Efficacy and Safety Study of rTMS for Upper Extremity Motor Function Recovery in Ischemic Stroke Patients (TAMAS)

September 7, 2020 updated by: Nam-Jong Paik, Seoul National University Bundang Hospital

A Randomized, Double-Blind, Sham-Controlled, Multi-center Clinical Trial to Evaluate Efficacy and Safety of rTMS 『TMS』 for Upper Extremity Motor Function Recovery in Patients With Ischemic Stroke

The purpose of this study is to Evaluate Efficacy and Safety of rTMS 『TMS』 for Upper Extremity Motor Function Recovery in Patients with Ischemic Stroke

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Repetitive transcranial magnetic stimulation (rTMS) can modulate the excitability of cortex but exact efficacy and safety of rTMS is not well established.

Eighty four patients will be recruited and will be divided into two groups. Each group will receive the real rTMS or sham rTMS, respectively, over the primary motor cortex of the dominant hand. Individual subject will receive ten sessions of rTMS. Each rTMS session is low frequency (1Hz), total 1800 stimulations.

The purpose of this study is to evaluate efficacy and safety of rTMS 『TMS』 for upper extremity motor function recovery in patients with ischemic stroke.

Study Type

Interventional

Enrollment (Actual)

77

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 Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-773
        • Dongguk University Ilsan Hospital
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 20-80 yrs old
  • Radiologically confirmed ischemic stroke within 90 days
  • Brunnström stage 3-5 in the affected hand (ischemic stroke-induced hemiplegic side)
  • Patients received stroke treatment and on secondary prevention medication
  • Written informed consent

Exclusion Criteria:

  • Previous medical histories of stroke, cerebral vascular operation, seizure
  • Pregnancy, Breastfeeding
  • Patients with hemorrhagic stroke, traumatic brain injury
  • Skin lesion in the stimulation site of scalp
  • Metal implants in the body (cardiac pacemaker or aneurysm clip)
  • Unable to have regular physical and occupational therapies on the affected hand

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: true coil
Use the true coil / Low frequency rTMS / Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: tangential to scalp
Device: Low frequency rTMS
Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: tangential to scalp
Other Names:
  • TMS
Sham Comparator: sham coil
Use the sham coil / Low frequency rTMS / Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: vertical to scalp
Device: Low frequency rTMS
Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: tangential to scalp
Other Names:
  • TMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Box and Block Test (affected hand)
Time Frame: up to 17 days
Before rTMS (baseline) and 10 days after the completion of 10 sessions of rTMS
up to 17 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Box and Block Test (Affected and unaffected hand)
Time Frame: up to 40 days
Before rTMS (baseline), 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
up to 40 days
Barthel Index
Time Frame: up to 40 days
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
up to 40 days
National Institutes of Health Stroke Scale
Time Frame: up to 40 days
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
up to 40 days
Fugl-Meyer Assessment Scale
Time Frame: up to 40 days
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
up to 40 days
Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck)
Time Frame: up to 40 days
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
up to 40 days
Finger tapping
Time Frame: up to 40 days
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
up to 40 days
B-stage (hand and arm)
Time Frame: up to 40 days
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
up to 40 days
Modified Ashworth scale (wrist flexor and extensor, Elbow flexor and extensor, Long finger flexor spasticity)
Time Frame: up to 40 days
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
up to 40 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital Sign
Time Frame: up to 40 days
Before rTMS (baseline), 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
up to 40 days

Collaborators and Investigators

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

Sponsor

Seoul National University Bundang Hospital

Collaborators

Seoul National University Hospital
DongGuk University
REMED

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 (Actual)

April 1, 2014

Primary Completion (Actual)

January 23, 2018

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

March 6, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimate)

March 7, 2014

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 7, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-1308-214-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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