The Combining rTMS With Visual Feedback Training for Patients With Stroke

Stroke Clinical Trial

— rTMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03689491
• Other study ID #: 105TMU-TMUH-14
• Status: Completed
• Phase: N/A
• Start date: January 5, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: September 2018
• Source: Taipei Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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 >? 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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Motor evoked potential	Measurement of motor evoked potential of anterior tibialis	Change from baseline to 4 weeks
Secondary	Chang of Motor Assessment Score	Lower Limb motor function	Change from baseline to 4 weeks
Secondary	Chang of Berg Balance Test	standing balance	Change from baseline to 4 weeks
Secondary	Chang of Fugl-Meyer Assessment-Lower Limb section	Lower Limb section	Change from baseline to 4 weeks
Secondary	Chang of Modified barthel index	Activity of daily live ability	Change from baseline to 4 weeks
Secondary	Chang of Time Up and Go	functional ambulation	Change from baseline to 4 weeks