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Completed

NCT Number: NCT03689491

The Combining rTMS With Visual Feedback Training for Patients With Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Monohemispheric ischemic or hemorrhage stroke
  • 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

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

Treatment and study plan

rTMS

Behavioral

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.

Visual Feedback Training

Behavioral

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

Traditional Rehabilitation

Behavioral

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

Primary outcomes

  1. Change of Motor evoked potential

    Time frame: Change from baseline to 4 weeks

    Measurement of motor evoked potential of anterior tibialis

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Taipei Medical University Hospital

Other

Registry information

Official study title

Investigating the Effects of Combining rTMS With Visual Feedback Training to Improve Movements in the Paretic Lower Limb and Gait Performance

Acronym: rTMS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 28, 2018
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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