Clinical trial NCT03159351: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Post-stroke Depression
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 66
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: response rate
timeFrame: baseline, 2nd and 4th week
measure: remission rate
timeFrame: baseline, 2nd and 4th week
Secondary outcomes:
measure: DTI results of FA
timeFrame: baseline and 4th week
measure: DTI results of ADC
timeFrame: baseline and 4th week
measure: DTI results of NFN
timeFrame: baseline and 4th week
measure: Neuropsychological tests results of NIHSS
timeFrame: baseline and 4th week
measure: Neuropsychological tests results of ADLs
timeFrame: baseline and 4th week
measure: Neuropsychological tests results of MoCA
timeFrame: baseline and 4th week
measure: Neuropsychological tests results of ABC
timeFrame: baseline and 4th week
measure: Neuropsychological tests results of SSRS
timeFrame: baseline and 4th week
measure: Neuropsychological tests results of MCMQ
timeFrame: baseline and 4th week
measure: Neuropsychological tests results of CGI
timeFrame: baseline and 4th week
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital
state: Guangdong
Study officials:
References:
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.