Effects of transcranial direct current stimulation (tDCS) in obsessive-compulsive disorder
| ISRCTN | ISRCTN99571476 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99571476 |
| Secondary identifying numbers | KO 3744/11-1 |
- Submission date
- 18/03/2022
- Registration date
- 22/03/2022
- Last edited
- 23/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims:
Obsessive-compulsive disorder (OCD) is a psychiatric disease characterized by obsessions and compulsions. Obsessions are described as recurrent and persistent thoughts or impulses which are perceived by the patients as unwanted and hard to inhibit. Compulsions are defined as repetitive behaviours or mental thoughts which patients are unable to control or inhibit. Hence, a deficit in inhibition is considered as a core characteristic of OCD. Inhibition deficits in OCD have been shown to go along with altered activity in specific regions of the brain. There is mounting evidence indicating that transcranial direct current stimulation (tDCS) (i.e., stimulation of the brain by a very light electric current) improves inhibition performance in healthy subjects but no comparable studies have been performed in patients with OCD up to now. Against this background this study aims to investigate the effects of tDCS on clinical symptoms, behavioral inhibition and brain activation in a group of patients suffering from OCD. A tDCS-related improvement in behavioral inhibition and clinical state would underline the clinical relevance of inhibitory capacities and demonstrate the effectiveness of tDCS for OCD. Moreover, normalized brain activation as a result of tDCS would reveal the mechanisms underlying the associated improvements in behavioral inhibition.
Who can participate?
Patients with a primary diagnosis of OCD according to DSM V.
What does the study involve?
tDCS during magnetic resonance imaging (MRI) for 20 minutes
What are the possible benefits and risks of participating:?
There are no personal benefits of participating, except for reimbursement (i.e., 150 €) and a screening of your brain performed by a neuroradiologist. The risks of participating are incidental findings in the MRI image that may cause subjective worries or might require additional treatment. tDCS risks are minimal and can involve transient symptoms such as warming at the stimulation site, tingling at the stimulation site, a slight headache or a slight feeling of dizziness. MRI risks are likewise minimal and can also comprise a transient feeling of dizziness or a slight headache.
Where is the study run from?
Klinikum rechts der Isar, München (Germany)
When is the study started and how long is it expected to run for?
November 2020 to December 2023
Who is funding the study?
Deutsche Forschungsgemeinschaft (DFG KO 3744/11-1) (Germany)
Who is the main contact?
Prof. Dr. Kathrin Koch, kathrin.koch@tum.de
Contact information
Principal Investigator
Klinikum rechts der Isar
Abteilung für diagnostische und interventionelle Neuroradiologie
Neuroimaging Center (TUM-NIC)
Einsteinstr. 1
81675 München
Munich
81675
Germany
 ORCID ID |
0000-0003-4664-8016 |
|---|---|
| Phone | +49 (0)8941407972 |
| kathrin.koch@tum.de |
Study information
| Study design | Single center interventional double-blinded randomized cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not availabe in web format, please use contact details to request a participant information sheet |
| Scientific title | Effects of transcranial direct current stimulation (tDCS) on response inhibition and neuronal activity in obsessive-compulsive disorder |
| Study acronym | TDCSOCD |
| Study hypothesis | 1. tDCS as compared to sham stimulation will go along with a significant improvement in response inhibition 2. tDCS as compared to sham stimulation will go along with an increased activation during inhibition in preSMA and vmPFC. This increased activation will be correlated with the improvement in response inhibition |
| Ethics approval(s) | Approved 21/03/2022, Ethics Committee of Klinikum Rechts der Isar, Technische Universität München (Ethikkommission der Technischen Universität München, Ismaninger Straße 22, 81675 München, Germany; +49 (0)89/4140-7737; ethikkommission@mri.tum.de), ref: 141/22 S |
| Condition | Effects of transcranial direct current stimulation (tDCS) in patients suffering from obsessive-compulsive disorder |
| Intervention | tDCS (active condition) vs. sham tDCS (control condition) will be applied in a double-blinded randomized cross-over design. tDCS in the active condition will comprise 20 minutes of anodal tDCS over the preSMA region with a current of 2mA in the MRI. tDCS in the control condition will comprise 20 minutes of sham tDCS (20 sec. fade-in, fade out) over the preSMA region. Participants are randomly assigned to the different arms using a random number generator system. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Transcranial direct current stimulation (tDCS) |
| Primary outcome measure | 1. Brain activation and connectivity measured during real tDCS and sham tDCS using functional magnetic resonance imaging (fMRI) during two response inhibition tasks. Real tDCS and sham tDCS take place 1 week apart. 2. Inhibition performance measured with two well-established inhibition tasks (Stroop task, Stop-Signal-task) at T0 (i.e., first MRI measurement timepoint) and T1 (i.e., 1 week later). |
| Secondary outcome measures | Clinical symptoms assessed with the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at T0 (i.e., first MRI measurement timepoint) and T1 (i.e., 1 week later) |
| Overall study start date | 01/11/2020 |
| Overall study end date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 44 |
| Total final enrolment | 47 |
| Participant inclusion criteria | 1. MRI compatibility, age 18-65 years, right-handedness 2. OCD according to DSM-V 3. At least a score of 8 in the Y-BOCS scale 4. No additional psychopharmacological medication (e.g. antipsychotic medication) 5. No bipolar disorder, no schizophrenia, no schizo-affective disorder, no posttraumatic stres disorder, no substance abuse (apart from nicotine), no personality disorder |
| Participant exclusion criteria | 1. Suicidality 2. Neurological disorder 3. Pregnancy 4. Inability to provide consent 5. No willingness to provide consent after information about the study 6. Medicated with benzodiazepines within the last 24 hours |
| Recruitment start date | 01/04/2022 |
| Recruitment end date | 31/05/2023 |
Locations
Countries of recruitment
- Germany
Study participating centre
Abteilung für diagnostische und interventionelle Neuroradiologie
Neuroimaging Center (TUM-NIC)
Einsteinstr. 1
München
81675
Germany
Sponsor information
Research organisation
Deutsche Forschungsgemeinschaft e.V.
Kennedyallee 40
Bonn
53175
Germany
| Phone | +49 (228) 885-1 |
|---|---|
| postmaster@dfg.de | |
| Website | http://www.dfg.de/en/ |
"ROR" |
https://ror.org/018mejw64 |
Funders
Funder type
Research organisation
Government organisation / National government
- Alternative name(s)
- German Research Association, German Research Foundation, DFG
- Location
- Germany
Results and Publications
| Intention to publish date | 01/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Raw data will not be shared |
Editorial Notes
23/01/2025: The intention to publish date was changed from 01/01/2024 to 01/03/2025. Total final enrolment added.
01/04/2022: The ethics approval was added.
21/03/2022: Trial's existence confirmed by Deutsche Forschungsgemeinschaft.
