Clinical trial NCT04326205: Neural Mechanisms and Efficacy of Dual Neurotechnology-aided Mirror Therapy in Chronic Stroke: Neural and Motor Plasticity, Movement Performance, Daily Function, and Quality of Life
Official title: Neural Mechanisms and Efficacy of Dual Neurotechnology-aided Mirror Therapy in Chronic Stroke: Neural and Motor Plasticity, Movement Performance, Daily Function, and Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: mirror therapy
transcranial direct current stimulation
functional electrical stimulation
neurotechnology-aided intervention
stroke
neurorehabilitation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 112
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Mirror therapy (MT) has been demonstrated, in terms of neuroplasticity, to improve sensorimotor function of paretic upper extremity (UE) in chronic stroke patients. Central and peripheral electrical stimulation techniques such as ranscranial direct current stimulation (tDCS) and functional electrical stimulation (FES) can individually enhance effects of MT, combining both of them with MT can be a potentially valuable approach to maximize neural and functional recovery post stroke. To our knowledge, no studies combined central and peripheral neural network reorganization technique with motor behavioral learning approach to investigate its possible benefit after stroke. This project will be the first to design a "dual neurotechnology-aided MT (DNA-MT)", which combines tDCS and FES with contemporary neurorehabilitation approaches (i.e., MT) to stimulate both central and peripheral nervous systems to maximize neural and functional recovery post stroke. Investigators will determine the efficacy and neurophysiological and motor mechanisms related to this novel DNA-MT approach and identify potential responders to this novel intervention.


Eligibility criteria: Inclusion Criteria:

* sustained a unilateral stroke with onset ≥ 3 months (Figlewski et al., 2017);
* UE Fugl-Meyer assessment (UE-FMA) score between 18 and 56 indicating mild to moderate mild motor severity (Menezes et al., 2018; Woodbury, Velozo, Richards, \& Duncan, 2013);
* aged 35 to 85 years old; and
* able to follow instructions and perform the tasks (Mini Mental State Examination ≥24).

Exclusion Criteria:

* with excessive spasticity or joint contracture of the paretic UE;
* enrolled in other rehabilitation experiments or drug studies;
* with additional neurological or psychological disorders other than stroke;
* having received Botulinum toxin injections 3 months before enrollment;
* having unstable cardiovascular status such as uncontrolled hypertension or New York Heart Association (NYHA) Class III/IV heart failure;
* having contradictions to tDCS including a history of epilepsy, migraine headache, uncontrolled medical status, being pregnant, having a pacemaker, or metal implanted in their head or body (not including dental fillings or hardware)(Meeker et al., 2019; Rossi, Hallett, Rossini, Pascual-Leone, \& Group, 2009);
* having a history of drug or alcohol abuse, dermatosis preventing tDCS from being applied, brain tumor, brain injury, arteriovenous malformation, other brain diseases (such as intracranial hypertension or cerebral edema), or are not suitable for using tDCS by the physician's assessment; and (8) having existence of skin rash, allergy or wounds at the locations where stimulation electrodes would be placed.

Primary outcomes:
measure: Change scores of Fugl-Meyer Assessment (FMA)
timeFrame: Baseline, 3 months, 6 months
measure: Change scores of Modified Ashworth Scale (MAS)
timeFrame: Baseline, 3 months, 6 months
measure: Change scores of Revised Nottingham Sensory Assessment (rNSA)
timeFrame: Baseline, 3 months, 6 months
measure: Change scores of Dual-Task Test
timeFrame: Baseline, 3 months, 6 months
measure: Change scores of Medical Research Council scale (MRC)
timeFrame: Baseline, 3 months, 6 months
measure: Change scores of Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, 3 months, 6 months
measure: Change scores of Wolf Motor Function Test (WMFT)
timeFrame: Baseline, 3 months, 6 months
measure: Change scores of Motor Activity Log (MAL)
timeFrame: Baseline, 3 months, 6 months
measure: Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)
timeFrame: Baseline, 3 months, 6 months
measure: Change scores of Stroke Impact Scale Version 3.0 (SIS 3.0)
timeFrame: Baseline, 3 months, 6 months
measure: Change scores of Functional Abilities Confidence Scale (FACS)
timeFrame: Baseline, 3 months, 6 months
measure: Change scores of Stroke Self-Efficacy Questionnaire (SSEQ)
timeFrame: Baseline, 3 months, 6 months
measure: Change scores of Daily Living Self-Efficacy Scale (DLSES)
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ching-yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References: