Obsessive-compulsive DisorderNCT00932204
Study of Sequentially Applied Repetitive Transcranial Magnetic Stimulation in Obsessive- Compulsive Disorders
A study testing repetitive transcranial magnetic stimulation (Magstim rapid magnetic stimulator) in people with Obsessive-compulsive Disorder, run by Severance Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Obsessive-compulsive Disorder
- What is being tested?
- repetitive transcranial magnetic stimulation (Magstim rapid magnetic stimulator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2007to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei Univ. Health System Severance Hospital
Seoul, 120-752
About this study
Official title: A Randomized, Controlled Study of Sequentially Applied Repetitive Transcranial Magnetic Stimulation in Obsessive- Compulsive Disorders
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).
Read the 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
- Being tested
- repetitive transcranial magnetic stimulation (Magstim rapid magnetic stimulator)
- Keywords
- obsessive-compulsive disorder, repetitive transcranial magnetic stimulation, right dorsolateral prefrontal cortex, supplementary motor area (SMA)
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulation (Magstim rapid magnetic stimulator)Device
Also called A Magstim rapid magnetic stimulator with a 70-mm figure-of-eight coil (Magstim Company Ltd, Whitland, UK) was used for treatment.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: repetitive transcranial magnetic stimulation (Magstim rapid magnetic stimulator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: baseline, week 1, week 2, and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startFeb 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obsessive-compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Se Joo Kim, Severance Hospital
- Investigators
- Se Joo Kim, M.D., Principal investigator, Yonsei Univ. College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932204
- Sponsor's protocol ID
- 4-2006-0318
- Status last verified
- Sep 2018
- First submitted
- 1 Jul 2009
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15982444Sachdev 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.
PubMed 11780880Kang 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.
PubMed 19709504
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study of Sequentially Applied Repetitive Transcranial Magnetic Stimulation in Obsessive- Compulsive Disorders
- ClinicalTrials.gov ID
- NCT00932204
- Acronym / sponsor ID
- 4-2006-0318
- Conditions
- Obsessive-compulsive Disorder
- Keywords
- obsessive-compulsive disorder, repetitive transcranial magnetic stimulation, right dorsolateral prefrontal cortex, supplementary motor area (SMA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 3 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Experimental | Device: 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). |
| Sham stimulation | Sham comparator | Device: repetitive transcranial magnetic stimulation (Magstim rapid magnetic stimulator)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. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- Subjects were excluded if:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive transcranial magnetic stimulation (Magstim rapid magnetic stimulator)Also: A Magstim rapid magnetic stimulator with a 70-mm figure-of-eight coil (Magstim Company Ltd, Whitland, UK) was used for treatment.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. | Device | Active stimulation, Sham stimulation |
Primary outcome
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)
Time frame: baseline, week 1, week 2, and week 4
1 secondary outcome
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.
Time frame: baseline, week 1, week 2, and week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Results publication: PubMed 15982444Mantovani 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.
- Results publication: PubMed 11780880Sachdev 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.
- Derived from this study: PubMed 19709504Kang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Se Joo Kim, M.D. principal investigator
Yonsei Univ. College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation (Magstim rapid magnetic stimulator) in people with Obsessive-compulsive Disorder, run by Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: baseline, week 1, week 2, and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00932204, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.