Obsessive Compulsive DisorderPhase 2NCT01540305
Efficacy Study of Transcranial Magnetic Stimulation for Treatment of Obsessive-Compulsive Disorder
A Phase 2 study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Obsessive Compulsive Disorder, run by University of Brasilia at 1 site in Brazil.
Trial summary
This study aimed at verifying whether sessions of repetitive transcranial magnetic stimulation over a certain brain area (the supplementary motor area) could be useful in the relief of Obsessive-Compulsive Disorder symptoms. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to Sep 2011
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18 to 60 years
- diagnosis of obsessive-compulsive disorder (OCD) according to DSM-IV-TR criteria and having OCD of at least moderate severity (YBOCS score of 16 or above).
Who cannot join
- subjects with comorbid psychiatric disorders (except depression - HAM-D ) or history of drug abuse
- significant head injury, or of any neurosurgical procedure
- pregnant women
- patients with metal implants or illnesses that prevent attendance to sessions
- patients with a history of seizure or bearing pacemakers
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory of Neurosciences and Behavior, Biology Institute, University of Brasília
Brasília, Federal District, 70000-000
About this study
Official title: A Randomized Double-blind Trial of Repetitive Transcranial Magnetic Stimulation in Obsessive -Compulsive Disorder With Three Months Follow-up
This study aimed at verifying whether sessions of repetitive transcranial magnetic stimulation over a certain brain area (the supplementary motor area) could be useful in the relief of Obsessive-Compulsive Disorder symptoms.
Read the detailed description
Patients were randomly administered either real (n = 12) or sham (n = 10) rTMS, once a day, 5 days a week, for 2 weeks. Randomization was performed according to a computer-generated schedule. Subjects and scale-rater physician were blind to treatment status of individuals. Only the rTMS administrator was aware of group allocations. Treatment response was assessed by self-and clinician-rated scales before treatment, immediately after treatment and 3 months thereafter, with the same examiner following a subject throughout the study. All patients included in the study had failed adequate pharmacological treatment for at least 2 antiobsessional drugs. Their prescription drugs were continued without change in dosage regimens throughout the study.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), Sham repetitive transcranial magnetic stimulation
- Keywords
- Obsessive Compulsive Disorder, Transcranial Magnetic Stimulation, Treatment
- 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 (rTMS)Device
Also called Neuro-MS Transcranial Magnetic Stimulator
rTMS was administered by means of a NEURO-MS (NEUROSOFT LTD®, Russia) with a focal 8-shaped 70 mm coil. Stimulation parameters were 1-Hz, 20-min trains (1200 pulses/day) at 100% of resting MT, once a day, 5 days a week, for 2 weeks.
Sham repetitive transcranial magnetic stimulationDevice
Also called Neurosoft sham coil
The sham treatment was performed using the Neurosoft ® sham coil. A metal plate placed inside this coil prevents the magnetic field from stimulating the cortex. This coil looks and sounds like an active coil.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Magnetic Stimulation | Active comparator | Actual transcranial magnetic stimulation of supplementary motor areas bilaterally. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Sham Transcranial Magnetic Stimulation | Sham comparator | Sham transcranial magnetic stimulation over the supplementary motor areas. Receives: Device: Sham repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Y-BOCS scale scores relative to baseline
Y-BOCS: Yale-Brown Obsessive-Compulsive Scale
Measured: assessments were at baseline, at 2 weeks and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquim Brasil-Neto, University of Brasilia
- Investigators
- Joaquim Brasil-Neto, MD, PhD, Study director, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540305
- Sponsor's protocol ID
- 49/09
- Status last verified
- Feb 2012
- First submitted
- 15 Feb 2012
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19691873Mantovani 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 15982444
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Trial of Repetitive Transcranial Magnetic Stimulation in Obsessive -Compulsive Disorder With Three Months Follow-up
- ClinicalTrials.gov ID
- NCT01540305
- Acronym / sponsor ID
- 49/09
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- Obsessive Compulsive Disorder, Transcranial Magnetic Stimulation, Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 28 Feb 2012 (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.
This study aimed at verifying whether sessions of repetitive transcranial magnetic stimulation over a certain brain area (the supplementary motor area) could be useful in the relief of Obsessive-Compulsive Disorder symptoms.
Detailed description
Patients were randomly administered either real (n = 12) or sham (n = 10) rTMS, once a day, 5 days a week, for 2 weeks. Randomization was performed according to a computer-generated schedule. Subjects and scale-rater physician were blind to treatment status of individuals. Only the rTMS administrator was aware of group allocations. Treatment response was assessed by self-and clinician-rated scales before treatment, immediately after treatment and 3 months thereafter, with the same examiner following a subject throughout the study. All patients included in the study had failed adequate pharmacological treatment for at least 2 antiobsessional drugs. Their prescription drugs were continued without change in dosage regimens throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation | Active comparator | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Actual transcranial magnetic stimulation of supplementary motor areas bilaterally. |
| Sham Transcranial Magnetic Stimulation | Sham comparator | Device: Sham repetitive transcranial magnetic stimulationSham transcranial magnetic stimulation over the supplementary motor areas. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age 18 to 60 years
- diagnosis of obsessive-compulsive disorder (OCD) according to DSM-IV-TR criteria and having OCD of at least moderate severity (YBOCS score of 16 or above).
Key exclusion criteria (5 listed)
- subjects with comorbid psychiatric disorders (except depression - HAM-D ) or history of drug abuse
- significant head injury, or of any neurosurgical procedure
- pregnant women
- patients with metal implants or illnesses that prevent attendance to sessions
- patients with a history of seizure or bearing pacemakers
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 (rTMS)Also: Neuro-MS Transcranial Magnetic StimulatorrTMS was administered by means of a NEURO-MS (NEUROSOFT LTD®, Russia) with a focal 8-shaped 70 mm coil. Stimulation parameters were 1-Hz, 20-min trains (1200 pulses/day) at 100% of resting MT, once a day, 5 days a week, for 2 weeks. | Device | Transcranial Magnetic Stimulation |
| Sham repetitive transcranial magnetic stimulationAlso: Neurosoft sham coilThe sham treatment was performed using the Neurosoft ® sham coil. A metal plate placed inside this coil prevents the magnetic field from stimulating the cortex. This coil looks and sounds like an active coil. | Device | Sham Transcranial Magnetic Stimulation |
Primary outcome
Changes in Y-BOCS scale scores relative to baseline
Time frame: assessments were at baseline, at 2 weeks and at 3 months
Y-BOCS: Yale-Brown Obsessive-Compulsive Scale
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 28 Feb 2012.
- Background: PubMed 19691873Mantovani 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.
- Background: 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.
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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.
Joaquim Brasil-Neto, MD, PhD study director
University of Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Obsessive Compulsive Disorder, run by University of Brasilia at 1 site in Brazil.
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 2 inclusion and 5 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 28 Feb 2012. 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in Y-BOCS scale scores relative to baseline (time frame: assessments were at baseline, at 2 weeks and at 3 months). 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 NCT01540305, which also lists 2 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 28 Feb 2012.