NCT01311271

Brief Summary

The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_2 stroke

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

1.1 years

First QC Date

March 4, 2011

Last Update Submit

May 18, 2015

Conditions

StrokeHemiplegia

Keywords

StrokeCerebrovascular diseasehemiplegiaTranscranial magnetic stimulationrepetitive transcranial magnetic stimulationrTMSrehabilitationUpper Extremity

Outcome Measures

Primary Outcomes (1)

  • Change in the Fugl-Meyer Assessment scale (upper extremity)

    Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up

Secondary Outcomes (1)

  • Change in grip strength, lateral pinch force, tip pinch force, Purdue pegboard test, K-MBI, mRS,and brunnström stage

    Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up

Study Arms (3)

Sham rTMS-Sham rTMS

SHAM COMPARATOR

Sham rTMS for 2 weeks

Device: repetitive transcranial magnetic stimulation (rTMS)

Sham rTMS-Real rTMS

EXPERIMENTAL

Sham rTMS in the first week and real rTMS in the second week

Device: repetitive transcranial magnetic stimulation (rTMS)

Real rTMS-Real rTMS

EXPERIMENTAL

Real rTMS for 2 weeks

Device: repetitive transcranial magnetic stimulation (rTMS)

Interventions

repetitive transcranial magnetic stimulation (rTMS)DEVICE

1 Hz frequency, 15 minutes, intensity of 90% resting motor threshold, with one session a day, * Real: unaffected M1 hotspot * Sham: coil perpendicular to scalp

Also known as: TAMAS
Real rTMS-Real rTMSSham rTMS-Real rTMSSham rTMS-Sham rTMS

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • single mono-hemispheric ischemic or hemorrhagic stroke
  • st onset stroke patient
  • Upper extremity functional deficit attributable to acute stroke
  • A stage of at least 3 on brunnström pre-treatment
  • Written signed consent

You may not qualify if:

  • Multiple lesion
  • Bilateral cortical lesion and motor problems
  • Cerebellar, or brainstem lesions
  • History of more than one stroke
  • Uncontrolled medical problems, such as: cardiopulmonary disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer, or renal disease;
  • Increased intracranial pressure
  • History of seizure confirmed by interview and medical chart review
  • Any individual who is on medication which is known to lower seizure threshold
  • Other conditions that increase the risk of side effects due to rTMS procedures: a metal plate or metal object in the skull or eye, intracardiac line, increased intracranial pressure, cardiac pacemaker, implanted medication pump, tricyclic antidepressants, neuroleptics, history of seizure in the immediate family
  • An age of less than 20 years old
  • Any current actively treated medical or surgical condition or neurological or psychiatric illness other than stroke
  • Complications that would prevent participation in the intervention, such as severe pain and severe spasticity
  • Inability to cooperate outcome measure-related task
  • Severe language disturbances
  • Serious cognitive deficits
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

MeSH Terms

Conditions

StrokeHemiplegiaCerebrovascular Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Nam-Jong Paik, MD, PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 4, 2011

First Posted

March 9, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2012

Last Updated

May 19, 2015

Record last verified: 2015-05

Locations

KR(1)