NCT03529305

Brief Summary

In this study, the investigators aim to evaluate functional and structural improvements in the brain of stroke patients after rTMS treatment using multi-modal MRI techniques. Specifically, the investigators sought to determine whether rTMS treatment modulate the brain function and structure in patients and, if so, whether different frequency of the rTMS treatment will affect the degree of the motor recovery in patients' brain. The patients will be randomized into three groups: Experimental group 1 (TMS group) received low frequency rTMS; Experimental group 2 (TMS group) received high frequency rTMS; The third group who received only physical therapy constituted the control group. All patients undergo MRI scan one day before and after rTMS treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

April 19, 2018

Last Update Submit

August 5, 2019

Conditions

Stroke

Keywords

StrokerTMSMRI

Outcome Measures

Primary Outcomes (3)

  • Brain functional changes after rTMS treatment

    Brain functional changes in patients' brain measured by fMRI

    One day before and after two weeks' treatment

  • Brain morphological changes after rTMS treatment

    Gray matter morphological changes in patients' brain measured by high resolution T1-weighted MRI

    One day before and after two weeks' treatment

  • Brain structural changes after rTMS treatment

    White matter anatomical changes in patients' brain measured by DTI

    One day before and after two weeks' treatment

Study Arms (3)

Low frequency rTMS

EXPERIMENTAL

Patients receive low frequency rTMS treatment and physical therapy. rTMS is applied over primary motor (M1) cortex of the unaffected side for two weeks, 5 consecutive days each week.

Device: rTMSOther: Physical therapy

High frequency rTMS

EXPERIMENTAL

Patients receive high frequency rTMS treatment and physical therapy. rTMS is applied over primary motor (M1) cortex of the affected side for two weeks, 5 consecutive days each week.

Device: rTMSOther: Physical therapy

Physical therapy

ACTIVE COMPARATOR

Patients receive physical therapy for two weeks.

Other: Physical therapy

Interventions

rTMSDEVICE

Receive rTMS treatment to the primary motor cortex (M1)

High frequency rTMSLow frequency rTMS
Physical therapyOTHER

Receive physical therapy

High frequency rTMSLow frequency rTMSPhysical therapy

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First-ever ischemic stroke
  • One to six months after stroke onset;
  • Mini Mental State Examination (MMSE) score \> 24;
  • Brunnstrom recovery stage (BRS) for hand fingers of 3-5
  • Motor deficits of the unilateral upper limb

You may not qualify if:

  • Patients with hemorrhage, leukoaraiosis, epilepsy, migraine or psychiatric diseases history are excluded in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Affiliated Hospital of Nanjing University of Chinese Medicine

Nanjing, Jiangsu, 210000, China

RECRUITING

Hangzhou Normal University

Hangzhou, Zhejiang, 311121, China

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Yu-Feng Zang, MD

    Hangzhou Normal University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yating Lv, PhD

CONTACT

+86-13396508848lvyating198247@gmail.com

Lingyu Li, Bachelor

CONTACT

+86-15990149749llyxl621@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Investigator

Study Record Dates

First Submitted

April 19, 2018

First Posted

May 18, 2018

Study Start

January 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations

CN(2)