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

NCT ID: NCT05733858

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-07-31

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

tRNS with digital MT

Group Type: EXPERIMENTAL

tRNS

Intervention Type: DEVICE

For tRNS, the electrical current is delivered alternatively (an alternating current). The stimulation intensity will be set as 1.5 to 2 mA (based on the tolerance of participants). The stimulation frequency will be random frequencies ranging from 101 and 640 Hz.The stimulation period of tRNS and tDCS will be 20 minutes.

digital MT

Intervention Type: BEHAVIORAL

For the digital MT, the participants will be encouraged to move the affected arm as symmetrically and simultaneously as the unaffected hand while looking at the real-time image on the computer screen. The activities practiced during digital MT will include intransitive movements (e.g., flexion and extension of the wrist) and transitive movements (e.g., picking up a pen). The amount of time exposed to intransitive and transitive movements will be balanced for each participant. The participants will practice 30 intransitive and 30 transitive tasks over the 20 training sessions, and the actual movements will be selected based on each individual's ability and his/her needs.

tDCS with digital MT

Group Type: EXPERIMENTAL

tDCS

Intervention Type: DEVICE

For tDCS, the electrical current is delivered in a continuous and consistent manner (direct current). The stimulation intensity will be the same as that of tRNS (1.5 to 2 mA based on the tolerance of participants), which is safe for stroke patients.The stimulation period of tRNS and tDCS will be 20 minutes.

digital MT

Intervention Type: BEHAVIORAL

For the digital MT, the participants will be encouraged to move the affected arm as symmetrically and simultaneously as the unaffected hand while looking at the real-time image on the computer screen. The activities practiced during digital MT will include intransitive movements (e.g., flexion and extension of the wrist) and transitive movements (e.g., picking up a pen). The amount of time exposed to intransitive and transitive movements will be balanced for each participant. The participants will practice 30 intransitive and 30 transitive tasks over the 20 training sessions, and the actual movements will be selected based on each individual's ability and his/her needs.

sham stimulation with digital MT

Group Type: SHAM_COMPARATOR

sham stimulation

Intervention Type: DEVICE

For the sham stimulation condition, the electrode placement will be the same as the other real eletrical stimulation conditions. The current will first turn up for 30 seconds and subsequently turn off in the next 30 seconds to provide sensory feeling without actually stimulating the brain.

digital MT

Intervention Type: BEHAVIORAL

For the digital MT, the participants will be encouraged to move the affected arm as symmetrically and simultaneously as the unaffected hand while looking at the real-time image on the computer screen. The activities practiced during digital MT will include intransitive movements (e.g., flexion and extension of the wrist) and transitive movements (e.g., picking up a pen). The amount of time exposed to intransitive and transitive movements will be balanced for each participant. The participants will practice 30 intransitive and 30 transitive tasks over the 20 training sessions, and the actual movements will be selected based on each individual's ability and his/her needs.

Interventions

tRNS

For tRNS, the electrical current is delivered alternatively (an alternating current). The stimulation intensity will be set as 1.5 to 2 mA (based on the tolerance of participants). The stimulation frequency will be random frequencies ranging from 101 and 640 Hz.The stimulation period of tRNS and tDCS will be 20 minutes.

Intervention Type: DEVICE

tDCS

For tDCS, the electrical current is delivered in a continuous and consistent manner (direct current). The stimulation intensity will be the same as that of tRNS (1.5 to 2 mA based on the tolerance of participants), which is safe for stroke patients.The stimulation period of tRNS and tDCS will be 20 minutes.

Intervention Type: DEVICE

sham stimulation

For the sham stimulation condition, the electrode placement will be the same as the other real eletrical stimulation conditions. The current will first turn up for 30 seconds and subsequently turn off in the next 30 seconds to provide sensory feeling without actually stimulating the brain.

Intervention Type: DEVICE

digital MT

For the digital MT, the participants will be encouraged to move the affected arm as symmetrically and simultaneously as the unaffected hand while looking at the real-time image on the computer screen. The activities practiced during digital MT will include intransitive movements (e.g., flexion and extension of the wrist) and transitive movements (e.g., picking up a pen). The amount of time exposed to intransitive and transitive movements will be balanced for each participant. The participants will practice 30 intransitive and 30 transitive tasks over the 20 training sessions, and the actual movements will be selected based on each individual's ability and his/her needs.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

202102210A0

Identifier Type: -

Identifier Source: org_study_id