Obsessive-Compulsive DisorderTDCSTOCNCT02407288
tDCS as an add-on Treatment in SSRI-resistant OCD
A study testing transcranial dirrect current stimulation in people with Obsessive-Compulsive Disorder, run by Hôpital le Vinatier at 1 site in France.
Trial summary
The purpose of this study is to determine whether tDCS is effective as an add-on treatment in SSRI-resistant patients with obsessive and compulsive disorder Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- transcranial dirrect current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2015to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with OCD according to DSM V criteria
- YBOCS score of 16 and above, stable (<20% of variation) during at least one month.
- have received for at least 12 weeks of which 6 weeks was either at the maximum tolerated dose or alternatively the manufacturer's recommended maxi- mum daily dose.
- age between 18 and 70
- voluntary and competent to consent
Who cannot join
- Major depressive disorder diagnosed with the DSM V criteria with a MADRS score >30 (actual)
- schizophrenia and other psychotic disorder
- drugs or alcohol abuse
- acutely suicidal
- significant head injury, or of any neurosurgical procedure with implanted material
- pregnant women
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Le Vinatier
Bron, 69500
remy bation, MD, 33437915565, remy.bation@chu-lyon.fr
About this study
Official title: Transcranial Direct Current Stimulation as an add-on Treatment in SSRI-resistant Obsessive Compulsive Disorder : a Randomized Clinical Trial
The purpose of this study is to determine whether tDCS is effective as an add-on treatment in SSRI-resistant patients with obsessive and compulsive disorder
Read the detailed description
Total number of scheduled patients to be recruited: 46 We used the effect size of the study of Ruffini and colleagues (2009) in which rTMS was used to target the left orbito frontal cortex to calculate the number of patients to be recruited. With a risk alpha of 5%, a power of 80%, the number of patients to be included was 46 with an anticipated rate of 10% of lost to follow-up patients. (calculation was made on the http://www.spc.univ-lyon1.fr/mfcalc/NSN/assistant.htm)
Statistical analysis to address the primary and secondary objectives:
Chi squared test will be applied for quantitative data.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- transcranial dirrect current stimulation, Sham tDCS
- Keywords
- OCD
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial dirrect current stimulationDevice
Also called tdcs
The tDCS device will deliver a direct current of 2mA during 20 minutes. Cathode will be localized in front of the left orbito-frontal on the FP3 point according to the EEG international reference. Anode will be localized in front of the right cerebellum 3 cm below the inion and 1 cm right from the midline
Sham tDCSDevice
| Study group | Role | What they receive |
|---|---|---|
| active tDCS | Active comparator | patients will received 2 sessions per day for 5 consecutive days. Each session will last 20 minutes. The tDCS device will deliver a direct current of 2mA during 20 minutes. Cathode will be localized in front of the left orbito-frontal on the FP3 point according to the EEG international reference. Anode will be localized in front of the right cerebellum 3 cm below the inion and 1 cm right from the midline Receives: Device: transcranial dirrect current stimulation |
| SHAM tDCS | Placebo comparator | The same procedure will be applied except that the tDCS device will only deliver a current stimulation for the 10 first seconds. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
score improvement on the Yale Brown Obsessive and Compulsive Scale after one month
% of improvement compare to baseline
Measured: 1 month after treatment
Secondary outcomes (2)
Number of responders on the YBOCS
Number of responders (decrease >35%) on the Yale Brown Obsessive and Compulsive Scale) or a score of 2 or less on the CGI-I (much or very much improved)
Measured: 1 month after treatment
score improvement on the Yale Brown Obsessive and Compulsive Scale after 3 months
% of improvement compare to baseline
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study start12 Mar 2015
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BATION Rémy, Hôpital le Vinatier
- Investigators
- Bation Remy, MD, Principal investigator, CH le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407288
- Sponsor's protocol ID
- CSR G01
- Acronym
- TDCSTOC
- Status last verified
- May 2017
- First submitted
- 30 Mar 2015
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation as an add-on Treatment in SSRI-resistant Obsessive Compulsive Disorder : a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02407288
- Acronym / sponsor ID
- TDCSTOC / CSR G01
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- OCD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 12 Mar 2015 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether tDCS is effective as an add-on treatment in SSRI-resistant patients with obsessive and compulsive disorder
Detailed description
Total number of scheduled patients to be recruited: 46 We used the effect size of the study of Ruffini and colleagues (2009) in which rTMS was used to target the left orbito frontal cortex to calculate the number of patients to be recruited. With a risk alpha of 5%, a power of 80%, the number of patients to be included was 46 with an anticipated rate of 10% of lost to follow-up patients. (calculation was made on the http://www.spc.univ-lyon1.fr/mfcalc/NSN/assistant.htm)
Statistical analysis to address the primary and secondary objectives:
Chi squared test will be applied for quantitative data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tDCS | Active comparator | Device: transcranial dirrect current stimulationpatients will received 2 sessions per day for 5 consecutive days. Each session will last 20 minutes. The tDCS device will deliver a direct current of 2mA during 20 minutes. Cathode will be localized in front of the left orbito-frontal on the FP3 point according to the EEG international reference. Anode will be localized in front of the right cerebellum 3 cm below the inion and 1 cm right from the midline |
| SHAM tDCS | Placebo comparator | Device: Sham tDCSThe same procedure will be applied except that the tDCS device will only deliver a current stimulation for the 10 first seconds. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients diagnosed with OCD according to DSM V criteria
- YBOCS score of 16 and above, stable (<20% of variation) during at least one month.
- have received for at least 12 weeks of which 6 weeks was either at the maximum tolerated dose or alternatively the manufacturer's recommended maxi- mum daily dose.
- age between 18 and 70
- voluntary and competent to consent
Key exclusion criteria (6 listed)
- Major depressive disorder diagnosed with the DSM V criteria with a MADRS score >30 (actual)
- schizophrenia and other psychotic disorder
- drugs or alcohol abuse
- acutely suicidal
- significant head injury, or of any neurosurgical procedure with implanted material
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial dirrect current stimulationAlso: tdcsThe tDCS device will deliver a direct current of 2mA during 20 minutes. Cathode will be localized in front of the left orbito-frontal on the FP3 point according to the EEG international reference. Anode will be localized in front of the right cerebellum 3 cm below the inion and 1 cm right from the midline | Device | active tDCS |
| Sham tDCS | Device | SHAM tDCS |
Primary outcome
score improvement on the Yale Brown Obsessive and Compulsive Scale after one month
Time frame: 1 month after treatment
% of improvement compare to baseline
2 secondary outcomes
Number of responders on the YBOCS
Time frame: 1 month after treatment
score improvement on the Yale Brown Obsessive and Compulsive Scale after 3 months
Time frame: 3 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bation Remy, MD principal investigator
CH le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial dirrect current stimulation in people with Obsessive-Compulsive Disorder, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bation Remy, MD (33437915565, remy.bation@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score improvement on the Yale Brown Obsessive and Compulsive Scale after one month (time frame: 1 month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.