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

March 15, 2018 updated by: Zhujiang Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Zhujiang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

（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;

Exclusion Criteria

  1. Aphasia or severe cognitive impairment, severe hearing impairment;
  2. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: "personalized" rTMS+drug treatment
Received "personalized" rTMS treatment 15 times for 15 days;Take paroxetine for 2 weeks
Device: "personalized" rTMS+drug treatment
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.
Other Names:
  • P rTMS
Active Comparator: Traditional rTMS +drug treatment
Received traditional rTMS treatment 15 times for 15 days;Take paroxetine for 2 weeks
Device: Traditional rTMS +drug treatment
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.
Other Names:
  • T rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychological tests results of SAS
Time Frame: Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment
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.
Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment
Neuropsychological tests results of ADLs
Time Frame: Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment
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.
Before treatment.1week, 2weeks, 4weeks, 8weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Investigators

  • Study Chair: Wen Wu, M.D., Zhujiang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

July 18, 2017

First Submitted That Met QC Criteria

August 16, 2017

First Posted (Actual)

August 22, 2017

Study Record Updates

Last Update Posted (Actual)

March 19, 2018

Last Update Submitted That Met QC Criteria

March 15, 2018

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-KFYXK-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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