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

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ClinicalTrials.gov Identifier: NCT02082015
Recruitment Status : Active, not recruiting
First Posted : March 7, 2014
Last Update Posted : January 26, 2018
Sponsor:
Collaborators:
DongGuk University
Seoul National University Hospital
REMED CO., Ltd.
Information provided by (Responsible Party):
Nam-Jong Paik, Seoul National University Bundang Hospital

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Stroke Hemiplegia Device: Low frequency rTMS Not Applicable

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  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 2014
Actual Primary Completion Date : January 23, 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: TMS



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Barthel Index [ Time Frame: up to 40 days ]
    10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start

  3. 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

  4. 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

  5. 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

  6. Finger tapping [ Time Frame: up to 40 days ]
    10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start

  7. 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

  8. 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


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082015


Locations
Korea, Republic of
DongGuk University Ilsan Hospital
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-773
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Bundang Hospital
DongGuk University
Seoul National University Hospital
REMED CO., Ltd.
Investigators
Principal Investigator: Nam-Jong Paik, MD, PhD Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea

Responsible Party: Nam-Jong Paik, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02082015     History of Changes
Other Study ID Numbers: E-1308-214-002
First Posted: March 7, 2014    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Nam-Jong Paik, Seoul National University Bundang Hospital:
Neuronal plasticity
Transcranial magnetic stimulation
Stroke
Upper extremity
Function
Recovery

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