Ali-Reza Ghazi-Noori, Rachel D Woodham, Hakimeh Rezaei, Mhd Saeed Sharif, Elvira Bramon, Philipp Ritter, Michael Bauer, Allan H Young, Cynthia H Y Fu
{"title":"基于家庭的经颅直流电刺激治疗双相抑郁症：一项关于临床结果、可接受性和不良反应的开放标签治疗研究。","authors":"Ali-Reza Ghazi-Noori, Rachel D Woodham, Hakimeh Rezaei, Mhd Saeed Sharif, Elvira Bramon, Philipp Ritter, Michael Bauer, Allan H Young, Cynthia H Y Fu","doi":"10.1186/s40345-024-00352-9","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Current treatments for bipolar depression have limited effectiveness, tolerability and acceptability. Transcranial direct current stimulation (tDCS) is a novel non-invasive brain stimulation method that has demonstrated treatment efficacy for major depressive episodes. tDCS is portable, safe, and individuals like having sessions at home. We developed a home-based protocol with real-time remote supervision. In the present study, we have examined the clinical outcomes, acceptability and feasibility of home-based tDCS treatment in bipolar depression.</p><p><strong>Results: </strong>Participants were 44 individuals with bipolar disorder (31 women), mean age 47.27 ± 12.89 years, in current depressive episode of at least moderate severity (mean Montgomery Asberg Depression Rating Scale (MADRS) score 24.59 ± 2.64). tDCS was provided in bilateral frontal montage, F3 anode, F4 cathode, 2 mA, for 30 min, in a 6-week trial, for total 21 sessions, a follow up visit was conducted 5 months from baseline. Participants maintained their current treatment (psychotherapy, antidepressant or mood stabilising medication) or maintained being medication-free. A research team member was present by video conference at each session. 93.2% participants (n = 41) completed the 6-week treatment and 72.7% of participants (n = 32) completed the 5 month follow up. There was a significant improvement in depressive symptoms following treatment (mean MADRS 8.77 ± 5.37) which was maintained at the 5 month follow up (mean MADRS 10.86 ± 6.90), rate of clinical response was 77.3% (MADRS improvement of 50% or greater from baseline), and rate of clinical remission was 47.7% (MADRS rating of 9 or less). Acceptability was endorsed as \"very acceptable\" or \"quite acceptable\" by all participants. No participants developed mania or hypomania.</p><p><strong>Conclusions: </strong>In summary, home-based tDCS with real-time supervision was associated with significant clinical improvements and high acceptability in bipolar depression. Due to the open-label design, efficacy findings are preliminary.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov number NCT05436613 registered on 23 June 2022 https//www.</p><p><strong>Clinicaltrials: </strong>gov/study/NCT05436613.</p>","PeriodicalId":13944,"journal":{"name":"International Journal of Bipolar Disorders","volume":"12 1","pages":"30"},"PeriodicalIF":2.8000,"publicationDate":"2024-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11336151/pdf/","citationCount":"0","resultStr":"{\"title\":\"Home-based transcranial direct current stimulation in bipolar depression: an open-label treatment study of clinical outcomes, acceptability and adverse events.\",\"authors\":\"Ali-Reza Ghazi-Noori, Rachel D Woodham, Hakimeh Rezaei, Mhd Saeed Sharif, Elvira Bramon, Philipp Ritter, Michael Bauer, Allan H Young, Cynthia H Y Fu\",\"doi\":\"10.1186/s40345-024-00352-9\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Current treatments for bipolar depression have limited effectiveness, tolerability and acceptability. Transcranial direct current stimulation (tDCS) is a novel non-invasive brain stimulation method that has demonstrated treatment efficacy for major depressive episodes. tDCS is portable, safe, and individuals like having sessions at home. We developed a home-based protocol with real-time remote supervision. In the present study, we have examined the clinical outcomes, acceptability and feasibility of home-based tDCS treatment in bipolar depression.