Status:
UNKNOWN
High-definition Transcranial Electrical Stimulation for Lower Limb Stroke Rehabilitation
Lead Sponsor:
Taipei Medical University Hospital
Conditions:
Stroke
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
Transcranial electrical stimulation (tCES) is a non-invasive and safe treatment, which uses a low direct current or alternating current to change the excitability of the cerebral cortex. The tCES has ...
Eligibility Criteria
Inclusion
- With a diagnosis of stroke.
- Age ≥ 20 years.
- Hemiplegia, Brunnstrom stage III-V.
- 6 months to 5 years after stroke.
- Muscular inelasticity (spasticity) 1-3 on the affected lower limb, evaluated by the Modified Ashworth Scale.
- Ability to walk for 10 min non-stop with no gait aids or ability to walk 20 m with supervision or slight assistance.
Exclusion
- Intolerance to electrical stimulation.
- Contracture on lower extremities, and limitation in joint range of motion.
- Severe spasticity.
- Ossification or inflammation in muscle tissue.
- A history of arrhythmia.
- Implantable medical electronic devices (e.g., like pacemaker).
- Metal implants in the head or neck.
- Wounds on the skin of head.
- A history of brain surgery or severe brain trauma.
- Severe cognitive or psychiatric disorders (e.g., schizophrenia, depression or bipolar disorder).
- A history of seizure or other brain pathology.
- Drug or alcohol abuse.
- Malignant neoplasm or rheumatism disorder (e.g., SLE, RA, AS, IBD)
- Undergoing other non-invasive brain stimulation.
- Intra-cerebral lesions (such as brain tumors, arteriovenous tumors).
- History of encephalitis or meningitis.
- Stroke lesion in cerebellum or brainstem.
- Leg amputation.
- Sleep deprivation.
- Severe or recent heart disease.
- Subjects who use drugs that may lower the seizure threshold.
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
August 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04515121
Start Date
August 20 2020
End Date
December 31 2023
Last Update
January 31 2023
Active Locations (3)
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1
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, Taiwan, 235
2
Taipei Medical University Hospital
Taipei, Taiwan, 110
3
Taipei Municipal Wanfang Hospital - Taipei Medical University
Taipei, Taiwan, 116