Cerebrovascular AccidentNCT05238272
Novel Brain Neurotechnology for Optimizing Precision Mirror Therapy in Stroke
A study testing Transcranial random noise stimulation (tRNS), the unilateral MT and the bilateral MT in people with Cerebrovascular Accident, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Transcranial random noise stimulation (tRNS), the unilateral MT and the bilateral MT
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memotial Hospital
Taoyuan, 333
Ching-Yi Wu, ScD, +886-3-2118800 ext. 5761, cywu@mail.cgu.edu.tw
About this study
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.
Read the detailed description
Developing effective rehabilitation interventions to maximize functional recovery remains to be a major challenge for stroke rehabilitation. Transcranial random noise stimulation (tRNS) has emerged as a promising brain neurotechnology to enhance neural plasticity to augment treatment effects of stroke neuorehabilitation therapies. Compared to traditional brain neurotechnology such as transcranial direct current stimulation (tDCS), tRNS does not have polarity constraints, thus providing more consistent modulatory effects, less response variability and less adverse effects, which make it a potentially ideal approach to combine with stroke rehabilitation therapies. Mirror therapy (MT) is effective at improving sensorimotor recovery in stroke patients. Because of its easiness for use in clinical settings, MT has been recommended by American Heart Association as a promising intervention for stroke patients. Combining tRNS with MT could be an appealing approach to further boost brain plasticity to maximize MT treatment benefits in the clinical settings. However, MT can be delivered using unilateral or bilateral approaches, which may induce differential treatment benefits. Identifying the optimal combination of MT with tRNS on recovering functions and brain mechanisms will be imperative for development of evidence-based precision brain neurotechnology-augmented stroke rehabilitation.
Therefore, this research project will (1) compare 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) comprehensively on motor function, daily function, quality of life and self-efficacy, motor control strategy and brain activities (electroencephalography, EEG) in stroke patients; (2) examine the retention effects and possible delayed response of tRNS-augmented unilateral and bilateral MT at 3-month and 6-month follow-up and (3) identify the predictors of the treatment success to determine good responders to the tRNS-augmented unilateral and bilateral MT to facilitate clinical translation of the intervention.
The investigator will conduct a randomized, sham controlled clinical trial with 128 stroke patients in this 5-year project. Patients will be randomly assigned to (1) tRNS-augmented unilateral MT, (2) tRNS-augmented bilateral MT, (3) sham tRNS with unilateral MT, and (4) sham tRNS with bilateral MT. Participants will receive 20 intervention sessions (90 minutes/day, 5 days/week, for 4 consecutive weeks). The outcome measures will include behavioral assessments to evaluate motor and daily function, quality of life and self-efficacy; kinematic assessments to evaluate motor control strategy; and EEG to assess brain activities (power). The behavioral measures will be performed at pre-test, interim-test, post-test, and 3-month and 6-month follow-up. The kinematic and EEG assessment will be administered at pre-test and post-test. In addition, the EEG assessment will be conducted during the intervention period to evaluate the dynamical changes of brain activities.
This research project will provide scientific evidence of the treatment effects of brain neurotechnology-augmented stroke rehabilitation therapy. Specifically, the findings will elucidate behavioral changes and possible biomechanical and brain mechanisms associated with the novel tRNS-augmented MT. In addition, the results will reveal the characteristics of good responders to the combined intervention. The overall results will contribute to formulation of precision hybrid brain neurotechnology with stroke rehabilitation therapies to maximize neural and functional recovery after stroke.
- Conditions
- Cerebrovascular Accident
- Being tested
- Transcranial random noise stimulation (tRNS), sham tRNS, the unilateral MT, the bilateral MT
- Keywords
- Mirror therapy, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
sham tRNSDevice
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
the unilateral MTBehavioural
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.
the bilateral MTBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: sham tRNS; Behavioral: the bilateral MT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238272
- Sponsor's protocol ID
- 202100509A0
- Status last verified
- Jan 2022
- First submitted
- 23 Jan 2022
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Brain Neurotechnology for Optimizing Precision Mirror Therapy in Stroke
- ClinicalTrials.gov ID
- NCT05238272
- Acronym / sponsor ID
- 202100509A0
- Conditions
- Cerebrovascular Accident
- Keywords
- Mirror therapy, stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Developing effective rehabilitation interventions to maximize functional recovery remains to be a major challenge for stroke rehabilitation. Transcranial random noise stimulation (tRNS) has emerged as a promising brain neurotechnology to enhance neural plasticity to augment treatment effects of stroke neuorehabilitation therapies. Compared to traditional brain neurotechnology such as transcranial direct current stimulation (tDCS), tRNS does not have polarity constraints, thus providing more consistent modulatory effects, less response variability and less adverse effects, which make it a potentially ideal approach to combine with stroke rehabilitation therapies. Mirror therapy (MT) is effective at improving sensorimotor recovery in stroke patients. Because of its easiness for use in clinical settings, MT has been recommended by American Heart Association as a promising intervention for stroke patients. Combining tRNS with MT could be an appealing approach to further boost brain plasticity to maximize MT treatment benefits in the clinical settings. However, MT can be delivered using unilateral or bilateral approaches, which may induce differential treatment benefits. Identifying the optimal combination of MT with tRNS on recovering functions and brain mechanisms will be imperative for development of evidence-based precision brain neurotechnology-augmented stroke rehabilitation.
