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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 : Completed
First Posted : March 7, 2014
Last Update Posted : September 9, 2020
Sponsor:
Collaborators:
DongGuk University
Seoul National University Hospital
REMED
Information provided by (Responsible Party):
Nam-Jong Paik, Seoul National University Bundang Hospital

Tracking Information
First Submitted Date  ICMJE March 6, 2014
First Posted Date  ICMJE March 7, 2014
Last Update Posted Date September 9, 2020
Actual Study Start Date  ICMJE April 2014
Actual Primary Completion Date January 23, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2017)
  • 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
  • Barthel Index [ Time Frame: up to 40 days ]
    10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
  • 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
  • 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
  • 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
  • Finger tapping [ Time Frame: up to 40 days ]
    10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2014)
  • 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
  • Barthel Index [ Time Frame: up to 40 days ]
    10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
  • 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
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: March 6, 2014)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of rTMS for Upper Extremity Motor Function Recovery in Ischemic Stroke Patients
Official Title  ICMJE 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
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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Hemiplegia
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Device: Low frequency rTMS
  • 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
    Intervention: Device: Low frequency rTMS
Publications * Kim WS, Kwon BS, Seo HG, Park J, Paik NJ. Low-Frequency Repetitive Transcranial Magnetic Stimulation Over Contralesional Motor Cortex for Motor Recovery in Subacute Ischemic Stroke: A Randomized Sham-Controlled Trial. Neurorehabil Neural Repair. 2020 Sep;34(9):856-867. doi: 10.1177/1545968320948610. Epub 2020 Aug 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2019)
77
Original Estimated Enrollment  ICMJE
 (submitted: March 6, 2014)
84
Actual Study Completion Date  ICMJE February 28, 2018
Actual Primary Completion Date January 23, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02082015
Other Study ID Numbers  ICMJE E-1308-214-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nam-Jong Paik, Seoul National University Bundang Hospital
Study Sponsor  ICMJE Seoul National University Bundang Hospital
Collaborators  ICMJE
  • DongGuk University
  • Seoul National University Hospital
  • REMED
Investigators  ICMJE
Principal Investigator: Nam-Jong Paik, MD, PhD Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
PRS Account Seoul National University Bundang Hospital
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP