Neurostimulation and OCD, a MRI Study (ASLTOC)

August 5, 2022 updated by: Hospital Center Guillaume Régnier

Effects of rTMS Over Right COF Blood Perfusion in OCD Patients: an ASL Double Blinded Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ille Et Vilaine
      • Rennes, Ille Et Vilaine, France, 35000
        • Centre Hospitalier Guillaume Regnier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants over 18 to 65
  • Score at YBOCS over 15
  • Diagnosis of Obsessive Compulsive Disorder acknowledged by two psychiatrists using the DSM V criteria
  • Patient is able to receive and understand information about the trial, and agrees to participate in the trial
  • Indication of treatment by rTMS

Exclusion Criteria:

Related to MRI and / or rTMS:

  • Cardiac Stimulator or Implantable Automatic Defibrillator
  • Neurosurgical Clips
  • Cochlear Implant
  • Intra ocular or cranial metallic foreign body
  • Endoprosthesis lasting from less than four weeks
  • Ostheosynthesis material lasting from less than six weeks
  • Claustrophobia

Other criteria:

  • Pregnancy or breast feeding
  • Unstable hemodynamics, acute respiratory failure, need for constant surveillance not possible during the MRI, precarious general condition
  • Patient over legal protection, care without consent
  • Active psychiatric pathology other than anxious or mood disorder
  • Active severe somatic disease
  • History of seizures or other neurologic pathologies (Parkinson's Disease, CVA, Alzheimer's Disease, Multiple Sclerosis, Lewy Body Dementia...)
  • Patient without social security

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham rTMS

The investigators will perform sham rTMS at 30% of the Motor Threshold, with a 1Hz frequency and 1200 pulses during one session. The target will be the right Orbito Frontal Cortex, localized using Neuronavigation. Sessions will last fifteen minutes; subjects will perform two sessions a day during five days. The coil will have a 180° rotation compared to the active coil position, thus making the magnetic field ineffective on the patient's cortex.

Participants will undergo a MRI with anatomical and ASL sequences one week before and four weeks after treatment.

All participants of this group will have the opportunity to undergo an active rTMS treatment right after the end of each one's participation in the study.
Other: Sham rTMS
Participants will undergo sham rTMS for five days with two daily fifteen minutes rTMS sessions.
Active Comparator: Active rTMS

The investigators will perform active rTMS at 120% of the Motor Threshold, with a 1Hz frequency and 1200 pulses during one session. The target will be the right Orbito Frontal Cortex, localized using Neuronavigation. Sessions will last fifteen minutes; subjects will perform two sessions a day during five days.

Participants will undergo a MRI with anatomical and ASL sequences one week before and four weeks after treatment
Other: Active rTMS
Participants will undergo active rTMS for five days with two daily fifteen minutes rTMS sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral Blood Flow of the Orbito-Frontal Cortex from Arterial Spin Labeling Data
Time Frame: one measure four weeks after end of treatment
Comparison between the sham rTMS group and the active rTMS group will be analyzed from the ASL data about cerebral blood flow in the Orbito-Frontal Cortex. We expect to find a significant difference between the two groups four weeks after the treatment on the mean of cerebral blood flow, as raw data will be converted into numerical data for analysis.
one measure four weeks after end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score at Yale-Brown Obsessive Compulsive Scale (YBOCS)
Time Frame: one measure before treatment, one four weeks after end of treatment
YBOCS is a scale used to make an accurate and objective measure of the intensity of OCD symptoms for a patient at a precise time, ranging from 0 to 40 (maximum severity), analyzes will be based on each group's mean score.
one measure before treatment, one four weeks after end of treatment
Score at Montgomery and Asberg Depression Rating Scale (MADRS)
Time Frame: one measure before treatment, one four weeks after end of treatment
MADRS is a clinical scale used to measure the severity of depressive symptoms for a patient, ranging from 0 to 60 (maximum severity), analyzes will be based on each group's mean score.
one measure before treatment, one four weeks after end of treatment
Score at General Assessment Functioning Scale (GAF)
Time Frame: one measure before treatment, one four weeks after end of treatment
GAF is a scale representing the functional abilities of a patient in his daily life and the way his illness potentially impairs his normal social, personal and professional quality of life, ranging from 0 to 100 (representing a normal fully functioning life), analyzes will be based on each group's mean score.
one measure before treatment, one four weeks after end of treatment
Score at Hamilton Anxiety Rating Scale (HAMA)
Time Frame: one measure before treatment, one four weeks after end of treatment
HAMA is a scale used to measure the intensity of anxious symptoms of a patient at a given time, ranging from 0 to 60 (maximum severity), analyzes will be based on each group's mean score.
one measure before treatment, one four weeks after end of treatment
Blindness Evaluation
Time Frame: measure will occur four weeks after the treatment, at the same assessment than clinical outcomes
Participants will pass an evaluation of their perception of the sham devices, which will allow us to analyze the masking strategy the investigators use considering this double blind study. A five propositions assessment will be used, ranging from 1 to 5 (1 representing the patient's certainty of being in the active treatment group and 5 representing the patient's certainty of being in the sham treatment group). Analyses will be carried using Bang's Blinding Index (Bang et al, Assessment of blinding in clinical trials. Control Clin Trials. 2004).
measure will occur four weeks after the treatment, at the same assessment than clinical outcomes
Intra Group CBF Comparison
Time Frame: one measure before treatment, one four weeks after end of treatment
We will be using the ASL data to compare the evolution of cerebral blood flow in the Orbito-Frontal Cortex within each patient's brain.
one measure before treatment, one four weeks after end of treatment
Score at Clinical Global Impression scale (CGI)
Time Frame: one measure before treatment, one four weeks after end of treatment
CGI is a scale used to give a clinical impression of a patient from the physician's observation, being able to evaluate if the patient's condition has worsened or improved between two evaluations, scores ranging from 0 to 7 (maximum severity or important degradation of the patient's condition), analyzes will be based on each group's mean score.
one measure before treatment, one four weeks after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Center Guillaume Régnier

Collaborators

Fondation de l'Avenir

Investigators

  • Principal Investigator: Dominique DRAPIER, MD PHD, Centre Hospitalier Guillaume Regnier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2019

Primary Completion (Actual)

June 24, 2022

Study Completion (Actual)

June 24, 2022

Study Registration Dates

First Submitted

April 11, 2019

First Submitted That Met QC Criteria

April 16, 2019

First Posted (Actual)

April 18, 2019

Study Record Updates

Last Update Posted (Actual)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 5, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC19_01DD_ASLTOC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data about study protocol and clinical information will be available on request from other researchers. MRI raw data will not be shared but processed data is planned to be available.

IPD Sharing Time Frame

Data will be available from the moment a scientific publication is accepted to 5 years later.

IPD Sharing Access Criteria

Access to data will be granted for researchers aiming to perform another analysis or to review the topic, or to perform a meta-analysis.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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