Clinical trial NCT03839810: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Ischemic
Healthy
Keywords: stochastic resonance
proprioception
motor control
motor recovery
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
Collaborators: name: Taipei Veterans General Hospital, Taiwan
First posted: 2019-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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.

Primary outcomes:
measure: EEG
timeFrame: baseline and one minute after stimulation
measure: Fugl-Meyer Assessment for Upper Extremity
timeFrame: baseline and one minute after stimulation
Secondary outcomes:
measure: force deviation
timeFrame: baseline and one minute after stimulation
measure: joint angle
timeFrame: baseline and one minute after stimulation
measure: muscle activation
timeFrame: baseline and one minute after stimulation
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang-Ming University
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Li-Wei Chou, PhD
role: PRINCIPAL_INVESTIGATOR
References: