Neurostimulation and OCD, a MRI Study

NCT03918837 | Completed

• 2 other identifiers: RC19_01DD_ASLTOC2019-A00165-52
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obsessive Compulsive Disorder

Keywords

Arterial Spin Labeling; Obsessive Compulsive Disorder; Magnetic Resonance Imaging; Repetitive Transcranial Magnetic Stimulation; Double blinded; Sham

Outcome Measures

Primary Outcomes (1)

• Cerebral Blood Flow of the Orbito-Frontal Cortex from Arterial Spin Labeling Data

  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 Outcomes (7)

• Score at Yale-Brown Obsessive Compulsive Scale (YBOCS)

  one measure before treatment, one four weeks after end of treatment

• Score at Montgomery and Asberg Depression Rating Scale (MADRS)

  one measure before treatment, one four weeks after end of treatment

• Score at General Assessment Functioning Scale (GAF)

  one measure before treatment, one four weeks after end of treatment

• Score at Hamilton Anxiety Rating Scale (HAMA)

  one measure before treatment, one four weeks after end of treatment

• Blindness Evaluation

  measure will occur four weeks after the treatment, at the same assessment than clinical outcomes

Study Arms (2)

Sham rTMS

SHAM COMPARATOR

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

Active rTMS

ACTIVE COMPARATOR

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

Interventions

Sham rTMS OTHER

Participants will undergo sham rTMS for five days with two daily fifteen minutes rTMS sessions.

Sham rTMS

Active rTMS OTHER

Participants will undergo active rTMS for five days with two daily fifteen minutes rTMS sessions.

Active rTMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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...)

Sponsors & Collaborators

• Hospital Center Guillaume Régnier: lead
• Fondation de l'Avenir: collaborator

Study Sites (1)

Centre Hospitalier Guillaume Régnier

Rennes, ille et vilaine, 35000, France

Location

Related Publications (5)

• Anticevic A, Hu S, Zhang S, Savic A, Billingslea E, Wasylink S, Repovs G, Cole MW, Bednarski S, Krystal JH, Bloch MH, Li CS, Pittenger C. Global resting-state functional magnetic resonance imaging analysis identifies frontal cortex, striatal, and cerebellar dysconnectivity in obsessive-compulsive disorder. Biol Psychiatry. 2014 Apr 15;75(8):595-605. doi: 10.1016/j.biopsych.2013.10.021. Epub 2013 Nov 4.

  PMID: 24314349 BACKGROUND

• van der Straten AL, Denys D, van Wingen GA. Impact of treatment on resting cerebral blood flow and metabolism in obsessive compulsive disorder: a meta-analysis. Sci Rep. 2017 Dec 12;7(1):17464. doi: 10.1038/s41598-017-17593-7.

  PMID: 29234089 BACKGROUND

• Le Jeune F, Verin M, N'Diaye K, Drapier D, Leray E, Du Montcel ST, Baup N, Pelissolo A, Polosan M, Mallet L, Yelnik J, Devaux B, Fontaine D, Chereau I, Bourguignon A, Peron J, Sauleau P, Raoul S, Garin E, Krebs MO, Jaafari N, Millet B; French Stimulation dans le trouble obsessionnel compulsif (STOC) study group. Decrease of prefrontal metabolism after subthalamic stimulation in obsessive-compulsive disorder: a positron emission tomography study. Biol Psychiatry. 2010 Dec 1;68(11):1016-22. doi: 10.1016/j.biopsych.2010.06.033. Epub 2010 Oct 16.

  PMID: 20951978 BACKGROUND

• Nauczyciel C, Le Jeune F, Naudet F, Douabin S, Esquevin A, Verin M, Dondaine T, Robert G, Drapier D, Millet B. Repetitive transcranial magnetic stimulation over the orbitofrontal cortex for obsessive-compulsive disorder: a double-blind, crossover study. Transl Psychiatry. 2014 Sep 9;4(9):e436. doi: 10.1038/tp.2014.62.

  PMID: 25203167 BACKGROUND

• Ruffini C, Locatelli M, Lucca A, Benedetti F, Insacco C, Smeraldi E. Augmentation effect of repetitive transcranial magnetic stimulation over the orbitofrontal cortex in drug-resistant obsessive-compulsive disorder patients: a controlled investigation. Prim Care Companion J Clin Psychiatry. 2009;11(5):226-30. doi: 10.4088/PCC.08m00663.

  PMID: 19956460 BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Dominique DRAPIER, MD PHD

  Centre Hospitalier Guillaume Régnier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The masking model will use the same rTMS coil as the active group, bit with a 180° rotation, making the magnetic field face the opposite direction, and thus not being able to produce Neuromodulation on the patient. The stimulation intensity will be decreased at 30% of the motor threshold, to keep the characteristic sound of active rTMS. The patient will not know their group; neither will the investigator nor the rater. Only the rTMS performing technician will know the randomization group to be able to choose the right setting.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 18, 2019
• Study Start: April 26, 2019
• Primary Completion: June 24, 2022
• Study Completion: June 24, 2022
• Last Updated: October 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available from the moment a scientific publication is accepted to 5 years later.
• 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.

Locations

FR (1)