ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 428 for:    Taipei Medical University Hospital

The Combining rTMS With Visual Feedback Training for Patients With Stroke (rTMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03689491
Recruitment Status : Active, not recruiting
First Posted : September 28, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University Hospital

Brief Summary:
After stroke, patients often experience motor deficits that interrupt normal lower extremity movement and gait function. Recent developments in neuroimaging have focus on the reasons why some patients recover well while some do poorly. However, there is still no consensus on the exact mechanisms involved in regaining the functions after rehabilitation. Application of repetitive transcranial magnetic stimulation (rTMS) to facilitate neural plasticity during stroke treatment has recently gained considerable attention. The possible mechanism through which rTMS acts is based on the interhemispheric competition (IHC) model, which explains that patients with stroke experience alterations in cortical excitability and exhibit abnormally high interhemispheric inhibition from the unaffected hemisphere to the affected hemisphere. The visual feedback training can improve postural control and enhance motor performance. Several rTMS studies have evaluated the lower extremity dysfunction following stroke, but few studies have explored the efficacy of applying rTMS on the lower extremities. We expect the study can help us to further exploration of the change of clinical function and cortical excitability following rTMS and visual feedback training in subjects with stroke. In addition, the results of this project will be provided for further rehabilitation programs in people with stroke.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: rTMS Behavioral: visual feedback training Behavioral: traditional rehabilitation Not Applicable

Detailed Description:

Objective: To investigate the effects of combining rTMS with visual feedback training to improve movements in the paretic lower limb and gait performance.

Methods: Thirty patients with monohemispheric after ischemic stroke will recruited and randomized into 3 groups. The group 1 received a 10-minute rTMS intervention then a 30-minute visual feedback training. The group 2 received a 10-minute sham rTMS intervention then a 30-minute visual feedback training. The group 3 received a 10-minute sham rTMS intervention then a 30-minute traditional rehabilitation training. All subjects received treatments 3 times a week for 4 weeks. The performance was assessed by a blinded assessor for two times (baseline and after 4 weeks). The outcome measures included Motor evoked potential (MEP), Fugl-Meyer Assessment-Lower Limb section(FMA-LE),Motor Assessment Score(MAS), Berg Balance Test (BBS),Time Up and Go (TUG), and Modified Barthel Index for ADL ability. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at 0.05. The hypothesis is combining rTMS with visual feedback training has positive effects on lower limb and gait performance among patients with stroke.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized
Masking: Single (Outcomes Assessor)
Masking Description: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigating the Effects of Combining rTMS With Visual Feedback Training to Improve Movements in the Paretic Lower Limb and Gait Performance
Actual Study Start Date : February 13, 2015
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Arm Intervention/treatment
Experimental: rTMS+visual feedback
10-minute rTMS and then a 30-minute visual feedback training ,3 times a week, for 4 weeks
Behavioral: rTMS
The EMG measured the MEPs of the anterior tibialis in response to the TMS delivered using a Magstim Rapid2 stimulator (Magstim Co, Ltd, Carmarthenshire, Wales, UK) with a 70-mm figure-8 coil (maximum power, 2.2 T) over the contralateral M1. The intensity was initially set at 100% of the machine output (MO) to determine the optimal stimulation site (hotspot). The hotspot was marked on the scalp with oil ink and recorded as x, y, in centimeters from the vertex (cz). The participants received real rTMS or sham rTMS, respectively (1 Hz, 10 min), which was before a 30-minute visual feedback training and/or traditional rehabilitation training.

Behavioral: visual feedback training
Game-based visual feedback training system and software.The system was designed to enable the subjects to perform ankle movements in multiple axes.

Active Comparator: sham rTMS+visual feedback
10-minute sham rTMS and then a 30-minute visual feedback training ,3 times a week, for 4 weeks
Behavioral: rTMS
The EMG measured the MEPs of the anterior tibialis in response to the TMS delivered using a Magstim Rapid2 stimulator (Magstim Co, Ltd, Carmarthenshire, Wales, UK) with a 70-mm figure-8 coil (maximum power, 2.2 T) over the contralateral M1. The intensity was initially set at 100% of the machine output (MO) to determine the optimal stimulation site (hotspot). The hotspot was marked on the scalp with oil ink and recorded as x, y, in centimeters from the vertex (cz). The participants received real rTMS or sham rTMS, respectively (1 Hz, 10 min), which was before a 30-minute visual feedback training and/or traditional rehabilitation training.

Behavioral: visual feedback training
Game-based visual feedback training system and software.The system was designed to enable the subjects to perform ankle movements in multiple axes.

Active Comparator: sham rTMS+traditional training
10-minute sham rTMS and then a 30-minute traditional rehabilitation training,3 times a week, for 4 weeks
Behavioral: rTMS
The EMG measured the MEPs of the anterior tibialis in response to the TMS delivered using a Magstim Rapid2 stimulator (Magstim Co, Ltd, Carmarthenshire, Wales, UK) with a 70-mm figure-8 coil (maximum power, 2.2 T) over the contralateral M1. The intensity was initially set at 100% of the machine output (MO) to determine the optimal stimulation site (hotspot). The hotspot was marked on the scalp with oil ink and recorded as x, y, in centimeters from the vertex (cz). The participants received real rTMS or sham rTMS, respectively (1 Hz, 10 min), which was before a 30-minute visual feedback training and/or traditional rehabilitation training.

Behavioral: traditional rehabilitation
30 min traditional rehabilitation. The traditional rehabilitation programs included balance training, postural training, muscle strengthening, ambulation training and etc..




Primary Outcome Measures :
  1. Change of Motor evoked potential [ Time Frame: Change from baseline to 4 weeks ]
    Measurement of motor evoked potential of anterior tibialis


Secondary Outcome Measures :
  1. Chang of Motor Assessment Score [ Time Frame: Change from baseline to 4 weeks ]
    Lower Limb motor function

  2. Chang of Berg Balance Test [ Time Frame: Change from baseline to 4 weeks ]
    standing balance

  3. Chang of Fugl-Meyer Assessment-Lower Limb section [ Time Frame: Change from baseline to 4 weeks ]
    Lower Limb section

  4. Chang of Modified barthel index [ Time Frame: Change from baseline to 4 weeks ]
    Activity of daily live ability

  5. Chang of Time Up and Go [ Time Frame: Change from baseline to 4 weeks ]
    functional ambulation



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Monohemispheric ischemic or hemorrhage stroke
  2. Subjects with first-ever stroke 3.6 months after stroke onset

4.The Brunnstrom stage of lower limb >Ⅲ 5.>23 in the mini-mental state exam 6.The Modified Ashworth Scale of lower limb <3 7.Clear consciousness can meet the relevant assessments

Exclusion Criteria:

  1. Recurrent stoke
  2. Severe spasticity of lower limb and difficult to perform isolative movement.
  3. History of seizures or epileptic
  4. Have implanted ferromagnetic devices or other magnetic-sensitive metal implants
  5. Concomitant vestibular and cerebellum diseases
  6. Joint contracture of lower limb/foot and other orthopedic problems
  7. Subjects with severe cognitive impairment
  8. Subjects with depression and/or mood disorder
  9. Presence of any comorbid neurological diseases or psychological diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689491


Locations
Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University Hospital
Investigators
Principal Investigator: Cheng Hsien-Lin, Master Taipei Medical University Hospital

Responsible Party: Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT03689491     History of Changes
Other Study ID Numbers: 105TMU-TMUH-14
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taipei Medical University Hospital:
rTMS
visual feedback
gait

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