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

NCT ID: NCT00932204

Last Updated: 2018-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2008-01-31

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).

Detailed Description

Obsessive-compulsive disorder (OCD) is a relatively common psychiatric disorder characterized by repetitive, intrusive thoughts and time-consuming behavioral or mental acts. Many OCD patients who do not respond to conventional treatments experience severe distress and disruptions in their daily activities. Novel approaches including psychopharmacological therapy and surgical techniques for treatment-resistant OCD have been proposed. With recent advances in non-invasive technique for stimulating the cerebral cortex, repetitive transcranial magnetic stimulation (rTMS) has been proposed as a potential therapeutic approach for various psychiatric illnesses including OCD.

Because of contradictory findings and a lack of controlled trials in OCD, rTMS cannot be yet recommended as routine therapy for OCD. However, it may have a potential clinical effect as a putative add-on treatment for OCD and an alternative therapy for treatment-resistant OCD.

For useful clinical applications, it is very important to develop methods to enhance the efficacy of rTMS. There are a number of putative ways to do this, and one of them is sequentially combining two forms of stimulation which are considered to have potential therapeutic effects. More recently, the sequential application of two stimulation regimens (high-frequency left-side rTMS and low-frequency right-side rTMS to the prefrontal cortex) has been found to have a substantial therapeutic effect in patients with treatment-resistant major depression. Therefore, the investigation for a sequentially combining effect of both the right prefrontal and the SMA stimulation would be worthwhile in OCD patients.

Conditions

Obsessive-compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active stimulation

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).

Group Type: EXPERIMENTAL

repetitive transcranial magnetic stimulation (Magstim rapid magnetic stimulator)

Intervention Type: 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.

Sham stimulation

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.

Group Type: SHAM_COMPARATOR

repetitive transcranial magnetic stimulation (Magstim rapid magnetic stimulator)

Intervention Type: 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.

Interventions

repetitive transcranial magnetic stimulation (Magstim rapid magnetic stimulator)

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.

Intervention Type: DEVICE

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Se Joo Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Se Joo Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yonsei Univ. College of Medicine

Locations

Yonsei Univ. Health System Severance Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: RESULT

PMID: 15982444 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11780880 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19709504 (View on PubMed)

Other Identifiers

4-2006-0318

Identifier Type: -

Identifier Source: org_study_id