Feasibility and acceptability of transcranial stimulation in obsessive–compulsive symptoms (FEATSOCS): study protocol for a randomised controlled trial of transcranial direct current stimulation (tDCS) in obsessive–compulsive disorder (OCD)
Abstract Background Obsessive–compulsive disorder (OCD) is a neuropsychiatric disorder which often proves refractory to current treatment approaches. Transcranial direct current stimulation (tDCS), a noninvasive form of neurostimulation, with potential for development as a self-administered interven...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2021-12-01
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| Series: | Pilot and Feasibility Studies |
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| Online Access: | https://doi.org/10.1186/s40814-021-00945-6 |
| _version_ | 1818575672387305472 |
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| author | Eduardo Cinosi David Adam Ibrahim Aslan David Baldwin Kieran Chillingsworth Arun Enara Tim Gale Kabir Garg Matthew Garner Robert Gordon Natalie Hall Nathan T. M. Huneke Sonay Kucukterzi-Ali Joanne McCarthy Daniel Meron Deela Monji-Patel Roisin Mooney Trevor Robbins Megan Smith Nick Sireau David Wellsted Solange Wyatt Naomi A. Fineberg |
| author_facet | Eduardo Cinosi David Adam Ibrahim Aslan David Baldwin Kieran Chillingsworth Arun Enara Tim Gale Kabir Garg Matthew Garner Robert Gordon Natalie Hall Nathan T. M. Huneke Sonay Kucukterzi-Ali Joanne McCarthy Daniel Meron Deela Monji-Patel Roisin Mooney Trevor Robbins Megan Smith Nick Sireau David Wellsted Solange Wyatt Naomi A. Fineberg |
| author_sort | Eduardo Cinosi |
| collection | DOAJ |
| description | Abstract Background Obsessive–compulsive disorder (OCD) is a neuropsychiatric disorder which often proves refractory to current treatment approaches. Transcranial direct current stimulation (tDCS), a noninvasive form of neurostimulation, with potential for development as a self-administered intervention, has shown potential as a safe and efficacious treatment for OCD in a small number of trials. The two most promising stimulation sites are located above the orbitofrontal cortex (OFC) and the supplementary motor area (SMA). Methods The aim of this feasibility study is to inform the development of a definitive trial, focussing on the acceptability, safety of the intervention, feasibility of recruitment, adherence and tolerability to tDCS and study assessments and the size of the treatment effect. To this end, we will deliver a double-blind, sham-controlled, crossover randomised multicentre study in 25 adults with OCD. Each participant will receive three courses of tDCS (SMA, OFC and sham), randomly allocated and given in counterbalanced order. Each course comprises four 20-min stimulations, delivered over two consecutive days, separated by at least 4 weeks’ washout period. We will collect information about recruitment, study conduct and tDCS delivery. Blinded raters will assess clinical outcomes before, during and up to 4 weeks after stimulation using validated scales. We will include relevant objective neurocognitive tasks, testing cognitive flexibility, motor disinhibition, cooperation and habit learning. Discussion We will analyse the magnitude of the effect of the interventions on OCD symptoms alongside the standard deviation of the outcome measure, to estimate effect size and determine the optimal stimulation target. We will also measure the duration of the effect of stimulation, to provide information on spacing treatments efficiently. We will evaluate the usefulness and limitations of specific neurocognitive tests to determine a definitive test battery. Additionally, qualitative data will be collected from participants to better understand their experience of taking part in a tDCS intervention, as well as the impact on their overall quality of life. These clinical outcomes will enable the project team to further refine the methodology to ensure optimal efficiency in terms of both delivering and assessing the treatment in a full-scale trial. Trial registration ISRCTN17937049 . (date applied 08/07/2019). Recruitment (ongoing) began 23rd July 2019 and is anticipated to complete 30th April 2021. |
