Post-stroke DepressionNCT03256305
A Study of rTMS Personalized Precision Treatment of Post-stroke Depression
A study testing "personalized" rTMS+drug treatment and Traditional rTMS +drug treatment in people with Post-stroke Depression, run by Zhujiang Hospital at 1 site in China.
Trial summary
This is a multicenter, randomized trial aims to reveal the efficacy and safety of Repetitive transcranial magnetic stimulation (rTMS) individualized therapy based on the 'emotional loop destabilization' mechanism of PSD .One hundred and twenty participants will be recruited from three centers and randomized with a 1:1… 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?
- "personalized" rTMS+drug treatment and Traditional rTMS +drug treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Oct 2021
- 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
- （1） First-time ischemic stroke with clinical and MRI or CT findings of basal ganglia stroke (ICD-10-CM code 293.83[F06.32]) (3) Right-handedness (4)Clear consciousness (5)Aged 25-75 years with a recent (less than 24 months) ischemic stroke;
Who cannot join
- Aphasia or severe cognitive impairment, severe hearing impairment;
- Contraindications of MRI scan and rTMS treatment such as pacemaker implantation; (3)Depression caused by psychoactive substances and non addictive substances;（4）Prior history of depressive disorders or major trauma within 1 year, severe depression or any other severe mental disorders;
- （5）Pregnant or breast-feeding women; （6）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, 510000
Wen Wu, M.D., +86-020-62783189, wuwen66@163.com
About this study
Official title: A Clinical Control Study of rTMS Personalized Precision Treatment of Post-stroke Depression Based on Mechanism of Emotional Circuit Imbalance
This is a multicenter, randomized trial aims to reveal the efficacy and safety of Repetitive transcranial magnetic stimulation (rTMS) individualized therapy based on the 'emotional loop destabilization' mechanism of PSD .One hundred and twenty participants will be recruited from three centers and randomized with a 1:1 ratio to receive "Personalized" rTMS treatment or traditional rTMS treatment in addition to routine antidepressant treatments.The data of neuropsychological tests and MRI will be collected at 0, 2，4 and 8 weeks after the commencement of the treatment.
Read the detailed description
This is a multicenter, randomized trial aims to reveal the efficacy and safety of rTMS individualized therapy based on the 'emotional loop destabilization' mechanism of PSD .One hundred and twenty participants will be recruited from three centers and randomized with a 1:1 ratio to receive "Personalized" rTMS treatment or traditional rTMS treatment in addition to routine antidepressant treatments.
Based on inclusion and exclusion criteria, after stroke depression (post-stroke depression, PSD) cases were collected and randomized into two groups: "individualized" rTMS+ drug treatment group and traditional rTMS plus traditional drug treatment group. The main indicators were the effective rate of treatment.Based on inclusion and exclusion criteria, after stroke depression (post-stroke depression, PSD) cases were collected and randomized into two groups: "individualized" rTMS+ drug treatment group and traditional rTMS plus traditional drug treatment group. The main indicators were the effective rate of treatment. The primary outcome is the measurement of 24-item Hamilton Depression Rating Scale (HAMD-24) scores, the secondary outcomes include National Institutes of Health Stroke Scale (NIHSS), Activities of Daily Living Scale (ADLs),self-rating anxiety scale(SAS). The record of the adverse reactions and sequelae during treatment and follow-up, with a view to providing a better clinical method for the treatment of PSD.
- Conditions
- Post-stroke Depression
- Being tested
- "personalized" rTMS+drug treatment, Traditional rTMS +drug treatment
- Keywords
- Repetitive transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"personalized" rTMS+drug treatmentDevice
Also called P rTMS
High frequency（10HZ）stimulation of brain regions corresponding to lesion, low-frequency （1HZ）stimulation of the contralateral brain, intensity=90%MT（motor thresholds). Each sequence is 20 times, duration is 10 seconds, each sequence spaced 60s, 20 sequences per day, 1 times a day ,total times is 15. Taking paroxetine 2 weeks, Take 20 mg a day.
