The Effects of Transcranial Magnetic Stimulation on Retina and Choroidal Structures

NCT06615804 | Completed

• 1 other identifier: 46418926-2022/334
• Study Type: interventional
• Target: 58
• 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 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.

Conditions

Major Depressive Disorders

Keywords

Depressive Disorders; TMS; Treatment Resistance; Retina; Choroid; Retinal Nerve Fiber Layer; Macula

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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).

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (4)

• Retinal Structural Variations after Transcranial Magnetic Stimulation

  From enrollment to the end of treatment at 4 weeks

• Side Effects Assessment

  From enrollment to the end of treatment at 4 weeks

• Tracking reductions in depression severity

  From enrollment to the end of treatment at 4 weeks

• Drug Interaction Effects

  From enrollment to the end of treatment at 4 weeks

Study Arms (1)

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.

Biological: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation BIOLOGICAL

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

Treatment resistant depression group

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.
• 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).

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
• Western University, Canada: collaborator

Study Sites (1)

Gulhane Training and Research Hospital

Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Beyazit Garip, MD

  Gulhane Trainig 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: Medical Doctor

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: August 22, 2024
• First Posted: September 27, 2024
• Study Start: December 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• 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)