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

Chang Gung Medical Foundation

Status: Unknown

Conditions: Cerebrovascular Accident

Treatments: Device: functional electrical stimulation, FES; Other: no stimulation; Device: transcranial direct current stimulation, tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT04326205

201902241A0

Details and patient eligibility

About

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.

Enrollment: 112 estimated patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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112 participants in 4 patient groups, including a placebo group

Dual-aided

Experimental group

Description:

active tDCS to the ipsilesional primary motor cortex (M1lesioned) followed by FES to the paretic hand during MT

Treatment:

Device: functional electrical stimulation, FES

Device: transcranial direct current stimulation, tDCS

FES-alone

Active Comparator group

Description:

sham tDCS to the M1lesioned followed by FES to the paretic hand during MT

Treatment:

Device: functional electrical stimulation, FES

tDCS-alone

Active Comparator group

Description:

active tDCS to the M1lesioned followed by sham FES to the paretic hand during MT

Treatment:

Device: transcranial direct current stimulation, tDCS

Dual-sham

Placebo Comparator group

Description:

sham tDCS to the M1lesioned followed by sham FES to the paretic hand during M

Treatment:

Other: no stimulation