Novel Brain Neurotechnology for Optimizing Precision Mirror Therapy in Stroke

NCT05238272 | Recruiting

• 1 other identifier: 202100509A0
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this project will be to determine the effects of the tRNS-augmented unilateral and bilateral MT, and their effects relative to the control interventions (sham tRNS with unilateral or bilateral MT) on restoring health outcomes including motor function, daily function, quality of life and self-efficacy, and motor control strategy as well as brain activities (electroencephalography, EEG) in stroke patients.

Conditions

Cerebrovascular Accident

Keywords

Mirror therapy; stroke

Outcome Measures

Primary Outcomes (11)

• Fugl-Meyer Assessment (FMA)

  The upper-extremity subscale of FMA will be used to assess sensorimotor impairment. It examines 33 movements scored on a 3-point ordinal scale (score range: 0-66). A higher FMA score suggests less impairment

  Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention

• Modified Ashworth Scale (MAS)

  The MAS is a 6-point ordinal scale assessing muscle spasticity. The MAS scores of arm muscles, including biceps, triceps, wrist flexors and extensors, and finger flexors and extensors will be examined.

  Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention

• Revised Nottingham Sensory Assessment (rNSA)

  The rNSA will be used to evaluate changes in sensation. It equips with various sensory modalities to assess tactile sensation, proprioception, and stereognosis of different segments of the body. Scoring of rNSA is based on a 3-point ordinal scale (0-2), with a lower score suggesting greater sensory impairment.

  Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention

• Medical Research Council scale (MRC)

  The MRC is an ordinal scale assessing muscle strength. The scoring for each muscle ranges from 0 to 5, with a higher score indicates greater muscle strength.

  Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention

• Wolf Motor Function Test (WMFT)

  The WMFT evaluates upper extremity motor function via 15 function-based tasks and 2 strength-based tasks. The WMFT-time evaluates the time required to complete the function-based tasks, and the WMFT-quality assesses functional ability on a 6-point ordinal scale. A lower WMFT-time performance indicates faster movement, whereas a higher WMFT-quality score suggests better quality of movement.

  Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention

• Motor Activity Log (MAL)

  The MAL evaluates the amount of use (AOU) and quality of movement (QOM) of the affected hand in completing 30 common daily tasks. Scoring of each task ranges from 0 to 5, with higher scores indicating more use or better movement quality.

  Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention

• Nottingham Extended Activities of Daily Living Scale (NEADL)

  The NEADL is a self-report scale assessing instrumental activities of daily living (IADL). It consists of 4 subscales, including mobility, kitchen, domestic, and leisure activities. The total score is 0 to 66, and a higher score indicates better IADL.

  Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention

• Stroke Impact Scale Version 3.0 (SIS 3.0).

  The SIS 3.0 is a stroke-specific health-related quality of life instrument. It consists of 59 items grouped into 8 domains (strength, hand function, ADL/instrumental ADL, mobility, communication, emotion, memory and thinking, and participation/role function). The participants will be asked to rate each item in a 5-point Likert scale for the perceived difficulty in completing the task.

  Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention

• Functional Abilities Confidence Scale (FACS).

  It measures the degree of self-efficacy and confidence when the participants perform various movements and postures. It consists of 15 questions scoring from 0% (not confidence at all) to 100% (fully confidence). The higher scores indicate higher confidence of performing the movements.

  Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention

• Stroke Self-Efficacy Questionnaire (SSEQ).

  It measures the self-efficacy in domains related to functional performance and self-management for stroke. It includes 13 items based on a 10-point scale from 0 (not at all confident) to 10 (very confident).

  Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention

• Daily Living Self-Efficacy Scale (DLSES)

  DLSES assesses the self-efficacy in daily functions. It is divided into 2 subscales (psychosocial functioning and ADL) with a total of 12 items that score from 0 to 100 (0 = cannot do at all, 100 = highly certain can do). A higher score suggest higher self-efficacy.

  Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention

Study Arms (4)

tRNS-augmented unilateral MT

EXPERIMENTAL

A battery driven multi-channel electrical stimulator will deliver alternating electrical current over the scalp through sailine-soaked sponge electrodes (surface area = 25 cm2). The stimulation electrodes were directly positioned on an adult sized cap that will be worn by the participants, and labeled according to the 10-20 EEG system of electrode positioning. The stimulation intensity will be ramp up to 1.5 to 2 mA. For the unilateral MT, the participants will practice movements using only the unaffected arm while the affected arm will remain relaxed behind the mirror during MT training. The training therapists will instruct the participants to look at the mirror reflection of the unaffected arm and imagine that it is the affected arm performing the task.

