Major Depressive DisordersTMSEYENCT06615804
The Effects of Transcranial Magnetic Stimulation on Retina and Choroidal Structures
A study testing Transcranial Magnetic Stimulation in people with Major Depressive Disorders, 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 in treatment-resistant depression. The present study aims to investigate the effect of TMS treatment on eye structures such as retina, macula, and choroid. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorders
- What is being tested?
- Transcranial Magnetic Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 30 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with Major Depressive Disorder according to DSM-5 TR.
- Diagnosed with Obsessive-Compulsive Disorder according to DSM-5 TR.
- Lack of response to treatment after being administered at least two different antidepressants and anti-obsessive agents at effective doses and durations.
- The clinical condition cannot be better explained by a metabolic or organic disorder.
- Routine electroencephalography (EEG) findings before TMS do not indicate electrical activity consistent with an epileptic focus.
- Routine blood tests before TMS show no conditions that could affect treatment levels, particularly thyroid issues, vitamin deficiencies, or inflammation parameters that might cause depression or cognitive impairment (consultation with relevant departments if necessary).
- No history of hearing loss identified during routine evaluations (if a history of hearing loss exists, consultation will be requested; if none, the process will proceed accordingly).
Who cannot join
- According to the pre-TMS risk assessment form, there is a contraindication for treatment,
- Epileptic focus is detected in the pre-TMS electroencephalography findings,
- Previous head trauma, loss of consciousness and intra-cerebral surgery,
- A metal particle caused by an aneurysm clip, connection tongs or explosive substances that will affect the electromagnetic field in the brain,
- A significant disorder in the thyroid hormone profile in routine blood checks before TMS,
- A significant increase in inflammation markers in routine checks before TMS,
Show all 13Show fewer
- A vitamin deficiency that may cause cognitive impairment or forgetfulness in routine blood checks before TMS,
- A presence of electrolyte imbalance in routine blood checks before TMS,
- The patient has previously had a psychotic attack or bipolar mood attack,
- The patient has previously had a substance-induced psychosis or bipolar mood disorder,
- The patient has previously used substances known as alcohol, drugs or stimulants according to DSM-V TR and semi-structured clinical interview (SCID-5 TR) have abuse or addiction (except if they have not used in the last 12 months or have not abused alcohol),
- Those who want to terminate TMS treatment voluntarily,
- If an unexpected clinical situation occurs during TMS treatment, the patient will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Training and Research Hospital
Ankara, 06000
About this study
Official title: The Effects of Transcranial Magnetic Stimulation Treatment on the Structures in Eyes of the Patients With Depression
Transcranial Magnetic Stimulation (TMS) therapy is an approved and effective treatment option in treatment-resistant depression. The present study aims to investigate the effect of TMS treatment on eye structures such as retina, macula, and choroid. These patients will be evaluated using the Optic Coherence Tomography (OCT) device, which is routinely used in ophthalmology practice, before and after a month long TMS treatment. The main question it aims to answer is:
- Does TMS treatment influence the structures in eyes. The patients will visit the ophthalmology clinic before and after the TMS treatment.
- TMS treatment will be applied 5 days a week for 4 weeks.
Read the detailed description
This prospective cohort study aims to investigate the impact of transcranial magnetic stimulation (TMS) on retinal structures in patients with treatment-resistant depression (TRD). TRD represents a subset of major depressive disorder where patients do not adequately respond to conventional antidepressant treatments. Emerging evidence suggests that TMS, a non-invasive brain stimulation technique, can effectively alleviate symptoms in TRD patients. However, the implications of TMS on ocular health, particularly the retina, remain poorly understood. This study seeks to fill this knowledge gap by assessing retinal nerve fiber layer (RNFL), macular, and choroidal thickness before and after a structured TMS treatment protocol.
The study will enroll 58 patients diagnosed with TRD according to The Diagnostic and Statistical Manual of Mental Illnesses (DSM-5) criteria. Participants will undergo a TMS treatment regimen using the MagVenture™ MagProX100™ device. The treatment protocol includes 20 sessions over four weeks, delivering 18,000 pulses in total. The stimulation targets the left dorsolateral prefrontal cortex, with parameters set to achieve optimal therapeutic effects without inducing adverse side effects. Motor threshold measurements will be conducted prior to the initiation of treatment and adjusted weekly to maintain consistent treatment intensity. The control group will be consisted of 60 healthy participants. They will not be treated nor followed, they just will be evaluated for ophthalmologic measurements for once.
