Feasibility, acceptability and practicality of transcranial stimulation in obsessive compulsive symptoms (FEATSOCS): A randomised controlled crossover trial
Background: Transcranial direct current stimulation (tDCS) is a non-invasive form of neurostimulation with potential for development as a self-administered intervention. It has shown promise as a safe and effective treatment for obsessive compulsive disorder (OCD) in a small number of studies. The t...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-04-01
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| Series: | Comprehensive Psychiatry |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S0010440X23000081 |
| _version_ | 1811161903253159936 |
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| author | Naomi A. Fineberg Eduardo Cinosi Megan V.A. Smith Amanda D. Busby David Wellsted Nathan T.M. Huneke Kabir Garg Ibrahim H. Aslan Arun Enara Matthew Garner Robert Gordon Natalie Hall Daniel Meron Trevor W. Robbins Solange Wyatt Luca Pellegrini David S. Baldwin |
| author_facet | Naomi A. Fineberg Eduardo Cinosi Megan V.A. Smith Amanda D. Busby David Wellsted Nathan T.M. Huneke Kabir Garg Ibrahim H. Aslan Arun Enara Matthew Garner Robert Gordon Natalie Hall Daniel Meron Trevor W. Robbins Solange Wyatt Luca Pellegrini David S. Baldwin |
| author_sort | Naomi A. Fineberg |
| collection | DOAJ |
| description | Background: Transcranial direct current stimulation (tDCS) is a non-invasive form of neurostimulation with potential for development as a self-administered intervention. It has shown promise as a safe and effective treatment for obsessive compulsive disorder (OCD) in a small number of studies. The two most favourable stimulation targets appear to be the left orbitofrontal cortex (L-OFC) and the supplementary motor area (SMA). We report the first study to test these targets head-to-head within a randomised sham-controlled trial. Our aim was to inform the design of future clinical research studies, by focussing on the acceptability and safety of the intervention, feasibility of recruitment, adherence to and tolerability of tDCS, and the size of any treatment-effect. Methods: FEATSOCS was a randomised, double-blind, sham-controlled, cross-over, multicentre study. Twenty adults with DSM-5-defined OCD were randomised to treatment, comprising three courses of clinic-based tDCS (SMA, L-OFC, Sham), randomly allocated and delivered in counterbalanced order. Each course comprised four 20-min 2 mA stimulations, delivered over two consecutive days, separated by a ‘washout’ period of at least four weeks. Assessments were carried out by raters who were blind to stimulation-type. Clinical outcomes were assessed before, during, and up to four weeks after stimulation. Patient representatives with lived experience of OCD were actively involved at all stages. Results: Clinicians showed willingness to recruit participants and recruitment to target was achieved. Adherence to treatment and study interventions was generally good, with only two dropouts. There were no serious adverse events, and adverse effects which did occur were transient and mostly mild in intensity. Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores were numerically improved from baseline to 24 h after the final stimulation across all intervention groups but tended to worsen thereafter. The greatest effect size was seen in the L-OFC arm, (Cohen's d = −0.5 [95% CI −1.2 to 0.2] versus Sham), suggesting this stimulation site should be pursued in further studies. Additional significant sham referenced improvements in secondary outcomes occurred in the L-OFC arm, and to a lesser extent with SMA stimulation. Conclusions: tDCS was acceptable, practicable to apply, well-tolerated and appears a promising potential treatment for OCD. The L-OFC represents the most promising target based on clinical changes, though the effects on OCD symptoms were not statistically significant compared to sham. SMA stimulation showed lesser signs of promise. Further investigation of tDCS in OCD is warranted, to determine the optimal stimulation protocol (current, frequency, duration), longer-term effectiveness and brain-based mechanisms of effect. If efficacy is substantiated, consideration of home-based approaches represents a rational next step.Trial registration: ISRCTN17937049. https://doi.org/10.1186/ISRCTN17937049 |
