Back to resultsThe Antidepressant Effects of rTMS After Ischemic Stroke
Primary Purpose
Post-stroke Depression
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
active rTMS treatment
sham rTMS treatment
Sponsored by
About this trial
This is an interventional treatment trial for Post-stroke Depression
Eligibility Criteria
Inclusion Criteria:
- First-time ischemic stroke with clinical and MRI or CT findings of basal ganglia ischemic stroke and a diagnosis of depression due to stroke based on The Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) and The International Classification of Diseases-10 (ICD-10-CM code 293.83[F06.32]);
- Aged 25-75 years with a recent (from 3 weeks to 3 months) ischemic stroke;
- Clear signs of neurological deficits in the acute phase;
- Clear consciousness;
- Right-handedness.
Exclusion Criteria:
- Aphasia or severe cognitive impairment, severe hearing impairment, or severe language comprehension deficits due to other causes;
- Other cerebral diseases such as Parkinson's disease, encephalitis, dementia, multiple sclerosis, head injury, ect.;
- Severe systemic disease or ongoing neoplasia;
- Ongoing post-operative recovery;
- Prior history of depressive disorders or major trauma within 1 year, severe depression or any other severe mental disorders;
- Current or prior antidepressant use for any reason;
- Addiction to drugs, alcohol or other substances;
- Contraindications of MRI scan and rTMS treatment such as pacemaker implantation, a history of epilepsy, major head trauma, and seizures, ect;
- Pregnant or breast-feeding women;
- Participation in other clinical research projects;
- Refusal to sign informed consent of this study.
Sites / Locations
- Zhujiang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
active rTMS treatment
sham rTMS treatment
Arm Description
received active rTMS treatment 20 times for 20 days
received sham rTMS treatment 20 times for 20 days
Outcomes
Primary Outcome Measures
response rate
Compare the HAMD-24 scores from baseline to the end of the treatment.the response to treatment is defined as at least a 50% reduction of the HAMD-24 total score with a final HAMD-24 score below 9. The response rate is defined as the percentage of number of response.
remission rate
Compare the HAMD-24 scores from baseline to the end of the treatment. The remission is defined as a reduction of the HAMD-24 total score by at least 50% from the baseline. The remission rate is defined as the percentage of number of remission.
Secondary Outcome Measures
DTI results of FA
DTI parameters including the fractional anisotropy (FA), apparent diffusion coefficient (ADC), neural fiber number (NFN). Get the change of FA by Comparing the change of FA from baseline to the end of the treatment in each group.
DTI results of ADC
DTI parameters including the fractional anisotropy (FA), apparent diffusion coefficient (ADC), neural fiber number (NFN). Get the change of ADC by Comparing the change of ADC from baseline to the end of the treatment in each group.
DTI results of NFN
DTI parameters including the fractional anisotropy (FA), apparent diffusion coefficient (ADC), neural fiber number (NFN). Get the change of NFN by Comparing the change of NFN from baseline to the end of the treatment in each group.
Neuropsychological tests results of NIHSS
Neuropsychological tests including National Institutes of Health Stroke Scale (NIHSS), Activities of Daily Living Scale (ADLs), Montreal Cognitive Assessment (MoCA), Aphasia Battery in Chinese (ABC), Social Support Revalued Scale (SSRS) and Medical Coping Questionnaire score (MCMQ). Get the change of the result of NIHSS by Comparing the change of NIHSS scores from baseline to the end of the treatment in each group.
Neuropsychological tests results of ADLs
Neuropsychological tests including National Institutes of Health Stroke Scale (NIHSS), Activities of Daily Living Scale (ADLs), Montreal Cognitive Assessment (MoCA), Aphasia Battery in Chinese (ABC), Social Support Revalued Scale (SSRS) and Medical Coping Questionnaire score (MCMQ). Get the change of the result of ADLs by Comparing the change of ADLs scores from baseline to the end of the treatment in each group.
Neuropsychological tests results of MoCA
Neuropsychological tests including National Institutes of Health Stroke Scale (NIHSS), Activities of Daily Living Scale (ADLs), Montreal Cognitive Assessment (MoCA), Aphasia Battery in Chinese (ABC), Social Support Revalued Scale (SSRS) and Medical Coping Questionnaire score (MCMQ). Get the change of the result of MoCA by Comparing the change of MoCA scores from baseline to the end of the treatment in each group.
Neuropsychological tests results of ABC
Neuropsychological tests including National Institutes of Health Stroke Scale (NIHSS), Activities of Daily Living Scale (ADLs), Montreal Cognitive Assessment (MoCA), Aphasia Battery in Chinese (ABC), Social Support Revalued Scale (SSRS) and Medical Coping Questionnaire score (MCMQ). Get the change of the result of ABC by Comparing the change of ABC scores from baseline to the end of the treatment in each group.
Neuropsychological tests results of SSRS
Neuropsychological tests including National Institutes of Health Stroke Scale (NIHSS), Activities of Daily Living Scale (ADLs), Montreal Cognitive Assessment (MoCA), Aphasia Battery in Chinese (ABC), Social Support Revalued Scale (SSRS) and Medical Coping Questionnaire score (MCMQ). Get the change of the result of SSRS by Comparing the change of SSRS scores from baseline to the end of the treatment in each group.
