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rTMS Over the Supplementary Motor Area for Treatment-resistant Obsessive-compulsive Disorder. (rTMSOCD)

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ClinicalTrials.gov Identifier: NCT03211221
Recruitment Status : Unknown
Verified July 2017 by CNS Onlus.
Recruitment status was:  Recruiting
First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Collaborator:
University of Florence
Information provided by (Responsible Party):
CNS Onlus

Brief Summary:
The aim of this study is to investigate the effectiveness of low-frequency (1Hz) rTMS (repetitive transcranial magnetic stimulation) over the pre-SMA (pre-supplementary motor area) in a sample of treatment-resistant OCD patients in a multicenter, controlled design.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Device: rTMS (repetitive transcranial magnetic stimulation) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to receive 15 sessions of active rTMS or sham rTMS over the bilateral pre-SMA with a 1:1: ratio. After the randomized phase, all patients will undergo a 4 weeks washout phase. At the end of the wash phase each patient will be classified as responder, partial responder or non-responder. After the washout phase responder patients will enter a follow-up phase up to 12 months while partial responders or non-responders in both the active and sham rTMS groups, will undergo an open phase of 15 sessions of active rTMS over the bilateral pre-SMA. Partial responders and non-responders after the randomized phase who will choose not to go into the open phase will end the study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants, the investigators and the outcome assessor will be blind to the type of intervention (TMS or SHAM). The TMS operator will be unblinded.
Primary Purpose: Treatment
Official Title: rTMS Over the Supplementary Motor Area for Treatment-resistant Obsessive-compulsive Disorder: a Multicenter, Double-blind, Controlled Trial.
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active rTMS
Active stimulation parameters will be 1-Hz, 10 seconds per train, 10 pulses per train (3 seconds inter-train interval) for a total of 160 trains (1600 pulses/session) at 130% of resting motor threshold (MT) (using the lowest value of the dominant hemisphere), once a day, 5 day/week, for 3 weeks. The coil will be positioned over the pre-SMA, targeted using the International 10-20 EEG System. Pre-SMA is defined at 15% of the distance between inion and nasion anterior to Cz (vertex) on the sagittal midline. The coil will be placed with the handle along the sagittal midline, pointing towards the occiput to stimulate bilaterally and simultaneously the pre-SMA.
Device: rTMS (repetitive transcranial magnetic stimulation)
rTMS is a non-invasive neuromodulation technique that is able to modulate cortical and subcortical function with the use of rapidly changing electromagnetic fields generated by a coil placed over the scalp (George and Post, 2011). Depending on the parameters of stimulation, rTMS can either decrease or increase cortical excitability in relatively focal areas, with frequencies < or = 1 Hz (low frequency rTMS or LF-rTMS) being usually inhibitory and higher frequencies (> or = 5 Hz; high frequency rTMS or HF-rTMS) being usually excitatory (Rosa and Lisanby, 2012). Moreover, rTMS has proven to have long-lasting effects on brain neuroplasticity through different mechanisms (e.g. by inducing long-term potentiation, increasing several neurotrophic factors etc.) (Chervyakov et al., 2015).

Placebo Comparator: Sham rTMS
Sham TMS will be administered by tilting the coil 90° off the scalp, with one wing of the coil touching the scalp. This sham-TMS approach produces a clicking sound that is very similar to an active TMS pulse and induces a voltage in the brain that is more than 75% lower than active TMS.
Device: rTMS (repetitive transcranial magnetic stimulation)
rTMS is a non-invasive neuromodulation technique that is able to modulate cortical and subcortical function with the use of rapidly changing electromagnetic fields generated by a coil placed over the scalp (George and Post, 2011). Depending on the parameters of stimulation, rTMS can either decrease or increase cortical excitability in relatively focal areas, with frequencies < or = 1 Hz (low frequency rTMS or LF-rTMS) being usually inhibitory and higher frequencies (> or = 5 Hz; high frequency rTMS or HF-rTMS) being usually excitatory (Rosa and Lisanby, 2012). Moreover, rTMS has proven to have long-lasting effects on brain neuroplasticity through different mechanisms (e.g. by inducing long-term potentiation, increasing several neurotrophic factors etc.) (Chervyakov et al., 2015).




Primary Outcome Measures :
  1. rTMS effects on OC symptoms [ Time Frame: end of the study ]
    Standard criteria for the treatment outcome will be included in the trial: response (>35% improvement in baseline Y-BOCS scores and a CGI-I of 1 or 2), partial response (≥ 25% improvement in baseline Y-BOCS scores), and non-response (<25% improvement in baseline Y-BOCS scores).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 18 and 65 yy
  • DSM-5 criteria for OCD
  • Y-BOCS total score > or = 20
  • History of treatment-resistant OCD, established by a trained psychiatrist with extensive expertise in the OCD field. Treatment-resistance is defined as non-response (less than 25% reduction of the Y-BOCS score) after at least one SRIs trials (clomipramine, fluoxetine, sertraline, paroxetine, fluvoxamine, citalopram, escitalopram) at the maximum tolerable dose for at least 12 weeks.

Exclusion Criteria:

  • any additional current psychiatric comorbidity, except for mild depressive and anxious symptoms or tics;
  • a lifetime DSM-5 diagnosis of schizophrenia or other psychotic syndromes, substance dependence or substance abuse, including alcohol, bipolar I or II disorder, mental disorder due to a general medical condition;
  • serious suicide risk;
  • episodic OCD;
  • illness duration less than two years
  • hospitalization in the last 6 months;
  • refractory OCD (defined as non response to two SRIs trials, one antidopaminergic augmentation and at least one CBT with ERP trial);
  • patient who did not response to a previous ECT trial;
  • the inability to receive rTMS because of metallic implants, or history of seizures (personal or family history of seizure in first degree relatives);
  • any major medical disease;
  • pregnancy or nursing of an infant;
  • the inability or refusal to provide written informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211221


Locations
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Italy
Stefano Pallanti Recruiting
Florence, I, Italy, 50100
Contact: Stefano Pallanti, M.D.    55 587889 ext 0039    stefanopallanti@yahoo.it   
Sponsors and Collaborators
CNS Onlus
University of Florence

Publications:
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Responsible Party: CNS Onlus
ClinicalTrials.gov Identifier: NCT03211221    
Other Study ID Numbers: Pallanti
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by CNS Onlus:
OCD
TMS
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders