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
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2017
CompletedFirst Posted
Study publicly available on registry
May 18, 2017
CompletedStudy Start
First participant enrolled
November 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2020
CompletedJanuary 18, 2018
January 1, 2018
2.5 years
May 1, 2017
January 16, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (10)
DTI results of FA
baseline and 4th week
DTI results of ADC
baseline and 4th week
DTI results of NFN
baseline and 4th week
Neuropsychological tests results of NIHSS
baseline and 4th week
Neuropsychological tests results of ADLs
baseline and 4th week
- +5 more secondary outcomes
Study Arms (2)
active rTMS treatment
EXPERIMENTALreceived active rTMS treatment 20 times for 20 days
sham rTMS treatment
SHAM COMPARATORreceived sham rTMS treatment 20 times for 20 days
Interventions
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 rTMS treatment protocol parameters: sham rTMS treatment in the localization of left DLPFC and right DLPFC for 30 minutes,total times=20.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhujiang Hospital
Guangzhou, Guangdong, 510282, China
Related Publications (1)
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.
PMID: 29431126DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2017
First Posted
May 18, 2017
Study Start
November 20, 2017
Primary Completion
May 31, 2020
Study Completion
May 31, 2020
Last Updated
January 18, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share