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| ID | Type | Description | Link |
|---|---|---|---|
| PI 2022-280-1 | Other Grant/Funding Number | Carlos III Health Institute | |
| 21-0040 | Other Identifier | AEMPS, NEOPS code |
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| Name | Class |
|---|---|
| Spanish Agency of Medicines and Health Products | OTHER_GOV |
| Hospital Universitario La Fe | OTHER |
| Instituto de Salud Carlos III | OTHER_GOV |
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Theta Burst Transcranial Magnetic Stimulation (TBS) in dorsolateral prefrontal cortex (DLPFC) has shown efficacy and safety as an adjuvant strategy for resistant to treatment depression (RTD) in daily sessions during 4-6 weeks (20-30 sessions). Current investigation in TBS aims to design intensive treatment protocols so as to achieve earlier responses and higher rates of efficacy. However, the implementation of TBS in the Public National Health Service requires cost-effective protocols that ensure and facilitate patients adherence to treatment, and whose design is based on clinical and neuroimaging biomarkers of response so as to adequately select candidate patients. The aim of this study is to assess the efficacy and safety of novel bilateral and unilateral intensive and spaced protocols of TBS in outpatients with unipolar and bipolar RTD compared with sham stimulation. Specific objectives: I) Comparison of mood change, response and remission of depressive illness at the end of TBS protocol in the groups and maintenance of its effect at 3 months; II) Characterization of neuroimaging cerebral connectivity networks and cerebral metabolism patterns of patients with RTD related to the effects of bilateral or unilateral TBS; III) Identification of clinical and demographic predictors contributing to response to TBS; IV) Analysis of the interaction between clinical, demographic and neuroimaging predictors so as to determine a RTD profile of patient that can benefit from TBS.
Participants will receive 22 bilateral sessions of sham/active continuous (right DLPFC) and intermittent (left DLPFC) TBS during 6 weeks. Simultaneous cerebral PET-MRI will be performed before (week 0) and after the treatment with TBS (week 7)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Bilateral | Active Comparator | 32 patients, bilateral active TBS stimulation, Will receive an intensive-spaced protocol Intermittent TBS in left DLPFC and Continuous TBS in right DLPFC |
|
| Group Unilateral | Active Comparator | 32 patients, unilateral left DLPFC active TBS stimulation. Will receive an intensive-spaced protocol Intermittent TBS in left DLPFC and Sham Continuous TBS in right DLPFC |
|
| Group Placebo | Placebo Comparator | 32 patients, bilateral sham TBS stimulation. Will receive an intensive-spaced protocol of Sham Intermittent TBS in left DLPFC and Sham Continuous TBS in right DLPFC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theta Burst Transcranial Magnetic Bilateral Stimulation | Device | TMS protocol of 22 sessions of bilateral active 1800 pulses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale 17 items (HDRS-17) at the end of the treatment respect to basal. | Hetero-administered | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory (BDI-II) respect to basal. | Self-administered | 2, 6 weeks |
| Montgomery Asberg Depression Rating Scale (MADRS) respect to basal. | Hetero-administered |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yolanda Cañada, MD | Contact | +34961244154 | canyada_yol@gva.es |
| Name | Affiliation | Role |
|---|---|---|
| Pilar Sierra San Miguel, PhD | Instituto de Investigación Sanitaria La Fe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario y Politécnico La Fe | Recruiting | Valencia | 46026 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29726344 | Background | Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26. | |
| 31477542 |
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| Theta Burst Transcranial Magnetic Sham Stimulation | Device | TMS protocol of 22 sessions of sham bilateral 1800 pulses. |
|
| Theta Burst Transcranial Magnetic Unilateral Stimulation | Device | TMS protocol of 22 sessions of left active 1800 pulses and right sham 1800 pulses. |
|
| 2, 6 weeks |
| Young Mania Rating Scale (YMRS) at the end of the treatment respect to basal. | Hetero-administered | 2, 6 weeks |
| Altman Self Rating Mania Scale (ASRM) at the end of the treatment respect to basal. | Self-administered | 2, 6 weeks |
| Clinical Global Impression Scale (CGI) respect to basal. | Hetero-administered | 2,6 weeks |
| Hamilton Anxiety Scale (HAM-A) respect to basal. | Hetero-administered | 2,6 weeks |
| Oviedo Sleep Questionnaire (OSQ) respect to basal. | Hetero-administered | 2, 6 weeks |
| Dimensional Apathy Scale (DAS) respect to basal | Self-administered | 6 weeks |
| Screening for Cognitive Impairment por Psychiatry (SCIP) at the end of the treatment respect to basal. | Hetero-administered (versions A and B) | 6 weeks |
| Short Form Health Survey (SF 36) at the end of the treatment respect to basal. | Self-administered | 6 weeks |
| Functional Assessment Short Test (FAST) at the end of the treatment respect to basal. | Hetero-administered | 6 weeks |
| Global assessment of Functioning (GAF) at the end of the treatment respect to basal. | Hetero-administered | 6 weeks |
| Response to treatment | 50% reduction in HDRS-17 | 2 and 6 weeks |
| Response to treatment | 50% reduction in MADRS | 2 and 6 weeks |
| Remission | HDRS-17<8 points | 2 and 6 weeks |
| Remission | MADRS<11 POINTS | 2 and 6 weeks |
| Background |
| Fitzgerald PB, Chen L, Richardson K, Daskalakis ZJ, Hoy KE. A pilot investigation of an intensive theta burst stimulation protocol for patients with treatment resistant depression. Brain Stimul. 2020 Jan-Feb;13(1):137-144. doi: 10.1016/j.brs.2019.08.013. Epub 2019 Aug 22. |
| 24817188 | Background | Li CT, Chen MH, Juan CH, Huang HH, Chen LF, Hsieh JC, Tu PC, Bai YM, Tsai SJ, Lee YC, Su TP. Efficacy of prefrontal theta-burst stimulation in refractory depression: a randomized sham-controlled study. Brain. 2014 Jul;137(Pt 7):2088-98. doi: 10.1093/brain/awu109. Epub 2014 May 10. |
| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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