Traditional rTMS +drug treatmentDevice
Also called T rTMS
Traditional rTMS treatment protocol parameters: localization of left DLPFC: frequency=10 Hz; localization of right DLPFC: frequency=1 Hz, intensity=90%MT, Each sequence is 20 times, duration is 10 seconds, each sequence spaced 60s, 20 sequences per day,1 times a day,total times is 15. Taking paroxetine 2 weeks, Take 20 mg a day.
| Study group | Role | What they receive |
|---|---|---|
| "personalized" rTMS+drug treatment | Experimental | Received "personalized" rTMS treatment 15 times for 15 days;Take paroxetine for 2 weeks Receives: Device: "personalized" rTMS+drug treatment |
| Traditional rTMS +drug treatment | Active comparator | Received traditional rTMS treatment 15 times for 15 days;Take paroxetine for 2 weeks Receives: Device: Traditional rTMS +drug 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 30% reduction of the HAMD-24 total score with a final HAMD-24 score. The score decreased by more than 50% for the treatment of good results.The response rate is defined as the percentage of number of response.
Measured: Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment
Secondary outcomes (2)
Neuropsychological tests results of SAS
Get the change of the result of self-rating anxiety scale (SAS) by Comparing the change of SAS scores from baseline to the end of the treatment in each group.
Measured: Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment
Neuropsychological tests results of ADLs
Get the change of the result of Activities of Daily Living Scale (ADLs) by Comparing the change of ADLs scores from baseline to the end of the treatment in each group.
Measured: Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study startDec 2016
- Primary completionOct 2018 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)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
- Model description
- Care Provider, Investigator, Outcomes Assessor
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Wu, M.D., Study chair, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256305
- Sponsor's protocol ID
- 2017-KFYXK-001
- Status last verified
- Aug 2017
- First submitted
- 18 Jul 2017
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Broomfield NM, Quinn TJ, Abdul-Rahim AH, Walters MR, Evans JJ. Depression and anxiety symptoms post-stroke/TIA: prevalence and associations in cross-sectional data from a regional stroke registry. BMC Neurol. 2014 Oct 1;14:198. doi: 10.1186/s12883-014-0198-8.
PubMed 25269762Concerto C, Lanza G, Cantone M, Ferri R, Pennisi G, Bella R, Aguglia E. Repetitive transcranial magnetic stimulation in patients with drug-resistant major depression: A six-month clinical follow-up study. Int J Psychiatry Clin Pract. 2015;19(4):252-8. doi: 10.3109/13651501.2015.1084329. Epub 2015 Sep 23.
PubMed 26398527Damasio A, Carvalho GB. The nature of feelings: evolutionary and neurobiological origins. Nat Rev Neurosci. 2013 Feb;14(2):143-52. doi: 10.1038/nrn3403.
PubMed 23329161De Ryck A, Brouns R, Geurden M, Elseviers M, De Deyn PP, Engelborghs S. Risk factors for poststroke depression: identification of inconsistencies based on a systematic review. J Geriatr Psychiatry Neurol. 2014 Sep;27(3):147-58. doi: 10.1177/0891988714527514. Epub 2014 Apr 7.
PubMed 24713406De Ryck A, Fransen E, Brouns R, Geurden M, Peij D, Marien P, De Deyn PP, Engelborghs S. Poststroke depression and its multifactorial nature: results from a prospective longitudinal study. J Neurol Sci. 2014 Dec 15;347(1-2):159-66. doi: 10.1016/j.jns.2014.09.038. Epub 2014 Oct 2.
PubMed 25451004Dwyer Hollender K. Screening, diagnosis, and treatment of post-stroke depression. J Neurosci Nurs. 2014 Jun;46(3):135-41. doi: 10.1097/JNN.0000000000000047.
