Search / Trial NCT06615804

The Effects of Transcranial Magnetic Stimulation on Retina and Choroidal Structures

Launched by GULHANE TRAINING AND RESEARCH HOSPITAL · Sep 23, 2024

Trial Information

Current as of October 07, 2024

Completed

Keywords

Depressive Disorders Tms Treatment Resistance Retina Choroid Retinal Nerve Fiber Layer Macula

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 ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * 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).
  • 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.

About Gulhane Training And Research Hospital

Gulhane Training and Research Hospital is a leading healthcare institution dedicated to advancing medical knowledge and patient care through innovative clinical research. Located in Turkey, the hospital serves as a prominent center for training healthcare professionals and conducting rigorous clinical trials across various medical fields. With a commitment to excellence, Gulhane integrates cutting-edge technology and evidence-based practices to enhance therapeutic outcomes and contribute to the global medical community. The hospital's collaborative approach fosters partnerships with academic institutions and industry leaders, ensuring the highest standards of ethical conduct and scientific integrity in all research endeavors.

Locations

Ankara, , Turkey

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0