Status:
NOT_YET_RECRUITING
The Effect of Combined Transcranial Pulse Current Stimulation (tPCS) and Transcutaneous Electrical Nerve Stimulation (TENS) on Lower Limb Motor Function in Subacute to Chronic Stroke Patients With Hemiplegia (COMPENSATOR-Stroke)
Lead Sponsor:
National University Health System, Singapore
Conditions:
Stroke Patients With Hemiplegia or Hemiparesis in the Subacute Stage
Eligibility:
All Genders
21-79 years
Phase:
NA
Brief Summary
The goal of this study is to evaluate the effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in lower limb motor function recovery in stroke patients with hemip...
Detailed Description
In this prospective, double-blind, sham-controlled randomized control study, a total of 90 participants with hemiplegia or hemiparesis post stroke will be recruited from National University Hospital (...
Eligibility Criteria
Inclusion
- Participants aged 21 years old and below 80 years old with a clinically diagnosed first onset ischaemic stroke confirmed by imaging modalities such as computerised tomography (CT) or magnetic resonance imaging (MRI). Previous transient ischemic attack or clinically silent infarct detected by CT/MRI are not considered as previous stroke.
- Participants within the subacute stage of stroke (Within 14 days from stoke onset)
- Able to walk with or without assistance
- Able to understand instructions and give informed consent
Exclusion
- History of craniotomy or placement of implant materials/ device in the body that may affect NIBS including, but not limited to, deep brain stimulator, cardiac implant, cochlear implant
- Intracranial haemorrhage in the cortical regions
- History of epilepsy or seizures
- History of major depression and a history of psychotic disorders
- Contraindications to tPCS/TENS e.g., pregnancy, presence of skin lesion at the intended treatment areas.
- Concurrent use of benzodiazepine pyschoactive class of drugs which may affect effects of tPCS
- Concurrent use of anti-seizure medications (ASMs) which may affect effects of tPCS
- Presence of significant cognitive impairment/ aphasia rendering patient unable to comply with the treatment protocol
- Presence of disabling comorbidities that compromises limb function such as orthopaedics or neurological pathologies other than stroke
- Previous treatments of the lower limb spasticity with botulinum toxin, or alcohol.
- Prior history of non-invasive brain stimulations
Key Trial Info
Start Date :
May 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06999876
Start Date
May 31 2025
End Date
December 31 2026
Last Update
May 31 2025
Active Locations (2)
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1
National University Hospital
Singapore, Singapore, Singapore, 119228
2
Alexandra Hospital
Singapore, Singapore, Singapore, 159964