Comprehensive ophthalmologic examinations will be performed on all patients both before and after the completion of the TMS treatment. These examinations will include assessments of RNFL, macula, and choroidal thickness using spectral-domain optical coherence tomography (SD-OCT) equipped with an enhanced depth imaging (EDI) mode. Psychiatric assessments using the the PAtient Health Questionnaire (PHQ-9) and Hamilton Depression Rating Scale (Ham17) will be conducted to evaluate changes in the severity of depressive symptoms.
The primary objective is to determine whether TMS therapy induces changes in the thickness of the RNFL, macula, and choroid in TRD patients. Secondary objectives include evaluating the safety and tolerability of TMS in this population, assessing changes in depressive symptomatology, and examining potential interactions between TMS and concurrent antidepressant use.
Primary outcomes will focus on changes in retinal measurements pre- and post-TMS treatment. Secondary outcomes will assess the clinical response to TMS based on standard psychiatric scales, record any TMS-related side effects, and explore associations between treatment effects and antidepressant use.
This study is crucial for understanding the broader implications of TMS in the treatment of TRD and its potential effects on ocular health. It will provide valuable data for clinicians and researchers, guiding safer and more effective use of TMS in psychiatric practice.
- Conditions
- Major Depressive Disorders
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- Depressive Disorders, TMS, Treatment Resistance, Retina, Choroid, Retinal Nerve Fiber Layer, Macula
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationBiological
Transcranial Magnetic Stimulation (TMS) is a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain. It's primarily used to treat depression, especially in patients who haven't responded well to traditional treatments like medications or psychotherapy. The most common target is the dorsolateral prefrontal cortex, a region often underactive in people with depression. The magnetic pulses stimulate or inhibit brain activity in the targeted area. This is believed to help reset or correct patterns of neural activity associated with depression and other psychiatric disorders. TMS represents an alternative for those struggling with depression, offering a non-invasive approach with relatively few side effects and significant potential benefits
| Study group | Role | What they receive |
|---|---|---|
| Treatment resistant depression group | Experimental | Participants will be treated with transcranial magnetic stimulation (TMS) using the MagVenture™ MagProX100™ device. The treatment includes 20 sessions over 4 weeks, delivering 18000 pulses in total. The stimulation targets the left dorsolateral prefrontal cortex, with parameters set to achieve optimal therapeutic effects without inducing adverse side effects. Motor threshold measurements are conducted prior to the initiation of treatment and adjusted weekly to maintain consistent treatment intensity.
Comprehensive ophthalmologic examinations will be performed on all participants both before and after the completion of the TMS treatment. These examinations will include assessments of retinal nerve fiber layer, macula, and choroidal thickness using spectral-domain optical coherence tomography equipped with an enhanced depth imaging mode. The patient health questionnaire and Hamilton Depression Rating Scale will be conducted to evaluate changes in the severity of depressive symptoms. Receives: Biological: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effects of Transcranial Magnetic Stimulation Treatment on thickness of Retinal nerve fiber layer (RNFL) in Eyes of the Patients with Depression
The changes in retinal nerve fiber layer (RNFL) thickness in treatment resistant depression (TRD) patients before and after transcranial magnetic stimulation (TMS) treatment, as assessed by spectral domain optical coherence tomography (SD-OCT).
Measured: From enrollment to the end of treatment at 4 weeks
The Effects of Transcranial Magnetic Stimulation Treatment on thickness of Macula in Eyes of the Patients with Depression
The changes in macula in treatment resistant depression (TRD) patients before and after transcranial magnetic stimulation (TMS) treatment, as assessed by spectral domain optical coherence tomography (SD-OCT).
Measured: From enrollment to the end of treatment at 4 weeks
The Effects of Transcranial Magnetic Stimulation Treatment on Choroidal Thickness in Eyes of the Patients with Depression
The changes in choroid tissue in treatment resistant depression (TRD) patients before and after transcranial magnetic stimulation (TMS) treatment, as assessed by enhanced depth imaging in spectral-domain optical coherence tomography (EDI SD-OCT).
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (4)
Retinal Structural Variations after Transcranial Magnetic Stimulation
Analyzing the changes in nasal and inferior quadrants of the retina assessed by spectral domain optical coherence tomography (SD-OCT) to see if transcranial magnetic stimulation has broader ocular impacts.
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 reductions in depression severity
The depressive symptoms will be measured using the Patient Health Questionnaire (PHQ-9) and the Hamilton Depression Rating Scale (Ham17) before and after TMS treatment (effectiveness of the TMS protocol).
The PHQ-9 consists of nine questions that assess symptoms of depression over the past two weeks. Each question is scored on a scale of 0 to 3, with higher scores indicating more severe symptoms. The total score ranges from 0 to 27.
The Ham17 consists of 17 questions and it is used to determine the presence and type of depression. Each item is scored on a scale of 0 to 2, with 0 indicating no symptoms, 1 indicating mild symptoms, and 2 indicating severe symptoms. The total score ranges from 0 to 34, with higher scores indicating more severe depression.