</p><p><strong>Results: </strong>Participants were 44 individuals with bipolar disorder (31 women), mean age 47.27 ± 12.89 years, in current depressive episode of at least moderate severity (mean Montgomery Asberg Depression Rating Scale (MADRS) score 24.59 ± 2.64). tDCS was provided in bilateral frontal montage, F3 anode, F4 cathode, 2 mA, for 30 min, in a 6-week trial, for total 21 sessions, a follow up visit was conducted 5 months from baseline. Participants maintained their current treatment (psychotherapy, antidepressant or mood stabilising medication) or maintained being medication-free. A research team member was present by video conference at each session. 93.2% participants (n = 41) completed the 6-week treatment and 72.7% of participants (n = 32) completed the 5 month follow up. There was a significant improvement in depressive symptoms following treatment (mean MADRS 8.77 ± 5.37) which was maintained at the 5 month follow up (mean MADRS 10.86 ± 6.90), rate of clinical response was 77.3% (MADRS improvement of 50% or greater from baseline), and rate of clinical remission was 47.7% (MADRS rating of 9 or less). Acceptability was endorsed as \\\"very acceptable\\\" or \\\"quite acceptable\\\" by all participants. 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Home-based transcranial direct current stimulation in bipolar depression: an open-label treatment study of clinical outcomes, acceptability and adverse events.
Background: Current treatments for bipolar depression have limited effectiveness, tolerability and acceptability. Transcranial direct current stimulation (tDCS) is a novel non-invasive brain stimulation method that has demonstrated treatment efficacy for major depressive episodes. tDCS is portable, safe, and individuals like having sessions at home. We developed a home-based protocol with real-time remote supervision. In the present study, we have examined the clinical outcomes, acceptability and feasibility of home-based tDCS treatment in bipolar depression.
Results: Participants were 44 individuals with bipolar disorder (31 women), mean age 47.27 ± 12.89 years, in current depressive episode of at least moderate severity (mean Montgomery Asberg Depression Rating Scale (MADRS) score 24.59 ± 2.64). tDCS was provided in bilateral frontal montage, F3 anode, F4 cathode, 2 mA, for 30 min, in a 6-week trial, for total 21 sessions, a follow up visit was conducted 5 months from baseline. Participants maintained their current treatment (psychotherapy, antidepressant or mood stabilising medication) or maintained being medication-free. A research team member was present by video conference at each session. 93.2% participants (n = 41) completed the 6-week treatment and 72.7% of participants (n = 32) completed the 5 month follow up. There was a significant improvement in depressive symptoms following treatment (mean MADRS 8.77 ± 5.37) which was maintained at the 5 month follow up (mean MADRS 10.86 ± 6.90), rate of clinical response was 77.3% (MADRS improvement of 50% or greater from baseline), and rate of clinical remission was 47.7% (MADRS rating of 9 or less). Acceptability was endorsed as "very acceptable" or "quite acceptable" by all participants. No participants developed mania or hypomania.
Conclusions: In summary, home-based tDCS with real-time supervision was associated with significant clinical improvements and high acceptability in bipolar depression. Due to the open-label design, efficacy findings are preliminary.
Trial registration: ClinicalTrials.gov number NCT05436613 registered on 23 June 2022 https//www.
期刊介绍：
The International Journal of Bipolar Disorders is a peer-reviewed, open access online journal published under the SpringerOpen brand. It publishes contributions from the broad range of clinical, psychological and biological research in bipolar disorders. It is the official journal of the ECNP-ENBREC (European Network of Bipolar Research Expert Centres ) Bipolar Disorders Network, the International Group for the study of Lithium Treated Patients (IGSLi) and the Deutsche Gesellschaft für Bipolare Störungen (DGBS) and invites clinicians and researchers from around the globe to submit original research papers, short research communications, reviews, guidelines, case reports and letters to the editor that help to enhance understanding of bipolar disorders.
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