PubMed 24670433Eriksen S, Gay CL, Lerdal A. Acute phase factors associated with the course of depression during the first 18 months after first-ever stroke. Disabil Rehabil. 2016;38(1):30-5. doi: 10.3109/09638288.2015.1009181. Epub 2015 Feb 6.
PubMed 25655394Jastorff J, Huang YA, Giese MA, Vandenbulcke M. Common neural correlates of emotion perception in humans. Hum Brain Mapp. 2015 Oct;36(10):4184-201. doi: 10.1002/hbm.22910. Epub 2015 Jul 28.
PubMed 26219630Li W, Ling S, Yang Y, Hu Z, Davies H, Fang M. Systematic hypothesis for post-stroke depression caused inflammation and neurotransmission and resultant on possible treatments. Neuro Endocrinol Lett. 2014;35(2):104-9.
PubMed 24878979Narushima K, Kosier JT, Robinson RG. A reappraisal of poststroke depression, intra- and inter-hemispheric lesion location using meta-analysis. J Neuropsychiatry Clin Neurosci. 2003 Fall;15(4):422-30. doi: 10.1176/jnp.15.4.422.
PubMed 14627768Riccelli R, Passamonti L, Cerasa A, Nigro S, Cavalli SM, Chiriaco C, Valentino P, Nistico R, Quattrone A. Individual differences in depression are associated with abnormal function of the limbic system in multiple sclerosis patients. Mult Scler. 2016 Jul;22(8):1094-105. doi: 10.1177/1352458515606987. Epub 2015 Oct 9.
PubMed 26453680Robinson RG, Lipsey JR, Rao K, Price TR. Two-year longitudinal study of post-stroke mood disorders: comparison of acute-onset with delayed-onset depression. Am J Psychiatry. 1986 Oct;143(10):1238-44. doi: 10.1176/ajp.143.10.1238.
PubMed 3766786Sun N, Li QJ, Lv DM, Man J, Liu XS, Sun ML. A survey on 465 patients with post-stroke depression in China. Arch Psychiatr Nurs. 2014 Dec;28(6):368-71. doi: 10.1016/j.apnu.2014.08.007. Epub 2014 Sep 3.
PubMed 25457685Valiengo L, Casati R, Bolognini N, Lotufo PA, Bensenor IM, Goulart AC, Brunoni AR. Transcranial direct current stimulation for the treatment of post-stroke depression in aphasic patients: a case series. Neurocase. 2016;22(2):225-8. doi: 10.1080/13554794.2015.1130231. Epub 2016 Jan 8.
PubMed 26743441Wichowicz HM, Gasecki D, Landowski J, Lass P, Swierkocka M, Wisniewski G, Nyka WN, Wilkowska A. Clinical utility of chosen factors in predicting post-stroke depression: a one year follow-up. Psychiatr Pol. 2015;49(4):683-96. doi: 10.12740/PP/38439. English, Polish.
PubMed 26488345
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Control Study of rTMS Personalized Precision Treatment of Post-stroke Depression Based on Mechanism of Emotional Circuit Imbalance
- ClinicalTrials.gov ID
- NCT03256305
- Acronym / sponsor ID
- 2017-KFYXK-001
- Conditions
- Post-stroke Depression
- Keywords
- Repetitive transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 22 Aug 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 trial aims to reveal the efficacy and safety of Repetitive transcranial magnetic stimulation (rTMS) individualized therapy based on the 'emotional loop destabilization' mechanism of PSD .One hundred and twenty participants will be recruited from three centers and randomized with a 1:1 ratio to receive "Personalized" rTMS treatment or traditional rTMS treatment in addition to routine antidepressant treatments.The data of neuropsychological tests and MRI will be collected at 0, 2，4 and 8 weeks after the commencement of the treatment.
Detailed description
This is a multicenter, randomized trial aims to reveal the efficacy and safety of rTMS individualized therapy based on the 'emotional loop destabilization' mechanism of PSD .One hundred and twenty participants will be recruited from three centers and randomized with a 1:1 ratio to receive "Personalized" rTMS treatment or traditional rTMS treatment in addition to routine antidepressant treatments.
