Efficacy of intermittent Theta Burst Stimulation (iTBS) and 10-Hz high-frequency repetitive transcranial magnetic stimulation (rTMS) in treatment-resistant unipolar depression: study protocol for a randomised controlled trial
Identifieur interne : 000038 ( Main/Exploration ); précédent : 000037; suivant : 000039Efficacy of intermittent Theta Burst Stimulation (iTBS) and 10-Hz high-frequency repetitive transcranial magnetic stimulation (rTMS) in treatment-resistant unipolar depression: study protocol for a randomised controlled trial
Auteurs : Samuel Bulteau [France] ; Veronique Sébille [France] ; Guillemette Fayet [France] ; Veronique Thomas-Ollivier [France] ; Thibault Deschamps [France] ; Annabelle Bonnin-Rivalland [France] ; Edouard Laforgue [France] ; Anne Pichot [France] ; Pierre Valrivière [France] ; Elisabeth Auffray-Calvier [France] ; June Fortin [France] ; Yann Péréon [France] ; Jean-Marie Vanelle [France] ; Anne Sauvaget [France]Source :
- Trials [ 1745-6215 ] ; 2017.
Abstract
The treatment of depression remains a challenge since at least 40% of patients do not respond to initial antidepressant therapy and 20% present chronic symptoms (more than 2 years despite standard treatment administered correctly). Repetitive transcranial magnetic stimulation (rTMS) is an effective adjuvant therapy but still not ideal. Intermittent Theta Burst Stimulation (iTBS), which has only been used recently in clinical practice, could have a faster and more intense effect compared to conventional protocols, including 10-Hz high-frequency rTMS (HF-rTMS). However, no controlled study has so far highlighted the superiority of iTBS in resistant unipolar depression.
This paper focuses on the design of a randomised, controlled, double-blind, single-centre study with two parallel arms, carried out in France, in an attempt to assess the efficacy of an iTBS protocol versus a standard HF- rTMS protocol. Sixty patients aged between 18 and 75 years of age will be enrolled. They must be diagnosed with major depressive disorder persisting despite treatment with two antidepressants at an effective dose over a period of 6 weeks during the current episode. The study will consist of two phases: a treatment phase comprising 20 sessions of rTMS to the left dorsolateral prefrontal cortex, localised via a neuronavigation system and a 6-month longitudinal follow-up. The primary endpoint will be the number of responders per group, defined by a decrease of at least 50% in the initial score on the Montgomery and Asberg Rating Scale (MADRS) at the end of rTMS sessions. The secondary endpoints will be: response rate 1 month after rTMS sessions; number of remissions defined by a MADRS score of <8 at the endpoint and 1 month after; the number of responses and remissions maintained over the next 6 months; quality of life; and the presence of predictive markers of the therapeutic response: clinical (dimensional scales), neuropsychological (evaluation of cognitive functions), motor (objective motor testing) and neurophysiological (cortical excitability measurements).
The purpose of our study is to check the assumption of iTBS superiority in the management of unipolar depression and we will discuss its effect over time. In case of a significant increase in the number of therapeutic responses with a prolonged effect, the iTBS protocol could be considered a first-line protocol in resistant unipolar depression.
ClinicalTrials.gov, Identifier
The online version of this article (doi:10.1186/s13063-016-1764-8) contains supplementary material, which is available to authorized users.