Measured: From enrollment to the end of treatment at 4 weeks
Drug Interaction Effects
Examining how concurrent antidepressant therapy might interact with transcranial magnetic stimulation (TMS) outcomes, particularly in terms of retinal measurements. There will be no intervention with the antidepressant treatment. The information on the drug name, dose, and treatment duration will be collected to analyse together with the above mentioned assessments.
Measured: From enrollment to the end of 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 posted27 Sep 2024
- Study start1 Dec 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisordersStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Treatment resistant depression patient group will be evaluated before and after Transcranial Magnetic stimulation (TMS) treatment. There is a control group consist of healthy participants that will be only evaluated for ophthalmologic measurements.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Western University, Canada
- Responsible party
- Principal investigator, Beyazit Garip, Gulhane Training and Research Hospital
- Investigators
- Beyazit Garip, MD, Principal investigator, Gulhane Trainig and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615804
- Sponsor's protocol ID
- 46418926-2022/334
- Acronym
- TMSEYE
- Status last verified
- Sep 2024
- First submitted
- 22 Aug 2024
- Last updated
- 27 Sep 2024
- 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 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transcranial Magnetic Stimulation Treatment on the Structures in Eyes of the Patients With Depression
- ClinicalTrials.gov ID
- NCT06615804
- Acronym / sponsor ID
- TMSEYE / 46418926-2022/334
- Conditions
- Major Depressive Disorders
- Keywords
- Depressive Disorders, TMS, Treatment Resistance, Retina, Choroid, Retinal Nerve Fiber Layer, Macula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Collaborators
- Western University, Canada
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 27 Sep 2024 (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 in treatment-resistant depression. The present study aims to investigate the effect of TMS treatment on eye structures such as retina, macula, and choroid. These patients will be evaluated using the Optic Coherence Tomography (OCT) device, which is routinely used in ophthalmology practice, before and after a month long TMS treatment. The main question it aims to answer is:
- Does TMS treatment influence the structures in eyes. The patients will visit the ophthalmology clinic before and after the TMS treatment.
- TMS treatment will be applied 5 days a week for 4 weeks.
Detailed description
This prospective cohort study aims to investigate the impact of transcranial magnetic stimulation (TMS) on retinal structures in patients with treatment-resistant depression (TRD). TRD represents a subset of major depressive disorder where patients do not adequately respond to conventional antidepressant treatments. Emerging evidence suggests that TMS, a non-invasive brain stimulation technique, can effectively alleviate symptoms in TRD patients. However, the implications of TMS on ocular health, particularly the retina, remain poorly understood. This study seeks to fill this knowledge gap by assessing retinal nerve fiber layer (RNFL), macular, and choroidal thickness before and after a structured TMS treatment protocol.
The study will enroll 58 patients diagnosed with TRD according to The Diagnostic and Statistical Manual of Mental Illnesses (DSM-5) criteria. Participants will undergo a TMS treatment regimen using the MagVenture™ MagProX100™ device. The treatment protocol includes 20 sessions over four weeks, delivering 18,000 pulses in total. The stimulation targets the left dorsolateral prefrontal cortex, with parameters set to achieve optimal therapeutic effects without inducing adverse side effects. Motor threshold measurements will be conducted prior to the initiation of treatment and adjusted weekly to maintain consistent treatment intensity. The control group will be consisted of 60 healthy participants. They will not be treated nor followed, they just will be evaluated for ophthalmologic measurements for once.
Comprehensive ophthalmologic examinations will be performed on all patients both before and after the completion of the TMS treatment. These examinations will include assessments of RNFL, macula, and choroidal thickness using spectral-domain optical coherence tomography (SD-OCT) equipped with an enhanced depth imaging (EDI) mode. Psychiatric assessments using the the PAtient Health Questionnaire (PHQ-9) and Hamilton Depression Rating Scale (Ham17) will be conducted to evaluate changes in the severity of depressive symptoms.
The primary objective is to determine whether TMS therapy induces changes in the thickness of the RNFL, macula, and choroid in TRD patients. Secondary objectives include evaluating the safety and tolerability of TMS in this population, assessing changes in depressive symptomatology, and examining potential interactions between TMS and concurrent antidepressant use.
Primary outcomes will focus on changes in retinal measurements pre- and post-TMS treatment. Secondary outcomes will assess the clinical response to TMS based on standard psychiatric scales, record any TMS-related side effects, and explore associations between treatment effects and antidepressant use.
