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Not yet recruitingNCT06999876COMPENSATORUpdated May 31, 2025

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)

An interventional study of The AscenZ-VIII Stimulator (Investigational Medical Device) and The AscenZ-VIII Stimulator (Investigational Medical Device) in Stroke Patients With Hemiplegia or Hemiparesis in the Subacute Stage, sponsored by National University Health System, Singapore. Not yet recruiting at 2 sites in Singapore. Open to participants aged 21 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by National University Health System, Singapore · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
21 Years to 79 Years
Sex
All
01

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
Read the detailed description

In this prospective, double-blind, sham-controlled randomized control study, a total of 90 participants with hemiplegia or hemiparesis post stroke will be recruited from National University Hospital (NUH) and Alexandra Hospital (AH) inpatient wards and outpatient clinic. 45 participants will be randomized to the intervention arm (Intervened with tPCS + TENS) and 45 participants will be randomized to the control arm (Sham device stimulation + TENS).

The study will consist of a Screening period of up to 14 days. Participants who fulfil all the inclusion criteria will be consented and recruited during this screening period, constituting as Visit 1 (Recruitment). During this visit, PI/ Co-I obtaining consent will ensure that patient/ caregiver meets the following criteria:

  1. For patients where the caregiver is administering the treatment, study team will ensure that they are the primary caregiver of the patient.
  2. Patient/ caregiver must be comfortable and committed in following directions for device usage.
  3. Patient/ caregiver must not have mental disability.

After confirmation of the above criteria, patient/ caregiver will undergo a 2-hour hands-on training at NUH by trained study team.

A set of training slides titled "AscenZ-VIII User training slides" that is adapted from the standard "Instruction Manual AscenZVIII" will be utilized for the training session for patient/ caregiver. After which, a checklist titled "Home Training Checklist" will be completed by both the trainer and patient/caregiver. This checklist is aimed to ensure that all necessary components of training have been covered by the trainer and also for trainers to indicate confidence of patient/ caregiver during the training before both trainer and patient/ caregiver signs as a form of training acknowledgement.

Post training, a copy of the standard "Instruction Manual AscenZVIII" will be given to patient/ caregiver. Study team will emphasize to patient/ caregiver that they can contact study team at any juncture where they need additional clarifications relating to the device.

Depending on the hospitalization status at time of screening, the patient will be seen in the inpatient ward or specialist outpatient clinic at day 14 which is considered as Visit 2 (Randomization with allowance + 3 days). Allowance of up to 3 days is given in the event day 14 falls on a weekend/long weekend. Following Visit 2 (Randomization with allowance + 3 days), up to 3 days of habituation for device use and tolerability will take place. Participants will be required to receive the intervention at low levels of intensity to allow conditioning for the habituation period. Because of the nature of the intervention, it may cause some discomfort to the participants, hence conditioning will increase the tolerability of the treatment for the participants.

Intervention with tPCS will take place over 30 days either in the inpatient setting of NUH and AH or in the home setting, while the rehabilitation therapy sessions with physiotherapy and occupational therapy happening concurrently as per existing clinical treatment protocol. Treatment with tPCS and TENS will consist of a daily session of 30 minutes for 30 days. Compliance will be checked by research assistant via telephone or video call interview at regular interval. One group will be randomised to the sham device stimulation + TENS (Control) arm and one group will be randomised to the active device intervention arm (intervened with tPCS + TENS). The sham device stimulation (Control) arm have electrode placement in the exact manner as the treatment arm but receive very little transcranial stimulation such that the output is negligible.

Assessment will be done at the time of recruitment which constitutes as Visit 1 (Recruitment), and again at the 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).

