rTMS Study to Improve Functional Performance for Patients With Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02006875
• Other study ID #: 102-wf-eva-04
• Status: Completed
• Phase: Phase 3
• First received: December 4, 2013
• Last updated: December 10, 2015
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Shuang Ho Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed Up and Go (TUG)		Up to 3 months after interventions completed	No
Secondary	the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE)		up to 3 months after the intervention completed	No
Secondary	The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g)		up to 3 months after the interventions completed	No
Secondary	Barthel Index (BI)		Up to 3 months after interventions completed	No
Secondary	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.	up to 3 months after the intervention completed	Yes
Secondary	modified Rankin Scale (MRS)		Up to 3 months after interventions completed	No