Obsessive-compulsive Disorder (OCD)NEP-TOCNCT03605316
Deep Electrical Neuromodulation in Obsessive-compulsive Disorder
An observational study of Obsessive-compulsive Disorder (OCD), run by University Hospital, Montpellier at 1 site in France.
Trial summary
Obsessive-compulsive disorder (OCD) is a neuropsychiatric disease characterised by intrusive, recurrent and persistent thoughts, urges or images (obsessions) and the resulting excessive repetitive behaviours or mental acts according to rigid rules unrealistically aimed at reducing distress (compulsions). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-compulsive Disorder (OCD)
- What is being tested?
- Deep brain stimulation (DBS)
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2018to 30 Jun 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Six patients consisting in three males and three females aged 18 years and over implanted at the University Hospital (CHU) of Montpellier (France) between June 2003 and February 2013.
Who may be able to join
- all patients with severe and refractory OCD according to DSM-IV criteria, confirmed by experienced psychiatrist
- treated by DBS at the CHU of Montpellier
Who cannot join
- already enrolled in a study protocol at time of implantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electric Neuromodulation in Refractory Obsessive-compulsive Disorder : the Montpellier Experience (France)
Obsessive-compulsive disorder (OCD) is a neuropsychiatric disease characterised by intrusive, recurrent and persistent thoughts, urges or images (obsessions) and the resulting excessive repetitive behaviours or mental acts according to rigid rules unrealistically aimed at reducing distress (compulsions).
Its lifetime prevalence in the general population is usually estimated between 1 - 3% (Ruscio, Mol Psychiatry, 2010). Despite appropriate pharmacological and cognitive-behavioural treatments, it is commonly estimated that 10% of patients are therapy-refractory and that among improved or recovered patients, sustained efficacy is uncertain.
Read more
For treatment refractory OCD patients, a neurosurgical treatment by deep brain stimulation (DBS), has emerged in the late 1990s as a new therapeutic option (Nuttin et al, Lancet, 1999).
The objective of the current study is to report the long-term treatment effects (safety and effectiveness) of DBS from the cohort of six severe and therapy-refractory OCD patients implanted at the French university hospital of Montpellier since 2003.
Read the detailed description
The data needed to carry out the study will be extracted from the medical files of the 6 patients concerned.
The following data will be collected:
- Age, sex
- Medical, surgical and psychiatric history
- History of pharmacological treatments
- Elements from clinical examination
- any reported adverse effect
- scores of the various questionnaires completed throughout the follow-up (including Y-BOCS and GAF)
- results of biological, morphological, neuropsychological tests
- Stimulation parameters applied since implantation.
- Conditions
- Obsessive-compulsive Disorder (OCD)
- Being tested
- Deep brain stimulation (DBS)
- Keywords
- Deep brain stimulation, obsessive-compulsive disorder, neuromodulation, psychiatry, quality of life
- 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.
Deep brain stimulation (DBS)Procedure or surgery
Neurosurgical treatment by stereotactic implantation of electrodes in the brain that affects the functioning of subcortical neuronal circuits
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
10-item scale with scores ranging from 0 to 40; higher scores indicating more severe OCD symptoms.
Patients are defined as responders if they have a score decrease of at least 35% on the Y-BOCS
Measured: Baseline
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
10-item scale with scores ranging from 0 to 40; higher scores indicating more severe OCD symptoms.
Patients are defined as responders if they have a score decrease of at least 35% on the Y-BOCS
Measured: 12 months
Secondary outcomes (2)
Global Assessment of Functioning (GAF), axis V of the DSM-IV (APA, 1994).
a rating scale used to subjectively assess the social and occupational functioning as well as psychological symptoms of adults. The scale ranges from 1 to 100, divided into 10-point intervals describing the level of functioning and symptoms.
