Obsessive-Compulsive DisorderMAGTOCNCT02884674

Repetitive Transcranial Magnetic Stimulation in Obsessive Compulsive Disorder

A study testing Active Repetitive Transcranial Magnetic Stimulation in people with Obsessive-Compulsive Disorder, run by University Hospital, Grenoble at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Evaluate the therapeutic effect of a functional Magnetic Resonance Imaging (fMRI)-guided and robotized neuronavigated theta burst Transcranial Magnetic Stimulation (TMS) targeting right inferior frontal region in resistant obsessive compulsive disorder (OCD) in a double-blind, randomized, placebo-controlled… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Obsessive-Compulsive Disorder
What is being tested?: Active Repetitive Transcranial Magnetic Stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: 1 siteFrance
Study dates: May 2015to May 2021
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Volunteer subjects with Obsessive Compulsive Disorders (OCD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM IV-TR) criteria and validated by an experimented clinician following instruments like SCID (Structured Clinical Interview for DSM IV) or MINI (Mini-International Neuropsychiatric Interview)
with or without associated tics ("Gilles de la Tourette" Syndrome)
Age > 18 years old
Y-BOCS score > 20 and CGI (Clinical Global Impression Scale) score ≥ 4
Resistant patients to standard treatments - where treatment resistance is defined by partial but insufficient response (Global Assessment of Functioning score GAF score < 60 and/or reduction of Yale Brown Obsessions and Compulsion Scale score < 35%) or lack of response to previous well conducted treatment including:
pharmacotherapy : optimal tolerated dose and adequate duration (> 12 weeks) of at least 2 Serotonin Reuptake Inhibitors (selective serotonin reuptake inhibitors, clomipramine), and one augmentation strategy (adjunction of an antipsychotic - such as risperidone or olanzapine or aripiprazole - or lithium or buspirone) ;
psychotherapy (at least 6 months of cognitive and behavioral therapy)

Who cannot join

other primary diagnosis than OCD (comorbid tics and depression are tolerated)
comorbid diagnosis of schizophrenia/ psychotic disorder, bipolar disorder, substance abuse or dependance
medical condition involving cognitive decline and affecting brain structures such as Parkinson disease, dementia, multiple sclerosis, HIV (human immunodeficiency virus) infection, lupus etc.
Magnetic Resonance Imaging exclusion criteria (ferromagnetic implants etc)
common TMS exclusion criteria (neurological condition with an increased risk of seizure, cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, intracranial implants (e.g. cochlear implants, electrodes, aneurysm clips, stimulators... ) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed will be excluded
Current use of any investigational drug
pregnancy / breast feeding patients
visual or auditive important deficit

Trial locations and contacts

1 site in 1 country.

Mircea POLOSAN, Professor contact

mpolosan@chu-grenoble.fr

France1 site, 1 recruiting

CHU de Grenoble - Pavillon Dominique Villars
Grenoble, Auvergne-Rhône-Alpes, 38000
POLOSAN Mircea, Professor, mpolosan@chu-grenoble.fr
Recruiting

Other trials in France

About this study

Official title: Stimulation magnétique transcrânienne répétitive Dans le Traitement Des Troubles Obsessionnels Compulsifs

Read the detailed description

This study evaluates the therapeutic effect of a fMRI-guided and robotized neuronavigated theta burst Transcranial Magnetic Stimulation (TMS) targeting right inferior frontal region in resistant obsessive compulsive disorder (OCD) in a double-blind, randomized, placebo-controlled, monocentric study. The study will also assess the interest of some clinical, neuropsychological, neuroimaging, electrophysiological variables in response prediction, besides physiopathological information.

There is an increasing interest in developping treatments for resistant OCD, which are not responding to the conventional treatment, represented by pharmacotherapy associated to cognitive behavioral therapy. Repetitive TMS represents a promising non invasive brain stimulation approach, but efficacy, best available brain target, optimal responder profile and stimulation parameters need to be further documented.

In this study, the included patients will be randomly assigned to an active (theta burst TMS) or sham-placebo treatment group. TMS will be added to their stable pharmacotherapy. The brain target, the right inferior frontal region, involved in the inhibition control brain network, will be defined in a personalized manner via a fMRI paradigm for each patient. TMS will be delivered daily for 2 successive weeks. Measures of different clinical, neuropsychological , electrophysiological (cortical excitability) variables will be performed at baseline, as well as at the end of the TMS course, and 1 week after. Other assessments are planned at 3 and 6 months, in order to highlight the evolution of the potential benefit.