This study is crucial for understanding the broader implications of TMS in the treatment of TRD and its potential effects on ocular health. It will provide valuable data for clinicians and researchers, guiding safer and more effective use of TMS in psychiatric practice.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatment resistant depression patient group will be evaluated before and after Transcranial Magnetic stimulation (TMS) treatment. There is a control group consist of healthy participants that will be only evaluated for ophthalmologic measurements.
| Arm | Type | Receives |
|---|---|---|
| Treatment resistant depression group | Experimental | Biological: Transcranial Magnetic StimulationParticipants will be treated with transcranial magnetic stimulation (TMS) using the MagVenture™ MagProX100™ device. The treatment includes 20 sessions over 4 weeks, delivering 18000 pulses in total. The stimulation targets the left dorsolateral prefrontal cortex, with parameters set to achieve optimal therapeutic effects without inducing adverse side effects. Motor threshold measurements are conducted prior to the initiation of treatment and adjusted weekly to maintain consistent treatment intensity. Comprehensive ophthalmologic examinations will be performed on all participants both before and after the completion of the TMS treatment. These examinations will include assessments of retinal nerve fiber layer, macula, and choroidal thickness using spectral-domain optical coherence tomography equipped with an enhanced depth imaging mode. The patient health questionnaire and Hamilton Depression Rating Scale will be conducted to evaluate changes in the severity of depressive symptoms. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with Major Depressive Disorder according to DSM-5 TR.
- Diagnosed with Obsessive-Compulsive Disorder according to DSM-5 TR.
- Lack of response to treatment after being administered at least two different antidepressants and anti-obsessive agents at effective doses and durations.
- The clinical condition cannot be better explained by a metabolic or organic disorder.
- Routine electroencephalography (EEG) findings before TMS do not indicate electrical activity consistent with an epileptic focus.
Key exclusion criteria (13 listed)
- According to the pre-TMS risk assessment form, there is a contraindication for treatment,
- Epileptic focus is detected in the pre-TMS electroencephalography findings,
- Previous head trauma, loss of consciousness and intra-cerebral surgery,
- A metal particle caused by an aneurysm clip, connection tongs or explosive substances that will affect the electromagnetic field in the brain,
- A significant disorder in the thyroid hormone profile in routine blood checks before TMS,
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 |
|---|---|---|
| Transcranial Magnetic StimulationTranscranial Magnetic Stimulation (TMS) is a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain. It's primarily used to treat depression, especially in patients who haven't responded well to traditional treatments like medications or psychotherapy. The most common target is the dorsolateral prefrontal cortex, a region often underactive in people with depression. The magnetic pulses stimulate or inhibit brain activity in the targeted area. This is believed to help reset or correct patterns of neural activity associated with depression and other psychiatric disorders. TMS represents an alternative for those struggling with depression, offering a non-invasive approach with relatively few side effects and significant potential benefits | Biological | Treatment resistant depression group |
Primary outcome
The Effects of Transcranial Magnetic Stimulation Treatment on thickness of Retinal nerve fiber layer (RNFL) in Eyes of the Patients with Depression
Time frame: From enrollment to the end of treatment at 4 weeks
The changes in retinal nerve fiber layer (RNFL) thickness in treatment resistant depression (TRD) patients before and after transcranial magnetic stimulation (TMS) treatment, as assessed by spectral domain optical coherence tomography (SD-OCT).
The Effects of Transcranial Magnetic Stimulation Treatment on thickness of Macula in Eyes of the Patients with Depression
Time frame: From enrollment to the end of treatment at 4 weeks
The changes in macula in treatment resistant depression (TRD) patients before and after transcranial magnetic stimulation (TMS) treatment, as assessed by spectral domain optical coherence tomography (SD-OCT).
The Effects of Transcranial Magnetic Stimulation Treatment on Choroidal Thickness in Eyes of the Patients with Depression
Time frame: From enrollment to the end of treatment at 4 weeks
The changes in choroid tissue in treatment resistant depression (TRD) patients before and after transcranial magnetic stimulation (TMS) treatment, as assessed by enhanced depth imaging in spectral-domain optical coherence tomography (EDI SD-OCT).
4 secondary outcomes
Retinal Structural Variations after Transcranial Magnetic Stimulation
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 reductions in depression severity
Time frame: From enrollment to the end of treatment at 4 weeks
Drug Interaction Effects
Time frame: From enrollment to the end of 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 27 Sep 2024.
- 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, MD principal investigator
Gulhane Trainig 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 Transcranial Magnetic Stimulation in people with Major Depressive Disorders, 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 7 inclusion and 13 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 27 Sep 2024. 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 Effects of Transcranial Magnetic Stimulation Treatment on thickness of Retinal nerve fiber layer (RNFL) in Eyes of the Patients with Depression (time frame: From enrollment to the end of treatment at 4 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 27 Sep 2024.