rTMS Study to Improve Functional Performance for Patients With Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Taipei Medical University WanFang Hospital
Sponsor:
Information provided by (Responsible Party):
Yen-Nung Lin, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT02006875
First received: December 4, 2013
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Stroke
Device: rTMS
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Potential Benefit of 1-Hz rTMS to Improve Gross Motor Function After Stroke: A Randomized Controlled Trial.

Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:
  • Postural control was assessed by Postural Assessment Scale for Stroke (PASS) [ Time Frame: up to 3 months after the intervention completed ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE) [ Time Frame: up to 3 months after the intervention completed ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Barthel Index (BI) [ Time Frame: Up to 3 months after interventions completed ] [ Designated as safety issue: No ]
  • Timed Up and Go (TUG) [ Time Frame: Up to 3 months after interventions completed ] [ Designated as safety issue: No ]
  • modified Rankin Scale (MRS) [ Time Frame: Up to 3 months after interventions completed ] [ Designated as safety issue: No ]
  • Corticomotor excitability assessments measured by TMS [ Time Frame: before and immediatly after the 15-day interventions ] [ Designated as safety issue: No ]

    parameters includes:

    1. Motor threshold.
    2. Latency of Motor evoked potentials (MEP-latency)
    3. Amplitude of Motor evoked potentials (MEP-amplitude)


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: real rTMS
Experimental included the a daily real rTMS session for 15 mins followed by a physical therapy for 45 mins.
Device: rTMS
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 Name: Magstim Rapid2
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 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 Name: Magstim Rapid2

Detailed Description:

Protocol:

  1. Setting: inpatient rehabilitation department of Shuang-Ho Hospital.
  2. Study population: Patients received inpatient treatment or rehabilitation for stroke in Shuang-Ho Hospital (SHH).
  3. Eligibility. Screening for eligibility was done by the 2 physiatrists from rehabilitation department of SHH.
  4. Study design: controlled trial with stratified randomization
  5. 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.
  6. 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. Corticomotor excitability assessments. e. Timing of measurements: pretest (1 day before the intervention), the and post-test (immediately after the 15-day interventions are completed), and 3 months after the interventions are completed.
    4. These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements.
  7. 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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02006875

Contacts
Contact: Yen-Nung Lin, MD, MS 0970746879 semitune@gmail.com

Locations
Taiwan
Shuang Ho Hospital Recruiting
New Taipei City, Taiwan
Contact: Yen-Nung Lin, MD, MS    0970746879    semitune@gmail.com   
Principal Investigator: Chaur-Jong Hu, MD         
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Yen-Nung Lin, MD, MS Department of Physical Medicine and Rehabilitation, Wan Fang Hospital, Taipei Medical University
  More Information

No publications provided

Responsible Party: Yen-Nung Lin, Medical doctor of Department of Physical Medicine & Rehabilitation, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT02006875     History of Changes
Other Study ID Numbers: 102-wf-eva-04
Study First Received: December 4, 2013
Last Updated: March 26, 2014
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by Taipei Medical University WanFang Hospital:
repetitive transcranial magnetic stimulation
postural
balance
mobility
leg
stroke

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014