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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).

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cam.issuedOnline2021-12-06
dc.contributor.authorCinosi, Eduardo
dc.contributor.authorAdam, David
dc.contributor.authorAslan, Ibrahim
dc.contributor.authorBaldwin, David
dc.contributor.authorChillingsworth, Kieran
dc.contributor.authorEnara, Arun
dc.contributor.authorGale, Tim
dc.contributor.authorGarg, Kabir
dc.contributor.authorGarner, Matthew
dc.contributor.authorGordon, Robert
dc.contributor.authorHall, Natalie
dc.contributor.authorHuneke, Nathan TM
dc.contributor.authorKucukterzi-Ali, Sonay
dc.contributor.authorMcCarthy, Joanne
dc.contributor.authorMeron, Daniel
dc.contributor.authorMonji-Patel, Deela
dc.contributor.authorMooney, Roisin
dc.contributor.authorRobbins, Trevor
dc.contributor.authorSmith, Megan
dc.contributor.authorSireau, Nick
dc.contributor.authorWellsted, David
dc.contributor.authorWyatt, Solange
dc.contributor.authorFineberg, Naomi A
dc.contributor.orcidCinosi, Eduardo [0000-0002-8903-181X]
dc.contributor.orcidRobbins, Trevor [0000-0003-0642-5977]
dc.date.accessioned2021-12-24T13:36:06Z
dc.date.available2021-12-24T13:36:06Z
dc.date.issued2021-12-06
dc.date.submitted2021-01-26
dc.date.updated2021-12-24T13:36:06Z
dc.description.abstractBACKGROUND: 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.
dc.identifier.doi10.17863/CAM.79241
dc.identifier.eissn2055-5784
dc.identifier.issn2055-5784
dc.identifier.others40814-021-00945-6
dc.identifier.other945
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/331792
dc.languageen
dc.publisherSpringer Science and Business Media LLC
dc.subjectStudy Protocol
dc.subjectObsessive–compulsive disorder (OCD)
dc.subjectTranscranial direct current stimulation (tDCS)
dc.subjectNoninvasive neurostimulation
dc.subjectFeasibility study
dc.subjectRandomised controlled trial
dc.titleFeasibility 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).
dc.typeArticle
dcterms.dateAccepted2021-11-01
prism.issueIdentifier1
prism.publicationNamePilot Feasibility Stud
prism.volume7
pubs.funder-project-idResearch for Patient Benefit Programme (PB-PG-1216-20005)
pubs.funder-project-idORCHARD (ORCHARD OCD contract)
rioxxterms.licenseref.urihttp://creativecommons.org/licenses/by/4.0/
rioxxterms.versionVoR
rioxxterms.versionofrecord10.1186/s40814-021-00945-6

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