Based on inclusion and exclusion criteria, after stroke depression (post-stroke depression, PSD) cases were collected and randomized into two groups: "individualized" rTMS+ drug treatment group and traditional rTMS plus traditional drug treatment group. The main indicators were the effective rate of treatment.Based on inclusion and exclusion criteria, after stroke depression (post-stroke depression, PSD) cases were collected and randomized into two groups: "individualized" rTMS+ drug treatment group and traditional rTMS plus traditional drug treatment group. The main indicators were the effective rate of treatment. The primary outcome is the measurement of 24-item Hamilton Depression Rating Scale (HAMD-24) scores, the secondary outcomes include National Institutes of Health Stroke Scale (NIHSS), Activities of Daily Living Scale (ADLs),self-rating anxiety scale(SAS). The record of the adverse reactions and sequelae during treatment and follow-up, with a view to providing a better clinical method for the treatment of PSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Care Provider, Investigator, Outcomes Assessor
| Arm | Type | Receives |
|---|---|---|
| "personalized" rTMS+drug treatment | Experimental | Device: "personalized" rTMS+drug treatmentReceived "personalized" rTMS treatment 15 times for 15 days;Take paroxetine for 2 weeks |
| Traditional rTMS +drug treatment | Active comparator | Device: Traditional rTMS +drug treatmentReceived traditional rTMS treatment 15 times for 15 days;Take paroxetine for 2 weeks |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- （1） First-time ischemic stroke with clinical and MRI or CT findings of basal ganglia stroke (ICD-10-CM code 293.83[F06.32]) (3) Right-handedness (4)Clear consciousness (5)Aged 25-75 years with a recent (less than 24 months) ischemic stroke;
Key exclusion criteria (3 listed)
- Aphasia or severe cognitive impairment, severe hearing impairment;
- Contraindications of MRI scan and rTMS treatment such as pacemaker implantation; (3)Depression caused by psychoactive substances and non addictive substances;（4）Prior history of depressive disorders or major trauma within 1 year, severe depression or any other severe mental disorders;
- （5）Pregnant or breast-feeding women; （6）Refusal to sign informed consent of this study
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 |
|---|---|---|
| "personalized" rTMS+drug treatmentAlso: P rTMSHigh frequency（10HZ）stimulation of brain regions corresponding to lesion, low-frequency （1HZ）stimulation of the contralateral brain, intensity=90%MT（motor thresholds). Each sequence is 20 times, duration is 10 seconds, each sequence spaced 60s, 20 sequences per day, 1 times a day ,total times is 15. Taking paroxetine 2 weeks, Take 20 mg a day. | Device | "personalized" rTMS+drug treatment |
| Traditional rTMS +drug treatmentAlso: T rTMSTraditional rTMS treatment protocol parameters: localization of left DLPFC: frequency=10 Hz; localization of right DLPFC: frequency=1 Hz, intensity=90%MT, Each sequence is 20 times, duration is 10 seconds, each sequence spaced 60s, 20 sequences per day,1 times a day,total times is 15. Taking paroxetine 2 weeks, Take 20 mg a day. | Device | Traditional rTMS +drug treatment |
Primary outcome
response rate
Time frame: Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment
Compare the HAMD-24 scores from baseline to the end of the treatment.the response to treatment is defined as at least a 30% reduction of the HAMD-24 total score with a final HAMD-24 score. The score decreased by more than 50% for the treatment of good results.The response rate is defined as the percentage of number of response.
2 secondary outcomes
Neuropsychological tests results of SAS
Time frame: Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment
Neuropsychological tests results of ADLs
Time frame: Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Background: PubMed 25269762Broomfield NM, Quinn TJ, Abdul-Rahim AH, Walters MR, Evans JJ. Depression and anxiety symptoms post-stroke/TIA: prevalence and associations in cross-sectional data from a regional stroke registry. BMC Neurol. 2014 Oct 1;14:198. doi: 10.1186/s12883-014-0198-8.
