University of Hertfordshire

From the same journal

By the same authors

  • Eduardo Cinosi
  • David Adam
  • Ibrahim Aslan
  • David Baldwin
  • Kieran Chillingsworth
  • Arun Enara
  • Tim Gale
  • Kabir Garg
  • Matthew Garner
  • Robert Gordon
  • Nathan Huneke
  • Sonay-Gul Kucukterzi
  • Joanne McCarthy
  • Daniel Meron
  • Deela Monji-Patel
  • Roisin Mooney
  • Trevor W. Robbins
  • Nick Sireau
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Original languageEnglish
JournalBMC Pilot and Feasibility Studies
Publication statusAccepted/In press - 22 Sep 2021

Abstract

Background
Obsessive Compulsive Disorder (OCD) is a neuropsychiatric disorder which often proves refractory to current treatment approaches. Transcranial Direct Current Stimulation (tDCS), a non-invasive 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, cross-over 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 minutes-stimulations, delivered over two consecutive days, separated by at least four 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 four 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.

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