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

December 4, 2013
March 26, 2014
January 2013
January 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02006875 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
rTMS Study to Improve Functional Performance for Patients With Stroke
The Potential Benefit of 1-Hz rTMS to Improve Gross Motor Function After Stroke: A Randomized Controlled Trial.

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.

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Stroke
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
  • Experimental: real rTMS
    Experimental included the a daily real rTMS session for 15 mins followed by a physical therapy for 45 mins.
    Intervention: 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.
    Intervention: Device: rTMS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
January 2016
January 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Yen-Nung Lin, MD, MS 0970746879 semitune@gmail.com
Taiwan
 
NCT02006875
102-wf-eva-04
No
Yen-Nung Lin, Taipei Medical University WanFang Hospital
Taipei Medical University WanFang Hospital
Not Provided
Principal Investigator: Yen-Nung Lin, MD, MS Department of Physical Medicine and Rehabilitation, Wan Fang Hospital, Taipei Medical University
Taipei Medical University WanFang Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP