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NCT05238272Recruiting

Novel Brain Neurotechnology for Optimizing Precision Mirror Therapy in Stroke

Source: ClinicalTrials.gov · Last updated 14 Feb 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
128 (estimated)
First submitted
23 Jan 2022
Start date
1 Mar 2022
Primary completion date
31 Dec 2026
Lead sponsor
Chang Gung Memorial Hospital
Diseases
Stroke
NCT number
NCT05238272

What you commit to

  • Study type: Interventional
  • Planned participants: 128
  • From 1 Mar 2022 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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);

Who the study is looking for

  • ≥ 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.

Age in the registry: 35 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chang Gung Memotial Hospital
Coordinator of this site? Confirm its status
TaoyuanTaiwanRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.