NCT02082015

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
25 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

3.8 years

First QC Date

March 6, 2014

Last Update Submit

September 7, 2020

Conditions

StrokeHemiplegia

Keywords

Neuronal plasticityTranscranial magnetic stimulationStrokeUpper extremityFunctionRecovery

Outcome Measures

Primary Outcomes (1)

  • Box and Block Test (affected hand)

    Before rTMS (baseline) and 10 days after the completion of 10 sessions of rTMS

    up to 17 days

Secondary Outcomes (8)

  • Box and Block Test (Affected and unaffected hand)

    up to 40 days

  • Barthel Index

    up to 40 days

  • National Institutes of Health Stroke Scale

    up to 40 days

  • Fugl-Meyer Assessment Scale

    up to 40 days

  • Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck)

    up to 40 days

  • +3 more secondary outcomes

Other Outcomes (1)

  • Vital Sign

    up to 40 days

Study Arms (2)

true coil

EXPERIMENTAL

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

sham coil

SHAM COMPARATOR

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

Interventions

Low frequency rTMSDEVICE

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

Also known as: TMS
sham coiltrue coil

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

DongGuk University Ilsan Hospital

Goyang-si, Gyeonggi-do, 410-773, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 32807013DERIVED

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nam-Jong Paik, MD, PhD

    Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 6, 2014

First Posted

March 7, 2014

Study Start

April 1, 2014

Primary Completion

January 23, 2018

Study Completion

February 28, 2018

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

KR(3)