Obsessive-Compulsive DisorderCogFlexTMSNCT06769243
Cognitive Flexibility and Response to TMS Therapy
A study testing TMS in people with Obsessive-Compulsive Disorder and Cognitive Flexiblity, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Transcranial Magnetic Stimulation (TMS) therapy is an approved and effective treatment option for treatment-resistant obsessive-compulsive disorder. The present study aims to investigate the relationship between cognitive flexibility and TMS treatment. 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, Cognitive Flexiblity
- What is being tested?
- TMS
- 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
- 15 Apr 2023to 15 Mar 2024
- 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
- According to the DSM-5 TR, those diagnosed with Obsessive-Compulsive Disorder (OCD),
- Failure to respond to at least two different antidepressants and anti-obsessive agents at effective doses and durations,
- The condition cannot be better explained by a metabolic or organic disorder,
- No contraindications to treatment were identified based on the risk assessment scale applied before TMS.
Who cannot join
- Detection of a contraindication for treatment based on the pre-TMS risk assessment form,
- Detection of an epileptic focus in the pre-TMS electroencephalography findings,
- Diagnosis of a psychotic disorder or bipolar mood disorder,
- Active suicidal thoughts and high risk for suicide,
- The participant to be included in the study has a history of alcohol, substance, or stimulant abuse or addiction (excluding cases where they have not used these substances in the last 12 months or have no history of alcohol misuse), based on a semi-structured clinical interview.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Training and Research Hospital
Ankara, Ankara, 06000
About this study
Official title: Cognitive Flexibility and Response to TMS Therapy in Obsessive-Compulsive Disorder
Transcranial Magnetic Stimulation (TMS) therapy is an approved and effective treatment option for treatment-resistant obsessive-compulsive disorder. The present study aims to investigate the relationship between cognitive flexibility and TMS treatment. The main question it aims to answer is:
Does cognitive flexibility predict the TMS treatment response rate? Patients will undergo neuropsychological tests to evaluate cognitive flexibility before the TMS application. A clinical scale to assess the severity of obsessive-compulsive symptoms will be administered using psychometric scales both before and after the TMS procedure.
TMS treatment will be applied five days a week for four weeks.
Read the detailed description
This prospective cohort study aims to investigate the relationship between transcranial magnetic stimulation (TMS) and cognitive flexibility in patients with treatment-resistant obsessive-compulsive disorder (OCD). Treatment-resistant OCD represents a subset of OCD in which patients do not adequately respond to conventional treatments such as cognitive-behavioral therapy (CBT) and selective serotonin reuptake inhibitors (SSRIs). Emerging evidence suggests that TMS, a noninvasive brain stimulation technique, can effectively alleviate symptoms in treatment-resistant OCD. However, its relationship with cognitive flexibility remains poorly understood.
This study seeks to fill this knowledge gap by assessing cognitive flexibility before TMS treatment to identify patients cognitively suitable for this intervention and understand how they respond to TMS. Another important factor to be investigated is whether there are differences between TMS responders and non-responders.
The study will enroll 30 patients diagnosed with treatment-resistant obsessive-compulsive disorder (OCD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria. Participants will undergo a TMS treatment treatment using the MagVenture™ X100™ device. The treatment protocol will include 20 sessions over four weeks, delivering a total of 24.000 pulses.
The stimulation will target the supplementary motor area (SMA), a region associated with OCD symptom regulation, with parameters optimized to achieve therapeutic effects while minimizing adverse side effects. Motor threshold measurements will be conducted prior to the initiation of treatment and adjusted weekly to ensure consistent treatment intensity.
A control group of 60 healthy participants will undergo a single neuropsychological evaluation for baseline comparison but will not receive TMS treatment or follow-up.
Comprehensive neuropsychological and clinical psychometric assessments will be conducted for all patients prior to the TMS treatment. After completing the 20 sessions of TMS treatment, patients will undergo clinical psychometric evaluations again.
The neuropsychological assessments will include the Wisconsin Card Sorting Test (WCST), Trail Making Test (TMT), and Verbal Fluency (VF) test. Psychiatric assessments will utilize the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), Patient Health Questionnaire (PHQ-9), and Clinical Global Impression-Improvement (CGI-I) scale to evaluate changes in the severity of OCD symptoms.
The primary objective is to determine whether cognitive flexibility in OCD patients plays a role in predicting the response to TMS treatment. Secondary objectives include identifying any differences in cognitive flexibility test results between TMS responders and non-responders.
The primary outcomes will focus on whether cognitive flexibility-defined as the ability to adapt and cope with stress-affects the outcome of TMS treatment. This is particularly important for identifying patients who are likely to benefit from this time-intensive and prolonged treatment. Knowing in advance which patients are unlikely to respond to TMS treatment could help guide them toward alternative therapies, benefiting both patients and physicians.
Additionally, although TMS is highly effective for OCD treatment, literature suggests that up to half of patients do not respond. Understanding whether these non-responders are cognitively inflexible could help identify specific cognitive subtypes of OCD patients. This knowledge would be invaluable for tailoring treatments and improving outcomes for this challenging subset of patients.
- Being tested
- TMS
- Keywords
- TMS, Cognitive Felxibility, Obsessive, Compulsive, Treatment Response
- 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.
TMSDevice
Transcranial Magnetic Stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain. It is primarily used to treat OCD, particularly in patients who have not responded well to traditional treatments such as medications or psychotherapy. The most common target is the supplementary motor area (SMA), which has an indirect connection with the Cortico-Striato-Thalamo-Cortical (CSTC) pathway, known to be hyperactive in OCD.
Another option to target the CSTC pathway is deep TMS, although it is not available in most advanced centers. The magnetic pulses from TMS stimulate or inhibit brain activity in the targeted area, which is believed to help reset or correct neural activity patterns associated with OCD and other psychiatric disorders.
TMS represents an alternative treatment for those struggling with OCD, offering a non-invasive approach with relatively few side effects and significant potential benefits.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Flexibility | Experimental | The TMS protocol was conducted using the MagVenture X100 device. Prior to treatment, a pre-evaluation was performed based on the pre-treatment risk assessment form for patients included in the study. Motor threshold measurement was carried out before the TMS application and repeated weekly. The treatment intensity was set at 100% of the measured motor threshold. As part of the OCD protocol, patients were subjected to 1 Hz rTMS pulses for 300 seconds, with a 60-second intertrain interval, totaling 1200 pulses per session. Each patient received 20 treatment sessions, resulting in a total of 24,000 pulses. The bilateral supplementary motor area (SMA) was targeted. To locate the SMA, after identifying the cranial apex, 15% of the total distance from the front was calculated. Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Cognitive Flexibility on TMS Treatment Response
The changes in psychometric scales before and after TMS treatment will determine whether a patient is a TMS responder. Cognitive flexibility, measured at the beginning of treatment, may influence the changes in these psychometric scales. This study will examine the relationship between TMS response rate and cognitive flexibility in OCD patients.
Measured: From enrollment to the end of treatment at 4 weeks
Cognitive Flexibility Features in TMS Responders vs. Non-Responders
Cognitive flexibility features in TMS responders will be compared with non-responders and healthy controls. Specific features in responders vs. non-responders will be evaluated in detail. Cognitive flexibility may be identified as a distinguishing factor in OCD subtypes within the non-responder group. This could be useful for navigating treatment options at the beginning of the TMS procedure.
Measured: From enrollment to the end of treatment at 4 weeks
Improvement of the Obsessive-Compulsive Scale: Y-BOCS
A reduction of more than 30% in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score will be used to evaluate treatment response. The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) is commonly used to assess the severity of obsessive-compulsive disorder (OCD).The Y-BOCS consists of 10 items, each rated on a scale from 0 (no symptoms) to 4 (extreme symptoms). These items are divided into obsessions (5 items) and compulsions (5 items), allowing for a subscore for each domain (maximum of 20 each). Minimum Score: 0 (indicating no symptoms). Maximum Score: 40 (indicating extreme severity of symptoms)
Measured: From enrollment to the end of treatment at 4 weeks
Changes in PHQ-9 Scores Among Patients with Obsessive-Compulsive Disorder
The Patient Health Questionnaire-9 (PHQ-9) is a self-administered tool used to screen, diagnose, monitor, and measure the severity of depression. A clinical response is typically defined by a measurable reduction in symptom severity, in depression, a clinical response is defined as a 50% or greater reduction in scores on PHQ-9. The PHQ-9 (Patient Health Questionnaire-9) has the following scoring range: Minimum Score: 0 (indicating no depressive symptoms). Maximum Score: 27 (indicating severe depressive symptoms).
Measured: From enrollment to the end of treatment at 4 weeks
Neuropsychological Test Changes in Obsessive-Compulsive Disorder:WCST
The Wisconsin Card Sorting Test (WCST) is a neuropsychological test designed to evaluate executive functions, including cognitive flexibility, problem-solving, and the ability to adapt to changing rules. It is commonly used in research and clinical settings to assess individuals with neurological or psychiatric conditions
Measures and Scoring:
Number of Categories Completed: Indicates how many correct sorting rules the participant identified.
Perseverative Errors: Reflects the tendency to persist with an incorrect rule despite feedback.
Non-perseverative Errors: Errors that are not related to the previously learned rule.
Failure to Maintain Set: Reflects the inability to consistently apply a correct sorting rule.
Trials to Complete the First Category: Measures the efficiency in initially identifying a rule.
Measured: From enrollment to the end of treatment at 4 weeks
Neuropsychological Test Changes in Obsessive-Compulsive Disorder: TMT A/B
The Trail Making Test (TMT) is a neuropsychological assessment tool used to measure cognitive flexibility, processing speed, and executive functioning.
TMT-A: Normal Performance: Typically, scores are within 30-60 seconds for healthy adults. Slower Time: Suggests processing speed or attention difficulties, which may be seen in conditions such as ADHD, depression, or neurological impairments.
TMT-B: Normal Performance: Usually takes 60-150 seconds for healthy adults. Slower Time: A significant delay in TMT-B (compared to TMT-A) can suggest difficulty with task-switching, cognitive flexibility, or executive function, often seen in frontal lobe dysfunction, dementia, Parkinson's disease, or other cognitive impairments.
Measured: From enrollment to the end of treatment at 4 weeks
Memory Performance in Obsessive-Compulsive Disorder: Verbal Fluency Test (VF)"
Verbal Fluency Test (VFT), is a neuropsychological test that measures a person's ability to generate words within a specific category (semantic fluency) or starting with a specific letter (phonemic fluency) in a set amount of time. It is used to assess executive functions, language, and cognitive flexibility.
Semantic Fluency (Category Fluency): The participant is asked to name as many items as possible within a given category, such as animals or fruits, in 60 seconds.
Phonemic Fluency (Letter Fluency): The participant is asked to generate as many words as possible that begin with a given letter (e.g., "K", "A", or "S") in 60 seconds.
Scoring: The score is based on the number of words the participant can generate within the time limit.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (6)
Analyzing the Relationship Between Cognitive Flexibility and Symptom Severity
Symptom severity, measured at the beginning of the TMS procedure, may have a relationship with the patient's cognitive flexibility level compared to healthy controls. Symptom severity, assessed using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), will reflect the clinical severity of OCD symptoms. Understanding any correlation between symptom severity and cognitive flexibility would be beneficial for guiding treatment during the TMS procedure.
Measured: From enrollment to the end of treatment at 4 weeks
Side Effects Assessment
Recording any adverse events or unexpected side effects noted during or after the transcranial magnetic stimulation (TMS) sessions, to evaluate the safety profile of the treatment. There is no standardized method for evaluating the side effects of TMS, a clinician will evaluate the participants for known side effects including changes in hearing, local pain, muscle contractions, headache, non-specific tingling, and discomfort.
Measured: From enrollment to the end of treatment at 4 weeks
Tracking Reduction in Symptom Severity: Yale-Brown Obsessive-Compulsive Scale
Symptom severity in Obsessive-Compulsive Disorder will be evaluated using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). A 30% reduction in Y-BOCS symptoms will be considered a response to treatment. The Y-BOCS assesses the severity of obsessive-compulsive symptoms, with a minimum score of 0, indicating no obsessive-compulsive symptoms, and a maximum score of 40, indicating extreme severity of obsessive-compulsive symptoms.
Measured: From enrollment to the end of treatment at 4 weeks
Tracking Reduction in Symptom Severity: Patient Health Questionnaire-9
A ≥ 50% reduction in the PHQ-9 score is often considered a clinically significant response to treatment. The PHQ-9 scoring ranges from a minimum score of 0, indicating no depressive symptoms, to a maximum score of 27, indicating severe depressive symptoms. The interpretation of PHQ-9 scores is as follows: 0-4 indicates minimal or no depression, 5-9 indicates mild depression, 10-14 indicates moderate depression, 15-19 indicates moderately severe depression, and 20-27 indicates severe depression.
Measured: From enrollment to the end of the treatment at 4 weeks.
Drug Side Effect: Common Terminology Criteria for Adverse Events (CTCAE)
The impact of drug side effects on TMS outcomes will be evaluated by assessing the incidence and severity of adverse events using the Common Terminology Criteria for Adverse Events (CTCAE). This standardized tool is commonly used to grade the severity of side effects, ranging from Grade 1 (mild) to Grade 5 (fatal).
Grade 1: Mild symptoms that do not require intervention. Grade 2: Moderate symptoms that require medical intervention. Grade 3: Severe symptoms that interfere with daily functioning. Grade 4: Life-threatening symptoms requiring urgent medical attention. Grade 5: Death caused by the adverse event.
Measured: From enrollment to the end of treatment at 4 weeks
Drug Side Effect: Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a commonly used tool for evaluating the intensity of side effects, especially pain, though it can also assess other subjective symptoms such as nausea, fatigue, or dizziness. The VAS consists of a 10 cm long straight line, with one end indicating no symptoms and the other end representing the most severe symptoms possible.
For assessing pain or side effects, the patient marks a point on the line that reflects the intensity they perceive. The distance from the "no symptoms" end is then measured to determine the severity score.
0: No pain or side effect 10: Worst possible pain or side effect.
Measured: From enrollment to the end of the treatment at 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start15 Apr 2023
- Primary completion20 Feb 2024
- Study completion15 Mar 2024
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
- Not applicable
- Intervention model
- Single group
- Model description
- The treatment-resistant OCD group will be evaluated both before and after TMS treatment. Cognitive flexibility levels of patients will be assessed only prior to the TMS procedure. A control group consisting of healthy participants will be evaluated solely from a neuropsychological and clinical perspective, without undergoing TMS treatment.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Beyazit Garip, Gulhane Training and Research Hospital
- Investigators
- BEYAZIT GARIP, Medical Doctor, Principal investigator, Gulhane Trainin and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769243
- Sponsor's protocol ID
- 2023-19
- Acronym
- CogFlexTMS
- Status last verified
- Jan 2025
- First submitted
- 29 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IDP) will be shared together with the Clinical Study Report
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Flexibility and Response to TMS Therapy in Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT06769243
- Acronym / sponsor ID
- CogFlexTMS / 2023-19
- Keywords
- TMS, Cognitive Felxibility, Obsessive, Compulsive, Treatment Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 10 Jan 2025 (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.