Device: Transcranial random noise stimulation (tRNS); Behavioral: the unilateral MT

tRNS-augmented bilateral MT

EXPERIMENTAL

A battery driven multi-channel electrical stimulator will deliver alternating electrical current over the scalp through sailine-soaked sponge electrodes (surface area = 25 cm2). The stimulation electrodes were directly positioned on an adult sized cap that will be worn by the participants, and labeled according to the 10-20 EEG system of electrode positioning. The stimulation intensity will be ramp up to 1.5 to 2 mA. For the bilateral MT, the participants will be encouraged to move the affected arm as symmetrically and simultaneously as the unaffected hand during MT training. At the same time, participants will also be instructed to look at the mirror reflection of the unaffected arm and imagine that it is the affected arm performing the task.

Device: Transcranial random noise stimulation (tRNS); Behavioral: the bilateral MT

sham tRNS with unilateral MT

SHAM COMPARATOR

For the sham tRNS condition, the electrode placement will be the same as the real stimulation conditions. The current will first turn up for 30 seconds and subsequently turn off in the next 30 seconds . For the unilateral MT, the participants will practice movements using only the unaffected arm while the affected arm will remain relaxed behind the mirror during MT training. The training therapists will instruct the participants to look at the mirror reflection of the unaffected arm and imagine that it is the affected arm performing the task.

Device: sham tRNS; Behavioral: the unilateral MT

sham tRNS with bilateral MT

SHAM COMPARATOR

For the sham tRNS condition, the electrode placement will be the same as the real stimulation conditions. The current will first turn up for 30 seconds and subsequently turn off in the next 30 seconds . For the bilateral MT, the participants will be encouraged to move the affected arm as symmetrically and simultaneously as the unaffected hand during MT training. At the same time, participants will also be instructed to look at the mirror reflection of the unaffected arm and imagine that it is the affected arm performing the task.

Device: sham tRNS; Behavioral: the bilateral MT

Interventions

Transcranial random noise stimulation (tRNS) DEVICE

There will be 20 minutes of stimulation (real tRNS or sham tRNS), 40 minutes of MT (unilateral or bilateral) and 30 minutes of functional task training.

tRNS-augmented bilateral MT; tRNS-augmented unilateral MT

sham tRNS DEVICE

the electrode placement will be the same as the real stimulation conditions. The current will first turn up for 30 seconds and subsequently turn off in the next 30 seconds

sham tRNS with bilateral MT; sham tRNS with unilateral MT

the unilateral MT BEHAVIORAL

For the unilateral MT, the participants will practice movements using only the unaffected arm while the affected arm will remain relaxed behind the mirror during MT training. The training therapists will instruct the participants to look at the mirror reflection of the unaffected arm and imagine that it is the affected arm performing the task.

sham tRNS with unilateral MT; tRNS-augmented unilateral MT

the bilateral MT BEHAVIORAL

For the bilateral MT, the participants will be encouraged to move the affected arm as symmetrically and simultaneously as the unaffected hand during MT training. At the same time, participants will also be instructed to look at the mirror reflection of the unaffected arm and imagine that it is the affected arm performing the task. The activities practiced during MT will include intransitive movements (e.g., flexion and extension of the wrist) and transitive movements (e.g., picking up a pen).

sham tRNS with bilateral MT; tRNS-augmented bilateral MT

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 3 months onset from a first-ever unilateral stroke;
• an initial FMA scores between 18 to 56, indicating moderate to mild upper extremity motor impairment (Thielman, Kaminski, \& Gentile, 2008);
• age between 35 to 85;
• no excessive spasticity in any of the joints of the affected arm (shoulder, elbow, wrist and fingers);
• ability to follow instructions and perform tasks (Mini Mental State Examination scores ≥24);
• no participation in any neurorehabilitation experiments or drug clinical trials and
• willing to provide written informed consent.

You may not qualify if:

• contradiction to tRNS including a history of epilepsy, pregnant, having pacemakers and metallic implants in the neck and heads (Rossi, Hallett, Rossini, Pascual-Leone, \& Safety of, 2009);
• History of drug or alcohol abuse(Rossi et al., 2009);
• concomitant neurological conditions such as dementia, Parkinson's disease, brain tumor, brain injury and other brain diseases (such as intracranial hypertension or cerebral edema);
• Botulinum toxin injections 3 months before enrollment
• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memotial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Ching-yi Wu, ScD

CONTACT

#886-3-2118800; cywu@mail.cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2022
• First Posted: February 14, 2022
• Study Start: March 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 14, 2022

Record last verified: 2022-01

Locations

TW (1)