Feasibility and acceptability of transcranial stimulation in obsessive-compulsive symptoms

ISRCTN	ISRCTN17937049
DOI	https://doi.org/10.1186/ISRCTN17937049
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	CPMS: 41100
Sponsor	Hertfordshire Partnership University NHS Foundation Trust
Funder	NIHR Central Commissioning Facility (CCF); Grant Codes: PB-PG-1216-20005

Submission date: 08/07/2019
Registration date: 22/07/2019
Last edited: 30/01/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Obsessive-compulsive disorder is a major mental disorder. About 40% of 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. The aim is 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. The researchers 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.

Who can participate?
Treatment-seeking adults with OCD are recruited from mental health units, GP referrals and improved access to psychological therapies services.

What does the study involve?
The study takes place in community mental health facilities. Twenty-five patients with OCD receive three courses of four twice-daily 20-minute sessions of tDCS (either active or sham stimulation) delivered to two separate brain targets. The courses are allocated in a random 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 are 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. Patients are asked if they found the treatment acceptable.

What are the possible benefits and risks of participating?
Those taking part in the study will have the chance to receive transcranial direct current stimulation (tDCS) which may turn out to be a helpful new treatment for OCD. However, the short course of stimulation received is not expected to provide real lasting clinical benefit. Participants will also have the opportunity to receive extra detailed assessments conducted by a member of the research team. The information gained from this study will help the researchers to decide whether or not to set up a larger study which in turn should provide information for improving the treatment of OCD. It is important to stress that the tDCS equipment used is designed to be used by patients with depression at their home without supervision. The researchers will be using it in a controlled laboratory environment under constant supervision. It is not anticipated that there will be any severe side effects from taking part in this study.

Where is the study run from?
Southampton University (UK)

When is the study starting and how long is it expected to run for?
December 2018 to July 2021

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
1. Megan Smith
m.smith25@herts.ac.uk
2. Prof. Naomi Fineberg
Naomi.fineberg@nhs.net

Contact information

Miss Megan Smith
Scientific

Health Research Building
University of Hertfordshire
Hatfield
AL10 9AB
United Kingdom

Email	m.smith25@herts.ac.uk

Prof Naomi Fineberg
Scientific

Rosanne House
Dept of Psychiatry
OCD Specialist Service
Welwyn Garden City
AL8 6HG
United Kingdom

