NCT06999876Not 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)
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
Source: ClinicalTrials.gov · Last updated 31 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 13 May 2025
- Start date
- May 2025
- Primary completion date
- Nov 2026
- Lead sponsor
- National University Health System, Singapore
- Diseases
- Stroke
- NCT number
- NCT06999876
What you commit to
- Study type: Interventional
- Planned participants: 90
- From May 2025 to the primary completion date, Nov 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Contraindications to tPCS/TENS e.g., pregnancy, presence of skin lesion at the intended treatment areas.
Who the study is looking for
- 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
Age in the registry: 21 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Alexandra Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| National University Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.