Obsessive-Compulsive DisorderNCT06077370
dTMS in Obsessive Compulsive Disorder
A study testing deep TMS in people with Obsessive-Compulsive Disorder, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
High-frequency deep transcranial magnetic stimulation (dTMS) over the medial prefrontal cortex (mPFC) and the anterior cingulate cortex (ACC) with an H-coil has been approved by the Food and Drug Administration for use in treatment-resistant obsessive-compulsive disorder (OCD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- deep TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Nov 2022to 25 May 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of obsessive-compulsive disorder
- Not having an adequate response to treatment despite using at least two selective serotonin reuptake inhibitors at a sufficient dose and duration for 12 weeks before the planned add-on treatment
- Aged 18-65 years
- Able to read and write
Who cannot join
- Not providing consent to participate in the study
- Diagnosis of a psychiatric disorder, such as psychotic disorder, bipolar disorder, major depressive disorder [Hamilton Depression Rating Scale (HDRS) score above 17], mental retardation, alcohol-substance use disorder, and organic mental disorder (dementia, delirium, and head trauma, etc.)
- Diagnosis of an important medical or neurological disease (e.g., epilepsy);
- Mental retardation
- Illiteracy
- Having received electroconvulsive therapy (ECT) or TMS within the last six months;
- Having any prosthesis, such as an implant and pacemaker.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Deep Transcranial Magnetic Stimulation to Medial Prefrontal Cortex and Anterior Cingulate Cortex in Obsessive-Compulsive Disorder Patients
High-frequency deep transcranial magnetic stimulation (dTMS) over the medial prefrontal cortex (mPFC) and the anterior cingulate cortex (ACC) with an H-coil has been approved by the Food and Drug Administration for use in treatment-resistant obsessive-compulsive disorder (OCD). However, there is not yet strong scientific evidence concerning the efficacy and safety of performing a similar procedure with a double-cone coil or in an accelerated manner. The aim of this study was evaluating the efficacy of dTMS over the medial prefrontal cortex (mPFC) and the anterior cingulate cortex (ACC) in an accelerated manner with double-cone coil.
Read the detailed description
The current study aimed to investigate the efficacy and safety of multiple deep stimulations per day with a double-cone coil to the mPFC and ACC in treatment-resistant patients with OCD. This study evaluated (I) the effectiveness of high-frequency stimulation of the mPFC and ACC with a double cone coil, and (II) the effectiveness of the application of this protocol in three weeks, not six weeks as approved by the FDA. The participants were randomized into two parallel groups in a double-blind manner. High frequency (20 Hz) dTMS was applied to the mPFC and ACC in one group and sham dTMS to the same regions in the other group, twice a day, for a total of 30 sessions. This application was for three weeks in total, excluding weekends.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- deep TMS, Sham TMS
- Keywords
- obsessive compulsive disorder, 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.
deep TMSDevice
Deep Transcranial magnetic stimulation on anterior Cingulate cortex and medial prefrontal cortex. 20 Hz.
Sham TMSDevice
Sham Transcranial magnetic stimulation on anterior Cingulate cortex and medial prefrontal cortex. 20 Hz.
| Study group | Role | What they receive |
|---|---|---|
| dTMS group | Active comparator | dTMS on anterior cingulate cortex and medial prefrontal cortex. Receives: Device: deep TMS |
| sham TMS | Sham comparator | Sham TMS on anterior cingulate cortex and medial prefrontal cortex. Receives: Device: Sham TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obsessive compulsive symptoms severity
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). The minimum and maximum values are 0-40, and higher scores mean a worse outcome.
Measured: pretreatment(0.weeks)-as soon as the work is completed (3 weeks)
Dimensional obsessive compulsive symptom severity
Dimensional Obsessive-Compulsive Scale (DOCS). The minimum and maximum values are 0-80, and higher scores mean a worse outcome.
Measured: pretreatment(0.weeks)-as soon as the work is completed (3 weeks)
Severity of side effects
Clinical Global Impression - The efficacy index. The minimum and maximum values are 1-4, and higher scores mean a worse outcome.
Measured: pretreatment(0.weeks)-as soon as the work is completed (3 weeks)
Secondary outcomes (2)
Severity of Depression
Hamilton Depression Rating Scale. The minimum and maximum values are 0-52, and higher scores mean a worse outcome.
Measured: pretreatment(0.weeks)-as soon as the work is completed (3 weeks)
Severity of anxiety
Hamilton Anxiety Rating Scale. The minimum and maximum values are 0-56, and higher scores mean a worse outcome.
Measured: pretreatment(0.weeks)-as soon as the work is completed (3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start27 Nov 2022
- Primary completion24 Feb 2023
- Study completion25 May 2023
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.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selim Tumkaya, Pamukkale University
- Investigators
- Selim Tümkaya, MD, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077370
- Sponsor's protocol ID
- 2021TIPF029
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Deep Transcranial Magnetic Stimulation to Medial Prefrontal Cortex and Anterior Cingulate Cortex in Obsessive-Compulsive Disorder Patients
- ClinicalTrials.gov ID
- NCT06077370
- Acronym / sponsor ID
- 2021TIPF029
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- obsessive compulsive disorder, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 27 Nov 2022 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 11 Oct 2023 (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.
High-frequency deep transcranial magnetic stimulation (dTMS) over the medial prefrontal cortex (mPFC) and the anterior cingulate cortex (ACC) with an H-coil has been approved by the Food and Drug Administration for use in treatment-resistant obsessive-compulsive disorder (OCD). However, there is not yet strong scientific evidence concerning the efficacy and safety of performing a similar procedure with a double-cone coil or in an accelerated manner. The aim of this study was evaluating the efficacy of dTMS over the medial prefrontal cortex (mPFC) and the anterior cingulate cortex (ACC) in an accelerated manner with double-cone coil.
Detailed description
The current study aimed to investigate the efficacy and safety of multiple deep stimulations per day with a double-cone coil to the mPFC and ACC in treatment-resistant patients with OCD. This study evaluated (I) the effectiveness of high-frequency stimulation of the mPFC and ACC with a double cone coil, and (II) the effectiveness of the application of this protocol in three weeks, not six weeks as approved by the FDA. The participants were randomized into two parallel groups in a double-blind manner. High frequency (20 Hz) dTMS was applied to the mPFC and ACC in one group and sham dTMS to the same regions in the other group, twice a day, for a total of 30 sessions. This application was for three weeks in total, excluding weekends.
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 |
|---|---|---|
| dTMS group | Active comparator | Device: deep TMSdTMS on anterior cingulate cortex and medial prefrontal cortex. |
| sham TMS | Sham comparator | Device: Sham TMSSham TMS on anterior cingulate cortex and medial prefrontal cortex. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of obsessive-compulsive disorder
- Not having an adequate response to treatment despite using at least two selective serotonin reuptake inhibitors at a sufficient dose and duration for 12 weeks before the planned add-on treatment
- Aged 18-65 years
- Able to read and write
Key exclusion criteria (7 listed)
- Not providing consent to participate in the study
- Diagnosis of a psychiatric disorder, such as psychotic disorder, bipolar disorder, major depressive disorder [Hamilton Depression Rating Scale (HDRS) score above 17], mental retardation, alcohol-substance use disorder, and organic mental disorder (dementia, delirium, and head trauma, etc.)
- Diagnosis of an important medical or neurological disease (e.g., epilepsy);
- Mental retardation
- Illiteracy
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 TMSDeep Transcranial magnetic stimulation on anterior Cingulate cortex and medial prefrontal cortex. 20 Hz. | Device | dTMS group |
| Sham TMSSham Transcranial magnetic stimulation on anterior Cingulate cortex and medial prefrontal cortex. 20 Hz. | Device | sham TMS |
Primary outcome
Obsessive compulsive symptoms severity
Time frame: pretreatment(0.weeks)-as soon as the work is completed (3 weeks)
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). The minimum and maximum values are 0-40, and higher scores mean a worse outcome.
Dimensional obsessive compulsive symptom severity
Time frame: pretreatment(0.weeks)-as soon as the work is completed (3 weeks)
Dimensional Obsessive-Compulsive Scale (DOCS). The minimum and maximum values are 0-80, and higher scores mean a worse outcome.
Severity of side effects
Time frame: pretreatment(0.weeks)-as soon as the work is completed (3 weeks)
Clinical Global Impression - The efficacy index. The minimum and maximum values are 1-4, and higher scores mean a worse outcome.
2 secondary outcomes
Severity of Depression
Time frame: pretreatment(0.weeks)-as soon as the work is completed (3 weeks)
Severity of anxiety
Time frame: pretreatment(0.weeks)-as soon as the work is completed (3 weeks)
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 11 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Selim Tümkaya, MD study director
Pamukkale 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 TMS in people with Obsessive-Compulsive Disorder, run by Pamukkale University 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 4 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 11 Oct 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 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. 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?
Obsessive compulsive symptoms severity (time frame: pretreatment(0.weeks)-as soon as the work is completed (3 weeks)). The study lists 3 primary outcomes in all. 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 11 Oct 2023.