Neuropsychological tests results of MCMQ
Neuropsychological tests including National Institutes of Health Stroke Scale (NIHSS), Activities of Daily Living Scale (ADLs), Montreal Cognitive Assessment (MoCA), Aphasia Battery in Chinese (ABC), Social Support Revalued Scale (SSRS) and Medical Coping Questionnaire score (MCMQ). Get the change of the result of MCMQ by Comparing the change of MCMQ scores from baseline to the end of the treatment in each group.
Neuropsychological tests results of CGI
Neuropsychological tests including Clinical Global Impressions scales
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03159351
Brief Title
The Antidepressant Effects of rTMS After Ischemic Stroke
Official Title
Repetitive Transcranial Magnetic Stimulation for Depression After Basal Ganglia Ischemic Stroke: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
May 31, 2020 (Anticipated)
Study Completion Date
May 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled trial aims to assess the effectiveness of repetitive transcranial magnetic stimulation(rTMS) in treating depression after basal ganglia ischemic stroke and to examine whether such effects are related to restoration of white matter integrity.Sixty-six participants will be recruited from three centers and randomized with a 1:1 ratio to receive active rTMS treatment or sham rTMS treatment in addition to routine supportive treatments.The data of neuropsychological tests and MRI will be collected at 0, 2 and 4 weeks after the commencement of the treatment.
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled trial aims to assess the effectiveness of rTMS in treating depression after basal ganglia ischemic stroke and to examine whether such effects are related to restoration of white matter integrity.Sixty-six participants will be recruited from three centers and randomized with a 1:1 ratio to receive active rTMS treatment or sham rTMS treatment in addition to routine supportive treatments.The data of neuropsychological tests and MRI will be collected at 0, 2 and 4 weeks after the commencement of the treatment.The primary outcome is the measurement of 24-item Hamilton Depression Rating Scale (HAMD-24) scores, and the secondary outcomes include diffusion tensor imaging (DTI) results and the results of neuropsychological tests including National Institutes of Health Stroke Scale (NIHSS), Activities of Daily Living Scale (ADLs), Montreal Cognitive Assessment (MoCA),Clinical Global Impressions scales(CGI), Aphasia Battery in Chinese (ABC), Social Support Revalued Scale (SSRS) and Medical Coping Questionnaire (MCMQ).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active rTMS treatment
Arm Type
Experimental
Arm Description
received active rTMS treatment 20 times for 20 days
Arm Title
sham rTMS treatment
Arm Type
Sham Comparator
Arm Description
received sham rTMS treatment 20 times for 20 days
Intervention Type
Device
Intervention Name(s)
active rTMS treatment
Intervention Description
active rTMS treatment protocol parameters: localization of left DLPFC: frequency=10 Hz, intensity=110% motor threshold(MT), times per train=200 seconds, trains=10, duration= 40 seconds, total times=20;localization of right DLPFC: frequency=1 Hz, intensity=100%MT, times per train=30 seconds, trains=10, duration= 10 seconds, total times=20.
Intervention Type
Device
Intervention Name(s)
sham rTMS treatment
Intervention Description
sham rTMS treatment protocol parameters: sham rTMS treatment in the localization of left DLPFC and right DLPFC for 30 minutes,total times=20.
Primary Outcome Measure Information:
Title
response rate
Description
Compare the HAMD-24 scores from baseline to the end of the treatment.the response to treatment is defined as at least a 50% reduction of the HAMD-24 total score with a final HAMD-24 score below 9. The response rate is defined as the percentage of number of response.
Time Frame
baseline, 2nd and 4th week
Title
remission rate
Description
Compare the HAMD-24 scores from baseline to the end of the treatment. The remission is defined as a reduction of the HAMD-24 total score by at least 50% from the baseline. The remission rate is defined as the percentage of number of remission.
Time Frame
baseline, 2nd and 4th week
Secondary Outcome Measure Information:
Title
DTI results of FA
Description
DTI parameters including the fractional anisotropy (FA), apparent diffusion coefficient (ADC), neural fiber number (NFN). Get the change of FA by Comparing the change of FA from baseline to the end of the treatment in each group.
Time Frame
baseline and 4th week
Title
DTI results of ADC
Description
DTI parameters including the fractional anisotropy (FA), apparent diffusion coefficient (ADC), neural fiber number (NFN). Get the change of ADC by Comparing the change of ADC from baseline to the end of the treatment in each group.
Time Frame
baseline and 4th week
Title
DTI results of NFN
Description
DTI parameters including the fractional anisotropy (FA), apparent diffusion coefficient (ADC), neural fiber number (NFN). Get the change of NFN by Comparing the change of NFN from baseline to the end of the treatment in each group.
