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

Trevor Robbins¹  Matthew Garner²  David Baldwin²  Ibrahim Aslan²  Kieran Chillingsworth²  Daniel Meron³  Nathan T. M. Huneke⁴  Arun Enara⁵  Kabir Garg⁵  Tim Gale⁶  Eduardo Cinosi⁶  Deela Monji-Patel⁶  Sonay Kucukterzi-Ali⁶  Naomi A. Fineberg⁷  David Adam⁸  Nick Sireau⁸  Robert Gordon⁹  Joanne McCarthy⁹  David Wellsted^1,10  Roisin Mooney^1,10  Solange Wyatt^1,10  Natalie Hall^1,10  Megan Smith^1,10 

[1] Department of Psychology, Behavioural and Clinical Neuroscience Institute, University of Cambridge, Cambridge, UK;Faculty of Medicine, Clinical and Experimental Sciences (CNS and Psychiatry), University of Southampton, Southampton, UK;Faculty of Medicine, Clinical and Experimental Sciences (CNS and Psychiatry), University of Southampton, Southampton, UK;Somerset NHS Foundation Trust, Taunton, UK;Faculty of Medicine, Clinical and Experimental Sciences (CNS and Psychiatry), University of Southampton, Southampton, UK;Southern Health NHS Foundation Trust, Southampton, UK;Highly Specialised OCD and BDD Service, Hertfordshire Partnership NHS University Foundation Trust, Rosanne House, Parkway, Welwyn Garden City, Hertfordshire, UK;Highly Specialised OCD and BDD Service, Hertfordshire Partnership NHS University Foundation Trust, Rosanne House, Parkway, Welwyn Garden City, Hertfordshire, UK;University of Hertfordshire, Hertfordshire, UK;Highly Specialised OCD and BDD Service, Hertfordshire Partnership NHS University Foundation Trust, Rosanne House, Parkway, Welwyn Garden City, Hertfordshire, UK;University of Hertfordshire, Hertfordshire, UK;Department of Psychology, Behavioural and Clinical Neuroscience Institute, University of Cambridge, Cambridge, UK;ORCHARD-Advancing Global OCD Research Charity, Cambridge, UK;Southern Health NHS Foundation Trust, Southampton, UK;University of Hertfordshire, Hertfordshire, UK;

关键词: Obsessive–compulsive disorder (OCD);    Transcranial direct current stimulation (tDCS);    Noninvasive neurostimulation;    Feasibility study;    Randomised controlled trial;   

DOI  :  10.1186/s40814-021-00945-6

来源: Springer

【 摘 要 】

BackgroundObsessive–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).MethodsThe 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.DiscussionWe 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 registrationISRCTN17937049. (date applied 08/07/2019).Recruitment (ongoing) began 23rd July 2019 and is anticipated to complete 30th April 2021.

【 授权许可】

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