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)

Launched by NATIONAL UNIVERSITY HEALTH SYSTEM, SINGAPORE · May 23, 2025

Keywords

ClinConnect Summary

The COMPENSATOR-Stroke clinical trial is studying the effects of two types of treatments—high frequency transcranial pulse current stimulation (tPCS) combined with transcutaneous electrical nerve stimulation (TENS)—on improving movement in the legs of stroke patients who have difficulty moving one side of their body, a condition known as hemiplegia or hemiparesis. This trial aims to see if this combined treatment helps patients recover better than a control group that receives a sham (fake) device along with TENS. Researchers will also look at how this treatment affects muscle stiffness, walking ability, and overall quality of life.

To be eligible for this study, participants should be between 21 and 80 years old, have had their first stroke within the last 14 days, and be able to walk, even with some assistance. They will participate in a training session to learn how to use the devices, followed by daily treatment sessions for 30 days. After the treatment, there will be follow-up calls or video chats, and clinic visits at 30 and 90 days to assess their progress. This trial is currently not recruiting participants, but it is an important step toward finding better ways to help stroke patients regain movement and improve their quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Participants within the subacute stage of stroke (Within 14 days from stoke onset)
• • 3. Able to walk with or without assistance
• • 4. Able to understand instructions and give informed consent
• Exclusion Criteria:
• • 1. 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
• • 2. Intracranial haemorrhage in the cortical regions
• • 3. History of epilepsy or seizures
• • 4. History of major depression and a history of psychotic disorders
• • 5. Contraindications to tPCS/TENS e.g., pregnancy, presence of skin lesion at the intended treatment areas.
• • 6. Concurrent use of benzodiazepine pyschoactive class of drugs which may affect effects of tPCS
• • 7. Concurrent use of anti-seizure medications (ASMs) which may affect effects of tPCS
• • 8. Presence of significant cognitive impairment/ aphasia rendering patient unable to comply with the treatment protocol
• • 9. Presence of disabling comorbidities that compromises limb function such as orthopaedics or neurological pathologies other than stroke
• • 10. Previous treatments of the lower limb spasticity with botulinum toxin, or alcohol.
• • 11. Prior history of non-invasive brain stimulations