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

NCT06708013 | Completed

• 1 other identifier: 46418926/2022-334
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Major Depressive Disorder (MDD)

Keywords

TMS; OCTA; MACULA; RETINA; DEPRESSION

Outcome Measures

Primary Outcomes (2)

• 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? 1. Capillary Density: Quantifies the density of blood vessels in the retina and choroid. 2. Vascular Perfusion: Assesses the degree of blood flow in retinal layers. 3. 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.

  From enrollment to the end of treatment at 4 weeks

• 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.

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (5)

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

  From enrollment to the end of treatment at 4 weeks

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

  From enrollment to the end of treatment at 4 weeks

• Transcranial Magnetic Stimulation Safety

  From enrollment to the end of the treatment at 4 weeks.

• Evaluation of the Effect of TMS Treatment on Depression Severity

  From enrollment to the end of treatment at 4 weeks

• Evaluation of the Effect of TMS Treatment on Clinical Global Impression

  From enrollment to the end of treatment at 4 weeks

Study Arms (1)

Transcranial Magnetic Stimualtion Treatment Arm

EXPERIMENTAL

Experimental: 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.

Biological: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation BIOLOGICAL

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

Transcranial Magnetic Stimualtion Treatment Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Gulhane Training and Research Hospital: lead

Study Sites (1)

Gulhane Training and Research Hospital

Ankara, Ankara, 6300, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 30596524 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• BEYAZIT GARİP, MD

  Gulhane Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: November 27, 2024
• Study Start: January 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be made available immediately after the publication, and will remain available for at least 5 years.
• Access Criteria: Anyone who wishes to access the data

Locations

TU (1)