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Major Depressive Disorder (MDD)

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

Sponsored by Gulhane Training and Research Hospital

About this trial

Last updated 10 months ago

Study ID

46418926/2022-334

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 65 Years
All
All

Trial Timing

Ended 2 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- 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).

No

Exclusion Criteria

- 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.

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Location

Status