Study of Sequentially Applied Repetitive Transcranial Magnetic Stimulation in Obsessive- Compulsive Disorders

NCT00932204 | Completed DMC

• 1 other identifier: 4-2006-0318
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of study was to investigate possible therapeutic effects and safety of sequentially combined low-frequency repetitive transcranial magnetic stimulation (rTMS) to the right dorsolateral prefrontal cortex (DLPFC) and supplementary motor area (SMA) in patients with treatment-resistant obsessive-compulsive disorder (OCD).

Conditions

Obsessive-compulsive Disorder

Keywords

obsessive-compulsive disorder; repetitive transcranial magnetic stimulation; right dorsolateral prefrontal cortex; supplementary motor area (SMA)

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure for the study was score on the Y-BOCS. The responder on Y-BOCS is defined as a Y-BOCS decrease at least 25% from the baseline at post-treatment (at 4 weeks)

  baseline, week 1, week 2, and week 4

Secondary Outcomes (1)

• The secondary outcome measures were the scores of MADRS and HARS, to examine the effects on cognitive functions of rTMS, a computerized Stroop task was conducted and side effect checklist.

  baseline, week 1, week 2, and week 4

Study Arms (2)

Active stimulation

EXPERIMENTAL

For the active group, rTMS over the right prefrontal cortex and the SMA was sequentially performed. The rTMS of the right dorsolateral prefrontal cortex was conducted at a point 5 cm anterior to the point at which the MT was determined, and it was administered at an intensity of 110% of the RMT, a frequency of 1 Hz, for 10 minutes, and with an inter-train interval of 2 minutes (1200 stimuli/d). The vertex (Cz) was measured for each patient, and the SMA was defined at 15% of the distance between the inion and nasion anterior to Cz on the sagittal midline, according to the international 10-20 EEG system. The rTMS over the SMA was administered at an intensity of 100% of the RMT, a frequency of 1 Hz, for 10 minutes and with an inter-train interval of 2 minutes (1200 stimuli/d).

Device: repetitive transcranial magnetic stimulation (Magstim rapid magnetic stimulator)

Sham stimulation

SHAM COMPARATOR

For the sham group, the sham stimulation was applied with the coil angled at 45° from the scalp using the same parameters as the active stimulation group over the same area.

Device: repetitive transcranial magnetic stimulation (Magstim rapid magnetic stimulator)

Interventions

repetitive transcranial magnetic stimulation (Magstim rapid magnetic stimulator) DEVICE

For the active group, rTMS over the right prefrontal cortex and the SMA was sequentially performed. The rTMS of the right dorsolateral prefrontal cortex was conducted at a point 5 cm anterior to the point at which the MT was determined, and it was administered at an intensity of 110% of the RMT, a frequency of 1 Hz, for 10 minutes, and with an inter-train interval of 2 minutes (1200 stimuli/d). The vertex (Cz) was measured for each patient, and the SMA was defined at 15% of the distance between the inion and nasion anterior to Cz on the sagittal midline, according to the international 10-20 EEG system. The rTMS over the SMA was administered at an intensity of 100% of the RMT, a frequency of 1 Hz, for 10 minutes and with an inter-train interval of 2 minutes (1200 stimuli/d). For the sham group, the sham stimulation was applied with the coil angled at 45° from the scalp using the same parameters as the active stimulation group over the same area.

Also known as: A Magstim rapid magnetic stimulator with a 70-mm figure-of-eight coil (Magstim Company Ltd, Whitland, UK) was used for treatment.

Active stimulation; Sham stimulation

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• OCD patients who had failed adequate trials (a lack of at least a 25% reduction in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) 15 after at least eight weeks of treatment) of at least two serotonin re-uptake inhibitors (SRI) and behavioral therapy.

You may not qualify if:

• Subjects were excluded if:
• they presented with a movement disorder other than a tic
• any psychotic symptoms
• other anxiety disorders
• mental retardation
• alcohol or other substance abuse within the last six months
• a history of psychosurgery, encephalitis or significant head trauma

Sponsors & Collaborators

• Severance Hospital: lead

Study Sites (1)

Yonsei Univ. Health System Severance Hospital

Seoul, 120-752, South Korea

Location

Related Publications (3)

• 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 RESULT

• 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 RESULT

• Kang JI, Kim CH, Namkoong K, Lee CI, Kim SJ. A randomized controlled study of sequentially applied repetitive transcranial magnetic stimulation in obsessive-compulsive disorder. J Clin Psychiatry. 2009 Dec;70(12):1645-51. doi: 10.4088/JCP.08m04500. Epub 2009 Aug 25.

  PMID: 19709504 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Magnetic Stimulation; Therapeutics

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy

Study Officials

• Se Joo Kim, M.D.

  Yonsei Univ. College of Medicine

  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: Professor

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 3, 2009
• Study Start: February 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

KR (1)