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
Qualifiers
≥ 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
Treatments tested in this trial
- Transcranial random noise stimulation (tRNS)
- sham tRNS
- the unilateral MT
- the bilateral MT
Treatment groups
128 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov