Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615804
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
The Effects of Transcranial Magnetic Stimulation on Retina and Choroidal Structures
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effects of Transcranial Magnetic Stimulation Treatment on the Structures in Eyes of the Patients With Depression
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TMSEYE
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
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
Detailed 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 by assessing retinal nerve fiber layer RNFL macular and choroidal thickness before and after a structured TMS treatment protocol
The study will enroll 58 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 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 will be conducted prior to the initiation of treatment and adjusted weekly to maintain consistent treatment intensity The control group will be consisted of 60 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 RNFL macula and choroidal thickness using spectral-domain optical coherence tomography SD-OCT equipped with an enhanced depth imaging EDI mode 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 the thickness of the RNFL macula and 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 measurements 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
This study is crucial for understanding the broader implications of TMS in the treatment of TRD and its potential effects on ocular health It will provide valuable data for clinicians and researchers guiding safer and more effective use of TMS in psychiatric practice
The study will enroll 58 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 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 will be conducted prior to the initiation of treatment and adjusted weekly to maintain consistent treatment intensity The control group will be consisted of 60 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 RNFL macula and choroidal thickness using spectral-domain optical coherence tomography SD-OCT equipped with an enhanced depth imaging EDI mode 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 the thickness of the RNFL macula and 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 measurements 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
This study is crucial for understanding the broader implications of TMS in the treatment of TRD and its potential effects on ocular health It will provide valuable data for clinicians and researchers guiding safer and more effective use of TMS in psychiatric practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None