Post-stroke DepressionNCT03159351
The Antidepressant Effects of rTMS After Ischemic Stroke
A study testing active rTMS treatment in people with Post-stroke Depression, run by Zhujiang Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Post-stroke Depression
- What is being tested?
- active rTMS treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2017to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital
Guangzhou, Guangdong, 510282
Lianxu Zhao, M.D, +86 13794419610, zhaolianxu@smu.edu.cn
About this study
Official title: 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.
Read the 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
- Being tested
- active rTMS treatment, sham rTMS treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active rTMS treatmentDevice
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 treatmentDevice
sham rTMS treatment protocol parameters: sham rTMS treatment in the localization of left DLPFC and right DLPFC for 30 minutes,total times=20.
| Study group | Role | What they receive |
|---|---|---|
| active rTMS treatment | Experimental | received active rTMS treatment 20 times for 20 days Receives: Device: active rTMS treatment |
| sham rTMS treatment | Sham comparator | received sham rTMS treatment 20 times for 20 days Receives: Device: sham rTMS treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline, 2nd and 4th week
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and 4th week
Neuropsychological tests results of CGI
Neuropsychological tests including Clinical Global Impressions scales
Measured: baseline and 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start20 Nov 2017
- Primary completion31 May 2020 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-stroke DepressionStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159351
- Sponsor's protocol ID
- 2016-SJNK-005
- Status last verified
- Jan 2018
- First submitted
- 1 May 2017
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29431126
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation for Depression After Basal Ganglia Ischemic Stroke: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03159351
- Acronym / sponsor ID
- 2016-SJNK-005
- Conditions
- Post-stroke Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active rTMS treatment | Experimental | Device: active rTMS treatmentreceived active rTMS treatment 20 times for 20 days |
| sham rTMS treatment | Sham comparator | Device: sham rTMS treatmentreceived sham rTMS treatment 20 times for 20 days |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active rTMS treatmentactive 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. | Device | active rTMS treatment |
| sham rTMS treatmentsham rTMS treatment protocol parameters: sham rTMS treatment in the localization of left DLPFC and right DLPFC for 30 minutes,total times=20. | Device | sham rTMS treatment |
Primary outcome
response rate
Time frame: baseline, 2nd and 4th week
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
Time frame: baseline, 2nd and 4th week
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.
10 secondary outcomes
DTI results of FA
Time frame: baseline and 4th week
DTI results of ADC
Time frame: baseline and 4th week
DTI results of NFN
Time frame: baseline and 4th week
Neuropsychological tests results of NIHSS
Time frame: baseline and 4th week
Neuropsychological tests results of ADLs
Time frame: baseline and 4th week
Neuropsychological tests results of MoCA
Time frame: baseline and 4th week
Neuropsychological tests results of ABC
Time frame: baseline and 4th week
Neuropsychological tests results of SSRS
Time frame: baseline and 4th week
Neuropsychological tests results of MCMQ
Time frame: baseline and 4th week
Neuropsychological tests results of CGI
Time frame: baseline and 4th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Derived from this study: PubMed 29431126Tang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active rTMS treatment in people with Post-stroke Depression, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lianxu Zhao, M.D (020-62783082, zhaolianxu@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: baseline, 2nd and 4th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03159351, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.