| first_indexed | 2024-04-10T06:21:30Z |
| format | Article |
| id | doaj.art-4c42a6e4f53a4e77ac1febd7f2363f7d |
| institution | Directory Open Access Journal |
| issn | 0010-440X |
| language | English |
| last_indexed | 2024-04-10T06:21:30Z |
| publishDate | 2023-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Comprehensive Psychiatry |
| spelling | doaj.art-4c42a6e4f53a4e77ac1febd7f2363f7d2023-03-02T04:58:40ZengElsevierComprehensive Psychiatry0010-440X2023-04-01122152371Feasibility, acceptability and practicality of transcranial stimulation in obsessive compulsive symptoms (FEATSOCS): A randomised controlled crossover trialNaomi A. Fineberg0Eduardo Cinosi1Megan V.A. Smith2Amanda D. Busby3David Wellsted4Nathan T.M. Huneke5Kabir Garg6Ibrahim H. Aslan7Arun Enara8Matthew Garner9Robert Gordon10Natalie Hall11Daniel Meron12Trevor W. Robbins13Solange Wyatt14Luca Pellegrini15David S. Baldwin16Hertfordshire Partnership NHS University Foundation Trust, Highly Specialised OCD and BDD Service, Rosanne House, Parkway, Welwyn Garden City, Hertfordshire, UK; School of Life and Medical Sciences, University of Hertfordshire, Hatfield, Hertfordshire, UK; Clinical Medical School, University of Cambridge, UKHertfordshire Partnership NHS University Foundation Trust, Highly Specialised OCD and BDD Service, Rosanne House, Parkway, Welwyn Garden City, Hertfordshire, UK; School of Life and Medical Sciences, University of Hertfordshire, Hatfield, Hertfordshire, UKSchool of Life and Medical Sciences, University of Hertfordshire, Hatfield, Hertfordshire, UK; Corresponding author at: Health Research Building, College Lane Campus, University of Hertfordshire, Hatfield, Hertfordshire AL10 9AB, UK.School of Life and Medical Sciences, University of Hertfordshire, Hatfield, Hertfordshire, UKSchool of Life and Medical Sciences, University of Hertfordshire, Hatfield, Hertfordshire, UKClinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK; Southern Health NHS Foundation Trust, Tatchbury Mount, Southampton, UKThe Lishman Unit, South London and Maudsley NHS Foundation Trust, UKClinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UKCamden and Islington NHS Foundation Trust, London, UKClinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK; School of Psychology, University of Southampton, Southampton, UKSouthern Health NHS Foundation Trust, Tatchbury Mount, Southampton, UKSchool of Life and Medical Sciences, University of Hertfordshire, Hatfield, Hertfordshire, UKClinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK; Somerset NHS Foundation Trust, Taunton, Somerset, UKClinical Medical School, University of Cambridge, UKSchool of Life and Medical Sciences, University of Hertfordshire, Hatfield, Hertfordshire, UKHertfordshire Partnership NHS University Foundation Trust, Highly Specialised OCD and BDD Service, Rosanne House, Parkway, Welwyn Garden City, Hertfordshire, UK; School of Life and Medical Sciences, University of Hertfordshire, Hatfield, Hertfordshire, UKClinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK; Southern Health NHS Foundation Trust, Tatchbury Mount, Southampton, UK; University Department of Psychiatry and Mental Health, University of Cape Town, South AfricaBackground: Transcranial direct current stimulation (tDCS) is a non-invasive form of neurostimulation with potential for development as a self-administered intervention. It has shown promise as a safe and effective treatment for obsessive compulsive disorder (OCD) in a small number of studies. The two most favourable stimulation targets appear to be the left orbitofrontal cortex (L-OFC) and the supplementary motor area (SMA). We report the first study to test these targets head-to-head within a randomised sham-controlled trial. Our aim was to inform the design of future clinical research studies, by focussing on the acceptability and safety of the intervention, feasibility of recruitment, adherence to and tolerability of tDCS, and the size of any treatment-effect. Methods: FEATSOCS was a randomised, double-blind, sham-controlled, cross-over, multicentre