Transcranial Magnetic Stimulation (TMS) therapy is an approved and effective treatment option for treatment-resistant obsessive-compulsive disorder. The present study aims to investigate the relationship between cognitive flexibility and TMS treatment. The main question it aims to answer is:
Does cognitive flexibility predict the TMS treatment response rate? Patients will undergo neuropsychological tests to evaluate cognitive flexibility before the TMS application. A clinical scale to assess the severity of obsessive-compulsive symptoms will be administered using psychometric scales both before and after the TMS procedure.
TMS treatment will be applied five days a week for four weeks.
Detailed description
This prospective cohort study aims to investigate the relationship between transcranial magnetic stimulation (TMS) and cognitive flexibility in patients with treatment-resistant obsessive-compulsive disorder (OCD). Treatment-resistant OCD represents a subset of OCD in which patients do not adequately respond to conventional treatments such as cognitive-behavioral therapy (CBT) and selective serotonin reuptake inhibitors (SSRIs). Emerging evidence suggests that TMS, a noninvasive brain stimulation technique, can effectively alleviate symptoms in treatment-resistant OCD. However, its relationship with cognitive flexibility remains poorly understood.
This study seeks to fill this knowledge gap by assessing cognitive flexibility before TMS treatment to identify patients cognitively suitable for this intervention and understand how they respond to TMS. Another important factor to be investigated is whether there are differences between TMS responders and non-responders.
The study will enroll 30 patients diagnosed with treatment-resistant obsessive-compulsive disorder (OCD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria. Participants will undergo a TMS treatment treatment using the MagVenture™ X100™ device. The treatment protocol will include 20 sessions over four weeks, delivering a total of 24.000 pulses.
The stimulation will target the supplementary motor area (SMA), a region associated with OCD symptom regulation, with parameters optimized to achieve therapeutic effects while minimizing adverse side effects. Motor threshold measurements will be conducted prior to the initiation of treatment and adjusted weekly to ensure consistent treatment intensity.
A control group of 60 healthy participants will undergo a single neuropsychological evaluation for baseline comparison but will not receive TMS treatment or follow-up.
Comprehensive neuropsychological and clinical psychometric assessments will be conducted for all patients prior to the TMS treatment. After completing the 20 sessions of TMS treatment, patients will undergo clinical psychometric evaluations again.
The neuropsychological assessments will include the Wisconsin Card Sorting Test (WCST), Trail Making Test (TMT), and Verbal Fluency (VF) test. Psychiatric assessments will utilize the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), Patient Health Questionnaire (PHQ-9), and Clinical Global Impression-Improvement (CGI-I) scale to evaluate changes in the severity of OCD symptoms.
The primary objective is to determine whether cognitive flexibility in OCD patients plays a role in predicting the response to TMS treatment. Secondary objectives include identifying any differences in cognitive flexibility test results between TMS responders and non-responders.
The primary outcomes will focus on whether cognitive flexibility-defined as the ability to adapt and cope with stress-affects the outcome of TMS treatment. This is particularly important for identifying patients who are likely to benefit from this time-intensive and prolonged treatment. Knowing in advance which patients are unlikely to respond to TMS treatment could help guide them toward alternative therapies, benefiting both patients and physicians.
Additionally, although TMS is highly effective for OCD treatment, literature suggests that up to half of patients do not respond. Understanding whether these non-responders are cognitively inflexible could help identify specific cognitive subtypes of OCD patients. This knowledge would be invaluable for tailoring treatments and improving outcomes for this challenging subset of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The treatment-resistant OCD group will be evaluated both before and after TMS treatment. Cognitive flexibility levels of patients will be assessed only prior to the TMS procedure. A control group consisting of healthy participants will be evaluated solely from a neuropsychological and clinical perspective, without undergoing TMS treatment.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Flexibility | Experimental | Device: TMSThe TMS protocol was conducted using the MagVenture X100 device. Prior to treatment, a pre-evaluation was performed based on the pre-treatment risk assessment form for patients included in the study. Motor threshold measurement was carried out before the TMS application and repeated weekly. The treatment intensity was set at 100% of the measured motor threshold. As part of the OCD protocol, patients were subjected to 1 Hz rTMS pulses for 300 seconds, with a 60-second intertrain interval, totaling 1200 pulses per session. Each patient received 20 treatment sessions, resulting in a total of 24,000 pulses. The bilateral supplementary motor area (SMA) was targeted. To locate the SMA, after identifying the cranial apex, 15% of the total distance from the front was calculated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- According to the DSM-5 TR, those diagnosed with Obsessive-Compulsive Disorder (OCD),
- Failure to respond to at least two different antidepressants and anti-obsessive agents at effective doses and durations,
- The condition cannot be better explained by a metabolic or organic disorder,
- No contraindications to treatment were identified based on the risk assessment scale applied before TMS.