| first_indexed | 2024-12-15T00:44:03Z |
| format | Article |
| id | doaj.art-00845da8a2404999a7fcbec23f9ab292 |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-12-15T00:44:03Z |
| publishDate | 2021-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-00845da8a2404999a7fcbec23f9ab2922022-12-21T22:41:35ZengBMCPilot and Feasibility Studies2055-57842021-12-017111610.1186/s40814-021-00945-6Feasibility and acceptability of transcranial stimulation in obsessive–compulsive symptoms (FEATSOCS): study protocol for a randomised controlled trial of transcranial direct current stimulation (tDCS) in obsessive–compulsive disorder (OCD)Eduardo Cinosi0David Adam1Ibrahim Aslan2David Baldwin3Kieran Chillingsworth4Arun Enara5Tim Gale6Kabir Garg7Matthew Garner8Robert Gordon9Natalie Hall10Nathan T. M. Huneke11Sonay Kucukterzi-Ali12Joanne McCarthy13Daniel Meron14Deela Monji-Patel15Roisin Mooney16Trevor Robbins17Megan Smith18Nick Sireau19David Wellsted20Solange Wyatt21Naomi A. Fineberg22Highly Specialised OCD and BDD Service, Hertfordshire Partnership NHS University Foundation TrustORCHARD-Advancing Global OCD Research CharityFaculty of Medicine, Clinical and Experimental Sciences (CNS and Psychiatry), University of SouthamptonFaculty of Medicine, Clinical and Experimental Sciences (CNS and Psychiatry), University of SouthamptonFaculty of Medicine, Clinical and Experimental Sciences (CNS and Psychiatry), University of SouthamptonHighly Specialised OCD and BDD Service, Hertfordshire Partnership NHS University Foundation TrustHighly Specialised OCD and BDD Service, Hertfordshire Partnership NHS University Foundation TrustHighly Specialised OCD and BDD Service, Hertfordshire Partnership NHS University Foundation TrustFaculty of Medicine, Clinical and Experimental Sciences (CNS and Psychiatry), University of SouthamptonSouthern Health NHS Foundation TrustUniversity of HertfordshireFaculty of Medicine, Clinical and Experimental Sciences (CNS and Psychiatry), University of SouthamptonHighly Specialised OCD and BDD Service, Hertfordshire Partnership NHS University Foundation TrustSouthern Health NHS Foundation TrustFaculty of Medicine, Clinical and Experimental Sciences (CNS and Psychiatry), University of SouthamptonHighly Specialised OCD and BDD Service, Hertfordshire Partnership NHS University Foundation TrustUniversity of HertfordshireDepartment of Psychology, Behavioural and Clinical Neuroscience Institute, University of CambridgeUniversity of HertfordshireORCHARD-Advancing Global OCD Research CharityUniversity of HertfordshireUniversity of HertfordshireHighly Specialised OCD and BDD Service, Hertfordshire Partnership NHS University Foundation TrustAbstract Background Obsessive–compulsive disorder (OCD) is a neuropsychiatric disorder which often proves refractory to current treatment approaches. Transcranial direct current stimulation (tDCS), a noninvasive form of neurostimulation, with potential for development as a self-administered intervention, has shown potential as a safe and efficacious treatment for OCD in a small number of trials. The two most promising stimulation sites are located above the orbitofrontal cortex (OFC) and the supplementary motor area (SMA). Methods The aim of this feasibility study is to inform the development of a definitive trial, focussing on the acceptability, safety of the intervention, feasibility of recruitment, adherence and tolerability to tDCS and study assessments and the size of the treatment effect. To this end, we will deliver a double-blind, sham-controlled, crossover randomised multicentre study in 25 adults with OCD. Each participant will receive three courses of tDCS (SMA, OFC and sham), randomly allocated and given in counterbalanced order. Each course comprises four 20-min stimulations, delivered over two consecutive days, separated by at least 4 weeks’ washout period. We will collect information about recruitment, study conduct and tDCS