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)
Stroke Patients With Hemiplegia or Hemiparesis in the Subacute Stage
Investigational drug(s) / intervention(s)
The AscenZ-VIII Stimulator (Investigational Medical Device)The AscenZ-VIII Stimulator (Investigational Medical Device)
The AscenZ-VIII Stimulator (Investigational Medical Device): Sham tPCS current will be delivered through Channel 1, while active TENS treatment delivered through Channel 2, 3 and 4 of The AscenZ-VIII Stimulator via surface electrodes. The placement of electrodes will be exactly the same as the active tPCS montage.
The AscenZ-VIII Stimulator (Investigational Medical Device): This group will receive active TENS treatment delivered through Channel 2, 3 and 4 of The AscenZ-VIII Stimulator via 6\*9cm Silica gel electrodes on top of the tPCS that is delivered through Channel 1. The placement of the electrodes will be on the part of the spinal segment innervating the lower limbs (L1-L5), the adductor muscles and the gastrocnemius muscles.
Study 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
Eligibility
Sex
ALL
Min age
21 Years
Max age
79 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Lower Extremity Portion of Fugl-Meyer Assessment (LE-FMA) — From enrollment to Day 90 post intervention (with allowance of + 7 days). Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in Lower Extremity Portion of Fugl-Meyer Assessment (LE-FMA).
Mean change in LE-FMA from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days) and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).
Functional Independence Measure (FIM) — From enrollment to Day 90 post intervention (with allowance of + 7 days). Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in functional independence measured using Functional Independence Measure (FIM) score, in stroke patients with hemiplegia or hemiparesis in the subacute stage.
Mean change in FIM from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days) and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).
Trial sites (2)
Facility
City
Region
Status
National University Hospital
Singapore
Singapore
Alexandra Hospital
Singapore
Singapore
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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