Conditions: Obsessive-Compulsive Disorder
Being tested: Active Repetitive Transcranial Magnetic Stimulation, Placebo Repetitive Transcranial Magnetic Stimulation
Keywords: Obsessive-Compulsive Disorder, Transcranial Magnetic Stimulation
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.

Active Repetitive Transcranial Magnetic StimulationDevice
modulation of the electrical activity of the right inferior frontal gyrus cortex in order to reduce Obsessive Compulsive Disorders symptoms by Active Transcranial Magnetic Stimulation (TMS) targeting the right frontal inferior gyrus, 2 sessions per day, each session 5min30 day, during 10 consecutive days, using theta burst stimulation and using a TMS neuronavigated robot
Placebo Repetitive Transcranial Magnetic StimulationDevice
Sham rTMS will be delivered using non active magnetic coil, targeting the right frontal inferior gyrus, 2 sessions per day, each session 5min30 day, during 10 consecutive days, using TMS neuronavigated robot. A subjective sensation will be obtained via frontal dermic electrical stimulation.

Study groups in NCT02884674
Study group	Role	What they receive
active Transcranial Magnetic Stimulation	Active comparator	Active Transcranial Magnetic Stimulation (TMS) targeting the right frontal inferior gyrus, 2 sessions per day, each session 5min30 day, during 10 consecutive days, Using theta burst stimulation and using Transcranial Magnetic Stimulation navigator and robot Receives: Device: Active Repetitive Transcranial Magnetic Stimulation
Placebo	Placebo comparator	Placebo comparator, using non active magnetic coil, targeting the right frontal inferior gyrus, 2 sessions per day, each session 5min30 day, during 10 consecutive days, using theta burst stimulation and using Transcranial Magnetic Stimulation navigator and robot Receives: Device: Placebo Repetitive Transcranial Magnetic Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline of the score at the Yale - Brown Obsessive and Compulsive Scale
Evaluation of Obsessive Compulsive Disorder symptoms using the Yale - Brown Obsessive and Compulsive Scale, at day 21, corresponding to 7 days after the end of the TMS cure, compared to baseline.
Measured: at baseline and at day 21

Secondary outcomes (11)

Score of Montgomery and Asberg Depression Rating Scale, as a Measure of effects on Mood (depression)
Evaluation of Mood using Montgomery Asberg Depression Rating Scale
Measured: At baseline, at day 21, day 90, day 180
Score of Young Mania Rating Scale, as a Measure of effects on Mood (hyperthymia)
Evaluation of Mood using Young Mania Rating Scale
Measured: At baseline, at day 21, day 90, day 180
Score of Multidimensional Assessment of Thymic States Scale as a Measure of effects on Emotional Reactivity
Evaluation of Emotional Reactivity using Multidimensional Assessment of Thymic States Scale
Measured: At baseline, at day 21, day 90, day 180
Number of patients with Side effects as a measure of Safety and Tolerability
collection of the side effects of the Transcranial Magnetic Stimulation, after each session, during the entire TMS cure
Measured: for each session of Transcranial Magnetic Stimulation, at day 15, day 21, day 90, day 180
Inferior Frontal Region Activity (percentage of the BOLD signal change (parameter estimates beta)
Performing a functional Magnetic Resonance Imaging, looking for biomarkers of response to the TMS cure.
Especially studying the right inferior cortex activation in functional Magnetic Resonance Imaging using a Signal Stop Task.
Measured: at baseline (day 0)
Fractional Anisotropy (FA), mean and radial diffusivity (MD, RD), tracti integrity of the inhibition network,
looking for anatomical biomarkers of response, or anatomical differences between the subjects on the inhibition network using Diffusing Tensor Imaging data
Measured: at day 0 (baseline)
Yale - Brown Obsessive and Compulsion Scale score after the TMS treatment as an evaluation of the persistence of the clinical benefit
The Yale - Brown Obsessive and Compulsion Scale will also be performed at day 15, day 90 and day 180 after the inclusion in order to assess the kinetics of clinical changes in Obsessive Compulsive symptoms after the TMS cure.
Measured: day 15, day 90 and day 180 after the inclusion.
Cortical Excitability
assessing a new biomarker linked to OCD and monitoring its evolution with the TMS cure, testing its predictive value for the clinical response
Measured: baseline - day 15 - day 21 - day 90 - day 180
Evaluation of Impulsivity using specific scales
Evaluation of impulsivity using UPPS (Urgency, Premeditation, and Sensation Seeking) Impulsive Behavior Scale.
Measured: At baseline, at day 21, day 90, day 180
Evaluation of the Clinical global State
Using Clinical Global Impression scale we will assess the evolution of the clinical global status
Measured: at baseline, day 15, day 21, day 90, day 180
type of side effects (pain, paresthesia, other) as a measure of Safety and Tolerability
collection of the side effects of the Transcranial Magnetic Stimulation, after each session, during the entire TMS cure
Measured: for each session of Transcranial Magnetic Stimulation, at day 15, day 21, day 90, day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015May 2021

