The NExT trial: Protocol for a two-phase randomized controlled trial testing transcranial magnetic stimulation to augment exposure therapy for youth with OCD
Abstract Background Exposure with Response Prevention (ERP) is a first-line treatment for OCD, but even when combined with first-line medications it is insufficiently effective for approximately half of patients. Compulsivity in OCD is thought to arise from an imbalance of two distinct neural circui...
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BMC
2024-12-01
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| Online Access: | https://doi.org/10.1186/s13063-024-08629-1 |
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| author | Christine Conelea Claire Breitenfeldt Alixandra Wilens Linda Carpenter Benjamin Greenberg Jennifer Herren Suma Jacob Charles Lewis Nicole McLaughlin Bryon A. Mueller Steve Nelson Erin O’Connor Giulia Righi Alik S. Widge Mark Fiecas Kristen Benito |
| author_facet | Christine Conelea Claire Breitenfeldt Alixandra Wilens Linda Carpenter Benjamin Greenberg Jennifer Herren Suma Jacob Charles Lewis Nicole McLaughlin Bryon A. Mueller Steve Nelson Erin O’Connor Giulia Righi Alik S. Widge Mark Fiecas Kristen Benito |
| author_sort | Christine Conelea |
| collection | DOAJ |
| description | Abstract Background Exposure with Response Prevention (ERP) is a first-line treatment for OCD, but even when combined with first-line medications it is insufficiently effective for approximately half of patients. Compulsivity in OCD is thought to arise from an imbalance of two distinct neural circuits associated with specific subregions of striatum. Targeted modulation of these circuits via key cortical nodes (dorsolateral prefrontal cortex [dlPFC] or presupplementary motor area [pSMA]) has the potential to improve ERP efficacy by decreasing compulsions during therapy. Methods The NExT (Neuromodulation + Exposure Therapy) trial is a two-phase, multisite early-stage randomized controlled trial designed to examine whether TMS augmentation of ERP alters activity in dlPFC and/or pSMA-associated circuitry and reduces compulsions during therapy in youth with OCD age 12–21 years. Phase 1 (N = 60) will compare two different active TMS regimens with sham: A. continuous theta burst stimulation (cTBS) to pSMA vs. B. intermittent theta burst stimulation (iTBS) to dlPFC. A priori “Go/No-Go” criteria will inform a decision to proceed to Phase 2 and the choice of TMS regimen. Phase 2 (N = 60) will compare the selected TMS regimen vs. sham in a new sample. Discussion This trial is the first to test TMS augmentation of ERP in youth with OCD. Results will inform the potential of TMS to enhance ERP efficacy and enhance knowledge about mechanisms of change. Trial registration ClinicalTrials.gov NCT05931913. Registered prospectively on July 5, 2023. |
| format | Article |
| id | doaj-art-7f3b179fcc7c4f969dabb484fa89a7c5 |
| institution | DOAJ |
| issn | 1745-6215 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj-art-7f3b179fcc7c4f969dabb484fa89a7c52025-08-20T02:40:15ZengBMCTrials1745-62152024-12-0125111510.1186/s13063-024-08629-1The NExT trial: Protocol for a two-phase randomized controlled trial testing transcranial magnetic stimulation to augment exposure therapy for youth with OCDChristine Conelea0Claire Breitenfeldt1Alixandra Wilens2Linda Carpenter3Benjamin Greenberg4Jennifer Herren5Suma Jacob6Charles Lewis7Nicole McLaughlin8Bryon A. Mueller9Steve Nelson10Erin O’Connor11Giulia Righi12Alik S. Widge13Mark Fiecas14Kristen Benito15Department of Psychiatry and Behavioral Sciences, University of MinnesotaDepartment of Psychiatry and Behavioral Sciences, University of MinnesotaPediatric Anxiety Research Center at Bradley Hospital COBRE Center for Neuromodulation, Butler Hospital COBRE Center for Neuromodulation, Butler HospitalPediatric Anxiety Research Center at Bradley HospitalDepartment of Psychiatry and Behavioral Sciences, University of MinnesotaDepartment of Psychiatry and Behavioral