delivery. Blinded raters will assess clinical outcomes before, during and up to 4 weeks after stimulation using validated scales. We will include relevant objective neurocognitive tasks, testing cognitive flexibility, motor disinhibition, cooperation and habit learning. Discussion We will analyse the magnitude of the effect of the interventions on OCD symptoms alongside the standard deviation of the outcome measure, to estimate effect size and determine the optimal stimulation target. We will also measure the duration of the effect of stimulation, to provide information on spacing treatments efficiently. We will evaluate the usefulness and limitations of specific neurocognitive tests to determine a definitive test battery. Additionally, qualitative data will be collected from participants to better understand their experience of taking part in a tDCS intervention, as well as the impact on their overall quality of life. These clinical outcomes will enable the project team to further refine the methodology to ensure optimal efficiency in terms of both delivering and assessing the treatment in a full-scale trial. Trial registration ISRCTN17937049 . (date applied 08/07/2019). Recruitment (ongoing) began 23rd July 2019 and is anticipated to complete 30th April 2021.https://doi.org/10.1186/s40814-021-00945-6Obsessive–compulsive disorder (OCD)Transcranial direct current stimulation (tDCS)Noninvasive neurostimulationFeasibility studyRandomised controlled trial |
| spellingShingle | Eduardo Cinosi David Adam Ibrahim Aslan David Baldwin Kieran Chillingsworth Arun Enara Tim Gale Kabir Garg Matthew Garner Robert Gordon Natalie Hall Nathan T. M. Huneke Sonay Kucukterzi-Ali Joanne McCarthy Daniel Meron Deela Monji-Patel Roisin Mooney Trevor Robbins Megan Smith Nick Sireau David Wellsted Solange Wyatt Naomi A. Fineberg Feasibility and acceptability of transcranial stimulation in obsessive–compulsive symptoms (FEATSOCS): study protocol for a randomised controlled trial of transcranial direct current stimulation (tDCS) in obsessive–compulsive disorder (OCD) Pilot and Feasibility Studies Obsessive–compulsive disorder (OCD) Transcranial direct current stimulation (tDCS) Noninvasive neurostimulation Feasibility study Randomised controlled trial |
| title | Feasibility and acceptability of transcranial stimulation in obsessive–compulsive symptoms (FEATSOCS): study protocol for a randomised controlled trial of transcranial direct current stimulation (tDCS) in obsessive–compulsive disorder (OCD) |
| title_full | Feasibility and acceptability of transcranial stimulation in obsessive–compulsive symptoms (FEATSOCS): study protocol for a randomised controlled trial of transcranial direct current stimulation (tDCS) in obsessive–compulsive disorder (OCD) |
| title_fullStr | Feasibility and acceptability of transcranial stimulation in obsessive–compulsive symptoms (FEATSOCS): study protocol for a randomised controlled trial of transcranial direct current stimulation (tDCS) in obsessive–compulsive disorder (OCD) |
| title_full_unstemmed | Feasibility and acceptability of transcranial stimulation in obsessive–compulsive symptoms (FEATSOCS): study protocol for a randomised controlled trial of transcranial direct current stimulation (tDCS) in obsessive–compulsive disorder (OCD) |
| title_short | Feasibility and acceptability of transcranial stimulation in obsessive–compulsive symptoms (FEATSOCS): study protocol for a randomised controlled trial of transcranial direct current stimulation (tDCS) in obsessive–compulsive disorder (OCD) |
| title_sort | feasibility and acceptability of transcranial stimulation in obsessive compulsive symptoms featsocs study protocol for a randomised controlled trial of transcranial direct current stimulation tdcs in obsessive compulsive disorder ocd |
| topic | Obsessive–compulsive disorder (OCD) Transcranial direct current stimulation (tDCS) Noninvasive neurostimulation Feasibility study Randomised controlled trial |
| url | https://doi.org/10.1186/s40814-021-00945-6 |
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