Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493747
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-01
Brief Title:
Acupuncture Neuromodulation for Post-Stroke Aphasia
Sponsor:
Shanghai Yueyang Integrated Medicine Hospital
Organization:
Shanghai Yueyang Integrated Medicine Hospital
Study Overview
Official Title:
Efficacy and Mechanism Study of Acupuncture Combined With Neuromodulation Technology for Post-Stroke Aphasia Based on Multimodal Functional Magnetic Resonance Imaging
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The aim of this clinical trial is to assess the therapeutic efficacy of acupuncture combined with neuromodulation techniques for the treatment of post-stroke aphasia and to explore the brain mechanisms involved The study seeks to answer two primary questions the effectiveness of the integrated intervention of acupuncture and repetitive transcranial magnetic stimulation rTMS on post-stroke aphasia and the mechanisms underlying language function impairment and recovery
The research is divided into two parts
Part One
Participants will be randomized into two groups
Group A Receives low-frequency rTMS followed by high-frequency rTMS Group B Receives high-frequency rTMS followed by low-frequency rTMS
Part Two
Participants will be randomized into four groups
rTMS Experimental Group Individualized targets and intervention methods based on integrated fMRI and behavioral data The rTMS intervention involves continuous treatment for two weeks 5 sessions per week each lasting 10-25 minutes at 80 of the active motor threshold AMT
rTMS Control Group Standard rTMS protocol guided by clinical recommendations with continuous treatment for two weeks 5 sessions per week each 20 minutes at 80 AMT
Electroacupuncture Group Points include Speech Area 1 Yan Yu Yi Qu 1 Speech Area 2 Yan Yu Yi Qu 2 Fengchi Fengchi GB20 Tiantu Tiantu CV22 Tongli Tongli HT5 Lianquan Lianquan CV23 and Paralianquan Pang Lianquan After needle insertion and obtaining Qi electrical stimulation is applied with a discontinuous wave at 2Hz at a tolerable intensity for the patient for 30 minutes each session
Combined rTMS and Electroacupuncture Group Combines both intervention methods as described above
The research is divided into two parts
Part One
Participants will be randomized into two groups
Group A Receives low-frequency rTMS followed by high-frequency rTMS Group B Receives high-frequency rTMS followed by low-frequency rTMS
Part Two
Participants will be randomized into four groups
rTMS Experimental Group Individualized targets and intervention methods based on integrated fMRI and behavioral data The rTMS intervention involves continuous treatment for two weeks 5 sessions per week each lasting 10-25 minutes at 80 of the active motor threshold AMT
rTMS Control Group Standard rTMS protocol guided by clinical recommendations with continuous treatment for two weeks 5 sessions per week each 20 minutes at 80 AMT
Electroacupuncture Group Points include Speech Area 1 Yan Yu Yi Qu 1 Speech Area 2 Yan Yu Yi Qu 2 Fengchi Fengchi GB20 Tiantu Tiantu CV22 Tongli Tongli HT5 Lianquan Lianquan CV23 and Paralianquan Pang Lianquan After needle insertion and obtaining Qi electrical stimulation is applied with a discontinuous wave at 2Hz at a tolerable intensity for the patient for 30 minutes each session
Combined rTMS and Electroacupuncture Group Combines both intervention methods as described above
Detailed Description:
Aphasia is a severe disabling consequence of stroke typically caused by damage to the cortical and subcortical structures perfused by the left middle cerebral artery Studies have indicated that over 20 of stroke patients develop aphasia Although most patients exhibit some degree of spontaneous recovery within the first month after stroke a significant number still suffer from chronic deficits six months post-stroke Conventional rehabilitation methods and traditional Chinese medicine techniques often encounter efficacy plateaus in the treatment process Therefore there is an urgent need for innovative language therapy strategies to maximize recovery from aphasia Non-invasive brain stimulation techniques such as transcranial magnetic stimulation TMS have the potential to modulate cortical excitability and plasticity Acupuncture therapy can activate language neural functions establish collateral cerebral vascular circulation and reconstruct the neural circuitry of language motor control However when facing patients with complex post-stroke aphasia there are certain limitations This study employs a randomized blinded controlled clinical design to verify the therapeutic efficacy of acupuncture combined with transcranial magnetic stimulation in treating post-stroke aphasia and to explore the underlying brain mechanisms of recovery
The research is divided into two parts
Part One
Participants will be randomized into two groups
Group A Receives low-frequency rTMS followed by high-frequency rTMS Group B Receives high-frequency rTMS followed by low-frequency rTMS
Part Two
Participants will be randomized into four groups
rTMS Experimental Group Individualized targets and intervention methods based on integrated fMRI and behavioral data The rTMS intervention involves continuous treatment for two weeks 5 sessions per week each lasting 10-25 minutes at 80 of the active motor threshold AMT
rTMS Control Group Standard rTMS protocol guided by clinical recommendations with continuous treatment for two weeks 5 sessions per week each 20 minutes at 80 AMT
Electroacupuncture Group Points include Speech Area 1 Yan Yu Yi Qu 1 Speech Area 2 Yan Yu Yi Qu 2 Fengchi Fengchi GB20 Tiantu Tiantu CV22 Tongli Tongli HT5 Lianquan Lianquan CV23 and Paralianquan Pang Lianquan After needle insertion and obtaining Qi electrical stimulation is applied with a discontinuous wave at 2Hz at a tolerable intensity for the patient for 30 minutes each session
Combined rTMS and Electroacupuncture Group Combines both intervention methods as described above
The research is divided into two parts
Part One
Participants will be randomized into two groups
Group A Receives low-frequency rTMS followed by high-frequency rTMS Group B Receives high-frequency rTMS followed by low-frequency rTMS
Part Two
Participants will be randomized into four groups
rTMS Experimental Group Individualized targets and intervention methods based on integrated fMRI and behavioral data The rTMS intervention involves continuous treatment for two weeks 5 sessions per week each lasting 10-25 minutes at 80 of the active motor threshold AMT
rTMS Control Group Standard rTMS protocol guided by clinical recommendations with continuous treatment for two weeks 5 sessions per week each 20 minutes at 80 AMT
Electroacupuncture Group Points include Speech Area 1 Yan Yu Yi Qu 1 Speech Area 2 Yan Yu Yi Qu 2 Fengchi Fengchi GB20 Tiantu Tiantu CV22 Tongli Tongli HT5 Lianquan Lianquan CV23 and Paralianquan Pang Lianquan After needle insertion and obtaining Qi electrical stimulation is applied with a discontinuous wave at 2Hz at a tolerable intensity for the patient for 30 minutes each session
Combined rTMS and Electroacupuncture Group Combines both intervention methods as described above
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?:
False
Is an FDA AA801 Violation?:
None