Activities and assessments that are done under research activities include:

Visit 1 (Recruitment)

  • Eligibility screening
  • Consent taking
  • Blood Pressure (Research procedure if not done clinically)
  • Standard physio and occupational therapy sessions as prescribed by patient's physician (Research procedure if not done clinically)
  • Stroke deficit scale (Baseline mRS, NIHSS)
  • Clinical measures on lower limb motor function (Lower Extremity - Fugl Meyer Assessment Baseline, Time UP and Go Baseline, 6 Minute Walk Test Baseline, 10 Meter Walk Test Baseline)
  • Clinical measures on lower limb spasticity - Hip, Knee Flexion, Ankle Flexor, Plantar (Modified Ashworth Scale Baseline, Modified Tardieu Scale Baseline)
  • Balance (Berg Balance Scale Baseline)
  • Pain (Pain Numeric Rating Scale Baseline)
  • Mood (Hospital Anxiety and Depression Scale Baseline)
  • FIM
  • EQ5D-5L Baseline
  • Overall length of stay in hospital
  • Outcomes events/Complications

Visit 2 (Randomization with allowance of + 3 days):

  • Randomization
  • Commence first day of habituation, up to 3 days

Follow-up Telephone/ Video Call Interview, at 2 weeks post intervention (Research procedure)

- Patients will be asked regarding: i) Device related side-effects ii) Hospital re-admissions iii) Changes in medications iv) Device management (eg. Difficulties faced while using the device, Device working condition Damage to device, Device parts that require replacement, Re-supply of consumables, etc)

Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days):

  • Treatment group OR Control Group - 30min daily for 30 days
  • Stroke deficit scale (mRS, NIHSS)
  • Clinical measures on lover limb motor function (Lower Extremity - Fugl Meyer Assessment, Time Up and Go, 6 Minute Walk Test, 10 Meter Walk Test )
  • Clinical measures on lower limb spasticity - Hip, Knee Flexion, Ankle Flexor, Plantar (Modified Ashworth Scale, Modified Tardieu Scale)
  • Balance (Berg Balance Scale)
  • Pain (Pain Numeric Rating Scale)
  • Mood (Hospital Anxiety and Depression Scale)
  • FIM
  • EQ5D-5L
  • Overall length of stay in hospital
  • Outcomes events/Complications

Visit 4 (Final follow-up, Day 90 post intervention with allowance of +/- 7 days):

  • Stroke deficit scale (mRS, NIHSS)
  • Clinical measures on lower limb motor function (Lower Extremity - Fugl Meyer Assessment, Time Up and Go, 6 Minute Walk Test, 10 Meter Walk Test)
  • Clinical measures on lower limb spasticity - Hip, Knee Flexion, Ankle Flexor, Plantar (Modified Ashworth Scale, Modified Tardieu Scale)
  • Balance (Berg Balance Scale)
  • Pain (Pain Numeric Rating Scale)
  • Mood (Hospital Anxiety and Depression Scale)
  • FIM
  • EQ5D-5L
  • Overall length of stay in hospital
  • Outcomes events/Complications

Management of adverse events (AEs and SAEs):

At recruitment (Visit 1), patients/ caregivers will be informed to take note and save research coordinator's contact number stated in the ICF. Patients/ caregivers will be reminded to contact research coordinators if patients experience any AE/SAE stated on ICF section 6 from the day of recruitment up to randomization (Visit 2). At randomization (Visit 2) it will again be emphasized to patients and caregivers that they are to continue to monitor for AE/SAE. During the duration of habituation through to the 30-day intervention period, patients/ caregivers are additionally required to report to the study coordinators with regards to any discomfort or issues with the device before proceeding with intervention. During the habituation and the 30-day intervention period, study coordinator will be keeping close contact with the patient/ caregiver by means of messaging apps to ensure compliance to the treatment regime and for AE/SAE reporting.

Patients who are starting the intervention in the inpatient setting will be monitored by the study team for any adverse events.

