NCT02006875

Brief Summary

To use repetitive transcranial magnetic stimulation (rTMS) to treat stroke patients is getting a popular idea. Previous studies seemed to support its effects on facilitating motor recovery after stroke. This study focuses on the motor recovery of lower extremities. Investigators conducted the study to evaluate the treatment effect of rTMS on the functional performance of lower extremities in terms of postural control, balance, and mobility in stroke patients. Investigators hypothesized that these performances could be improved through the better motor control of lower extremities caused by rTMS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3 stroke

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 11, 2015

Status Verified

December 1, 2015

Enrollment Period

2.9 years

First QC Date

December 4, 2013

Last Update Submit

December 10, 2015

Conditions

Stroke

Keywords

repetitive transcranial magnetic stimulationposturalbalancemobilitylegstroke

Outcome Measures

Primary Outcomes (1)

  • Timed Up and Go (TUG)

    Up to 3 months after interventions completed

Secondary Outcomes (5)

  • the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE)

    up to 3 months after the intervention completed

  • The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g)

    up to 3 months after the interventions completed

  • Barthel Index (BI)

    Up to 3 months after interventions completed

  • Postural control was assessed by Postural Assessment Scale for Stroke (PASS)

    up to 3 months after the intervention completed

  • modified Rankin Scale (MRS)

    Up to 3 months after interventions completed

Study Arms (2)

real rTMS

EXPERIMENTAL

Experimental included the a daily real rTMS session for 15 mins followed by a physical therapy for 45 mins.

Device: rTMS

sham rTMS

SHAM COMPARATOR

the control interventions included a daily sham rTMS session for 15 minutes followed by a physical therapy for 45 minutes.

Device: rTMS

Interventions

rTMSDEVICE

Interventions started on the next weekday after pretest and were performed once a day for 15 consecutive weekdays. Participants in the E and C groups received rTMS (either real or sham, 1 Hz, 15 minutes), followed by a session of physical therapy for 45 minutes.

Also known as: Magstim Rapid2
real rTMSsham rTMS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral hemiplegia caused by the stroke,
  • first ever stroke,
  • time since stroke: 10-90 days,
  • age: 18-80 y/o,
  • Functional ambulation classification (FAC): 0-2,

You may not qualify if:

  • contraindication to TMS (eg, pacemaker, seizure history, pregnancy),
  • cranial metal implants
  • intracranial hemorrhage associated with tumor or arteriovenous malformation, craniotomy
  • able to complete Timed Up and Go (TUG) test within 2 minutes
  • unable to walk normally before the stroke
  • those whose motor evoked potentials (MEP) of M1-UH were absent in the pretest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shuang Ho Hospital

New Taipei City, Taiwan

Location

Related Publications (1)

  • Lin YN, Hu CJ, Chi JY, Lin LF, Yen TH, Lin YK, Liou TH. Effects of repetitive transcranial magnetic stimulation of the unaffected hemisphere leg motor area in patients with subacute stroke and substantial leg impairment: A pilot study. J Rehabil Med. 2015 Apr;47(4):305-10. doi: 10.2340/16501977-1943.

    PMID: 25679340DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yen-Nung Lin, MD, MS

    Department of Physical Medicine and Rehabilitation, Wan Fang Hospital, Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor of Department of Physical Medicine & Rehabilitation

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 10, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 11, 2015

Record last verified: 2015-12

Locations

TW(1)