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Completed

NCT Number: NCT02006875

rTMS Study to Improve Functional Performance for Patients With Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shuang Ho Hospital

New Taipei City, Taiwan

About this study

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
  • The patients were blinded by the real or sham coil of rTMS
  • The assessors who performed the outcome measurements were blinded to the assignment of treatment.
  • Measurements.
  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

rTMS

Device

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.

Other names: Magstim Rapid2

Primary outcomes

  1. Timed Up and Go (TUG)

    Time frame: Up to 3 months after interventions completed

Secondary outcomes

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

    Time frame: up to 3 months after the intervention completed

  2. 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

  3. Barthel Index (BI)

    Time frame: Up to 3 months after interventions completed

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

    Time frame: up to 3 months after the intervention completed

    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.

  5. modified Rankin Scale (MRS)

    Time frame: Up to 3 months after interventions completed

Sponsors and collaborators

Lead sponsor

Taipei Medical University WanFang Hospital

Other

Registry information

Official study title

The Potential Benefit of 1-Hz rTMS to Improve Gross Motor Function After Stroke: A Randomized Controlled Trial.

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 10, 2013
Registry last updated
Dec 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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