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DOI: 10.1186/s13063-016-1764-8
PubMed: 28086851
PubMed Central: 5237321
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France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>CHU de Nantes, Clinical Investigation Unit 18, Department of Addictology and Consultation-liaison Psychiatry, F-44000 Nantes</wicri:regionArea><placeName><region type="region" nuts="2">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:aff id="Aff2">University of Nantes, University of Tours, INSERM, SPHERE U1246, F-44000 Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>University of Nantes, University of Tours, INSERM, SPHERE U1246, F-44000 Nantes</wicri:regionArea><placeName><region type="region" nuts="2">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Sebille, Veronique" sort="Sebille, Veronique" uniqKey="Sebille V" first="Veronique" last="Sébille">Veronique Sébille</name><affiliation wicri:level="3"><nlm:aff id="Aff2">University of Nantes, University of Tours, INSERM, SPHERE U1246, F-44000 Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>University of Nantes, University of Tours, INSERM, SPHERE U1246, F-44000 Nantes</wicri:regionArea><placeName><region type="region" nuts="2">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Fayet, Guillemette" sort="Fayet, Guillemette" uniqKey="Fayet G" first="Guillemette" last="Fayet">Guillemette Fayet</name><affiliation wicri:level="3"><nlm:aff id="Aff3">CHU de Nantes, Department of Clinical Neurophysiology, F-44000 Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>CHU de Nantes, Department of Clinical Neurophysiology, F-44000 Nantes</wicri:regionArea><placeName><region type="region" nuts="2">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Thomas Ollivier, Veronique" sort="Thomas Ollivier, Veronique" uniqKey="Thomas Ollivier V" first="Veronique" last="Thomas-Ollivier">Veronique Thomas-Ollivier</name><affiliation wicri:level="3"><nlm:aff id="Aff4">University of Nantes, Laboratory ‘Movement, Interactions, Performance’ (E.A. 4334), F-44000 Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>University of Nantes, Laboratory ‘Movement, Interactions, Performance’ (E.A. 4334), F-44000 Nantes</wicri:regionArea><placeName><region type="region" nuts="2">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Deschamps, Thibault" sort="Deschamps, Thibault" uniqKey="Deschamps T" first="Thibault" last="Deschamps">Thibault Deschamps</name><affiliation wicri:level="3"><nlm:aff id="Aff4">University of Nantes, Laboratory ‘Movement, Interactions, Performance’ (E.A. 4334), F-44000 Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>University of Nantes, Laboratory ‘Movement, Interactions, Performance’ (E.A. 4334), F-44000 Nantes</wicri:regionArea><placeName><region type="region" nuts="2">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Bonnin Rivalland, Annabelle" sort="Bonnin Rivalland, Annabelle" uniqKey="Bonnin Rivalland A" first="Annabelle" last="Bonnin-Rivalland">Annabelle Bonnin-Rivalland</name><affiliation wicri:level="3"><nlm:aff id="Aff1">CHU de Nantes, Clinical Investigation Unit 18, Department of Addictology and Consultation-liaison Psychiatry, F-44000 Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>CHU de Nantes, Clinical Investigation Unit 18, Department of Addictology and Consultation-liaison Psychiatry, F-44000 Nantes</wicri:regionArea><placeName><region type="region" nuts="2">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Laforgue, Edouard" sort="Laforgue, Edouard" uniqKey="Laforgue E" first="Edouard" last="Laforgue">Edouard Laforgue</name><affiliation wicri:level="3"><nlm:aff id="Aff1">CHU de Nantes, Clinical Investigation Unit 18, Department of Addictology and Consultation-liaison Psychiatry, F-44000 Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>CHU de Nantes, Clinical Investigation Unit 18, Department of Addictology and Consultation-liaison Psychiatry, F-44000 Nantes</wicri:regionArea><placeName><region type="region" nuts="2">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Pichot, Anne" sort="Pichot, Anne" uniqKey="Pichot A" first="Anne" last="Pichot">Anne Pichot</name><affiliation wicri:level="3"><nlm:aff id="Aff1">CHU de Nantes, Clinical Investigation Unit 18, Department of Addictology and Consultation-liaison Psychiatry, F-44000 Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>CHU de Nantes, Clinical Investigation Unit 18, Department of Addictology and Consultation-liaison Psychiatry, F-44000 Nantes</wicri:regionArea><placeName><region type="region" nuts="2">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Valriviere, Pierre" sort="Valriviere, Pierre" uniqKey="Valriviere P" first="Pierre" last="Valrivière">Pierre Valrivière</name><affiliation wicri:level="3"><nlm:aff id="Aff1">CHU de Nantes, Clinical Investigation Unit 18, Department of Addictology and Consultation-liaison Psychiatry, F-44000 Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>CHU de Nantes, Clinical Investigation