The Effect of Transcranial Magnetic Stimulation Treatment on Microvasculature Stracture of the Retina and the Choroid
NCT ID: NCT06708013
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2023-01-01
2023-07-01
Brief Summary
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* 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.
Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Transcranial Magnetic Stimualtion Treatment Arm
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.
Transcranial Magnetic Stimulation
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
Interventions
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Transcranial Magnetic Stimulation
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Gulhane Training and Research Hospital
OTHER_GOV
Responsible Party
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Beyazit Garip
Principal Investigator
Principal Investigators
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BEYAZIT GARİP, MD
Role: PRINCIPAL_INVESTIGATOR
Gulhane Training and Research Hospital
Locations
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Gulhane Training and Research Hospital
Ankara, Ankara, Turkey (Türkiye)
Countries
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References
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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.
Other Identifiers
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46418926/2022-334
Identifier Type: -
Identifier Source: org_study_id