The Antidepressant Effects of rTMS After Ischemic Stroke

Repetitive Transcranial Magnetic Stimulation for Depression After Basal Ganglia Ischemic Stroke: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Post-stroke Depression
• Intervention / Treatment: Device: active rTMS treatment; Device: sham rTMS 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).

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lianxu Zhao, M.D; Phone Number: 020-62783082; Email: zhaolianxu@smu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510282
      • Recruiting
      • Zhujiang Hospital
      • Contact: Lianxu Zhao, M.D; Phone Number: +86 13794419610; Email: zhaolianxu@smu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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]);
2. Aged 25-75 years with a recent (from 3 weeks to 3 months) ischemic stroke;
3. Clear signs of neurological deficits in the acute phase;
4. Clear consciousness;
5. Right-handedness.

Exclusion Criteria:

1. Aphasia or severe cognitive impairment, severe hearing impairment, or severe language comprehension deficits due to other causes;
2. Other cerebral diseases such as Parkinson's disease, encephalitis, dementia, multiple sclerosis, head injury, ect.;
3. Severe systemic disease or ongoing neoplasia;
4. Ongoing post-operative recovery;
5. Prior history of depressive disorders or major trauma within 1 year, severe depression or any other severe mental disorders;
6. Current or prior antidepressant use for any reason;
7. Addiction to drugs, alcohol or other substances;
8. Contraindications of MRI scan and rTMS treatment such as pacemaker implantation, a history of epilepsy, major head trauma, and seizures, ect;
9. Pregnant or breast-feeding women;
10. Participation in other clinical research projects;
11. Refusal to sign informed consent of this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active rTMS treatment; received active rTMS treatment 20 times for 20 days	Device: active rTMS treatment; 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.
Sham Comparator: sham rTMS treatment; received sham rTMS treatment 20 times for 20 days	Device: sham rTMS treatment; sham rTMS treatment protocol parameters: sham rTMS treatment in the localization of left DLPFC and right DLPFC for 30 minutes,total times=20.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, 2nd and 4th week
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.	baseline, 2nd and 4th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline and 4th week
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.	baseline and 4th week
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.	baseline and 4th week
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.	baseline and 4th week
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.	baseline and 4th week
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.	baseline and 4th week
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.	baseline and 4th week
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.	baseline and 4th week
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.	baseline and 4th week
Neuropsychological tests results of CGI	Neuropsychological tests including Clinical Global Impressions scales	baseline and 4th week

Collaborators and Investigators

• Sponsor: Zhujiang Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2017
• Primary Completion (Anticipated): May 31, 2020
• Study Completion (Anticipated): May 31, 2020

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (Actual): May 18, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Depression; Ischemic Stroke
• Other Study ID Numbers: 2016-SJNK-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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