Obsessive-Compulsive DisorderNCT05188833
EEG Results of Deep TMS in Patients With OCD
A study testing Deep Transcranial Magnetic Stimulation and Paroxetine in people with Obsessive-Compulsive Disorder and EEG With Periodic Abnormalities, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Obsessive Compulsive Disorder (OCD) is a psychiatric disorder in which involuntary thoughts and irresistible behaviors are seen and its prevalence affects 2%-3% of the general population. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder, EEG With Periodic Abnormalities
- What is being tested?
- Deep Transcranial Magnetic Stimulation and Paroxetine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 May 2020to May 2022
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being diagnosed with Obsessive Compulsive Disorder within the framework of DSM-5 criteria
Who cannot join
- Not volunteering to comply with the research program
- Presence of a metal piece on the head
- Having a pacemaker inserted
- Having had a previous epileptic seizure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34815
About this study
Official title: Electrophysiological Results of the Efficacy of Deep Transcranial Magnetic Stimulation on Mood State and Quality of Life in Obsessive Compulsive Disorder Patients
Obsessive Compulsive Disorder (OCD) is a psychiatric disorder in which involuntary thoughts and irresistible behaviors are seen and its prevalence affects 2%-3% of the general population. Deep TMS is a treatment method that provides stimulation of lower parts of the brain and larger brain volume, and in addition to drug treatment and psychotherapy approaches, magnetic stimulation of localized brain regions and disease symptoms are addressed. The presence of the medial prefrontal cortex and anterior cingulate cortex in the dysfunction on the specified cycle seen in OCD patients indicates that the stimulation of these regions is necessary for a meaningful result in the treatment of deep TMS; studies show that the effect of the deep TMS method emerges as a result of the stimulation of these regions. 30 patients with OCD will included into the study and dividen into 3 groups (DTMS (n=10), DTMS + Paroxetine (n=10), Control(n=10)). Patients will evaluated in terms of depression, quality of life, and EEG before and after the intervention.
- Being tested
- Deep Transcranial Magnetic Stimulation, Paroxetine
- Keywords
- Obsessive compulsive disorder, Deep Transcranial Magnetic Stimulation, Mood, Quality of Life, EEG
- 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.
Deep Transcranial Magnetic StimulationDevice
Deep TMS, unlike traditional TMS, is a treatment method that provides stimulation of lower parts of the brain and larger brain volume, in addition to drug treatment and psychotherapy approaches, in addition to localized brain regions magnetic stimulation is a treatment method where disease symptoms are addressed.
ParoxetineDrug
Paroxetine is a type of antidepressant known as an SSRI (selective serotonin reuptake inhibitor). It's often used to treat depression.
| Study group | Role | What they receive |
|---|---|---|
| Deep Transcranial Magnetic Stimulation | Active comparator | The treatment will be carried out for 6 weeks, 5 days a week, in total 30 sessions; 20 hz using Brainsway H-7 helmet. It will be applied to the mPFC and ACC simultaneously with a total of 2000 beats at a frequency of 50 beats in each string. Receives: Device: Deep Transcranial Magnetic Stimulation |
| Deep Transcranial Magnetic Stimulation and Paroxetine | Experimental | The treatment will be carried out for 6 weeks, 5 days a week, in total 30 sessions; 20 hz using Brainsway H-7 helmet. It will be applied to the mPFC and ACC simultaneously with a total of 2000 beats at a frequency of 50 beats in each string. In addtion to DTMMS, paroxetine will applied. Receives: Device: Deep Transcranial Magnetic Stimulation; Drug: Paroxetine |
| Paroxetine | Active comparator | Paroxetine is a type of antidepressant known as an SSRI (selective serotonin reuptake inhibitor). It's often used to treat depression in OCD. Receives: Drug: Paroxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalography
It is an electrophysiological neuroimaging method frequently used in neuroscience and clinic, in which the activity between neural circuits can be measured and observed non-invasively in the form of electrical waves.
Measured: 6 weeks after baseline
Secondary outcomes (2)
Beck Depression Scale
It is the scale used for evaluated the level of depression. Higher score means worse result.
Measured: 6 weeks after baseline
World Health Organization Quality of Life Scale Short Form
It is the scale used for evaluated the level of quality of life. It contains a total of 26 questions. Higher score means better result.