Unit 18, Department of Addictology and Consultation-liaison Psychiatry, F-44000 Nantes</wicri:regionArea><placeName><region type="region" nuts="2">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Auffray Calvier, Elisabeth" sort="Auffray Calvier, Elisabeth" uniqKey="Auffray Calvier E" first="Elisabeth" last="Auffray-Calvier">Elisabeth Auffray-Calvier</name><affiliation wicri:level="3"><nlm:aff id="Aff5">CHU de Nantes, Department of Neuroradiology, F-44000 Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>CHU de Nantes, Department of Neuroradiology, F-44000 Nantes</wicri:regionArea><placeName><region type="region" nuts="2">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Fortin, June" sort="Fortin, June" uniqKey="Fortin J" first="June" last="Fortin">June Fortin</name><affiliation wicri:level="3"><nlm:aff id="Aff6">CHU de Nantes, Delegation of Clinical Research and Innovation, F-44000 Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>CHU de Nantes, Delegation of Clinical Research and Innovation, F-44000 Nantes</wicri:regionArea><placeName><region type="region" nuts="2">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Pereon, Yann" sort="Pereon, Yann" uniqKey="Pereon Y" first="Yann" last="Péréon">Yann Péréon</name><affiliation wicri:level="3"><nlm:aff id="Aff3">CHU de Nantes, Department of Clinical Neurophysiology, F-44000 Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>CHU de Nantes, Department of Clinical Neurophysiology, F-44000 Nantes</wicri:regionArea><placeName><region type="region" nuts="2">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Vanelle, Jean Marie" sort="Vanelle, Jean Marie" uniqKey="Vanelle J" first="Jean-Marie" last="Vanelle">Jean-Marie Vanelle</name><affiliation wicri:level="3"><nlm:aff id="Aff1">CHU de Nantes, Clinical Investigation Unit 18, Department of Addictology and Consultation-liaison Psychiatry, F-44000 Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>CHU de Nantes, Clinical Investigation Unit 18, Department of Addictology and Consultation-liaison Psychiatry, F-44000 Nantes</wicri:regionArea><placeName><region type="region" nuts="2">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Sauvaget, Anne" sort="Sauvaget, Anne" uniqKey="Sauvaget A" first="Anne" last="Sauvaget">Anne Sauvaget</name><affiliation wicri:level="3"><nlm:aff id="Aff1">CHU de Nantes, Clinical Investigation Unit 18, Department of Addictology and Consultation-liaison Psychiatry, F-44000 Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>CHU de Nantes, Clinical Investigation Unit 18, Department of Addictology and Consultation-liaison Psychiatry, F-44000 Nantes</wicri:regionArea><placeName><region type="region" nuts="2">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:aff id="Aff2">University of Nantes, University of Tours, INSERM, SPHERE U1246, F-44000 Nantes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>University of Nantes, University of Tours, INSERM, SPHERE U1246, F-44000 Nantes</wicri:regionArea><placeName><region type="region" nuts="2">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>The treatment of depression remains a challenge since at least 40% of patients do not respond to initial antidepressant therapy and 20% present chronic symptoms (more than 2 years despite standard treatment administered correctly). Repetitive transcranial magnetic stimulation (rTMS) is an effective adjuvant therapy but still not ideal. Intermittent Theta Burst Stimulation (iTBS), which has only been used recently in clinical practice, could have a faster and more intense effect compared to conventional protocols, including 10-Hz high-frequency rTMS (HF-rTMS). However, no controlled study has so far highlighted the superiority of iTBS in resistant unipolar depression.</p></sec><sec><title>Methods/design</title><p>This paper focuses on the design of a randomised, controlled, double-blind, single-centre study with two parallel arms, carried out in France, in an attempt to assess the efficacy of an iTBS protocol versus a standard HF- rTMS protocol. Sixty patients aged between 18 and 75 years of age will be enrolled. They must be diagnosed with major depressive disorder persisting despite treatment with two antidepressants at an effective dose over a period of 6 weeks during the current episode. The study will consist of two phases: a treatment phase comprising 20 sessions of rTMS to the left dorsolateral prefrontal cortex, localised via a neuronavigation system and a 6-month longitudinal follow-up. The primary endpoint will be the number of responders per group, defined by a decrease of at least 50% in the initial score on the Montgomery and Asberg Rating Scale (MADRS) at the end of rTMS sessions. The secondary endpoints will be: response rate 1 month after rTMS sessions; number of remissions defined by a MADRS score of <8 at the endpoint and 1 month after; the number of responses and remissions maintained over the next 6 months; quality of life; and the presence of predictive markers of the therapeutic response: clinical (dimensional scales), neuropsychological (evaluation of cognitive functions), motor (objective motor testing) and neurophysiological (cortical excitability measurements).