The Antidepressant Effects of rTMS After Ischemic Stroke

NCT ID: NCT03159351

Last Updated: 2018-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-20
• Study Completion Date: 2020-05-31

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).

Conditions

Post-stroke Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

active rTMS treatment

received active rTMS treatment 20 times for 20 days

Group Type: EXPERIMENTAL

active rTMS treatment

Intervention Type: DEVICE

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

received sham rTMS treatment 20 times for 20 days

Group Type: SHAM_COMPARATOR

sham rTMS treatment

Intervention Type: DEVICE

sham rTMS treatment protocol parameters: sham rTMS treatment in the localization of left DLPFC and right DLPFC for 30 minutes,total times=20.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhujiang Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lianxu Zhao, M.D

Role: CONTACT

zhaolianxu@smu.edu.cn

020-62783082

Facility Contacts

Lianxu Zhao, M.D

Role: primary

zhaolianxu@smu.edu.cn

+86 13794419610

References

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.

Reference Type: DERIVED

PMID: 29431126 (View on PubMed)

Other Identifiers

2016-SJNK-005

Identifier Type: -

Identifier Source: org_study_id