Neurostimulation and OCD, a MRI Study
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      This study will focus on the use of repetitive Transcranial Magnetic Stimulation (rTMS) as a
      treatment of Obsessive Compulsive Disorder (OCD), which is a common illness that impairs
      quality of life and that can be hard to treat.

      To precisely analyze the effects of rTMS on OCD, the investigators are going to plan a study
      comparing cerebral blood flow before and after rTMS treatment. The measuring will occur on
      the Orbito Frontal Cortex (OFC), whose role in OCD has already been shown by our team
      (Nauczyciel et al, 2014 in Translational Psychiatry), using Magnetic Resonance Imaging in
      Arterial Spin Labeling, an MRI method allowing to measure arteriola blood flow.

      Our primary outcome is to show a significate difference between cerebral blood flow in OCD
      between one group of participants treated by rTMS and another one treated by placebo. The
      study will be double blinded with a placebo rTMS machine, monocentric and prospective, with
      participants suffering from OCD randomized between two groups.
    

Detailed description: 
      Obsessive Compulsive Disorders (OCD) are a frequent and debilitating disease. Impact on daily
      life is usually important, with a high rate of mood and anxious comorbidities, such as Major
      Depressive Disorder occurring in half of these participants. The effects can be dramatic,
      leading to higher suicide rate in this population.

      Guidelines for OCD treatment in France recommend the use of Serotonin Specific Recapture
      Inhibitors (SSRI) and Cognitive Behavioral Therapy (CBT), if possible simultaneously.
      However, those treatments are responsible for adverse effects for the first and not easily
      accessible for the second. Consequently, a non-negligible number of participants still
      suffers from symptoms of OCD with a non-optimal treatment.

      Repetitive Transcranial Magnetic Stimulation (rTMS), a noninvasive neurostimulation method,
      has shown its usefulness in the treatment of mental illnesses. It has been authorized by the
      Food and Drugs Administration in the United States for the treatment of OCD. It represents an
      alternative method for helping those participants, but pattern of modifications over OCD
      pathophysiology has still to be unraveled.

      In order to precisely analyze the effects of Low Frequency rTMS (LF rTMS) on OCD, the
      investigators designed a monocentric, prospective, double blind study comparing cerebral
      blood flow (CBF) before and after a rTMS treatment. Measurements will be performed on the
      Orbito Frontal Cortex (OFC), whose role in OCD has already been shown by our team (Nauczyciel
      et al, 2014 in Translational Psychiatry), using Magnetic Resonance Imaging (MRI) in Arterial
      Spin Labeling (ASL).

      Inclusion criteria will be OCD diagnosis, age between 18 and 65, and the lack of counter
      indication to MRI and rTMS. Participants will firstly undergo MRI before treatment, along
      with a psychometric assessment. Participants will then receive a one-week rTMS treatment,
      with two sessions of fifteen minutes per day. Second MRI and evaluation will be performed 4
      weeks after the end of the treatment.

      Psychometric assessment will consist of MINI, YBOCS, CGI, MADRS, HAMA, and GAF, administered
      before and four weeks after treatment. The psychiatrist giving the assessment will be blind
      to the randomization of the patient, so will be the radiologist performing the MRI.

      Our primary outcome is to show a significant difference between CBF in OCD in participants
      treated by rTMS versus participants treated by sham rTMS. A decrease of the CBF in the OFC is
      expected, in regards to the inhibitor effects of LF rTMS. This result will allow us to follow
      objectively the neurobiological effects of rTMS, developing the ability to plan more
      efficiently rTMS treatment for participants.
    

Intervention name(s): Sham rTMS; Active rTMS
Intervention type(s): Other; Other
Intervention description(s): Participants will undergo sham rTMS for five days with two daily fifteen minutes rTMS sessions.; Participants will undergo active rTMS for five days with two daily fifteen minutes rTMS sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigators will randomize participants between two parallel groups using a randomization list. One group will undergo active rTMS while the second one will undergo sham rTMS. The second group will have the possibility of performing an active rTMS treatment at the end of each patient's participation. All subjects will undergo a MRI with anatomical and ASL sequences one week before treatment and four weeks after treatment.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Arterial Spin Labeling; Obsessive Compulsive Disorder; Magnetic Resonance Imaging; Repetitive Transcranial Magnetic Stimulation; Double blinded; Sham