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

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02082015
Collaborator
DongGuk University (Other), Seoul National University Hospital (Other), REMED (Other)
77
Enrollment
3
Locations
2
Arms
46.9
Actual Duration (Months)
25.7
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Low frequency rTMS
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
77 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 :
Apr 1, 2014
Actual Primary Completion Date :
Jan 23, 2018
Actual Study Completion Date :
Feb 28, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Box and Block Test (affected hand) [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) [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 [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 [up to 40 days]

      10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start

    4. Fugl-Meyer Assessment Scale [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) [up to 40 days]

      10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start

    6. Finger tapping [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) [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) [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 [up to 40 days]

      Before rTMS (baseline), 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 DongGuk University Ilsan Hospital Goyang-si Gyeonggi-do Korea, Republic of 410-773
    2 Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Korea, Republic of 463-707
    3 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

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nam-Jong Paik, Professor, Seoul National University Bundang Hospital
    ClinicalTrials.gov Identifier:
    NCT02082015
    Other Study ID Numbers:
    • E-1308-214-002
    First Posted:
    Mar 7, 2014
    Last Update Posted:
    Sep 9, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Nam-Jong Paik, Professor, Seoul National University Bundang Hospital
    Neuronal plasticity
    Transcranial magnetic stimulation
    Stroke
    Upper extremity
    Function
    Recovery
    Additional relevant MeSH terms:
    Stroke
    Ischemic Stroke
    Hemiplegia

    Study Results

    No Results Posted as of Sep 9, 2020