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

NCT03211221 | Unknown Phase 1

• 1 other identifier: Pallanti
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

OCD; TMS

Outcome Measures

Primary Outcomes (1)

• rTMS effects on OC symptoms

  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).

  end of the study

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

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)

Sham rTMS

PLACEBO COMPARATOR

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)

Interventions

rTMS (repetitive transcranial magnetic stimulation) DEVICE

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).

Active rTMS; Sham 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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CNS Onlus: lead
• University of Florence: collaborator

Study Sites (1)

Stefano Pallanti

Florence, I, 50100, Italy

RECRUITING

Related Publications (3)

• Berlim MT, Neufeld NH, Van den Eynde F. Repetitive transcranial magnetic stimulation (rTMS) for obsessive-compulsive disorder (OCD): an exploratory meta-analysis of randomized and sham-controlled trials. J Psychiatr Res. 2013 Aug;47(8):999-1006. doi: 10.1016/j.jpsychires.2013.03.022. Epub 2013 Apr 21.

  PMID: 23615189 BACKGROUND

• Gomes PV, Brasil-Neto JP, Allam N, Rodrigues de Souza E. A randomized, double-blind trial of repetitive transcranial magnetic stimulation in obsessive-compulsive disorder with three-month follow-up. J Neuropsychiatry Clin Neurosci. 2012 Fall;24(4):437-43. doi: 10.1176/appi.neuropsych.11100242.

  PMID: 23224449 BACKGROUND

• Mantovani A, Simpson HB, Fallon BA, Rossi S, Lisanby SH. Randomized sham-controlled trial of repetitive transcranial magnetic stimulation in treatment-resistant obsessive-compulsive disorder. Int J Neuropsychopharmacol. 2010 Mar;13(2):217-27. doi: 10.1017/S1461145709990435. Epub 2009 Aug 20.

  PMID: 19691873 BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, the investigators and the outcome assessor will be blind to the type of intervention (TMS or SHAM). The TMS operator will be unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 7, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

IT (1)