study. Twenty adults with DSM-5-defined OCD were randomised to treatment, comprising three courses of clinic-based tDCS (SMA, L-OFC, Sham), randomly allocated and delivered in counterbalanced order. Each course comprised four 20-min 2 mA stimulations, delivered over two consecutive days, separated by a ‘washout’ period of at least four weeks. Assessments were carried out by raters who were blind to stimulation-type. Clinical outcomes were assessed before, during, and up to four weeks after stimulation. Patient representatives with lived experience of OCD were actively involved at all stages. Results: Clinicians showed willingness to recruit participants and recruitment to target was achieved. Adherence to treatment and study interventions was generally good, with only two dropouts. There were no serious adverse events, and adverse effects which did occur were transient and mostly mild in intensity. Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores were numerically improved from baseline to 24 h after the final stimulation across all intervention groups but tended to worsen thereafter. The greatest effect size was seen in the L-OFC arm, (Cohen's d = −0.5 [95% CI −1.2 to 0.2] versus Sham), suggesting this stimulation site should be pursued in further studies. Additional significant sham referenced improvements in secondary outcomes occurred in the L-OFC arm, and to a lesser extent with SMA stimulation. Conclusions: tDCS was acceptable, practicable to apply, well-tolerated and appears a promising potential treatment for OCD. The L-OFC represents the most promising target based on clinical changes, though the effects on OCD symptoms were not statistically significant compared to sham. SMA stimulation showed lesser signs of promise. Further investigation of tDCS in OCD is warranted, to determine the optimal stimulation protocol (current, frequency, duration), longer-term effectiveness and brain-based mechanisms of effect. If efficacy is substantiated, consideration of home-based approaches represents a rational next step.Trial registration: ISRCTN17937049. https://doi.org/10.1186/ISRCTN17937049http://www.sciencedirect.com/science/article/pii/S0010440X23000081Obsessive Compulsive DisorderOCDTranscranial Direct Current StimulationtDCSnon-invasive neurostimulationfeasibility study |
| spellingShingle | Naomi A. Fineberg Eduardo Cinosi Megan V.A. Smith Amanda D. Busby David Wellsted Nathan T.M. Huneke Kabir Garg Ibrahim H. Aslan Arun Enara Matthew Garner Robert Gordon Natalie Hall Daniel Meron Trevor W. Robbins Solange Wyatt Luca Pellegrini David S. Baldwin Feasibility, acceptability and practicality of transcranial stimulation in obsessive compulsive symptoms (FEATSOCS): A randomised controlled crossover trial Comprehensive Psychiatry Obsessive Compulsive Disorder OCD Transcranial Direct Current Stimulation tDCS non-invasive neurostimulation feasibility study |
| title | Feasibility, acceptability and practicality of transcranial stimulation in obsessive compulsive symptoms (FEATSOCS): A randomised controlled crossover trial |
| title_full | Feasibility, acceptability and practicality of transcranial stimulation in obsessive compulsive symptoms (FEATSOCS): A randomised controlled crossover trial |
| title_fullStr | Feasibility, acceptability and practicality of transcranial stimulation in obsessive compulsive symptoms (FEATSOCS): A randomised controlled crossover trial |
| title_full_unstemmed | Feasibility, acceptability and practicality of transcranial stimulation in obsessive compulsive symptoms (FEATSOCS): A randomised controlled crossover trial |
| title_short | Feasibility, acceptability and practicality of transcranial stimulation in obsessive compulsive symptoms (FEATSOCS): A randomised controlled crossover trial |
| title_sort | feasibility acceptability and practicality of transcranial stimulation in obsessive compulsive symptoms featsocs a randomised controlled crossover trial |
| topic | Obsessive Compulsive Disorder OCD Transcranial Direct Current Stimulation tDCS non-invasive neurostimulation feasibility study |
| url | http://www.sciencedirect.com/science/article/pii/S0010440X23000081 |
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