First posted31 Aug 2016 (estimated)
Study startMay 2015
Primary completionNov 2019
Study completionMay 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (34)Papers the sponsor has linked to this study.
Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
More trials run by University Hospital, GrenobleThe 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: 56 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02884674
Sponsor's protocol ID: 38RC14.156
Other IDs: 2014-A00668-39
Acronym: MAGTOC
Status last verified: May 2020
First submitted: 8 Jan 2015
Last updated: 8 May 2020
Results posted: No
Data monitoring committee: Yes

Publications

Heyman I, Mataix-Cols D, Fineberg NA. Obsessive-compulsive disorder. BMJ. 2006 Aug 26;333(7565):424-9. doi: 10.1136/bmj.333.7565.424. No abstract available.
PubMed 16931840
Denys D. Pharmacotherapy of obsessive-compulsive disorder and obsessive-compulsive spectrum disorders. Psychiatr Clin North Am. 2006 Jun;29(2):553-84, xi. doi: 10.1016/j.psc.2006.02.013.
PubMed 16650723
Barker AT, Jalinous R, Freeston IL. Non-invasive magnetic stimulation of human motor cortex. Lancet. 1985 May 11;1(8437):1106-7. doi: 10.1016/s0140-6736(85)92413-4. No abstract available.
PubMed 2860322
Baxter LR Jr, Phelps ME, Mazziotta JC, Guze BH, Schwartz JM, Selin CE. Local cerebral glucose metabolic rates in obsessive-compulsive disorder. A comparison with rates in unipolar depression and in normal controls. Arch Gen Psychiatry. 1987 Mar;44(3):211-8. doi: 10.1001/archpsyc.1987.01800150017003.
PubMed 3493749
Li CT, Chen MH, Juan CH, Huang HH, Chen LF, Hsieh JC, Tu PC, Bai YM, Tsai SJ, Lee YC, Su TP. Efficacy of prefrontal theta-burst stimulation in refractory depression: a randomized sham-controlled study. Brain. 2014 Jul;137(Pt 7):2088-98. doi: 10.1093/brain/awu109. Epub 2014 May 10.
PubMed 24817188
Plewnia C, Pasqualetti P, Grosse S, Schlipf S, Wasserka B, Zwissler B, Fallgatter A. Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial. J Affect Disord. 2014 Mar;156:219-23. doi: 10.1016/j.jad.2013.12.025. Epub 2013 Dec 28.
PubMed 24411682
Di Lazzaro V, Pilato F, Dileone M, Profice P, Oliviero A, Mazzone P, Insola A, Ranieri F, Meglio M, Tonali PA, Rothwell JC. The physiological basis of the effects of intermittent theta burst stimulation of the human motor cortex. J Physiol. 2008 Aug 15;586(16):3871-9. doi: 10.1113/jphysiol.2008.152736. Epub 2008 Jun 19.
PubMed 18566003
Prasko J, Paskova B, Zalesky R, Novak T, Kopecek M, Bares M, Horacek J. The effect of repetitive transcranial magnetic stimulation (rTMS) on symptoms in obsessive compulsive disorder. A randomized, double blind, sham controlled study. Neuro Endocrinol Lett. 2006 Jun;27(3):327-32.
PubMed 16816829
Sarkhel S, Sinha VK, Praharaj SK. Adjunctive high-frequency right prefrontal repetitive transcranial magnetic stimulation (rTMS) was not effective in obsessive-compulsive disorder but improved secondary depression. J Anxiety Disord. 2010 Jun;24(5):535-9. doi: 10.1016/j.janxdis.2010.03.011. Epub 2010 Mar 29.
PubMed 20392594
Sack AT, Cohen Kadosh R, Schuhmann T, Moerel M, Walsh V, Goebel R. Optimizing functional accuracy of TMS in cognitive studies: a comparison of methods. J Cogn Neurosci. 2009 Feb;21(2):207-21. doi: 10.1162/jocn.2009.21126.
PubMed 18823235
Sachdev PS, McBride R, Loo CK, Mitchell PB, Malhi GS, Croker VM. Right versus left prefrontal transcranial magnetic stimulation for obsessive-compulsive disorder: a preliminary investigation. J Clin Psychiatry. 2001 Dec;62(12):981-4. doi: 10.4088/jcp.v62n1211.
PubMed 11780880
Wu CC, Tsai CH, Lu MK, Chen CM, Shen WC, Su KP. Theta-burst repetitive transcranial magnetic stimulation for treatment-resistant obsessive-compulsive disorder with concomitant depression. J Clin Psychiatry. 2010 Apr;71(4):504-6. doi: 10.4088/JCP.09l05426blu. No abstract available.
PubMed 20409448
Aron AR, Fletcher PC, Bullmore ET, Sahakian BJ, Robbins TW. Stop-signal inhibition disrupted by damage to right inferior frontal gyrus in humans. Nat Neurosci. 2003 Feb;6(2):115-6. doi: 10.1038/nn1003. No abstract available.
PubMed 12536210
Chambers CD, Bellgrove MA, Stokes MG, Henderson TR, Garavan H, Robertson IH, Morris AP, Mattingley JB. Executive "brake failure" following deactivation of human frontal lobe. J Cogn Neurosci. 2006 Mar;18(3):444-55. doi: 10.1162/089892906775990606.
PubMed 16513008
Verbruggen F, Aron AR, Stevens MA, Chambers CD. Theta burst stimulation dissociates attention and action updating in human inferior frontal cortex. Proc Natl Acad Sci U S A. 2010 Aug 3;107(31):13966-71. doi: 10.1073/pnas.1001957107. Epub 2010 Jul 14.
PubMed 20631303

