Obsessive-Compulsive DisorderTIPICCONCT03667807
TMS-induced Plasticity Improving Cognitive Control in OCD
A study testing Repetitive transcranial magnetic stimulation in people with Obsessive-Compulsive Disorder, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Repetitive transcranial magnetic stimulation (rTMS) has been shown in several previous clinical trials to be an effective treatment for obsessive-compulsive disorder (OCD). However, the neural working mechanisms of rTMS in OCD are unknown, and the optimal stimulation sites have not yet been established. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 May 2019to 1 Jul 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- OCD patients:
- Age between 18 and 65
- Primary DSM-5 diagnosis of OCD
- Moderate to severe OCD symptoms (expressed as a minimum score of 16 on the Yale - Brown Obsessive Compulsive Scale (YBOCS)
- Unmedicated or stable dose of medication for at least 12 weeks prior to randomisation - with no plans to change dose during the study period
- At least 1 previous attempt at cognitive behavioural therapy (CBT) in lifetime
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- At least 1 previous attempt with serotonergic medication or strong preference for non-pharmacological treatment
- Capacity to provide informed consent
- Healthy controls (baseline measurements only):
- Age between 18 and 65
- Capacity to provide informed consent
Who cannot join
- OCD patients:
- MRI exclusion criteria (metal in body, pregnancy)
- TMS exclusion criteria (metal in body, history of epilepsy)
- Schizophrenia, bipolar disorder, active suicidal ideation, use of antipsychotics within last 12 weeks
- previous experience with rTMS as treatment
- Healthy controls:
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- Current Diagnostic and Statistical Manual (DSM)-5 diagnosis
- Personal history of DSM-5 diagnosis
- use of psychotropic medications within last 12 months
- 1st degree family member with OCD
- MRI exclusion criteria (as above)
- TMS exclusion criteria (as above)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam UMC, location VU Medical Center
Amsterdam, North Holland, 1081 HZ
About this study
Official title: Transcranial Magnetic Stimulation (TMS)-Induced Plasticity Improving Cognitive Control in Obsessive-compulsive Disorder (OCD)
Repetitive transcranial magnetic stimulation (rTMS) has been shown in several previous clinical trials to be an effective treatment for obsessive-compulsive disorder (OCD). However, the neural working mechanisms of rTMS in OCD are unknown, and the optimal stimulation sites have not yet been established. Our study aims to compare the clinical and neurobiological effects of three different rTMS stimulation protocols in OCD patients. 8 weeks of rTMS therapy will be delivered in combination with cognitive behavioural therapy. Multimodal neuroimaging will be carried out before and after treatment in order to demonstrate the neurobiological effects of the therapy.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Repetitive transcranial magnetic stimulation
- 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 stimulationDevice
Also called rTMS, TMS
Non invasive brain stimulation
| Study group | Role | What they receive |
|---|---|---|
| rTMS condition 1 | Experimental | Not described Receives: Device: Repetitive transcranial magnetic stimulation |
| rTMS condition 2 | Experimental | Not described Receives: Device: Repetitive transcranial magnetic stimulation |
| rTMS condition 3 | Experimental | Not described Receives: Device: Repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
task based functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) response
Change in task based fMRI BOLD response following rTMS
Measured: Baseline and 12 weeks (i.e. post-treatment)
Secondary outcomes (1)
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
OCD symptom severity
Measured: Baseline, 6 weeks, (i.e. during treatment), 12 weeks (i.e. post-treatment), 22 weeks (i.e. follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start8 May 2019
- Primary completion1 Oct 2022
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, O.A. van den Heuvel, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667807
- Sponsor's protocol ID
- 91717306
- Acronym
- TIPICCO
- Status last verified
- May 2023
- First submitted
- 6 Sep 2018
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fitzsimmons SMDD, Postma T, van Campen AD, Vriend C, Batelaan NM, van Oppen P, Hoogendoorn AW, van der Werf YD, van den Heuvel OA. TMS-induced plasticity improving cognitive control in OCD I: Clinical and neuroimaging outcomes from a randomised trial of rTMS for OCD. medRxiv [Preprint]. 2023 Nov 5:2023.11.04.23298100. doi: 10.1101/2023.11.04.23298100.
PubMed 37961433
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation (TMS)-Induced Plasticity Improving Cognitive Control in Obsessive-compulsive Disorder (OCD)
- ClinicalTrials.gov ID
- NCT03667807
- Acronym / sponsor ID
- TIPICCO / 91717306
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 8 May 2019 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 12 Sep 2018 (actual)
- 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.
Repetitive transcranial magnetic stimulation (rTMS) has been shown in several previous clinical trials to be an effective treatment for obsessive-compulsive disorder (OCD). However, the neural working mechanisms of rTMS in OCD are unknown, and the optimal stimulation sites have not yet been established. Our study aims to compare the clinical and neurobiological effects of three different rTMS stimulation protocols in OCD patients. 8 weeks of rTMS therapy will be delivered in combination with cognitive behavioural therapy. Multimodal neuroimaging will be carried out before and after treatment in order to demonstrate the neurobiological effects of the therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rTMS condition 1 | Experimental | Device: Repetitive transcranial magnetic stimulation |
| rTMS condition 2 | Experimental | Device: Repetitive transcranial magnetic stimulation |
| rTMS condition 3 | Experimental | Device: Repetitive transcranial magnetic stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age between 18 and 65
- Primary DSM-5 diagnosis of OCD
- Moderate to severe OCD symptoms (expressed as a minimum score of 16 on the Yale - Brown Obsessive Compulsive Scale (YBOCS)
- Unmedicated or stable dose of medication for at least 12 weeks prior to randomisation - with no plans to change dose during the study period
- At least 1 previous attempt at cognitive behavioural therapy (CBT) in lifetime
Key exclusion criteria (12 listed)
- MRI exclusion criteria (metal in body, pregnancy)
- TMS exclusion criteria (metal in body, history of epilepsy)
- Schizophrenia, bipolar disorder, active suicidal ideation, use of antipsychotics within last 12 weeks
- previous experience with rTMS as treatment
- Current Diagnostic and Statistical Manual (DSM)-5 diagnosis
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 stimulationAlso: rTMS, TMSNon invasive brain stimulation | Device | rTMS condition 1, rTMS condition 2, rTMS condition 3 |
Primary outcome
task based functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) response
Time frame: Baseline and 12 weeks (i.e. post-treatment)
Change in task based fMRI BOLD response following rTMS
1 secondary outcome
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: Baseline, 6 weeks, (i.e. during treatment), 12 weeks (i.e. post-treatment), 22 weeks (i.e. follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Derived from this study: PubMed 37961433Fitzsimmons SMDD, Postma T, van Campen AD, Vriend C, Batelaan NM, van Oppen P, Hoogendoorn AW, van der Werf YD, van den Heuvel OA. TMS-induced plasticity improving cognitive control in OCD I: Clinical and neuroimaging outcomes from a randomised trial of rTMS for OCD. medRxiv [Preprint]. 2023 Nov 5:2023.11.04.23298100. doi: 10.1101/2023.11.04.23298100.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Obsessive-Compulsive Disorder, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 11 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 11 May 2023. 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 Netherlands. 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. 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?
Results are not available in the source record.
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?
task based functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) response (time frame: Baseline and 12 weeks (i.e. post-treatment)). 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 NCT03667807, which also lists 1 linked publication.
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 11 May 2023.