Measured: Baseline
Global Assessment of Functioning (GAF), axis V of the DSM-IV (APA, 1994).
a rating scale used to subjectively assess the social and occupational functioning as well as psychological symptoms of adults. The scale ranges from 1 to 100, divided into 10-point intervals describing the level of functioning and symptoms.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start1 Apr 2018
- Primary completion1 May 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-compulsive Disorder (OCD)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne CYPRIEN, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605316
- Sponsor's protocol ID
- RECHMPL18_0141
- Acronym
- NEP-TOC
- Status last verified
- Apr 2018
- First submitted
- 13 Apr 2018
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electric Neuromodulation in Refractory Obsessive-compulsive Disorder : the Montpellier Experience (France)
- ClinicalTrials.gov ID
- NCT03605316
- Acronym / sponsor ID
- NEP-TOC / RECHMPL18_0141
- Conditions
- Obsessive-compulsive Disorder (OCD)
- Keywords
- Deep brain stimulation, obsessive-compulsive disorder, neuromodulation, psychiatry, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 30 Jul 2018 (actual)
- 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.
Obsessive-compulsive disorder (OCD) is a neuropsychiatric disease characterised by intrusive, recurrent and persistent thoughts, urges or images (obsessions) and the resulting excessive repetitive behaviours or mental acts according to rigid rules unrealistically aimed at reducing distress (compulsions).
Its lifetime prevalence in the general population is usually estimated between 1 - 3% (Ruscio, Mol Psychiatry, 2010). Despite appropriate pharmacological and cognitive-behavioural treatments, it is commonly estimated that 10% of patients are therapy-refractory and that among improved or recovered patients, sustained efficacy is uncertain.
For treatment refractory OCD patients, a neurosurgical treatment by deep brain stimulation (DBS), has emerged in the late 1990s as a new therapeutic option (Nuttin et al, Lancet, 1999).
The objective of the current study is to report the long-term treatment effects (safety and effectiveness) of DBS from the cohort of six severe and therapy-refractory OCD patients implanted at the French university hospital of Montpellier since 2003.
Detailed description
The data needed to carry out the study will be extracted from the medical files of the 6 patients concerned.
The following data will be collected:
- Age, sex
- Medical, surgical and psychiatric history
- History of pharmacological treatments
- Elements from clinical examination
- any reported adverse effect
- scores of the various questionnaires completed throughout the follow-up (including Y-BOCS and GAF)
- results of biological, morphological, neuropsychological tests
- Stimulation parameters applied since implantation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Six patients consisting in three males and three females aged 18 years and over implanted at the University Hospital (CHU) of Montpellier (France) between June 2003 and February 2013.
Key inclusion criteria (2 listed)
- all patients with severe and refractory OCD according to DSM-IV criteria, confirmed by experienced psychiatrist
- treated by DBS at the CHU of Montpellier
Key exclusion criteria (1 listed)
- already enrolled in a study protocol at time of implantation
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 |
|---|---|---|
| Deep brain stimulation (DBS)Neurosurgical treatment by stereotactic implantation of electrodes in the brain that affects the functioning of subcortical neuronal circuits | Procedure or surgery | – |
Primary outcome
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: Baseline
10-item scale with scores ranging from 0 to 40; higher scores indicating more severe OCD symptoms. Patients are defined as responders if they have a score decrease of at least 35% on the Y-BOCS
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: 12 months
10-item scale with scores ranging from 0 to 40; higher scores indicating more severe OCD symptoms. Patients are defined as responders if they have a score decrease of at least 35% on the Y-BOCS
2 secondary outcomes
Global Assessment of Functioning (GAF), axis V of the DSM-IV (APA, 1994).
Time frame: Baseline
Global Assessment of Functioning (GAF), axis V of the DSM-IV (APA, 1994).
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Individual participant dataSharing planned: Undecided. NC
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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.
Fabienne CYPRIEN principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obsessive-compulsive Disorder (OCD), run by University Hospital, Montpellier 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 30 Jul 2018. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (time frame: Baseline). The study lists 2 primary outcomes in all. 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 30 Jul 2018.