Clinical trial NCT02006875: rTMS Study to Improve Functional Performance for Patients With Stroke
Official title: The Potential Benefit of 1-Hz rTMS to Improve Gross Motor Function After Stroke: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Keywords: repetitive transcranial magnetic stimulation
postural
balance
mobility
leg
stroke
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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. 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 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

Primary outcomes:
measure: Timed Up and Go (TUG)
timeFrame: Up to 3 months after interventions completed
Secondary outcomes:
measure: the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE)
timeFrame: up to 3 months after the intervention completed
measure: The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g)
timeFrame: up to 3 months after the interventions completed
measure: Barthel Index (BI)
timeFrame: Up to 3 months after interventions completed
measure: Postural control was assessed by Postural Assessment Scale for Stroke (PASS)
timeFrame: up to 3 months after the intervention completed
measure: modified Rankin Scale (MRS)
timeFrame: Up to 3 months after interventions completed
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Shuang Ho Hospital
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Wan Fang Hospital, Taipei Medical University
name: Yen-Nung Lin, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.