Treating Refractory Obsessive Compulsive Disorder With rTMS

NCT00396552 | Completed

• 1 other identifier: 100/2006
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

Obsessive-compulsive disorder (OCD) is a severe psychiatric condition with only limited response to current first-line treatments, comprising pharmacotherapy and cognitive-behavioural therapy. Repetitive transcranial magnetic stimulation (rTMS) is a relatively new technique which has shown great promise in the treatment of refractory mood disorders, and schizophrenia, by alteration of brain activity. Previous work has demonstrated altered cortical excitability in OCD and preliminary studies have suggested that rTMS may have therapeutic potential in OCD. This pilot study will investigate the effectiveness of rTMS for treatment-refractory OCD, and establish appropriate treatment parameters. In addition, mechanisms whereby rTMS exerts its therapeutic effect will be explored using TMS to evaluate cortical inhibition and measures of cognitive biases and processing.

Conditions

Obsessive Compulsive Disorder

Keywords

refractory transcranial magnetic stimulation; obsessive compulsive disorder; randomized; placebo-controlled; double-blind

Outcome Measures

Primary Outcomes (1)

• Degree of change on the Yale-Brown Obsessive Compulsive Disorder Scale

  intermittent

Study Arms (2)

1

EXPERIMENTAL

Device: refractory transcranial magnetic stimulation (rTMS)

2

SHAM COMPARATOR

Device: Sham condition

Interventions

refractory transcranial magnetic stimulation (rTMS) DEVICE

Bilateral rTMS will be delivered according to the following protocol: high frequency left (HFL) stimulation will initially be applied at 20 Hz, in 25 trains of 1.5 second duration with a 30 second interval between trains and at 100% of the RMT for a total of 25 minutes of stimulation. Following this HFR stimulation will be applied at the same parameters. Therefore a total of 50 minutes of stimulation will be delivered.

1

Sham condition DEVICE

Sham stimulation will be made at the site of active treatment but with only the side edge resting on the scalp. It will be administered as HFL and HFR for 50 minutes but with the coil angled 45-90 degrees away from the skull in a single-wing tilt position. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those with active stimulation but with minimal direct brain effects. Participants will be unable to see the stimulating coil and therefore will remain blind to the treatment condition.

2

Eligibility Criteria

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

You may qualify if:

• voluntary and competent to consent based on their ability to provide a spontaneous narrative description of the key elements of the study
• have a Structured Clinical Interview for DSM-IV (SCID) confirmed diagnosis of OCD
• are between the ages of 18 and 65
• have failed to achieve a clinical response, or did not tolerate, at least 3 separate antidepressant trials of sufficient dose for at least 10 weeks
• have a score of greater than or equal to 17 on the Y-BOCS. A careful medical and neurological history will be taken to ensure that subjects have no unstable conditions that would preclude them from entering into the study. This history will focus on conditions such as seizures, stroke, hypertension, diabetes, coronary artery disease, thyroid problems, respiratory illness, allergies and presence of metal implants

You may not qualify if:

• have a history of DSM-IV substance dependence in the last 6 months, and have DSM-IV substance abuse in the last month
• have a concomitant major unstable medical or neurologic illness or have had a history of seizures
• acutely suicidal
• are pregnant
• have metal implants. With respect to concomitant medications, patients will be excluded if they are currently (or in the last 4 weeks) taking: (a) more than lorazepam 2 mg daily (or equivalent), (b) monoamine oxidase inhibitors, (c) and/or bupropion due to its associated increased risk for seizures.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Publications (8)

• Fitzgerald PB, Benitez J, de Castella A, Daskalakis ZJ, Brown TL, Kulkarni J. A randomized, controlled trial of sequential bilateral repetitive transcranial magnetic stimulation for treatment-resistant depression. Am J Psychiatry. 2006 Jan;163(1):88-94. doi: 10.1176/appi.ajp.163.1.88.

  PMID: 16390894 BACKGROUND

• Loo CK, Mitchell PB. A review of the efficacy of transcranial magnetic stimulation (TMS) treatment for depression, and current and future strategies to optimize efficacy. J Affect Disord. 2005 Nov;88(3):255-67. doi: 10.1016/j.jad.2005.08.001. Epub 2005 Sep 2.

  PMID: 16139895 BACKGROUND

• Klein E, Kolsky Y, Puyerovsky M, Koren D, Chistyakov A, Feinsod M. Right prefrontal slow repetitive transcranial magnetic stimulation in schizophrenia: a double-blind sham-controlled pilot study. Biol Psychiatry. 1999 Nov 15;46(10):1451-4. doi: 10.1016/s0006-3223(99)00182-1.

  PMID: 10578460 BACKGROUND

• Hoffman RE, Hawkins KA, Gueorguieva R, Boutros NN, Rachid F, Carroll K, Krystal JH. Transcranial magnetic stimulation of left temporoparietal cortex and medication-resistant auditory hallucinations. Arch Gen Psychiatry. 2003 Jan;60(1):49-56. doi: 10.1001/archpsyc.60.1.49.

  PMID: 12511172 BACKGROUND

• Greenberg BD, Ziemann U, Cora-Locatelli G, Harmon A, Murphy DL, Keel JC, Wassermann EM. Altered cortical excitability in obsessive-compulsive disorder. Neurology. 2000 Jan 11;54(1):142-7. doi: 10.1212/wnl.54.1.142.

  PMID: 10636140 BACKGROUND

• Mantovani A, Lisanby SH, Pieraccini F, Ulivelli M, Castrogiovanni P, Rossi S. Repetitive transcranial magnetic stimulation (rTMS) in the treatment of obsessive-compulsive disorder (OCD) and Tourette's syndrome (TS). Int J Neuropsychopharmacol. 2006 Feb;9(1):95-100. doi: 10.1017/S1461145705005729. Epub 2005 Jun 28.

  PMID: 15982444 BACKGROUND

• 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.

  PMID: 11780880 BACKGROUND

• Horwath E, Weissman MM. The epidemiology and cross-national presentation of obsessive-compulsive disorder. Psychiatr Clin North Am. 2000 Sep;23(3):493-507. doi: 10.1016/s0193-953x(05)70176-3.

  PMID: 10986723 BACKGROUND

Related Links

• Information about research at the Centre for Addiction and Mental Health

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Margaret A Richter, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2006
• First Posted: November 7, 2006
• Study Start: June 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

CA (2)