Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation(rTMS) on the Recovery After Stroke

May 18, 2015 updated by: Nam-Jong Paik, Seoul National University Bundang Hospital

Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation on the Recovery of Upper Motor Function After Stroke: a Randomized Controlled Trial

The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Repetitive transcranial magnetic stimulation (rTMS) can modulate excitability of the brain via non-invasive methods. In that sense, rTMS has been used to treat a variety of symptoms of stroke during last two decades. Especially, improvement of upper extremity function has been proved by many studies. However, it remains uncertain about the optimum amount of rTMS.

The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients.

Fifty-seven patients will be included with written consent. After randomization, the subject will receive 3 different amount of treatment rTMS-rTMS, Sham-rTMS, Sham-Sham) in double blind methods.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2
  • Phase 3

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
    • Gyeonggi-do
      • Seongnam, 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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • single mono-hemispheric ischemic or hemorrhagic stroke
  • 1st onset stroke patient
  • Upper extremity functional deficit attributable to acute stroke
  • A stage of at least 3 on brunnström pre-treatment
  • Written signed consent

Exclusion Criteria:

  • Multiple lesion
  • Bilateral cortical lesion and motor problems
  • Cerebellar, or brainstem lesions
  • History of more than one stroke
  • Uncontrolled medical problems, such as: cardiopulmonary disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer, or renal disease;
  • Increased intracranial pressure
  • History of seizure confirmed by interview and medical chart review
  • Any individual who is on medication which is known to lower seizure threshold
  • Other conditions that increase the risk of side effects due to rTMS procedures: a metal plate or metal object in the skull or eye, intracardiac line, increased intracranial pressure, cardiac pacemaker, implanted medication pump, tricyclic antidepressants, neuroleptics, history of seizure in the immediate family
  • An age of less than 20 years old
  • Any current actively treated medical or surgical condition or neurological or psychiatric illness other than stroke
  • Complications that would prevent participation in the intervention, such as severe pain and severe spasticity
  • Inability to cooperate outcome measure-related task
  • Severe language disturbances
  • Serious cognitive deficits
  • Non-vascular cause for the neurological symptoms other central nervous system
  • Disorder or peripheral neuropathy of the upper extremity
  • Taking medication which interrupt brain activity
  • Women who are pregnant

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham rTMS-Sham rTMS
Sham rTMS for 2 weeks
Device: repetitive transcranial magnetic stimulation (rTMS)

1 Hz frequency, 15 minutes, intensity of 90% resting motor threshold, with one session a day,

  • Real: unaffected M1 hotspot
  • Sham: coil perpendicular to scalp
Other Names:
  • TAMAS
Experimental: Sham rTMS-Real rTMS
Sham rTMS in the first week and real rTMS in the second week
Device: repetitive transcranial magnetic stimulation (rTMS)

1 Hz frequency, 15 minutes, intensity of 90% resting motor threshold, with one session a day,

  • Real: unaffected M1 hotspot
  • Sham: coil perpendicular to scalp
Other Names:
  • TAMAS
Experimental: Real rTMS-Real rTMS
Real rTMS for 2 weeks
Device: repetitive transcranial magnetic stimulation (rTMS)

1 Hz frequency, 15 minutes, intensity of 90% resting motor threshold, with one session a day,

  • Real: unaffected M1 hotspot
  • Sham: coil perpendicular to scalp
Other Names:
  • TAMAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the Fugl-Meyer Assessment scale (upper extremity)
Time Frame: Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up
Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in grip strength, lateral pinch force, tip pinch force, Purdue pegboard test, K-MBI, mRS,and brunnström stage
Time Frame: Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up
Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up

Collaborators and Investigators

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

Sponsor

Seoul National University Bundang Hospital

Collaborators

Asan Medical Center
Gyeongsang National University Hospital
Hanyang University
Seoul National University Boramae Hospital

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

January 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

March 4, 2011

First Submitted That Met QC Criteria

March 6, 2011

First Posted (Estimate)

March 9, 2011

Study Record Updates

Last Update Posted (Estimate)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-1011-056-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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