Key exclusion criteria (5 listed)
- Detection of a contraindication for treatment based on the pre-TMS risk assessment form,
- Detection of an epileptic focus in the pre-TMS electroencephalography findings,
- Diagnosis of a psychotic disorder or bipolar mood disorder,
- Active suicidal thoughts and high risk for suicide,
- The participant to be included in the study has a history of alcohol, substance, or stimulant abuse or addiction (excluding cases where they have not used these substances in the last 12 months or have no history of alcohol misuse), based on a semi-structured clinical interview.
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 |
|---|---|---|
| TMSTranscranial Magnetic Stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain. It is primarily used to treat OCD, particularly in patients who have not responded well to traditional treatments such as medications or psychotherapy. The most common target is the supplementary motor area (SMA), which has an indirect connection with the Cortico-Striato-Thalamo-Cortical (CSTC) pathway, known to be hyperactive in OCD. Another option to target the CSTC pathway is deep TMS, although it is not available in most advanced centers. The magnetic pulses from TMS stimulate or inhibit brain activity in the targeted area, which is believed to help reset or correct neural activity patterns associated with OCD and other psychiatric disorders. TMS represents an alternative treatment for those struggling with OCD, offering a non-invasive approach with relatively few side effects and significant potential benefits. | Device | Cognitive Flexibility |
Primary outcome
The Effect of Cognitive Flexibility on TMS Treatment Response
Time frame: From enrollment to the end of treatment at 4 weeks
The changes in psychometric scales before and after TMS treatment will determine whether a patient is a TMS responder. Cognitive flexibility, measured at the beginning of treatment, may influence the changes in these psychometric scales. This study will examine the relationship between TMS response rate and cognitive flexibility in OCD patients.
Cognitive Flexibility Features in TMS Responders vs. Non-Responders
Time frame: From enrollment to the end of treatment at 4 weeks
Cognitive flexibility features in TMS responders will be compared with non-responders and healthy controls. Specific features in responders vs. non-responders will be evaluated in detail. Cognitive flexibility may be identified as a distinguishing factor in OCD subtypes within the non-responder group. This could be useful for navigating treatment options at the beginning of the TMS procedure.
Improvement of the Obsessive-Compulsive Scale: Y-BOCS
Time frame: From enrollment to the end of treatment at 4 weeks
A reduction of more than 30% in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score will be used to evaluate treatment response. The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) is commonly used to assess the severity of obsessive-compulsive disorder (OCD).The Y-BOCS consists of 10 items, each rated on a scale from 0 (no symptoms) to 4 (extreme symptoms). These items are divided into obsessions (5 items) and compulsions (5 items), allowing for a subscore for each domain (maximum of 20 each). Minimum Score: 0 (indicating no symptoms). Maximum Score: 40 (indicating extreme severity of symptoms)
Changes in PHQ-9 Scores Among Patients with Obsessive-Compulsive Disorder
Time frame: From enrollment to the end of treatment at 4 weeks
The Patient Health Questionnaire-9 (PHQ-9) is a self-administered tool used to screen, diagnose, monitor, and measure the severity of depression. A clinical response is typically defined by a measurable reduction in symptom severity, in depression, a clinical response is defined as a 50% or greater reduction in scores on PHQ-9. The PHQ-9 (Patient Health Questionnaire-9) has the following scoring range: Minimum Score: 0 (indicating no depressive symptoms). Maximum Score: 27 (indicating severe depressive symptoms).
