The Combining rTMS With Visual Feedback Training for Patients With Stroke

NCT ID: NCT03689491

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-05
• Study Completion Date: 2019-07-31

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.

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

rTMS+visual feedback

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

Group Type: EXPERIMENTAL

rTMS

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

sham rTMS+visual feedback

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

Group Type: ACTIVE_COMPARATOR

rTMS

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

sham rTMS+traditional training

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

Group Type: ACTIVE_COMPARATOR

rTMS

Intervention Type: 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.

traditional rehabilitation

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

traditional rehabilitation

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheng Hsien-Lin, Master

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Hospital

Locations

Taipei Medical University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

105TMU-TMUH-14

Identifier Type: -

Identifier Source: org_study_id