A Study of rTMS Personalized Precision Treatment of Post-stroke Depression

NCT03256305 | Unknown

• 1 other identifier: 2017-KFYXK-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Post-stroke Depression

Keywords

Repetitive transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment

Secondary Outcomes (2)

• Neuropsychological tests results of SAS

  Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment

• Neuropsychological tests results of ADLs

  Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment

Study Arms (2)

"personalized" rTMS+drug treatment

EXPERIMENTAL

Received "personalized" rTMS treatment 15 times for 15 days;Take paroxetine for 2 weeks

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

Device: Traditional rTMS +drug treatment

Interventions

"personalized" rTMS+drug treatment DEVICE

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.

Also known as: P rTMS

"personalized" rTMS+drug treatment

Traditional rTMS +drug treatment DEVICE

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.

Also known as: T rTMS

Traditional rTMS +drug treatment

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• （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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (18)

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• Zhang X, Shi Y, Fan T, Wang K, Zhan H, Wu W. Analysis of Correlation Between White Matter Changes and Functional Responses in Post-stroke Depression. Front Aging Neurosci. 2021 Oct 11;13:728622. doi: 10.3389/fnagi.2021.728622. eCollection 2021.

  PMID: 34707489 DERIVED

Study Officials

• Wen Wu, M.D.

  Zhujiang Hospital

  STUDY CHAIR

Central Study Contacts

Wen Wu, M.D

CONTACT

+86-020-62783189; wuwen66@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Care Provider, Investigator, Outcomes Assessor

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: August 22, 2017
• Study Start: December 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2021
• Last Updated: March 19, 2018

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)