FEATSOCS
Research type
Research Study
Full title
Feasibility and Acceptability of Transcranial Stimulation in Obsessive Compulsive Symptoms
IRAS ID
254507
Contact name
Naomi Fineberg
Contact email
Sponsor organisation
Hertfordshire Partnership University NHS Foundation Trust
ISRCTN Number
ISRCTN17937049
Duration of Study in the UK
1 years, 9 months, 2 days
Research summary
Summary of Research
Obsessive compulsive disorder is major mental disorder. About 40% patients are not helped by available treatments. New approaches are needed. One promising treatment is transcranial direct current stimulation (tDCS). tDCS uses an electrode placed for a short time on the scalp to pass a small, almost imperceptible electric current into brain areas connected to OCD. This may help people with OCD think and behave differently and could help existing treatments work better. tDCS is relatively new and experimental in OCD though it has been used with some success in depression. This small-sized study is a pilot (feasibility study) preparing for a larger trial. We aim to answer basic questions, including if tDCS lessens OCD symptoms, the nature and severity of any side effects and if doctors and patients are willing to use it. We also investigate which specific brain areas should be targeted and how long positive effects last. This information would help the design and conduct of larger clinical trials. In this study, treatment-seeking adults with OCD are recruited from mental health units, GP referrals and improved access to psychological therapies services. The study takes place in community mental health facilities. Twenty-five patients with OCD will receive three courses of four twice-daily 20 minute sessions of tDCS (either active or sham stimulation) delivered to 2 separate brain targets. The courses are allocated in a randomised order. Each 2-day course of tDCS is spaced 4 weeks apart to avoid ‘carry over’ effects, and see how long the effects last. Patients will be asked about the experience and have their symptoms and any side effects assessed using questionnaires. The assessor will not know which patients have received which course of treatment to reduce bias. We will ask patients if they found the treatment acceptable. Recruitment is expected to take 12 months.Summary of Results
A total of 135 individuals were identified as potentially eligible to take part in the study, of whom 36 consented to initial screening. Twenty patients consented to take part and were randomly allocated to receive the three brain stimulation conditions in one of the 6 available sequences. Despite the impact of COVID-19, recruitment of participants to the study was shown to be achievable and clinicians were willing to recruit participants to the study.Following randomisation, two of the 20 participants withdrew from the study, both for reasons related to COVID-19 anxiety and unrelated to the study protocol. All other participants completed all three rounds of stimulation. One participant was unable to attend one of the stimulation days due to unconnected physical ill-health but continued with the study. For those patients who continued with the study, almost all assessments were completed.
Measures of OCD collected over the course of the stimulation-days showed a reduction in symptoms following brain stimulation, with most benefit seen for one of the two stimulation targets. The effects of the intervention on OCD symptoms however, seemed to diminish around 4 hours after stimulation. Of the side effects that were reported by participants, none were serious and most were mild, short-lived, and judged unlikely to be related to the intervention.
Overall, the intervention was acceptable to patients with OCD, practicable to apply, well-tolerated and safe. Recruitment was feasible and brain stimulation showed a reduction in OCD symptoms. Further research to determine the size and duration of effects in OCD is warranted.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
19/EE/0046
Date of REC Opinion
29 Mar 2019
REC opinion
Further Information Favourable Opinion