Want to know more?

Mircea POLOSAN, Professor

mpolosan@chu-grenoble.fr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)

All Obsessive-Compulsive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Stimulation magnétique transcrânienne répétitive Dans le Traitement Des Troubles Obsessionnels Compulsifs
ClinicalTrials.gov ID: NCT02884674
Acronym / sponsor ID: MAGTOC / 38RC14.156
Conditions: Obsessive-Compulsive Disorder
Keywords: Obsessive-Compulsive Disorder, Transcranial Magnetic Stimulation
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 56 participants (estimated)
Lead sponsor: University Hospital, GrenobleUniversity, hospital or other
Study start: May 2015
Primary completion: Nov 2019 (actual)
Study completion: May 2021 (estimated)
First posted: 31 Aug 2016 (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.

Detailed description

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 Transcranial Magnetic Stimulation	Active comparator	Device: Active Repetitive Transcranial Magnetic StimulationActive Transcranial Magnetic Stimulation (TMS) targeting the right frontal inferior gyrus, 2 sessions per day, each session 5min30 day, during 10 consecutive days, Using theta burst stimulation and using Transcranial Magnetic Stimulation navigator and robot
Placebo	Placebo comparator	Device: Placebo Repetitive Transcranial Magnetic StimulationPlacebo comparator, using non active magnetic coil, targeting the right frontal inferior gyrus, 2 sessions per day, each session 5min30 day, during 10 consecutive days, using theta burst stimulation and using Transcranial Magnetic Stimulation navigator and robot

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Volunteer subjects with Obsessive Compulsive Disorders (OCD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM IV-TR) criteria and validated by an experimented clinician following instruments like SCID (Structured Clinical Interview for DSM IV) or MINI (Mini-International Neuropsychiatric Interview)
with or without associated tics ("Gilles de la Tourette" Syndrome)
Age > 18 years old
Y-BOCS score > 20 and CGI (Clinical Global Impression Scale) score ≥ 4
Resistant patients to standard treatments - where treatment resistance is defined by partial but insufficient response (Global Assessment of Functioning score GAF score < 60 and/or reduction of Yale Brown Obsessions and Compulsion Scale score < 35%) or lack of response to previous well conducted treatment including:

