Tests electrical stimulation to help leg movement after stroke
Tests daily stimulation of the brain and nerves in adults with leg weakness after stroke.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Singapore, SingaporeSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 79 years old?
Source: NCT06999876, who can take part
Where in Singapore
- Alexandra HospitalSingapore, SingaporeNo longer taking part
- National University HospitalSingapore, SingaporeNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National University Health System, Singapore
- Trial code
- NCT06999876
- Record updated
- 31 May 2025
- Original description
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:Read full original descriptionShow less
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: A Double-blind, Sham-controlled, Randomized Controlled Study
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
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: 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; Previous treatments of the lower limb spasticity with botulinum toxin, or alcohol; Prior history of non-invasive brain stimulations; 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; 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; Contraindications to tPCS/TENS e.g., pregnancy, presence of skin lesion at the intended treatment areas.