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Stochastic Resonance Stimulation in Brain Plasticity and Post Stroke Motor Recovery

Primary Purpose

Stroke, Ischemic, Healthy

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
stochastic resonance electrical stimulation
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring stochastic resonance, proprioception, motor control, motor recovery

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Yang-Ming UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

stochastic resonance

sham stimulation

Arm Description

stochastic resonance electrical stimulation is applied to the upper extremity during the subjects perform upper extremity motor function.

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.

Outcomes

Primary Outcome Measures

EEG
we will calculate power spectral and see whether change in the alpha, beta, theta band
Fugl-Meyer Assessment for Upper Extremity
changes in upper extremity function of the stroke subjects

Secondary Outcome Measures

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
joint angle
ABS(the subject perform degree - target degree )
muscle activation
EMG changes in stimulation

Full Information

First Posted
January 17, 2019
Last Updated
February 11, 2019
Sponsor
National Yang Ming University
Collaborators
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03839810
Brief Title
Stochastic Resonance Stimulation in Brain Plasticity and Post Stroke Motor Recovery
Official Title
Effects of Stochastic Resonance Electrical Stimulation on Post Stroke Cortical Plasticity and Motor Function Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University
Collaborators
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Healthy
Keywords
stochastic resonance, proprioception, motor control, motor recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
stochastic resonance
Arm Type
Experimental
Arm Description
stochastic resonance electrical stimulation is applied to the upper extremity during the subjects perform upper extremity motor function.
Arm Title
sham stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
stochastic resonance electrical stimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
EEG
Description
we will calculate power spectral and see whether change in the alpha, beta, theta band
Time Frame
baseline and one minute after stimulation
Title
Fugl-Meyer Assessment for Upper Extremity
Description
changes in upper extremity function of the stroke subjects
Time Frame
baseline and one minute after stimulation
Secondary Outcome Measure Information:
Title
force deviation
Description
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
Time Frame
baseline and one minute after stimulation
Title
joint angle
Description
ABS(the subject perform degree - target degree )
Time Frame
baseline and one minute after stimulation
Title
muscle activation
Description
EMG changes in stimulation
Time Frame
baseline and one minute after stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: first-ever cerebral cortical region involved chronic stroke, onset over a month able to perform active grasp on the affected side with the scores of manual muscle test at least two points at stable medical condition for intervention confirmed by a specialized physician. The exclusion criteria were history of other neurological disorders cognitive impairment (Mini-Mental State Examination score < 24, MMSE)29 unable to follow instructions contraindications of ES under 20 years old.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li-Wei Chou, PhD
Phone
+886228267092
Email
lwchou@ym.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Shiang-Lin Hou
Phone
+886988563887
Email
g30622007@gm.ym.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Wei Chou, PhD
Organizational Affiliation
National Yang Ming University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Yang-Ming University
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li-Wei Chou, PhD
Phone
+88628267092
Email
lwchou@ym.edu.tw
First Name & Middle Initial & Last Name & Degree
Shiang-Lin Hou
Phone
+886988563887
Email
g30622007@gm.ym.edu.tw

12. IPD Sharing Statement

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Stochastic Resonance Stimulation in Brain Plasticity and Post Stroke Motor Recovery

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