Key exclusion criteria (8 listed)

other primary diagnosis than OCD (comorbid tics and depression are tolerated)
comorbid diagnosis of schizophrenia/ psychotic disorder, bipolar disorder, substance abuse or dependance
medical condition involving cognitive decline and affecting brain structures such as Parkinson disease, dementia, multiple sclerosis, HIV (human immunodeficiency virus) infection, lupus etc.
Magnetic Resonance Imaging exclusion criteria (ferromagnetic implants etc)
common TMS exclusion criteria (neurological condition with an increased risk of seizure, cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, intracranial implants (e.g. cochlear implants, electrodes, aneurysm clips, stimulators... ) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed will be excluded

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
Active Repetitive Transcranial Magnetic Stimulationmodulation of the electrical activity of the right inferior frontal gyrus cortex in order to reduce Obsessive Compulsive Disorders symptoms by Active Transcranial Magnetic Stimulation (TMS) targeting the right frontal inferior gyrus, 2 sessions per day, each session 5min30 day, during 10 consecutive days, using theta burst stimulation and using a TMS neuronavigated robot	Device	active Transcranial Magnetic Stimulation
Placebo Repetitive Transcranial Magnetic StimulationSham rTMS will be delivered using non active magnetic coil, targeting the right frontal inferior gyrus, 2 sessions per day, each session 5min30 day, during 10 consecutive days, using TMS neuronavigated robot. A subjective sensation will be obtained via frontal dermic electrical stimulation.	Device	Placebo

Primary outcome

Change from baseline of the score at the Yale - Brown Obsessive and Compulsive Scale
Time frame: at baseline and at day 21
Evaluation of Obsessive Compulsive Disorder symptoms using the Yale - Brown Obsessive and Compulsive Scale, at day 21, corresponding to 7 days after the end of the TMS cure, compared to baseline.

11 secondary outcomes

Score of Montgomery and Asberg Depression Rating Scale, as a Measure of effects on Mood (depression)
Time frame: At baseline, at day 21, day 90, day 180
Score of Young Mania Rating Scale, as a Measure of effects on Mood (hyperthymia)
Time frame: At baseline, at day 21, day 90, day 180
Score of Multidimensional Assessment of Thymic States Scale as a Measure of effects on Emotional Reactivity
Time frame: At baseline, at day 21, day 90, day 180
Number of patients with Side effects as a measure of Safety and Tolerability
Time frame: for each session of Transcranial Magnetic Stimulation, at day 15, day 21, day 90, day 180
Inferior Frontal Region Activity (percentage of the BOLD signal change (parameter estimates beta)
Time frame: at baseline (day 0)
Fractional Anisotropy (FA), mean and radial diffusivity (MD, RD), tracti integrity of the inhibition network,
Time frame: at day 0 (baseline)
Yale - Brown Obsessive and Compulsion Scale score after the TMS treatment as an evaluation of the persistence of the clinical benefit
Time frame: day 15, day 90 and day 180 after the inclusion.
Cortical Excitability
Time frame: baseline - day 15 - day 21 - day 90 - day 180
Evaluation of Impulsivity using specific scales
Time frame: At baseline, at day 21, day 90, day 180
Evaluation of the Clinical global State
Time frame: at baseline, day 15, day 21, day 90, day 180
type of side effects (pain, paresthesia, other) as a measure of Safety and Tolerability
Time frame: for each session of Transcranial Magnetic Stimulation, at day 15, day 21, day 90, day 180

