The Combining rTMS With Visual Feedback Training for Patients With Stroke

NCT03689491 | Completed

• 1 other identifier: 105TMU-TMUH-14
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

rTMS; visual feedback; gait

Outcome Measures

Primary Outcomes (1)

• Change of Motor evoked potential

  Measurement of motor evoked potential of anterior tibialis

  Change from baseline to 4 weeks

Secondary Outcomes (5)

• Chang of Motor Assessment Score

  Change from baseline to 4 weeks

• Chang of Berg Balance Test

  Change from baseline to 4 weeks

• Chang of Fugl-Meyer Assessment-Lower Limb section

  Change from baseline to 4 weeks

• Chang of Modified barthel index

  Change from baseline to 4 weeks

• Chang of Time Up and Go

  Change from baseline to 4 weeks

Study Arms (3)

rTMS+visual feedback

EXPERIMENTAL

10-minute rTMS and then a 30-minute visual feedback training ,3 times a week, for 4 weeks

Behavioral: rTMS; Behavioral: visual feedback training

sham rTMS+visual feedback

ACTIVE COMPARATOR

10-minute sham rTMS and then a 30-minute visual feedback training ,3 times a week, for 4 weeks

Behavioral: rTMS; Behavioral: visual feedback training

sham rTMS+traditional training

ACTIVE COMPARATOR

10-minute sham rTMS and then a 30-minute traditional rehabilitation training,3 times a week, for 4 weeks

Behavioral: rTMS; Behavioral: traditional rehabilitation

Interventions

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.

rTMS+visual feedback; sham rTMS+traditional training; sham rTMS+visual feedback

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.

rTMS+visual feedback; sham rTMS+visual feedback

traditional rehabilitation BEHAVIORAL

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

sham rTMS+traditional training

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Monohemispheric ischemic or hemorrhage stroke
• Subjects with first-ever stroke 3.6 months after stroke onset
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Cheng Hsien-Lin, Master

  Taipei Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single Blind (Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: September 28, 2018
• Study Start: January 5, 2017
• Primary Completion: June 30, 2019
• Study Completion: July 31, 2019
• Last Updated: January 18, 2023

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)