AzTrials
AzTrials

Major Depressive Disorder (MDD)TMS_OCT-ANCT06708013

The Effect of Transcranial Magnetic Stimulation Treatment on Microvasculature Stracture of the Retina and the Choroid

A study testing Transcranial Magnetic Stimulation in people with Major Depressive Disorder (MDD), run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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 microvasculature stracture of the retina and the 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 Disorder (MDD)
What is being tested?
Transcranial Magnetic Stimulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2023to 1 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Diagnosed with Major Depressive 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, Ankara, 6300

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Transcranial Magnetic Stimulation Treatment on Microvasculature Stracture of the Retina and the Choroid in Treatment-Resistant 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 microvasculature stracture of the retina and the choroid. These patients will be evaluated using the Optical Coherence Tomography Angiography (OCTA) device, which is quick and non-invasive, and provides volumetric data with the clinical capability of specifically localizing and delineating pathology along with the ability to show both structural and blood flow information in tandem. The main question it aims to answer is:

  • Does TMS treatment influence the retinal vasculature ? 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 microvasculature of the retina and the choroid 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 vasculature before and after a structured TMS treatment protocol.

The study will enroll 30 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 30 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 retinal vasculature using OCTA). 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 microvasculature of the retina and the 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 vasculature 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.

Keywords
TMS, OCTA, MACULA, RETINA, DEPRESSION
Medical subject headings
Depressive Disorder, Major, Depression

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 Transcranial Magnetic Stimulation (TMS) is a noninvasive 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 groups in NCT06708013
Study groupRoleWhat they receive
Transcranial Magnetic Stimualtion Treatment ArmExperimentalExperimental: Treatment resistant depression group Participants will be treated with 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 vasculature using OCTA. The PHQ-9 and Hamilton Depression Rating Scale 17 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.

  1. The Effects of Transcranial Magnetic Stimulation Treatment on the Retinal Vasculature in Eyes of the Patients with Depression

    Primary Outcome Measure:

    1. The Effects of Transcranial Magnetic Stimulation Treatment on the retinal vasculature in Eyes of the Patients with TRD. The changes in the retinal vasculature in TRD patients before and after TMS treatment, as assessed by OCTA. By using OCTA, what will be measured?
    2. Capillary Density: Quantifies the density of blood vessels in the retina and choroid.
    3. Vascular Perfusion: Assesses the degree of blood flow in retinal layers.
    4. Non-Perfusion Areas: Identifies areas with reduced or absent blood flow, often indicative of ischemia or disease.

    In addition to that, Foveal Avascular Zone, Microaneurysms and Neovascularization will be assessed by using this technique. Retinal side effects related to TMS in 30 TRD patients will be evaluated using the OCTA measurement method.

    Measured: From enrollment to the end of treatment at 4 weeks

  2. The Effects of Transcranial Magnetic Stimulation Treatment on the Retinal Vasculature in Eyes of the Patients with Depression

    Primary Outcome Measure:

    Before starting TMS treatment and during the 20th session of treatment, retinal microvascular structures will be measured using OCTA. The results obtained will be compared with those of healthy controls. Changes in retinal vascular structures due to treatment and whether they differ from healthy controls will be evaluated. Another measurement involves the application of psychometric scales to TRD patients, aiming to determine the severity of the disease.

    The relationship between these two measurements will also be explored. Specifically, differences in microvascular structures before and after TMS will be examined between the group responding to treatment (achieving a 50% reduction in psychometric scale scores) and the non-responding group.

    The different measurement units obtained from these scales will be used during evaluations within and data will be integrated to provide to provide comprehensive insight.

    Measured: From enrollment to the end of treatment at 4 weeks

Secondary outcomes (5)

  1. Determination of the effects of concomitant antidepressant use on retinal vascular structures using the OCTA method.

    In the treatment of TRD patients, the effectiveness, safety, and side effects of the medications used will be evaluated in detail, and it will be assessed whether the patients are using these medications at effective doses and durations. To evaluate whether these antidepressant medications have potential retinal side effects, no adjustments will be made to the patients' medication doses or the medications themselves for one month prior to TMS treatment and until the completion of 20 sessions. This approach will allow a comparison with healthy controls to determine whether the different antidepressants used have any side effects on the retina.The data collected will be combined and analyzed using advanced analytical methods to evaluate the antidepressant doses used by TRD patients undergoing TMS treatment in terms of treatment efficacy, improvement observed in psychometric scales (a reduction of more than 50% ), and their effects on retinal microvascular structures.

    Measured: From enrollment to the end of treatment at 4 weeks

  2. Determination of the effects of concomitant antidepressant use on retinal vascular structures using the OCTA method.

    To assess the effectiveness of the antidepressants administered, the HAM-17 and PHQ-9 scales will be used. A response to treatment will be defined as a 50% reduction in scores on these scales. The differences in retinal vascular structures measured by OCTA will be evaluated between the group responding to treatment and the group not responding to treatment.

    At this stage, psychometric scale data and OCTA measurements will be integrated, and advanced statistical methods will be employed to identify a retinal microvascular signature that could predict the response to TMS treatment. Additionally, it will be evaluated whether the use of specific antidepressants in conjunction with TMS has any side effects on retinal structures.

    Measured: From enrollment to the end of treatment at 4 weeks

  3. Transcranial Magnetic Stimulation Safety

    1. Side Effects Assessment Recording any adverse events or unexpected side effects noted during or after the 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 the treatment at 4 weeks.

  4. Evaluation of the Effect of TMS Treatment on Depression Severity

    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

  5. Evaluation of the Effect of TMS Treatment on Clinical Global Impression

    The Clinical Global Impression (CGI) Scale will be used to evaluate the response of TRD patients to treatment and the improvement observed as a result of the semi-structured clinical interviews conducted. The Clinical Global Impression (CGI) Scale is a widely used tool in clinical research and practice to assess treatment outcomes in psychiatric conditions. It is simple, quick to administer, and provides a global view of a patient's condition and treatment response.

    CGI-Improvement (CGI-I):Evaluates improvement or change in the patient's condition compared to baseline.

    Rated on a 7-point scale:

    1. = Very much improved
    2. = Much improved
    3. = Minimally improved
    4. = No change
    5. = Minimally worse
    6. = Much worse
    7. = Very much worse

    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.

  1. First posted27 Nov 2024
  2. Study start1 Jan 2023
  3. Primary completion1 Jul 2023
  4. Study completion1 Jul 2023

Resources

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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06708013
Sponsor's protocol ID
46418926/2022-334
Acronym
TMS_OCT-A
Status last verified
Nov 2024
First submitted
9 Oct 2024
Last updated
27 Nov 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 Supporting Information: * Study Protocol * Informed Consent Form (ICF) * Clinical Study Report (CSR)

Publications

  • Genc A, Dalkiran M, Pirdogan Aydin E, Turkyilmaz Uyar E, Alkan A, Guven D, Ozer OA, Karamustafalioglu O. The alteration of retinal nerve fibre layer thickness with repetitive transcranial magnetic stimulation in patients with treatment resistant major depression. Int J Psychiatry Clin Pract. 2019 Mar;23(1):57-61. doi: 10.1080/13651501.2018.1480785. Epub 2018 Dec 31.

    PubMed 30596524

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Magnetic Stimulation in people with Major Depressive Disorder (MDD), 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 6 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 Nov 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 the Retinal Vasculature in Eyes of the Patients with Depression (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06708013, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in