Neuropsychological Test Changes in Obsessive-Compulsive Disorder:WCST
Time frame: From enrollment to the end of treatment at 4 weeks
The Wisconsin Card Sorting Test (WCST) is a neuropsychological test designed to evaluate executive functions, including cognitive flexibility, problem-solving, and the ability to adapt to changing rules. It is commonly used in research and clinical settings to assess individuals with neurological or psychiatric conditions Measures and Scoring: Number of Categories Completed: Indicates how many correct sorting rules the participant identified. Perseverative Errors: Reflects the tendency to persist with an incorrect rule despite feedback. Non-perseverative Errors: Errors that are not related to the previously learned rule. Failure to Maintain Set: Reflects the inability to consistently apply a correct sorting rule. Trials to Complete the First Category: Measures the efficiency in initially identifying a rule.
Neuropsychological Test Changes in Obsessive-Compulsive Disorder: TMT A/B
Time frame: From enrollment to the end of treatment at 4 weeks
The Trail Making Test (TMT) is a neuropsychological assessment tool used to measure cognitive flexibility, processing speed, and executive functioning. TMT-A: Normal Performance: Typically, scores are within 30-60 seconds for healthy adults. Slower Time: Suggests processing speed or attention difficulties, which may be seen in conditions such as ADHD, depression, or neurological impairments. TMT-B: Normal Performance: Usually takes 60-150 seconds for healthy adults. Slower Time: A significant delay in TMT-B (compared to TMT-A) can suggest difficulty with task-switching, cognitive flexibility, or executive function, often seen in frontal lobe dysfunction, dementia, Parkinson's disease, or other cognitive impairments.
Memory Performance in Obsessive-Compulsive Disorder: Verbal Fluency Test (VF)"
Time frame: From enrollment to the end of treatment at 4 weeks
Verbal Fluency Test (VFT), is a neuropsychological test that measures a person's ability to generate words within a specific category (semantic fluency) or starting with a specific letter (phonemic fluency) in a set amount of time. It is used to assess executive functions, language, and cognitive flexibility. Semantic Fluency (Category Fluency): The participant is asked to name as many items as possible within a given category, such as animals or fruits, in 60 seconds. Phonemic Fluency (Letter Fluency): The participant is asked to generate as many words as possible that begin with a given letter (e.g., "K", "A", or "S") in 60 seconds. Scoring: The score is based on the number of words the participant can generate within the time limit.
6 secondary outcomes
Analyzing the Relationship Between Cognitive Flexibility and Symptom Severity
Time frame: From enrollment to the end of treatment at 4 weeks
Side Effects Assessment
Time frame: From enrollment to the end of treatment at 4 weeks
Tracking Reduction in Symptom Severity: Yale-Brown Obsessive-Compulsive Scale
Time frame: From enrollment to the end of treatment at 4 weeks
Tracking Reduction in Symptom Severity: Patient Health Questionnaire-9
Time frame: From enrollment to the end of the treatment at 4 weeks.
Drug Side Effect: Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: From enrollment to the end of treatment at 4 weeks
Drug Side Effect: Visual Analog Scale (VAS)
Time frame: From enrollment to the end of the treatment at 4 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 10 Jan 2025.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IDP) will be shared together with the Clinical Study Report
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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.
BEYAZIT GARIP, Medical Doctor principal investigator
Gulhane Trainin and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS in people with Obsessive-Compulsive Disorder and Cognitive Flexiblity, run by Gulhane Training and Research 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 4 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 10 Jan 2025. 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?
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 Effect of Cognitive Flexibility on TMS Treatment Response (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 7 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 10 Jan 2025.