Measured: 6 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start17 May 2020
- Primary completion20 Oct 2021
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miray BUDAK, PhD, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188833
- Sponsor's protocol ID
- EEG.DeepTMS.OCD
- Status last verified
- Oct 2021
- First submitted
- 26 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Results of the Efficacy of Deep Transcranial Magnetic Stimulation on Mood State and Quality of Life in Obsessive Compulsive Disorder Patients
- ClinicalTrials.gov ID
- NCT05188833
- Acronym / sponsor ID
- EEG.DeepTMS.OCD
- Keywords
- Obsessive compulsive disorder, Deep Transcranial Magnetic Stimulation, Mood, Quality of Life, EEG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 17 May 2020 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- May 2022 (estimated)
- First posted
- 12 Jan 2022 (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.
Obsessive Compulsive Disorder (OCD) is a psychiatric disorder in which involuntary thoughts and irresistible behaviors are seen and its prevalence affects 2%-3% of the general population. Deep TMS is a treatment method that provides stimulation of lower parts of the brain and larger brain volume, and in addition to drug treatment and psychotherapy approaches, magnetic stimulation of localized brain regions and disease symptoms are addressed. The presence of the medial prefrontal cortex and anterior cingulate cortex in the dysfunction on the specified cycle seen in OCD patients indicates that the stimulation of these regions is necessary for a meaningful result in the treatment of deep TMS; studies show that the effect of the deep TMS method emerges as a result of the stimulation of these regions. 30 patients with OCD will included into the study and dividen into 3 groups (DTMS (n=10), DTMS + Paroxetine (n=10), Control(n=10)). Patients will evaluated in terms of depression, quality of life, and EEG before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Deep Transcranial Magnetic Stimulation | Active comparator | Device: Deep Transcranial Magnetic StimulationThe treatment will be carried out for 6 weeks, 5 days a week, in total 30 sessions; 20 hz using Brainsway H-7 helmet. It will be applied to the mPFC and ACC simultaneously with a total of 2000 beats at a frequency of 50 beats in each string. |
| Deep Transcranial Magnetic Stimulation and Paroxetine | Experimental | Device: Deep Transcranial Magnetic Stimulation, Drug: ParoxetineThe treatment will be carried out for 6 weeks, 5 days a week, in total 30 sessions; 20 hz using Brainsway H-7 helmet. It will be applied to the mPFC and ACC simultaneously with a total of 2000 beats at a frequency of 50 beats in each string. In addtion to DTMMS, paroxetine will applied. |
| Paroxetine | Active comparator | Drug: ParoxetineParoxetine is a type of antidepressant known as an SSRI (selective serotonin reuptake inhibitor). It's often used to treat depression in OCD. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being diagnosed with Obsessive Compulsive Disorder within the framework of DSM-5 criteria
Key exclusion criteria (4 listed)
- Not volunteering to comply with the research program
- Presence of a metal piece on the head
- Having a pacemaker inserted
- Having had a previous epileptic seizure
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 |
|---|---|---|
| Deep Transcranial Magnetic StimulationDeep TMS, unlike traditional TMS, is a treatment method that provides stimulation of lower parts of the brain and larger brain volume, in addition to drug treatment and psychotherapy approaches, in addition to localized brain regions magnetic stimulation is a treatment method where disease symptoms are addressed. | Device | Deep Transcranial Magnetic Stimulation, Deep Transcranial Magnetic Stimulation and Paroxetine |
| ParoxetineParoxetine is a type of antidepressant known as an SSRI (selective serotonin reuptake inhibitor). It's often used to treat depression. | Drug | Deep Transcranial Magnetic Stimulation and Paroxetine, Paroxetine |
Primary outcome
Electroencephalography
Time frame: 6 weeks after baseline
It is an electrophysiological neuroimaging method frequently used in neuroscience and clinic, in which the activity between neural circuits can be measured and observed non-invasively in the form of electrical waves.
2 secondary outcomes
Beck Depression Scale
Time frame: 6 weeks after baseline
World Health Organization Quality of Life Scale Short Form
Time frame: 6 weeks after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
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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.
Miray BUDAK, PhD study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Transcranial Magnetic Stimulation and Paroxetine in people with Obsessive-Compulsive Disorder and EEG With Periodic Abnormalities, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 4 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 12 Jan 2022. 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 Turkey (Türkiye). 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?
Electroencephalography (time frame: 6 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2022.