent and disabling condition, with a worldwide prevalence of around 2–3%, considering both bipolar I and II subtypes. In our study, we employed no maintenance schedule from weeks 4 to 8 devising that the mood stabilizers the patients were in use would sustain clinical improvement after the acute treatment phase. There was also a trend for greater response rates in the active (48%) vs sham (24%) groups (OR=2.92; 95% CI=0.87 to 9.78, p=0.08). Google Scholar. https://doi.org/10.1038/npp.2017.26, Journal of Affective Disorders Effectiveness of adjunctive antidepressant treatment for bipolar depression. Both differences were not statistically significant (t=0.85, p=0.4; t=0.8, p=0.43 for raters and patients, respectively). Patients who presented >70% of MT of maximum stimulator output at baseline were not included. Brain Stimul 6: 1–13. Department and Institute of Psychiatry, Service of Interdisciplinary Neuromodulation (SIN-EMT), Faculty of Medicine, University of São Paulo, São Paulo, Brazil, Diego F Tavares, Martin L Myczkowski, Rodrigo L Alberto, Leandro Valiengo, Rosa M Rios, Pedro Gordon, Bernardo de Sampaio-Junior, Izio Klein, Carlos G Mansur, Beny Lafer & André R Brunoni, Department and Institute of Psychiatry, Mood Disorders Unit (GRUDA), Faculty of Medicine, University of São Paulo, São Paulo, Brazil, Department and Institute of Psychiatry, Laboratory of Neuroscience (LIM27), University of São Paulo, São Paulo, Brazil, Leandro Valiengo, Wagner Gattaz & André R Brunoni, University Hospital, University of São Paulo, São Paulo, Brazil, Bernardo de Sampaio-Junior, Izio Klein & André R Brunoni, Department and Institute of Neurology, Faculty of Medicine, University of São Paulo, São Paulo, Brazil, Clarke Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada, You can also search for this author in Complementary diagnostic exams consisted of, at physicians’ discretion, brain MRI, general laboratory tests (including pregnancy testing, thyroid stimulating hormone levels, lithium levels and others) and a 12-lead ECG. Bethesda, MD 20894, Copyright Google Scholar. We conducted a randomized sham-controlled trial to evaluate the efficacy and safety of dTMS in treatment-resistant BD patients. Further contrast comparisons revealed that active dTMS was superior to sham at weeks 4 (difference favoring dTMS=4.88; 95% CI 0.43 to 9.32, p=0.03) and 6 (5.2; 95% CI 0.75 to 9.64, p=0.02) but not at other time points. Levkovitz Y, Harel EV, Roth Y, Braw Y, Most D, Katz LN et al (2009). Safety was assessed using a dTMS adverse effects questionnaire and the Young Mania Rating Scale to assess treatment-emergent mania switch (TEMS). Int J Bipol Disor 3: 8. J Psychiatr Res 41: 606–615. World J Biol Psychiatry 12: 119–126. In fact, large, pragmatic clinical trials in bipolar disorder showed that benzodiazepine use in patients with bipolar depression seems to be a marker for a more severe course of illness, presents a higher risk of recurrence and is associated with greater illness complexity and higher burden of disease (Bobo et al, 2015; Perlis et al, 2010). In open-label studies, the response rate for bipolar … Accessibility Deep (H1-coil) transcranial magnetic stimulation (dTMS) is a novel TMS modality with established efficacy for unipolar depression. CAS  Long-term deep-TMS does not negatively affect cognitive functions in stroke and spinal cord injury patients with central neuropathic pain. Here TRD was conceptualized as the failure to achieve remission with ⩾2 interventions (Parker and Graham, 2016) approved as first (lithium, lithium+divalproex, quetiapine, or lamotrigine), second (divalproex, lithium+lamotrigine, or divalproex+lamotrigine), or third line (carbamazepine, olanzapine, lithium+carbamazepine, and quetiapine+lamotrigine) therapies for BD according to CANMAT guidelines ((Yatham et al, 2013). We conducted a single-center, double-blind, randomized, parallel-group, sham-controlled clinical trial (Clinicaltrials.gov identifier: NCT01962350) that lasted 8 weeks, comprising 4 weeks of the acute intervention phase, in which patients received 20 dTMS or sham sessions once daily excluding weekends; and 4 weeks of the follow-up phase, in which patients received no intervention. One novel approach includes the ‘deep’ (H1 coil) TMS (dTMS) (Levkovitz et al, 2015). Kedzior KK, Gierke L, Gellersen HM, Berlim MT. J Psychopharmacol 30: 495–553. Active dTMS was superior to sham at end point (difference favoring dTMS=4.88; 95% CI 0.43 to 9.32, p=0.03) but not at follow-up. 2020 Oct 15;12(5):128-133. eCollection 2020. The sham coil mimics scalp sensations and the acoustic artifact of the active stimulation without inducing neuronal activation. Regarding predictors of response, we performed general linear models using the difference between baseline and week 4 or week 8 HDRS scores as the dependent variable. Would you like email updates of new search results? Zimmerman M (2016). Demographic and clinical data were collected, including age, age at onset of the first episode, marital status, occupational status, diagnosis subtype, duration of illness, medication use, and others. The presence of treatment-emergent mania switch (TEMS) was assessed according to the ISBD recommendations that consider TEMS as likely when there are 2 or more manic symptoms (eg, irritability or euphoria (racing thoughts, grandiosity, decreased need for sleep), and YMRS>12; Tohen et al, 2009). BMJ 330: 267–268. The sample size was calculated based on a preliminary study evaluating the efficacy of dTMS in unipolar depression (Levkovitz et al, 2009). Bobo WV, Reilly-Harrington NA, Ketter TA, Brody BD, Kinrys G, Kemp DE et al (2015). Deep (H1-coil) transcranial magnetic stimulation (dTMS) is a novel TMS modality with established efficacy for … Even though, this adverse effect did not increase attrition and was considered mild by the participants who experimented it. At week 4, patients in the active group presented significant greater improvement compared to sham in the GAF (percentage of improvement 65.37% (53.46) vs 34.07% (48.62), p=0.03, respectively) and CGI scores (36.47% (22.87) vs 19.2% (30.96), p=0.03, respectively). Young RC, Biggs JT, Ziegler VE, Meyer DA (1978). Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of acute treatment outcomes in clinical practice. The treatment performs magnetic … The median duration of the current depressive episode was 6 months (IQR 3–12). ; Sheehan et al, 1998). Malhi GS, Bassett D, Boyce P, Bryant R, Fitzgerald PB, Fritz K et al (2015). The International Society for Bipolar Disorders (ISBD) Task Force report on the nomenclature of course and outcome in bipolar disorders. Acta Psychiatr Scand 134: 260–267. Standard repetitive transcranial magnetic stimulation (aka superficial transcranial magnetic stimulation), and deep transcranial magnetic stimulation, may be considered medically necessary when the criteria above are met. As a Brainsway Deep Transcranial Magnetic Stimulation (Deep TMS) specialist and board-certified psychiatrist, Dr. Drell can help you determine if Deep TMS treatments may help reduce your depressive symptoms.