Sciences, University of Minnesota COBRE Center for Neuromodulation, Butler HospitalDepartment of Psychiatry and Behavioral Sciences, University of MinnesotaDepartment of Pediatrics, University of MinnesotaPediatric Anxiety Research Center at Bradley HospitalPediatric Anxiety Research Center at Bradley HospitalDepartment of Psychiatry and Behavioral Sciences, University of MinnesotaDivision of Biostatistics and Health Data Science, University of MinnesotaPediatric Anxiety Research Center at Bradley HospitalAbstract Background Exposure with Response Prevention (ERP) is a first-line treatment for OCD, but even when combined with first-line medications it is insufficiently effective for approximately half of patients. Compulsivity in OCD is thought to arise from an imbalance of two distinct neural circuits associated with specific subregions of striatum. Targeted modulation of these circuits via key cortical nodes (dorsolateral prefrontal cortex [dlPFC] or presupplementary motor area [pSMA]) has the potential to improve ERP efficacy by decreasing compulsions during therapy. Methods The NExT (Neuromodulation + Exposure Therapy) trial is a two-phase, multisite early-stage randomized controlled trial designed to examine whether TMS augmentation of ERP alters activity in dlPFC and/or pSMA-associated circuitry and reduces compulsions during therapy in youth with OCD age 12–21 years. Phase 1 (N = 60) will compare two different active TMS regimens with sham: A. continuous theta burst stimulation (cTBS) to pSMA vs. B. intermittent theta burst stimulation (iTBS) to dlPFC. A priori “Go/No-Go” criteria will inform a decision to proceed to Phase 2 and the choice of TMS regimen. Phase 2 (N = 60) will compare the selected TMS regimen vs. sham in a new sample. Discussion This trial is the first to test TMS augmentation of ERP in youth with OCD. Results will inform the potential of TMS to enhance ERP efficacy and enhance knowledge about mechanisms of change. Trial registration ClinicalTrials.gov NCT05931913. Registered prospectively on July 5, 2023.https://doi.org/10.1186/s13063-024-08629-1Transcranial magnetic stimulationNeuromodulationCognitive Behavioral TherapyOCDExposure therapy |
| spellingShingle | Christine Conelea Claire Breitenfeldt Alixandra Wilens Linda Carpenter Benjamin Greenberg Jennifer Herren Suma Jacob Charles Lewis Nicole McLaughlin Bryon A. Mueller Steve Nelson Erin O’Connor Giulia Righi Alik S. Widge Mark Fiecas Kristen Benito The NExT trial: Protocol for a two-phase randomized controlled trial testing transcranial magnetic stimulation to augment exposure therapy for youth with OCD Trials Transcranial magnetic stimulation Neuromodulation Cognitive Behavioral Therapy OCD Exposure therapy |
| title | The NExT trial: Protocol for a two-phase randomized controlled trial testing transcranial magnetic stimulation to augment exposure therapy for youth with OCD |
| title_full | The NExT trial: Protocol for a two-phase randomized controlled trial testing transcranial magnetic stimulation to augment exposure therapy for youth with OCD |
| title_fullStr | The NExT trial: Protocol for a two-phase randomized controlled trial testing transcranial magnetic stimulation to augment exposure therapy for youth with OCD |
| title_full_unstemmed | The NExT trial: Protocol for a two-phase randomized controlled trial testing transcranial magnetic stimulation to augment exposure therapy for youth with OCD |
| title_short | The NExT trial: Protocol for a two-phase randomized controlled trial testing transcranial magnetic stimulation to augment exposure therapy for youth with OCD |
| title_sort | next trial protocol for a two phase randomized controlled trial testing transcranial magnetic stimulation to augment exposure therapy for youth with ocd |
| topic | Transcranial magnetic stimulation Neuromodulation Cognitive Behavioral Therapy OCD Exposure therapy |
| url | https://doi.org/10.1186/s13063-024-08629-1 |
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