Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06409143

High-definition Transcranial Electrical Stimulation for Upper Extremity Rehabilitation

Led by National Taiwan University Hospital · Updated on 2024-08-16

152

Participants Needed

3

Research Sites

119 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Upper limb hemiparesis is the most common sequelae in patients, severely impacting their independence and quality of life. 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. It can induces long-term potentiation-like or long-term depression-like effects, thereby modulating the cortical excitability. In recent years, researchers have developed high-definition (HD) devices, which integrate high definition ring electrode configurations and incorporate direct current with theta burst stimulation waveforms. Diverging from traditional transcranial direct current stimulation (tDCS), which applies weak currents (0.5-2 mA) through two large sponge electrodes (25\~35 cm\^2) externally to the scalp for widespread non-specific cortical stimulation, HD-tES employs an array of small-area electrodes (1 cm\^2) to control current distribution over localized cortical regions, thereby enhancing spatial accuracy. However, there is a lack of studies validating the optimal waveform for HD-tES, as well as clinical evidence in subacute stroke populations. The optimal unilateral versus bilateral stimulation modes and their neurological mechanisms for stroke rehabilitation also remain uncertain.

CONDITIONS

Official Title

High-definition Transcranial Electrical Stimulation for Upper Extremity Rehabilitation

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 and above
  • Confirmed right-handedness for healthy participants
  • Diagnosed with stroke for post-stroke patients
  • Stroke occurred more than 6 months ago for post-stroke patients
  • Stroke occurred between 7 days to 6 months ago for subacute stroke patients
  • Unilateral hemiparesis
  • Brunnstrom stage III to V for proximal and distal movements of affected upper limb in subacute stroke patients
  • No severe muscle spasticity in affected upper limb (Modified Ashworth Scale 64 2) in subacute stroke patients
Not Eligible

You will not qualify if you...

  • History of neurological disorders, psychiatric disorders, or musculoskeletal disorders of the upper limb in healthy participants
  • Contraindications to transcranial electrical stimulation such as epilepsy, atrial fibrillation, metal implants, pacemakers, skull defects, or increased intracranial pressure
  • Skin allergies, contact dermatitis, abnormal pain, hypersensitivity, wounds, or ulcers on the head
  • Participation in other brain stimulation studies
  • Pregnancy or lactating (with specific contraception requirements for fertile women and partners)
  • History of alcohol or substance abuse
  • Damaged skin at stimulation or device site
  • Long-term use of medications affecting the central nervous system or seizure threshold
  • Severe neurological or psychiatric disorders other than stroke
  • Use of medications lowering seizure threshold
  • Severe cognitive impairment or aphasia making instructions difficult
  • Hemineglect
  • Other muscle or joint problems affecting upper limb function
  • Ongoing invasive or non-invasive brain stimulation therapies
  • Affiliation with research institutions or execution units

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

New Taipei City Tucheng Hospital

New Taipei City, Taiwan

Not Yet Recruiting

2

National Taiwan University Hospital

Taipei, Taiwan

Actively Recruiting

3

Taipei Medical University Hospital

Taipei, Taiwan

Actively Recruiting

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Research Team

M

Mon-Ting Lin

CONTACT

Y

Yi-Jing Huang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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