Not Yet RecruitingNot Applicable

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)

Singapore90 participantsStarted 2025-05-31

Plain-language 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 hemiplegia or hemiparesis in the subacute stage.The main questions it aims to answer are: Primary objective - 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 hemiplegia or hemiparesis in the subacute stage Secondary Objectives - 1. To evaluate the effects of high frequency tPCS + TENS in treatment of lower limb spasticity related to stroke. 2. To evaluate the effects of high frequency tPCS + TENS in gait function improvement post stroke, including walking speed, mobility, balance and walking endurance. 3. To evaluate the effects of high frequency tPCS on pain, mood and QOL. Researchers will compare the effects of high frequency tPCS + TENS to a control group which involves intervention with Sham device stimulation + TENS. Participants will: * Be identified, recruited and have baseline assessments during screening period * First undergo a mandatory 2-hour device training at Visit 2 to ensure device competence. * Proceed with up to 7 days of habituation for device use and tolerability. * Carry out daily intervention sessions of 30 minutes for 30 days at home or inpatient setting. * Phone call follow-up (Telephone/ Video Call Interview) 2 weeks post intervention * Clinic visit at day 30 post intervention with allowance of + 7 days for study assessments * Clinic visit at day 90 post intervention with allowance of +/- 7 days for study assessments * Update study coordinators via messaging platforms with regards to device issues, adverse events, any other reporting or questions

Who can participate

Age range21 Years – 79 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Lower Extremity Portion of Fugl-Meyer Assessment (LE-FMA)

Timeframe: From enrollment to Day 90 post intervention (with allowance of + 7 days).

Functional Independence Measure (FIM)

Timeframe: From enrollment to Day 90 post intervention (with allowance of + 7 days).

Trial details

NCT IDNCT06999876

SponsorNational University Health System, Singapore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-30

View on ClinicalTrials.gov More Stroke Patients With Hemiplegia or Hemiparesis in the Subacute Stage trials