Stochastic Resonance Stimulation in Brain Plasticity and Post Stroke Motor Recovery

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

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

Study Overview

• Status: Unknown
• Conditions: Healthy; Stroke, Ischemic
• Intervention / Treatment: Other: stochastic resonance electrical stimulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shiang-Lin Hou; Phone Number: +886988563887; Email: g30622007@gm.ym.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Recruiting
    • National Yang-Ming University
    • Contact: Shiang-Lin Hou; Phone Number: +886988563887; Email: g30622007@gm.ym.edu.tw
    • Contact: Li-Wei Chou, PhD; Phone Number: +88628267092; Email: lwchou@ym.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

In first stage

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stochastic resonance; stochastic resonance electrical stimulation is applied to the upper extremity during the subjects perform upper extremity motor function.	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
Sham Comparator: sham stimulation; sham electrical stimulation (same electrode location, but no electrical current is applied) is applied to the upper extremity during the subjects perform upper extremity motor function.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG	we will calculate power spectral and see whether change in the alpha, beta, theta band	baseline and one minute after stimulation
Fugl-Meyer Assessment for Upper Extremity	changes in upper extremity function of the stroke subjects	baseline and one minute after stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
joint angle	ABS(the subject perform degree - target degree )	baseline and one minute after stimulation
muscle activation	EMG changes in stimulation	baseline and one minute after stimulation

Collaborators and Investigators

• Sponsor: National Yang Ming University
• Collaborators: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: February 11, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 11, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: proprioception; motor control; motor recovery; stochastic resonance
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: MOST107-2314-B-010-050

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No