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

Primary Purpose

Stroke, Hemiplegia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Low frequency rTMS
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Neuronal plasticity, Transcranial magnetic stimulation, Stroke, Upper extremity, Function, Recovery

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DongGuk University Ilsan Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

true coil

sham coil

Arm Description

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

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

Outcomes

Primary Outcome Measures

Box and Block Test (affected hand)
Before rTMS (baseline) and 10 days after the completion of 10 sessions of rTMS

Secondary Outcome Measures

Box and Block Test (Affected and unaffected hand)
Before rTMS (baseline), 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Barthel Index
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
National Institutes of Health Stroke Scale
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Fugl-Meyer Assessment Scale
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)
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Finger tapping
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
B-stage (hand and arm)
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)
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start

Full Information

First Posted
March 6, 2014
Last Updated
September 7, 2020
Sponsor
Seoul National University Bundang Hospital
Collaborators
DongGuk University, Seoul National University Hospital, REMED
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1. Study Identification

Unique Protocol Identification Number
NCT02082015
Brief Title
Efficacy and Safety Study of rTMS for Upper Extremity Motor Function Recovery in Ischemic Stroke Patients
Acronym
TAMAS
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
January 23, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
DongGuk University, Seoul National University Hospital, REMED

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegia
Keywords
Neuronal plasticity, Transcranial magnetic stimulation, Stroke, Upper extremity, Function, Recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
true coil
Arm Type
Experimental
Arm Description
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
Arm Title
sham coil
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Low frequency rTMS
Other Intervention Name(s)
TMS
Intervention Description
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
Primary Outcome Measure Information:
Title
Box and Block Test (affected hand)
Description
Before rTMS (baseline) and 10 days after the completion of 10 sessions of rTMS
Time Frame
up to 17 days
Secondary Outcome Measure Information:
Title
Box and Block Test (Affected and unaffected hand)
Description
Before rTMS (baseline), 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Time Frame
up to 40 days
Title
Barthel Index
Description
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Time Frame
up to 40 days
Title
National Institutes of Health Stroke Scale
Description
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Time Frame
up to 40 days
Title
Fugl-Meyer Assessment Scale
Description
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Time Frame
up to 40 days
Title
Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck)
Description
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Time Frame
up to 40 days
Title
Finger tapping
Description
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Time Frame
up to 40 days
Title
B-stage (hand and arm)
Description
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Time Frame
up to 40 days
Title
Modified Ashworth scale (wrist flexor and extensor, Elbow flexor and extensor, Long finger flexor spasticity)
Description
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Time Frame
up to 40 days
Other Pre-specified Outcome Measures:
Title
Vital Sign
Description
Before rTMS (baseline), 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Time Frame
up to 40 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nam-Jong Paik, MD, PhD
Organizational Affiliation
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
DongGuk University Ilsan Hospital
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-773
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32807013
Citation
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.
Results Reference
derived

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

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