Comparative Efficacy of Novel Transcranial Random Noise Stimulation Versus Direct Current Stimulation on Augmenting Digital Mirror Therapy in Chronic Stroke

Chang Gung Medical Foundation

Status: Not yet enrolling

Conditions: Transcranial Direct Current Stimulation (tDCS); Transcranial Random Noise Stimulation (tRNS)

Treatments: Device: tDCS; Device: sham stimulation; Device: tRNS; Behavioral: digital MT

Study type: Interventional

Funder types: Other

Identifiers

NCT05733858

202102210A0

Details and patient eligibility

About

This study will be the first to investigate the effects of novel brain neurotechnology, which is the tRNS combined with digital MT. The investigators will perform a head-to-head comparison of the effects of the innovative tRNS- and tDCS-augmented digital MT interventions comprehensively on clinical, neurophysiological and motor control outcomes in stroke patients. The EEG and kinematic assessment will be used for assessing brain activities and upper extremity motor control. In addition, the investigators will identify the good responders to the tRNS- and tDCS-augmented digital MT interventions to determine the appropriate candidate for the innovative hybrid interventions. The overall findings of this research project will help advance current knowledge of brain neurotechnology and lead to development of neurophysiological and clinical evidence-based brain neurotechnology-augmented digital MT interventions for use in the clinical settings.

Enrollment: 105 estimated patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 3 months onset from a first-ever unilateral stroke;
2. an initial FMA scores between 18 to 56, indicating moderate to mild upper extremity motor impairment55;
3. age between 35 to 85;
4. no excessive spasticity in any of the joints of the affected arm (shoulder, elbow, wrist and fingers);
5. ability to follow instructions and perform tasks (Mini Mental State Examination scores 24);
6. no participation in any neurorehabilitation experiments or drug clinical trials
7. willing to provide written informed consent

Exclusion criteria

1. contradiction to tRNS and tDCS including a history of epilepsy, pregnant, having pacemakers and metallic implants in the neck and head ;
2. History of drug or alcohol abuse ;
3. concomitant neurological conditions such as dementia, Parkinson's disease, brain tumor, brain injury and other brain diseases (such as intracranial hypertension or cerebral edema);
4. Botulinum toxin injections 3 months before enrollment
5. have unstable cardiovascular status such as uncontrolled hypertension or New York Heart Association (NYHA) Class III/IV heart failure or are not suitable for receiving tRNS by the physician's assessments.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

105 participants in 3 patient groups

tRNS with digital MT

Experimental group

Treatment:

Behavioral: digital MT

Device: tRNS

tDCS with digital MT

Experimental group

Treatment:

Behavioral: digital MT

Device: tDCS

sham stimulation with digital MT

Sham Comparator group

Treatment:

Behavioral: digital MT

Device: sham stimulation