Stochastic Resonance Stimulation in Brain Plasticity and Post Stroke Motor Recovery

Healthy Clinical Trial

Official title:

Effects of Stochastic Resonance Electrical Stimulation on Post Stroke Cortical Plasticity and Motor Function Recovery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03839810
• Other study ID #: MOST107-2314-B-010-050
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: National Yang Ming University
• Contact: Li-Wei Chou, PhD
• Phone: +886228267092
• Email: lwchou[@]ym.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effectiveness of stochastic resonance electric stimulation on neuromuscular control and proprioception in healthy and individuals with stroke.

Description:

Stroke is one of the leading causes of motor disability. The main intervention strategy in stroke rehabilitation is to induce cortical plasticity for motor re-learning.

It has been demonstrated that electrical stimulation applied to the periphery can elicit abundant sensory afferent inputs to enhance excitability and activation area in the sensorimotor cortex. Recent evidence suggested that a new type of electrical stimulation pattern, stochastic resonance stimulation, is capable of efficiently enhancing the activation of peripheral and central nervous system. Therefore, the purpose of this study are to identify the effects of stochastic resonance electrical stimulation on neuromuscular control and proprioception, and to investigate the effectiveness of combining stochastic resonance electrical stimulation with rehabilitation program on post stroke motor function recovery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

In first stage

Inclusion Criteria:

healthy adults without history of neurological disorders or limitation in range of motion for thumb ?exion

In the second stage

Inclusion Criteria:

1. first-ever cerebral cortical region involved chronic stroke, onset over a month

2. able to perform active grasp on the affected side with the scores of manual muscle test at least two points

3. at stable medical condition for intervention confirmed by a specialized physician.

The exclusion criteria were

1. history of other neurological disorders

2. cognitive impairment (Mini-Mental State Examination score < 24, MMSE)29

3. unable to follow instructions

4. contraindications of ES

5. under 20 years old.

Related Conditions & MeSH terms

• Healthy
• Stroke
• Stroke, Ischemic

Intervention

Other:
• stochastic resonance electrical stimulation
stochastic resonance electrical stimulation is applied in the upper extremity during motor functional training. Sham comparator group uses sham stimulation - same electrode location, but no electrical current is applied during motor functional training

Locations

Country	Name	City	State
Taiwan	National Yang-Ming University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Yang Ming University	Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG	we will calculate power spectral and see whether change in the alpha, beta, theta band	baseline and one minute after stimulation
Primary	Fugl-Meyer Assessment for Upper Extremity	changes in upper extremity function of the stroke subjects	baseline and one minute after stimulation
Secondary	force deviation	we first calculated the absolute value of the difference between force output and the value of 50%MVC for each data point and then calculated the average force deviation value by dividing the sum of all values by the number of data points	baseline and one minute after stimulation
Secondary	joint angle	ABS(the subject perform degree - target degree )	baseline and one minute after stimulation
Secondary	muscle activation	EMG changes in stimulation	baseline and one minute after stimulation