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

This study has been terminated.
(Only two subjects have been recruited from start of the study. We decided to start the study in this topic, after revising the study protocol.)
Sponsor:
Collaborators:
Asan Medical Center
Gyeongsang National University Hospital
Hanyang University
Seoul National University Boramae Hospital
Information provided by (Responsible Party):
Nam-Jong Paik, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01311271
First received: March 4, 2011
Last updated: March 12, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Stroke
Hemiplegia
Device: repetitive transcranial magnetic stimulation (rTMS)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation on the Recovery of Upper Motor Function After Stroke: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: TAMAS

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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311271

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Asan Medical Center
Gyeongsang National University Hospital
Hanyang University
Seoul National University Boramae Hospital
Investigators
Principal Investigator: Nam-Jong Paik, MD, PhD Seoul National University Bundang Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Nam-Jong Paik, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01311271     History of Changes
Other Study ID Numbers: E-1011-056-003
Study First Received: March 4, 2011
Last Updated: March 12, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Bundang Hospital:
Stroke
Cerebrovascular disease
hemiplegia
Transcranial magnetic stimulation
repetitive transcranial magnetic stimulation
rTMS
rehabilitation
Upper Extremity

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Hemiplegia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014