CompletedNCT02006875Updated Dec 11, 2015

rTMS Study to Improve Functional Performance for Patients With Stroke

A Phase 3 interventional study of rTMS in Stroke, sponsored by Taipei Medical University WanFang Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-12-11.

Sponsored by Taipei Medical University WanFang Hospital · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Read the detailed description

Protocol:

Setting: inpatient rehabilitation department of Shuang-Ho Hospital.
Study population: Patients received inpatient treatment or rehabilitation for stroke in Shuang-Ho Hospital (SHH).
Eligibility. Screening for eligibility was done by the 2 physiatrists from rehabilitation department of SHH.
Study design: controlled trial with stratified randomization
Blinding
1. The patients were blinded by the real or sham coil of rTMS
2. The assessors who performed the outcome measurements were blinded to the assignment of treatment.
Measurements.
1. Baseline demographic records. The stroke severity was measured by National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (MRS), Brunnstrum stage, and Manual muscle test (MMT) before intervention.
2. Clinical assessments.
  - Postural control was assessed by Postural Assessment Scale for Stroke Patients (PASS)
  - The motor recovery of lower extremities was assessed by the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE)
  - The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g)
  - Timed Up and Go (TUG) test was used to assess the gross mobility.
  - Barthel Index (BI) for the ADL independence
  - modified Rankin Scale (MRS) for disability classification were also collected.
3. These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements.
Compliance and side effect. The compliance of interventions were investigated. The attendance of treatments (including rTMS sessions and physical therapy sessions) and possible side effect/discomfort were recorded during the interventions by a researcher. He also tries to understand the reason of drop-out from the study.

Conditions studied

Stroke

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Stroke 7,286

Keywords

repetitive transcranial magnetic stimulation
postural
balance
mobility
leg
stroke

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 60 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Taipei Medical University WanFang Hospital is the lead sponsor of 196 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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,

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 60 participants (actual)

Study arms

Experimental
real rTMS
Experimental included the a daily real rTMS session for 15 mins followed by a physical therapy for 45 mins.
Device: rTMS
Sham comparator
sham rTMS
the control interventions included a daily sham rTMS session for 15 minutes followed by a physical therapy for 45 minutes.
Device: rTMS

Interventions

DevicerTMS
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

What researchers measure

Primary outcomes

Timed Up and Go (TUG)
Time frame: Up to 3 months after interventions completed

Secondary outcomes

the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE)
Time frame: up to 3 months after the intervention completed
The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g)
Time frame: up to 3 months after the interventions completed
Barthel Index (BI)
Time frame: Up to 3 months after interventions completed
Postural control was assessed by Postural Assessment Scale for Stroke (PASS)
PASS which examines the patient's ability to maintain or change a given posture and is applicable to patients with very poor postural performance. This instrument has been reported to have a good validity and reliability at different recovery stages after stroke, minimal floor and ceiling effect, and be sensitive to changes in severe stroke patients at early stage after stroke.
Time frame: up to 3 months after the intervention completed
modified Rankin Scale (MRS)
Time frame: Up to 3 months after interventions completed

Study locations

1 site

Shuang Ho Hospital
New Taipei City, Taiwan

References and documents

Publications

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. PubMed 25679340 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 11, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02006875
Lead sponsor: Taipei Medical University WanFang Hospital
Responsible party: Yen-Nung Lin (Medical doctor of Department of Physical Medicine & Rehabilitation, Taipei Medical University WanFang Hospital) — Principal investigator
First posted: Dec 10, 2013
Start date: Jan 2013
Primary completion: Dec 2015
Completion: Dec 2015
Last update: Dec 11, 2015

Study contacts

Yen-Nung Lin, MD, MS

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

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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