Phone	+44 (0)1707 364055
Email	Naomi.fineberg@nhs.net

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Treatment, Device
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Feasibility and acceptability of transcranial stimulation in obsessive-compulsive symptoms
Study acronym	FEATSOCS
Study objectives	Obsessive-compulsive disorder is a major mental disorder. About 40% of 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. The aim is 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. The researchers 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.
Ethics approval(s)	Approved 27/03/2019, East of England - Cambridgeshire and Hertfordshire Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; Tel: +44 (0)2071048102), ref: 19/EE/0046
Health condition(s) or problem(s) studied	Obsessive-compulsive disorder
Intervention	In this study, treatment-seeking adults with OCD are recruited from mental health units, GP referrals and improved access to psychological therapies services. 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. The researchers will ask patients if they found the treatment acceptable. Recruitment is expected to take 12 months.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	1. Acceptability, tolerability and safety of the intervention is determined using treatment logs recorded during and following study visits. Specifically: 1.1. Sessions completed and missed (acceptability, tolerability) 1.2. Recording of issues raised by patients at any point during the study. Adverse events reported at any point, specifically recorded at study visits (safety) 2. Feasibility of recruitment is determined using logs of referral into the services, by recording the numbers of potential patients, as well as why patients were excluded at each point, and the number of patients consented. 3. Adherence to tDCS and the study protocol assessed by recording sessions, and the proportion of study outcomes completed is determined using notes on issues raised by patients and researchers that are recorded during the study. 4. Willingness evaluated by recording the numbers of key staff approached, those declining study participation and the reasons given. 5. tDCS in a clinical setting assessed by recording any issues relating to setting up the sessions, delivery of the stimulation, and issues raised by the participants during or in the hours after the stimulation sessions. Difficulties with the application of the treatment protocols and equipment failures are noted
Key secondary outcome measure(s)	Current secondary outcome measures as of 24/07/2019: 1. Optimal stimulation target (OFC, SMA) effect on OCD symptoms is measured using Y-BOCS and Y-BOCS challenge (as appropriate)scores utilising all available data (from 1 hour after the first stimulation to 14 days after the last stimulation). 2. Likely magnitude of the effect of the intervention on OCD symptoms is measured using the Y-BOCS 24 hours after the final stimulation. 3. Duration of effect of stimulation is measured separately for the OFC and SMA targets using paired tests usingY-BOCS and Y-BOCS Challenge at all time points following the first stimulation. 4. Usefulness and limitations of specific neurocognitive tests is measured using the CANTAB (stop signal reaction time test, intra-extradimensional set shift), Prisoner's Dilemma test (cooperation test), andFabulous Fruit game (habit learning test) at baseline and 3 hours. Previous secondary outcome measures: 1. Optimal stimulation target (OFC, SMA) effect on OCD symptoms is measured using Y-BOCS and Y-BOCS challenge (as appropriate) scores utilising all available data (from 1 hour after the first stimulation to 14 days after the last stimulation) 2. Likely magnitude of the effect of the intervention on OCD symptoms is measured using the Y-BOCS 24 hours after the final stimulation 3. Duration of effect of stimulation is measured separately for the OFC and SMA targets using paired tests using Y-BOCS and Y-BOCS Challenge at all timepoints following the first stimulation 4. Usefulness and limitations of specific neurocognitive tests are measured using the CANTAB (stop signal reaction time test, intra-extradimensional set shift), Prisoner's Dilemma test (cooperation test), and Fabulous Fruit game (habit learning test) at baseline and 3 hours
Completion date	31/07/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	25
Total final enrolment	20
Key inclusion criteria	1. Community-based service-users, aged 18-65 years 2. DSM-5 defined obsessive-compulsive disorder determined by a research psychiatrist using the structured interview for DSM-5 3. Duration of symptoms > 1 year (from medical history) 4. Baseline score >= 20 on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) 5. Ongoing medication (SSRI, tricyclic antidepressant, antipsychotic, benzodiazepine) is allowed as long as the dose is kept stable for a sustained period before (> = 6 weeks) randomisation and remains so throughout the study. CBT is not allowed during or within 6 weeks of the start of the intervention
Key exclusion criteria	1. History of psychotic disorder (schizophrenia, psychotic symptoms, bipolar disorder), Tourette syndrome (tic disorders not amounting to Tourette syndrome will not be exclusionary), organic mental disorder, psychosurgery, personality disorder of borderline or histrionic type 2. Alcohol/substance-abuse disorders within the past 12 months 3. Any other DSM-5 disorder that is considered the primary focus of treatment 4. Severe depression, defined by a Montgomery-Åsberg Depression Rating Scale (MÅDRS) score > 30 at baseline 5. Actively planning suicide (scoring 5 or 6 on item 10 of MADRS) or judged by the clinician to be at significant risk of self-harm 6. Received CBT involving ERP from an accredited (British Association of Behavioural and Cognitive Psychotherapies (BABCP) approved or equivalent) therapist (e.g. IAPTs stage 2) in the last 6 weeks 7. Highly CBT resistant (inadequate clinical response, equivalent to < 25% improvement) > = 3 previous adequate (> 12 weeks) trials of CBT involving ERP from an accredited (BABCP-approved or equivalent) therapist 8. Highly medication resistant (inadequate clinical response, equivalent to < 25% improvement) > = 3 previous adequate (> 12 weeks) trials of any SSRI or clomipramine taken at optimal doses with adequate adherence 9. Needing regular psychotropic drugs other than permitted medication 10. Currently involved in a treatment research study 11. Acute or unstable physical illness 12. Skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites 13. History of surgical procedure with implanted body materials or devices (e.g. metal, pacemakers) 14. Epilepsy or other clinically defined neurological disorder or insult 15. Inadequate understanding of English to give informed consent or such that the outcome measurement is impossible 16. Women of child-bearing age not using reliable contraception (e.g. oral contraception pill, intra-uterine contraceptive device or condom) 17. Pregnant or breastfeeding women
Date of first enrolment	15/07/2019
Date of final enrolment	31/03/2021

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Rosanne House

HPFT
Welwyn Garden City
AL8 6HG
United Kingdom

Southampton University Department of Psychiatry

College Keep
4-12 Terminus Terrace
Southampton
SO14 3DT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The data will be made available in a generic format (e.g. tab-delimited) and will be available on completion of reporting of the main trial outcomes. Requests for data access should be directed to the CI (Prof Naomi Fineberg) or the Sponsor (University of Hertfordshire, email: uhclinicaltrialsupportnetwork@herts.ac.uk) who will review the data request to evaluate the extent to which the request is appropriate to the needs of the clinical and patient community and meets appropriate ethical standards.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		26/01/2023	30/01/2023	Yes	No
Protocol article		06/12/2021	08/12/2021	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

30/01/2023: Publication reference added.
02/08/2022: The intention to publish date was changed from 31/07/2022 to 30/09/2022.
13/12/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/01/2021 to 31/03/2021.
2. The intention to publish date was changed from 31/12/2021 to 31/07/2022.
08/12/2021: Publication reference added.
05/08/2021: The following changes were made to the trial record:
1. The total final enrolment number has been added.
2. The study contact has been updated and the plain English summary has been updated accordingly.
16/12/2020: IPD sharing statement added.
01/12/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 15/07/2020 to 31/01/2021.
2. The overall trial end date was changed from 01/12/2020 to 31/07/2021.
3. The intention to publish date was changed from 01/05/2021 to 31/12/2021.
4. Contact details updated.
24/07/2019: The secondary outcome measures were updated.
08/07/2019: Trial's existence confirmed by the NIHR.