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
Background: PubMed 16931840Heyman I, Mataix-Cols D, Fineberg NA. Obsessive-compulsive disorder. BMJ. 2006 Aug 26;333(7565):424-9. doi: 10.1136/bmj.333.7565.424. No abstract available.
Background: PubMed 16650723Denys D. Pharmacotherapy of obsessive-compulsive disorder and obsessive-compulsive spectrum disorders. Psychiatr Clin North Am. 2006 Jun;29(2):553-84, xi. doi: 10.1016/j.psc.2006.02.013.
Background: PubMed 2860322Barker AT, Jalinous R, Freeston IL. Non-invasive magnetic stimulation of human motor cortex. Lancet. 1985 May 11;1(8437):1106-7. doi: 10.1016/s0140-6736(85)92413-4. No abstract available.
Background: PubMed 3493749Baxter LR Jr, Phelps ME, Mazziotta JC, Guze BH, Schwartz JM, Selin CE. Local cerebral glucose metabolic rates in obsessive-compulsive disorder. A comparison with rates in unipolar depression and in normal controls. Arch Gen Psychiatry. 1987 Mar;44(3):211-8. doi: 10.1001/archpsyc.1987.01800150017003.
Background: PubMed 24817188Li CT, Chen MH, Juan CH, Huang HH, Chen LF, Hsieh JC, Tu PC, Bai YM, Tsai SJ, Lee YC, Su TP. Efficacy of prefrontal theta-burst stimulation in refractory depression: a randomized sham-controlled study. Brain. 2014 Jul;137(Pt 7):2088-98. doi: 10.1093/brain/awu109. Epub 2014 May 10.
Background: PubMed 24411682Plewnia C, Pasqualetti P, Grosse S, Schlipf S, Wasserka B, Zwissler B, Fallgatter A. Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial. J Affect Disord. 2014 Mar;156:219-23. doi: 10.1016/j.jad.2013.12.025. Epub 2013 Dec 28.
Background: PubMed 18566003Di Lazzaro V, Pilato F, Dileone M, Profice P, Oliviero A, Mazzone P, Insola A, Ranieri F, Meglio M, Tonali PA, Rothwell JC. The physiological basis of the effects of intermittent theta burst stimulation of the human motor cortex. J Physiol. 2008 Aug 15;586(16):3871-9. doi: 10.1113/jphysiol.2008.152736. Epub 2008 Jun 19.
Background: PubMed 16816829Prasko J, Paskova B, Zalesky R, Novak T, Kopecek M, Bares M, Horacek J. The effect of repetitive transcranial magnetic stimulation (rTMS) on symptoms in obsessive compulsive disorder. A randomized, double blind, sham controlled study. Neuro Endocrinol Lett. 2006 Jun;27(3):327-32.
Background: PubMed 20392594Sarkhel S, Sinha VK, Praharaj SK. Adjunctive high-frequency right prefrontal repetitive transcranial magnetic stimulation (rTMS) was not effective in obsessive-compulsive disorder but improved secondary depression. J Anxiety Disord. 2010 Jun;24(5):535-9. doi: 10.1016/j.janxdis.2010.03.011. Epub 2010 Mar 29.
Background: PubMed 18823235Sack AT, Cohen Kadosh R, Schuhmann T, Moerel M, Walsh V, Goebel R. Optimizing functional accuracy of TMS in cognitive studies: a comparison of methods. J Cogn Neurosci. 2009 Feb;21(2):207-21. doi: 10.1162/jocn.2009.21126.
Background: PubMed 11780880Sachdev PS, McBride R, Loo CK, Mitchell PB, Malhi GS, Croker VM. Right versus left prefrontal transcranial magnetic stimulation for obsessive-compulsive disorder: a preliminary investigation. J Clin Psychiatry. 2001 Dec;62(12):981-4. doi: 10.4088/jcp.v62n1211.
Background: PubMed 20409448Wu CC, Tsai CH, Lu MK, Chen CM, Shen WC, Su KP. Theta-burst repetitive transcranial magnetic stimulation for treatment-resistant obsessive-compulsive disorder with concomitant depression. J Clin Psychiatry. 2010 Apr;71(4):504-6. doi: 10.4088/JCP.09l05426blu. No abstract available.

Related trials for Obsessive-Compulsive Disorder

Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder
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Not yet recruitingObservational study
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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.

Mircea POLOSAN, Professor contact

mpolosan@chu-grenoble.fr

Mircea POLOSAN, Professor principal investigator

Institut National de la Santé Et de la Recherche Médicale, France

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active Repetitive Transcranial Magnetic Stimulation in people with Obsessive-Compulsive Disorder, run by University Hospital, Grenoble 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 7 inclusion and 8 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 2020. 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 Mircea POLOSAN, Professor (mpolosan@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline of the score at the Yale - Brown Obsessive and Compulsive Scale (time frame: at baseline and at day 21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02884674, which also lists 34 linked publications.

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 2020.