Time Frame
baseline and 4th week
Title
Neuropsychological tests results of NIHSS
Description
Neuropsychological tests including National Institutes of Health Stroke Scale (NIHSS), Activities of Daily Living Scale (ADLs), Montreal Cognitive Assessment (MoCA), Aphasia Battery in Chinese (ABC), Social Support Revalued Scale (SSRS) and Medical Coping Questionnaire score (MCMQ). Get the change of the result of NIHSS by Comparing the change of NIHSS scores from baseline to the end of the treatment in each group.
Time Frame
baseline and 4th week
Title
Neuropsychological tests results of ADLs
Description
Neuropsychological tests including National Institutes of Health Stroke Scale (NIHSS), Activities of Daily Living Scale (ADLs), Montreal Cognitive Assessment (MoCA), Aphasia Battery in Chinese (ABC), Social Support Revalued Scale (SSRS) and Medical Coping Questionnaire score (MCMQ). Get the change of the result of ADLs by Comparing the change of ADLs scores from baseline to the end of the treatment in each group.
Time Frame
baseline and 4th week
Title
Neuropsychological tests results of MoCA
Description
Neuropsychological tests including National Institutes of Health Stroke Scale (NIHSS), Activities of Daily Living Scale (ADLs), Montreal Cognitive Assessment (MoCA), Aphasia Battery in Chinese (ABC), Social Support Revalued Scale (SSRS) and Medical Coping Questionnaire score (MCMQ). Get the change of the result of MoCA by Comparing the change of MoCA scores from baseline to the end of the treatment in each group.
Time Frame
baseline and 4th week
Title
Neuropsychological tests results of ABC
Description
Neuropsychological tests including National Institutes of Health Stroke Scale (NIHSS), Activities of Daily Living Scale (ADLs), Montreal Cognitive Assessment (MoCA), Aphasia Battery in Chinese (ABC), Social Support Revalued Scale (SSRS) and Medical Coping Questionnaire score (MCMQ). Get the change of the result of ABC by Comparing the change of ABC scores from baseline to the end of the treatment in each group.
Time Frame
baseline and 4th week
Title
Neuropsychological tests results of SSRS
Description
Neuropsychological tests including National Institutes of Health Stroke Scale (NIHSS), Activities of Daily Living Scale (ADLs), Montreal Cognitive Assessment (MoCA), Aphasia Battery in Chinese (ABC), Social Support Revalued Scale (SSRS) and Medical Coping Questionnaire score (MCMQ). Get the change of the result of SSRS by Comparing the change of SSRS scores from baseline to the end of the treatment in each group.
Time Frame
baseline and 4th week
Title
Neuropsychological tests results of MCMQ
Description
Neuropsychological tests including National Institutes of Health Stroke Scale (NIHSS), Activities of Daily Living Scale (ADLs), Montreal Cognitive Assessment (MoCA), Aphasia Battery in Chinese (ABC), Social Support Revalued Scale (SSRS) and Medical Coping Questionnaire score (MCMQ). Get the change of the result of MCMQ by Comparing the change of MCMQ scores from baseline to the end of the treatment in each group.
Time Frame
baseline and 4th week
Title
Neuropsychological tests results of CGI
Description
Neuropsychological tests including Clinical Global Impressions scales
Time Frame
baseline and 4th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
First-time ischemic stroke with clinical and MRI or CT findings of basal ganglia ischemic stroke and a diagnosis of depression due to stroke based on The Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) and The International Classification of Diseases-10 (ICD-10-CM code 293.83[F06.32]);
Aged 25-75 years with a recent (from 3 weeks to 3 months) ischemic stroke;
Clear signs of neurological deficits in the acute phase;
Clear consciousness;
Right-handedness.
Exclusion Criteria:
Aphasia or severe cognitive impairment, severe hearing impairment, or severe language comprehension deficits due to other causes;
Other cerebral diseases such as Parkinson's disease, encephalitis, dementia, multiple sclerosis, head injury, ect.;
Severe systemic disease or ongoing neoplasia;
Ongoing post-operative recovery;
Prior history of depressive disorders or major trauma within 1 year, severe depression or any other severe mental disorders;
Current or prior antidepressant use for any reason;
Addiction to drugs, alcohol or other substances;
Contraindications of MRI scan and rTMS treatment such as pacemaker implantation, a history of epilepsy, major head trauma, and seizures, ect;
Pregnant or breast-feeding women;
Participation in other clinical research projects;
Refusal to sign informed consent of this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lianxu Zhao, M.D
Phone
020-62783082
Email
zhaolianxu@smu.edu.cn
Facility Information:
Facility Name
Zhujiang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510282
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lianxu Zhao, M.D
Phone
+86 13794419610
Email
zhaolianxu@smu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29431126
Citation
Tang Y, Chen A, Zhu S, Yang L, Zhou J, Pan S, Shao M, Zhao L. Repetitive transcranial magnetic stimulation for depression after basal ganglia ischaemic stroke: protocol for a multicentre randomised double-blind placebo-controlled trial. BMJ Open. 2018 Feb 3;8(2):e018011. doi: 10.1136/bmjopen-2017-018011.
Results Reference
derived
Learn more about this trial
The Antidepressant Effects of rTMS After Ischemic Stroke
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