</p></sec><sec><title>Discussion</title><p>The purpose of our study is to check the assumption of iTBS superiority in the management of unipolar depression and we will discuss its effect over time. In case of a significant increase in the number of therapeutic responses with a prolonged effect, the iTBS protocol could be considered a first-line protocol in resistant unipolar depression.</p></sec><sec><title>Trial registration</title><p>ClinicalTrials.gov, Identifier <ext-link ext-link-type="uri" xlink:href="http://clinicaltrials.gov/ct2/show/NCT02376491">NCT02376491</ext-link>. Registered on 17 February 2015 at <ext-link ext-link-type="uri" xlink:href="http://clinicaltrials.gov/">http://clinicaltrials.gov</ext-link>.</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1186/s13063-016-1764-8) contains supplementary material, which is available to authorized users.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Fava, M" uniqKey="Fava M">M Fava</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Heijnen, Wt" uniqKey="Heijnen W">WT Heijnen</name></author><author><name sortKey="Birkenh Ger, Tk" uniqKey="Birkenh Ger T">TK Birkenhäger</name></author><author><name sortKey="Wierdsma, Ai" uniqKey="Wierdsma A">AI Wierdsma</name></author><author><name sortKey="Van Den Broek, Ww" uniqKey="Van Den Broek W">WW van den Broek</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Xie, J" 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uniqKey="Wobrock T">T Wobrock</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Luborzewski, A" uniqKey="Luborzewski A">A Luborzewski</name></author><author><name sortKey="Schubert, F" uniqKey="Schubert F">F Schubert</name></author><author><name sortKey="Seifert, F" uniqKey="Seifert F">F Seifert</name></author><author><name sortKey="Danker Hopfe, H" uniqKey="Danker Hopfe H">H Danker-Hopfe</name></author><author><name sortKey="Brakemeier, E L" uniqKey="Brakemeier E">E-L Brakemeier</name></author><author><name sortKey="Schlattmann, P" uniqKey="Schlattmann P">P Schlattmann</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Yue, L" uniqKey="Yue L">L Yue</name></author><author><name sortKey="Xiao Lin, H" uniqKey="Xiao Lin H">H Xiao-lin</name></author><author><name sortKey="Tao, S" uniqKey="Tao S">S Tao</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>France</li></country><region><li>Pays de la Loire</li></region><settlement><li>Nantes</li></settlement></list><tree><country name="France"><region name="Pays de la Loire"><name sortKey="Bulteau, Samuel" sort="Bulteau, Samuel" uniqKey="Bulteau S" first="Samuel" last="Bulteau">Samuel Bulteau</name></region><name sortKey="Auffray Calvier, Elisabeth" sort="Auffray Calvier, Elisabeth" uniqKey="Auffray Calvier E" first="Elisabeth" last="Auffray-Calvier">Elisabeth Auffray-Calvier</name><name sortKey="Bonnin Rivalland, Annabelle" sort="Bonnin Rivalland, Annabelle" uniqKey="Bonnin Rivalland A" first="Annabelle" last="Bonnin-Rivalland">Annabelle Bonnin-Rivalland</name><name sortKey="Bulteau, Samuel" sort="Bulteau, Samuel" uniqKey="Bulteau S" first="Samuel" last="Bulteau">Samuel Bulteau</name><name sortKey="Deschamps, Thibault" sort="Deschamps, Thibault" uniqKey="Deschamps T" first="Thibault" last="Deschamps">Thibault Deschamps</name><name sortKey="Fayet, Guillemette" sort="Fayet, Guillemette" uniqKey="Fayet G" first="Guillemette" last="Fayet">Guillemette Fayet</name><name sortKey="Fortin, June" sort="Fortin, June" uniqKey="Fortin J" first="June" last="Fortin">June Fortin</name><name sortKey="Laforgue, Edouard" sort="Laforgue, Edouard" uniqKey="Laforgue E" first="Edouard" last="Laforgue">Edouard Laforgue</name><name sortKey="Pereon, Yann" sort="Pereon, Yann" uniqKey="Pereon Y" first="Yann" last="Péréon">Yann Péréon</name><name sortKey="Pichot, Anne" sort="Pichot, Anne" uniqKey="Pichot A" first="Anne" last="Pichot">Anne Pichot</name><name sortKey="Sauvaget, Anne" sort="Sauvaget, Anne" uniqKey="Sauvaget A" first="Anne" last="Sauvaget">Anne Sauvaget</name><name sortKey="Sauvaget, Anne" sort="Sauvaget, Anne" uniqKey="Sauvaget A" first="Anne" last="Sauvaget">Anne Sauvaget</name><name sortKey="Sebille, Veronique" sort="Sebille, Veronique" uniqKey="Sebille V" first="Veronique" last="Sébille">Veronique Sébille</name><name sortKey="Thomas Ollivier, Veronique" sort="Thomas Ollivier, Veronique" uniqKey="Thomas Ollivier V" first="Veronique" last="Thomas-Ollivier">Veronique Thomas-Ollivier</name><name sortKey="Valriviere, Pierre" sort="Valriviere, Pierre" uniqKey="Valriviere P" first="Pierre" last="Valrivière">Pierre Valrivière</name><name sortKey="Vanelle, Jean Marie" sort="Vanelle, Jean Marie" uniqKey="Vanelle J" first="Jean-Marie" last="Vanelle">Jean-Marie Vanelle</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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