Therefore, this research project will (1) compare 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) comprehensively on motor function, daily function, quality of life and self-efficacy, motor control strategy and brain activities (electroencephalography, EEG) in stroke patients; (2) examine the retention effects and possible delayed response of tRNS-augmented unilateral and bilateral MT at 3-month and 6-month follow-up and (3) identify the predictors of the treatment success to determine good responders to the tRNS-augmented unilateral and bilateral MT to facilitate clinical translation of the intervention.
The investigator will conduct a randomized, sham controlled clinical trial with 128 stroke patients in this 5-year project. Patients will be randomly assigned to (1) tRNS-augmented unilateral MT, (2) tRNS-augmented bilateral MT, (3) sham tRNS with unilateral MT, and (4) sham tRNS with bilateral MT. Participants will receive 20 intervention sessions (90 minutes/day, 5 days/week, for 4 consecutive weeks). The outcome measures will include behavioral assessments to evaluate motor and daily function, quality of life and self-efficacy; kinematic assessments to evaluate motor control strategy; and EEG to assess brain activities (power). The behavioral measures will be performed at pre-test, interim-test, post-test, and 3-month and 6-month follow-up. The kinematic and EEG assessment will be administered at pre-test and post-test. In addition, the EEG assessment will be conducted during the intervention period to evaluate the dynamical changes of brain activities.
This research project will provide scientific evidence of the treatment effects of brain neurotechnology-augmented stroke rehabilitation therapy. Specifically, the findings will elucidate behavioral changes and possible biomechanical and brain mechanisms associated with the novel tRNS-augmented MT. In addition, the results will reveal the characteristics of good responders to the combined intervention. The overall results will contribute to formulation of precision hybrid brain neurotechnology with stroke rehabilitation therapies to maximize neural and functional recovery after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tRNS-augmented unilateral MT | Experimental | Device: Transcranial random noise stimulation (tRNS), Behavioral: the unilateral MTA 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. |
| tRNS-augmented bilateral MT | Experimental | Device: Transcranial random noise stimulation (tRNS), Behavioral: the bilateral MTA 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. |
| sham tRNS with unilateral MT | Sham comparator | Device: sham tRNS, Behavioral: the unilateral MTFor 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. |
| sham tRNS with bilateral MT | Sham comparator | Device: sham tRNS, Behavioral: the bilateral MTFor 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. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 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);
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial random noise stimulation (tRNS)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. | Device | tRNS-augmented bilateral MT, tRNS-augmented unilateral MT |
| sham tRNSthe 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 | Device | sham tRNS with bilateral MT, sham tRNS with unilateral MT |
| the unilateral MTFor 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. | Behavioural | sham tRNS with unilateral MT, tRNS-augmented unilateral MT |
| the bilateral MTFor 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). | Behavioural | sham tRNS with bilateral MT, tRNS-augmented bilateral MT |
Primary outcome
Fugl-Meyer Assessment (FMA)
Time frame: Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention
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
Modified Ashworth Scale (MAS)
Time frame: Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention
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.
Revised Nottingham Sensory Assessment (rNSA)
Time frame: Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention
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.
Medical Research Council scale (MRC)
Time frame: Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention
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.
Wolf Motor Function Test (WMFT)
Time frame: Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention
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.
Motor Activity Log (MAL)
Time frame: Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention
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.
Nottingham Extended Activities of Daily Living Scale (NEADL)
Time frame: Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention
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.
Stroke Impact Scale Version 3.0 (SIS 3.0).
Time frame: Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention
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.
Functional Abilities Confidence Scale (FACS).
Time frame: Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention
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.
Stroke Self-Efficacy Questionnaire (SSEQ).
Time frame: Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention
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).
Daily Living Self-Efficacy Scale (DLSES)
Time frame: Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
Related trials for Cerebrovascular Accident
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial random noise stimulation (tRNS), the unilateral MT and the bilateral MT in people with Cerebrovascular Accident, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ching-yi Wu, ScD (#886-3-2118800 ext. 5761, cywu@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (FMA) (time frame: Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.