Ignite Creation Date:
2024-05-06 @ 6:01 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05516680
Status:
RECRUITING
Last Update Posted:
2023-03-23
First Post:
2022-08-15
Brief Title:
Effects and Central Mechanism of Electroacupuncture and MRI-navigated rTMS for PSD
Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Organization:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Overview
Official Title:
Effects and Central Mechanism of Electroacupuncture and MRI-navigated rTMS for PSD a fMRI-based Single-center Randomized Controlled Assessor-blinded Trial
Status:
RECRUITING
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction
Post-stroke depression PSD is the most common mental complication after stroke and has a serious impact on functional outcomes and quality of life Antidepressants are the first-line treatment for PSD but many reported side effects remain Clinical research and practice guidelines have shown that electro-acupuncture and rTMS have a positive effect on PSD This trial aims to study the efficacy and safety of electro-acupuncture and a modern MRI-navigated rTMS for PSD and to explore its fMRI-based central mechanism on depression It is hypothesized that electro-acupuncture and MRI-navigated rTMS treatment improves depressive symptoms neuro-patho-physiological behaviors quality of life and central response in PSD
Methods
In this randomized controlled assessors-blinded trial sixty-four patients with PSD will be randomly allocated into the experiment group n32 or control groupn32 The experiment group will receive electro-acupuncture and MRI-navigated rTMS and the control group will receive MRI-navigated rTMS treatment in 12-20 sessions over 4 weeks In addition ten healthy people for fMRI scanning will be recruited as a healthy control group without any intervention The primary outcome is the change from baseline in the Hamilton Depression Scale-24 items HAMD-24 scores at week 4 The primary analysis of central mechanism mainly involves cortical morphology local spontaneous brain activity and default mode network DMN functional connectivity based on fMRI at 0-wk and 4-wk Secondary outcomes include the neuro-patho-physiological and quality of life changes in cortical excitability with motor evoked potential testMEP National Institutes of Health Stroke ScaleNIHSS EuroQol Five Dimensions QuestionnaireEQ-5D Scale Modified Barthel IndexMBI Scale and Short Form-Health Scale of Traditional Chinese MedicineSF-HSTCM Additional indicators include the Acceptability Questionnaire and Health Economics Evaluation cost-effectiveness analysis to assess acceptability and economic practicality of the treatment in study Outcomes are assessed at baseline and post intervention
Discussion
Electro-acupuncture and MRI-navigated rTMS therapy could become an alternative treatment for PSD and it is expected that this trial will provide reliable clinical evidence and potential effect mechanism for the future use of electro-acupuncture and MRI-navigated rTMS for PSD
Post-stroke depression PSD is the most common mental complication after stroke and has a serious impact on functional outcomes and quality of life Antidepressants are the first-line treatment for PSD but many reported side effects remain Clinical research and practice guidelines have shown that electro-acupuncture and rTMS have a positive effect on PSD This trial aims to study the efficacy and safety of electro-acupuncture and a modern MRI-navigated rTMS for PSD and to explore its fMRI-based central mechanism on depression It is hypothesized that electro-acupuncture and MRI-navigated rTMS treatment improves depressive symptoms neuro-patho-physiological behaviors quality of life and central response in PSD
Methods
In this randomized controlled assessors-blinded trial sixty-four patients with PSD will be randomly allocated into the experiment group n32 or control groupn32 The experiment group will receive electro-acupuncture and MRI-navigated rTMS and the control group will receive MRI-navigated rTMS treatment in 12-20 sessions over 4 weeks In addition ten healthy people for fMRI scanning will be recruited as a healthy control group without any intervention The primary outcome is the change from baseline in the Hamilton Depression Scale-24 items HAMD-24 scores at week 4 The primary analysis of central mechanism mainly involves cortical morphology local spontaneous brain activity and default mode network DMN functional connectivity based on fMRI at 0-wk and 4-wk Secondary outcomes include the neuro-patho-physiological and quality of life changes in cortical excitability with motor evoked potential testMEP National Institutes of Health Stroke ScaleNIHSS EuroQol Five Dimensions QuestionnaireEQ-5D Scale Modified Barthel IndexMBI Scale and Short Form-Health Scale of Traditional Chinese MedicineSF-HSTCM Additional indicators include the Acceptability Questionnaire and Health Economics Evaluation cost-effectiveness analysis to assess acceptability and economic practicality of the treatment in study Outcomes are assessed at baseline and post intervention
Discussion
Electro-acupuncture and MRI-navigated rTMS therapy could become an alternative treatment for PSD and it is expected that this trial will provide reliable clinical evidence and potential effect mechanism for the future use of electro-acupuncture and MRI-navigated rTMS for PSD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None