- Background: PubMed 26398527Concerto C, Lanza G, Cantone M, Ferri R, Pennisi G, Bella R, Aguglia E. Repetitive transcranial magnetic stimulation in patients with drug-resistant major depression: A six-month clinical follow-up study. Int J Psychiatry Clin Pract. 2015;19(4):252-8. doi: 10.3109/13651501.2015.1084329. Epub 2015 Sep 23.
- Background: PubMed 23329161Damasio A, Carvalho GB. The nature of feelings: evolutionary and neurobiological origins. Nat Rev Neurosci. 2013 Feb;14(2):143-52. doi: 10.1038/nrn3403.
- Background: PubMed 24713406De Ryck A, Brouns R, Geurden M, Elseviers M, De Deyn PP, Engelborghs S. Risk factors for poststroke depression: identification of inconsistencies based on a systematic review. J Geriatr Psychiatry Neurol. 2014 Sep;27(3):147-58. doi: 10.1177/0891988714527514. Epub 2014 Apr 7.
- Background: PubMed 25451004De Ryck A, Fransen E, Brouns R, Geurden M, Peij D, Marien P, De Deyn PP, Engelborghs S. Poststroke depression and its multifactorial nature: results from a prospective longitudinal study. J Neurol Sci. 2014 Dec 15;347(1-2):159-66. doi: 10.1016/j.jns.2014.09.038. Epub 2014 Oct 2.
- Background: PubMed 24670433Dwyer Hollender K. Screening, diagnosis, and treatment of post-stroke depression. J Neurosci Nurs. 2014 Jun;46(3):135-41. doi: 10.1097/JNN.0000000000000047.
- Background: PubMed 25655394Eriksen S, Gay CL, Lerdal A. Acute phase factors associated with the course of depression during the first 18 months after first-ever stroke. Disabil Rehabil. 2016;38(1):30-5. doi: 10.3109/09638288.2015.1009181. Epub 2015 Feb 6.
- Background: PubMed 26219630Jastorff J, Huang YA, Giese MA, Vandenbulcke M. Common neural correlates of emotion perception in humans. Hum Brain Mapp. 2015 Oct;36(10):4184-201. doi: 10.1002/hbm.22910. Epub 2015 Jul 28.
- Background: PubMed 24878979Li W, Ling S, Yang Y, Hu Z, Davies H, Fang M. Systematic hypothesis for post-stroke depression caused inflammation and neurotransmission and resultant on possible treatments. Neuro Endocrinol Lett. 2014;35(2):104-9.
- Background: PubMed 14627768Narushima K, Kosier JT, Robinson RG. A reappraisal of poststroke depression, intra- and inter-hemispheric lesion location using meta-analysis. J Neuropsychiatry Clin Neurosci. 2003 Fall;15(4):422-30. doi: 10.1176/jnp.15.4.422.
- Background: PubMed 26453680Riccelli R, Passamonti L, Cerasa A, Nigro S, Cavalli SM, Chiriaco C, Valentino P, Nistico R, Quattrone A. Individual differences in depression are associated with abnormal function of the limbic system in multiple sclerosis patients. Mult Scler. 2016 Jul;22(8):1094-105. doi: 10.1177/1352458515606987. Epub 2015 Oct 9.
- Background: PubMed 3766786Robinson RG, Lipsey JR, Rao K, Price TR. Two-year longitudinal study of post-stroke mood disorders: comparison of acute-onset with delayed-onset depression. Am J Psychiatry. 1986 Oct;143(10):1238-44. doi: 10.1176/ajp.143.10.1238.
- 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.
Wen Wu, M.D. study chair
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "personalized" rTMS+drug treatment and Traditional rTMS +drug 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 1 inclusion and 3 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 19 Mar 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. 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 Wen Wu, M.D (+86-020-62783189, wuwen66@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment). 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 NCT03256305, which also lists 18 linked publications.
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 19 Mar 2018.