Novel Brain Neurotechnology for Optimizing Precision Mirror Therapy in Stroke
ConditionCerebrovascular Accident
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-85
SponsorChang Gung Memorial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 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);
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Transcranial random noise stimulation (tRNS)
DeviceThere 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 tRNS
Devicethe 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 MT
BehavioralFor 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 MT
BehavioralFor 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).
Treatment groups
128 Participants
are divided into 4 treatment groupsGroup A: tRNS-augmented unilateral MTExperimental treatment 2 interventions
Group B: tRNS-augmented bilateral MTExperimental treatment 2 interventions
Group C: sham tRNS with unilateral MTSham comparator 2 interventions
Group D: sham tRNS with bilateral MTSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention2
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.
Time frame
Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention3
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.
Time frame
Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing intervention4
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.
Time frame
Baseline, Midterm(2 week after completing intervention) , 3 -month after completing intervention, 6-month after completing interventionSponsors and contacts
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Source ClinicalTrials.gov