02

Conditions studied

  • Stroke Patients With Hemiplegia or Hemiparesis in the Subacute Stage

Keywords

  • Transcranial Pulsed Current Simulation
  • Transcutaneous Electrical Nerve Stimulation
  • Lower limb motor function recovery
  • Spasticity
  • Gait dysfunction
  • Standing balance
  • Ambulation
  • Stroke
  • Hemiplegia
  • Hemiparesis
03

In context

Muscle Spasticity

713 studies on the registry are indexed under Muscle Spasticity; 148 are open to participants now.

This study's planned enrollment of 90 is above the median of 36 across 532 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

National University Health System, Singapore is the lead sponsor of 42 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Intervention Arm

    Active tPCS + TENS treatment

    Device: The AscenZ-VIII Stimulator (Investigational Medical Device)

  • Sham comparator
    Control arm

    Sham tPCS + TENS treatment

    Device: The AscenZ-VIII Stimulator (Investigational Medical Device)

Interventions

  • DeviceThe 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.

  • DeviceThe 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.

06

What researchers measure

Primary outcomes

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

    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).

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

  2. Functional Independence Measure (FIM)

    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).

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

Secondary outcomes

  1. Modified Ashworth Scale (MAS)

    Effects of high frequency tPCS + TENS compared to Sham device stimulation +TENS (Control) in lower limb spasticity related to stroke objectively measured using Modified Ashworth scale (MAS). Mean change in MAS 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).

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

  2. Modified Tardieu Scale (MTS)

    Effects of high frequency tPCS + TENS compared to Sham device stimulation +TENS (Control) in treatment of lower limb spasticity related to stroke objectively measured using Modified Tardieu Scale (MTS).. Mean change in MTS 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).

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

  3. Time Up and Go (TUG)

    Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in walking speed, objectively measured with Time Up and Go (TUG). Mean change in TUG 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).

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

  4. 10-meter Walk Test (10MWT)

    Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in walking endurance objectively measured with 10-meter Walk Test (10MWT). Mean change in 10MWT 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).

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

  5. 6-minute Walk Test

    Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in walking endurance objectively measured using 6-minute Walk Test. Mean change in 6-minute Walk Test 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).

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

  6. Berg Balance Scale (BBS)

    Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in balance objectively measured using Berg Balance Scale (BBS). Mean change in BBS 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).

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

  7. Pain Numeric Rating Scale (NRS)

    Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) on pain using pain numeric rating scale (NRS). Mean change in NRS 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).

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

  8. EQ5D-5L

    Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) on quality of life (QOL) measured objectively using EQ5D-5L. Mean change in EQ5D-5L 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).

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

  9. Hospital Anxiety Depression Scale (HADS)

    Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) on mood using Hospital Anxiety Depression Scale (HADS). Mean change in HADS 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).

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

07

Study locations

2 sites
  • National University Hospital
    Singapore, Singapore 119228, Singapore
  • Alexandra Hospital
    Singapore, Singapore 159964, Singapore
08

References and documents

Publications

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Individual participant data

Plan to share: Yes — all IPD that underlie results in a publication

Time frame: Beginning 6 months and ending 1 years after the publication of results

Access criteria: Analyses that qualify for data sharing: meta-analysis Data sharing agreement needs to be signed. Applicant can email the study's Principal Investigator to submit request.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2025; primary completion for Nov 2026, 17 months later.

Of 250 non-industry interventional studies with no phase under Muscle Spasticity, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's planned 17 months is above that.

Counting every sponsor, half of 258 studies reached it within 14 months; a quarter within 5 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
May 13, 2025
First posted
May 31, 2025
StartEst.
May 31, 2025
Primary completionEst.
Nov 30, 2026
CompletionEst.
Dec 31, 2026
Last update
May 31, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06999876
Lead sponsor
National University Health System, Singapore
Responsible party
JING MINGXUE (Dr Jing Mingxue (Principal Investigator), National University Health System, Singapore) — Principal investigator
First posted
May 31, 2025
Start date
May 31, 2025 (estimated)
Primary completion
Nov 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 31, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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